CN109813923A - System and method for acquiring and transmitting measurement result - Google Patents

System and method for acquiring and transmitting measurement result Download PDF

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Publication number
CN109813923A
CN109813923A CN201910172255.9A CN201910172255A CN109813923A CN 109813923 A CN109813923 A CN 109813923A CN 201910172255 A CN201910172255 A CN 201910172255A CN 109813923 A CN109813923 A CN 109813923A
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sample
equipment
data
biological sample
subject
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E·A·霍姆斯
S·巴尔瓦尼
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Serranos Intellectual Property LLC
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00871—Communications between instruments or with remote terminals
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00871—Communications between instruments or with remote terminals
    • G01N2035/00881—Communications between instruments or with remote terminals network configurations
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A90/00—Technologies having an indirect contribution to adaptation to climate change
    • Y02A90/10—Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

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  • Investigating Or Analysing Biological Materials (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Cell Biology (AREA)
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  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
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  • Automatic Analysis And Handling Materials Therefor (AREA)

Abstract

The present invention relates to the system and method for acquiring and transmitting measurement result.Sample acquisition station can be used together with one or more sample-processing equipments.The sample-processing equipment is configurable to receive the sample from subject.The sample-processing equipment, which can execute, is related to the one or more sample preparation steps and/or chemical reaction of the sample.Data relevant to the sample can be sent to laboratory from the equipment.The laboratory can be accredited laboratory, which can be generated the report for being transmitted to health care professionals.The health care professionals may rely on this report to diagnose, treat and/or prevent the disease of subject.

Description

System and method for acquiring and transmitting measurement result
The application be international filing date be on 2 14th, 2014, application No. is No. 201480021565.6, denomination of invention For the divisional application of the Chinese patent application of " system and method for acquiring and transmitting measurement result ".
Background technique
Existing system and method for clinical trial is public from patient, health care professionals and taxpayer and insurance From the perspective of department, by the evil of many disadvantages.Current consumer can buy certain special tests from each place, for Consumer uses.For example, consumer can test pregnant test in pharmacy purchase and check result.However, such the result is that will be by disappearing What expense person checked, rather than relied on during forming screening, diagnosis or treatment plan by the doctor of consumer.
In addition, if test result will be carried out by doctor and be relied on by doctor, then sample is transported to sample The laboratory tested.For example, usually being taken out from subject's acquisition from fingerstick or vein in hospital or doctor's office The blood of blood.Blood sample is transported to the laboratory that clinical labororatory improves amendment (CLIA) certification, the laboratory is held Row is supplied to the test and analysis of the doctor of patient.Such technology redundant and complicated and cause in the test that is required by doctor of offer As a result the significant delays of aspect, especially because sample in kind must be transported to different places for analysis.In addition, sample Acquisition place often has the limited working time, this further brings inconvenience to patient.
Routine techniques is also problematic in that certain diagnosis.Some tests are to time-sensitive, and its result may need to count It or several weeks could complete.In such a period of time, disease may be in progress more than treatment site.Which compromises medical professionalism people Member provides the ability of high quality nursing.
Recurrent sample when due to transporting such sample in place of from acquisition place to progress sample actual analysis Product are degenerated, and traditional system and method also will affect the integrality and quality of clinical trial.For example, analyte is with certain speed The time delay of decay and analysis can lead to the forfeiture of sample integrity.Different laboratories also carries out work with different quality Make, this may result in different degrees of mistake.Each laboratory can have one group of reference of their own, and the group is referring into one Step extensive variability of introduction range in the coefficient of variation.In addition, the manual preparation to sample makes to acquire place from each sample Mistake early period be likely to occur.Intrinsic other shortcomings make the longitudinal direction of high quality in these disadvantages and conventional arrangement Analysis is difficult to carry out.
In addition, routine techniques usually not bery meets cost-effectiveness.For example, the delay of test result leads to diagnosing and treating Delay, this may have adverse effect the health of patient.For example, disease may further be in progress, patient is caused to need volume Outer treatment.For the paying party that the health plan of government contributes, health insurance companies and taxpayer etc. finally will be Treatment can avoid the problem that paying more by being easier to obtain with faster clinical test results originally.
Summary of the invention
In the presence of for allow higher nursing quality, more rapidly and more accurately screening, diagnose and/or treat it is improved The needs of system and method.In particular, in the presence of the sizable needs for acquiring, preparing and analyzing for sample.There is also for Convenient access sample acquisition place and allow simultaneously can be by the needs of data that health care professional is relied on analysis.
It also needs for being carried out by supporting the mistake of the smaller variability for executing data vertical analysis and reduction The system and method for early intervention and offer high quality nursing.System and methods described herein meet such demand and Associated advantages are also provided.
One aspect of the present invention is related to a kind of method of biological sample evaluated and acquired from subject, the method packet Include: (a) receive from be placed in subject's body with it or retailer's website the data transmitted of equipment, the wherein device configuration For handling biological sample as follows, these steps are as follows: (i) receives biological sample；(ii) biological sample is prepared to be used for Subsequent qualitative and/or quantitative assessment, to generate number necessary to the subsequent qualitative and/or quantitative assessment of the biological sample According to；It is described subsequent for executing that (iii) electronically sends data to analysis facility and/or its subsidiary body of authorization Qualitative and/or quantitative assessment；And (b) transmitted in the analysis facility of authorization and/or the analysis of its subsidiary body from the equipment Data, to provide the described qualitative and/or quantitative assessment of the biological sample.
According to another aspect of the present invention, a method of the biological sample that evaluation is acquired from subject can include: (a) connects The physical process or chemical reaction receiving the image for representing the biological sample and/or being carried out with the biological sample or part of it Image electronic data, the data, which are transferred from, to be placed in subject's body or setting with it or in specified sample acquisition station Standby, wherein the device configuration is for processing biology as follows, these steps are as follows: (i) receives biological sample；(ii) it prepares Biological sample be used for subsequent qualitative and/or quantitative assessment, wherein it is described preparation generate represent the biological sample image and/ Or the electronic data of the physical process or the image of chemical reaction；(iii) will represent the electronic data transfer of described image To the analysis facility of authorization and/or its subsidiary body for the execution subsequent qualitative and/or quantitative assessment；Wherein the processing is raw The electronic data of representative image necessary to subsequent qualitative and/or quantitative assessment at the biological sample, and (b) authorizing Analysis facility and/or the electronic data of representative image that is transmitted from the equipment of its subsidiary body analysis, to provide the life The described qualitative and/or quantitative assessment of object sample.
It can provide a kind of a plurality of types of biological samples evaluated and acquired from subject according to another aspect of the present invention Method.This method can include: (a) is received from being placed in subject's body or transmit with it or in the equipment of specified sample acquisition station Data, wherein the device configuration is for handling a plurality of types of biological samples as follows, these steps are as follows: (i) Receive a plurality of types of biological samples；(ii) biological sample is prepared for subsequent qualitative and/or quantitative assessment, described in generating Data necessary to the subsequent qualitative and/or quantitative assessment of a plurality of types of biological samples, and (iii) is electronically To the analysis facility of authorization and/or its subsidiary body transmission data for the execution subsequent qualitative and/or quantitative assessment；And (b) data transmitted from the equipment are analyzed in the analysis facility of authorization and/or its subsidiary body, to provide the multiple types Biological sample described qualitative and/or quantitative assessment.
Another aspect of the present invention can be related to a kind of side of biological sample that evaluation is acquired from the subject in specified sites Method, which comprises (a) is acquired in the designated place and is handled biological sample, and wherein the sample is acquired by following equipment, The device configuration receives biological sample for (i)；(ii) it prepares biological sample and is used for subsequent qualitative and/or quantitative assessment, with Data necessary to the subsequent qualitative and/or quantitative assessment of the biological sample are generated, and the data are transmitted to and award by (iii) The analysis facility of power and/or the health care provider of its subsidiary body are for the execution subsequent qualitative and/or quantitative assessment； (b) data are transmitted in the analysis facility of Xiang Shouquan and/or its subsidiary body；And (c) in the analysis facility of authorization and/or its is attached Belong to the data that analysis of mechanism is transmitted from the equipment, to provide the described qualitative and/or quantitative assessment of the biological sample.
In addition, a kind of method that various aspects of the invention can be related to biological sample evaluated and acquired from subject, described Method includes: that (a) is received from the data for being placed in the equipment transmission in subject's body or with it or in specified sample acquisition station, In the device configuration for handling biological sample as follows, these steps are as follows: (i) receives biological sample；(ii) it prepares Biological sample is used for subsequent qualitative and/or quantitative assessment, to generate the subsequent qualitative and/or quantitative assessment of the biological sample Necessary data；And (iii) data are transmitted to the analysis facility of authorization and/or the health care of its subsidiary body mentions Donor is for the execution subsequent qualitative and/or quantitative assessment；(b) in the analysis facility of authorization and/or its subsidiary body point The data transmitted from the equipment are analysed, to provide the described qualitative and/or quantitative assessment of the biological sample；And it (c) verifies (x) whether subject receives the prescription requirements from health care professionals and carries out the described subsequent qualitative of the biological sample And/or quantitative assessment, or (y) whether subsequent qualitative and/or quantitative assessment the prescription of the biological sample is being propped up Person or prescriber are paid in subsequent qualitative and/or quantitative assessment the rule limitation, and/or (z) for the biological sample The subsequent qualitative and/or quantitative assessment of product, whether subject is in the scope of insurance coverage of health insurance；The wherein verifying step Suddenly in step (a) and/or (b) before, execute later or simultaneously.
It can provide a kind of pathological research of biological sample acquire from subject according to another aspect of the present invention Method.This method can include: (a) receive represent the biological sample image, with the biological sample or part of it into The electronic data of the image of capable physical process and/or chemical reaction, wherein the data receiver from being placed in subject's body or With it or specified sample acquisition station equipment, wherein the device configuration is used for: (i) receives the biological sample；(ii) it makes Standby biological sample is used for subsequent qualitative and/or quantitative assessment, wherein preparation generation represents the biological sample and/or institute State the electronic data of the image of chemical reaction；And (iii) Xiang Shouquan analysis facility and/or its subsidiary body virologist Transmit the electronic data of the representative image；It (b) should by virologist's analysis of the analysis facility and/or its subsidiary body that authorize Electronic data, to provide described qualitative and/or quantitative assessment.
Other aspects of the present invention can be related to a kind of side of the pathological research of biological sample acquire from subject Method, which comprises (a) receive from be placed in subject's body with it or specified sample acquisition station equipment, Represent the biological sample and/or the electron number with the image of the chemical reaction of at least one component progress of the biological sample According to wherein the device configuration is used for: (i) receives the biological sample；(ii) prepare biological sample for subsequent qualitative and/or Quantitative assessment, wherein the preparation generates the electronic data for representing the image of the biological sample and/or the chemical reaction；With And the virologist of the analysis facility of (iii) Xiang Shouquan transmits the electronic data of the representative image；(b) it is set by the analysis authorized The virologist applied analyzes the electronic data, to provide the subsequent qualitative and/or quantitative assessment.
In addition, a kind of method that various aspects of the invention can be related to biological sample evaluated and acquired from subject, described Method includes: that (a) is received from the data for being placed in the equipment transmission in subject's body or with it or in specified sample acquisition station, In the device configuration for handling biological sample as follows, these steps are as follows: (i) receives biological sample；(ii) it prepares Biological sample is used for subsequent qualitative and/or quantitative assessment, to generate the subsequent qualitative and/or quantitative assessment of the biological sample Necessary data；(iii) electronically sends data to analysis facility and/or its subsidiary body of authorization；(b) exist The analysis facility of authorization and/or its subsidiary body analyze the data transmitted from the equipment, after providing the biological sample Continuous qualitative and/or quantitative assessment.
A kind of method that other aspects of the present invention can be related to biological sample evaluated and acquired from subject, the method packet Include: (a) receive from be placed in subject's body with it or retailer's website the data transmitted of equipment, the wherein device configuration For handling biological sample as follows, these steps are as follows: (i) receives biological sample；(ii) biological sample is prepared to be used for Subsequent qualitative and/or quantitative assessment, to generate number necessary to the subsequent qualitative and/or quantitative assessment of the biological sample According to；(iii) electronically sends data to analysis facility and/or its subsidiary body of authorization；And (b) in authorization Analysis facility and/or its subsidiary body analyze the data transmitted from the equipment, to provide the described subsequent of the biological sample Qualitative and/or quantitative assessment.
According to other aspects of the invention, a method of evaluation biological sample can include: (a) is by means of equipment, processing The biological sample acquired from subject, wherein the equipment is placed in subject's body or with it or in specified sample acquisition station, Described in processing generate data necessary to the subsequent qualitative and/or quantitative assessment of the biological sample, and the wherein equipment It is configured to (i) and receives biological sample；(ii) prepare biological sample for subsequent qualitative and/or quantitative assessment, and (iii) to Data are transmitted in the analysis facility of authorization and/or its subsidiary body；(b) in the analysis facility of the authorization and/or its subsidiary body The data from the equipment are transmitted, to provide the subsequent qualitative and/or quantitative assessment of the biological sample；And (c) Verifying subject whether have medical insurance guarantee covering, wherein the verification step in step (a) and/or (b) before, Zhi Houhuo Simultaneously carry out.
It can provide a kind of method of biological sample evaluated and acquired from subject according to another aspect of the present invention.This method Can include: (a) receive be transferred from be placed in subject's body with it or specified sample acquisition station equipment, represent described in The electronic data of biological sample and/or the image of the chemical reaction carried out at least one component of the biological sample wherein should Device configuration is for processing biology as follows, these steps are as follows: (i) receives biological sample；(ii) biological sample is prepared For subsequent qualitative and/or quantitative assessment, wherein preparation generation represents the biological sample and/or the chemical reaction Image electronic data；(iii) will represent the electronic data transfer of described image to the analysis facility of authorization and/or its is attached Belong to mechanism；Wherein the processing generates the electricity of representative image necessary to the subsequent qualitative and/or quantitative assessment of the biological sample Subdata, and the electricity of representative image (b) transmitted in the analysis facility of authorization and/or the analysis of its subsidiary body from the equipment Subdata, to provide the subsequent qualitative and/or quantitative assessment of the biological sample.
A kind of method that other aspects can be related to biological sample evaluated and acquired from subject, which comprises (a) connects It receives from the data for being placed in the equipment transmission in subject's body or with it or in specified sample acquisition station, wherein the device configuration is used In handling biological sample as follows, these steps are that (i) receives biological sample；(ii) biological sample is prepared for subsequent Qualitative and/or quantitative assessment, to generate data necessary to the subsequent qualitative and/or quantitative assessment of the biological sample, and (iii) data are transmitted to analysis facility and/or the health care provider of its subsidiary body of authorization；(b) it is authorizing Analysis facility and/or its subsidiary body analyze the data transmitted from the equipment, with provide the biological sample it is described after Continue qualitative and/or quantitative assessment；(c) whether verifying subject receives the prescription requirements from medical treatment and nursing professional and carries out institute State the subsequent qualitative and/or quantitative assessment of biological sample, wherein the verification step in step (a) and/or (b) before, It carries out later or simultaneously.
In addition, various aspects of the invention can be related to a kind of method for evaluating biological sample, which comprises (a) is borrowed Help equipment, handle the biological sample acquired from subject, which, which has received, requires to carry out the subsequent fixed of biological sample Property and/or quantitative assessment prescription, wherein the equipment is placed in subject's body or with it or in specified sample acquisition station, Described in processing generate data necessary to the subsequent qualitative and/or quantitative assessment of the biological sample, and the wherein equipment It is configured to (i) and receives biological sample；(ii) prepare biological sample for subsequent qualitative and/or quantitative assessment, and (iii) to Data are transmitted in the analysis facility of authorization and/or its subsidiary body；(b) from the equipment transmission data, for the analysis in authorization Facility and/or its subsidiary body are analyzed, to provide the subsequent qualitative and/or quantitative assessment of the biological sample；With And whether subsequent qualitative and/or quantitative assessment the prescription for the biological sample (c) is verified in disburser or prescription Doctor to it is described it is subsequent qualitative and/or quantitative assessment rule limitation in, wherein the verification step is in step (a) and/or (b) Before, it carries out later or simultaneously.
Another aspect of the present invention provides a kind of method of biological sample evaluated and acquired from subject, the method packet It includes: (a) receiving from the data for being placed in the equipment transmission in subject's body or with it or in specified sample acquisition station, wherein this sets It is standby to be configured to following steps processing biological sample, these steps are as follows: (i) receives biological sample；(ii) biological sample is prepared Product are used for subsequent qualitative and/or quantitative assessment, to generate necessary to the subsequent qualitative and/or quantitative assessment of the biological sample Information, and (iii) electronically transmit data to the analysis facility of authorization and/or its subsidiary body；(b) in authorization Analysis facility and/or its subsidiary body analyze the data transmitted from the equipment, to provide the described subsequent of the biological sample Qualitative and/or quantitative assessment, wherein the subsequent qualitative and/or quantitative assessment of the biological sample is generated in the following terms One or more analytes presence or concentration determination, these are as follows: sodium, potassium, chloride, TCO2, anionic gap, Ionized calcium, glucose, urea nitrogen, kreatinin, lactate, hematocrit, hemoglobin, pH value, PCO2、PO2、HCO3, it is remaining Alkali, sulfur dioxide, ACT kaolin, ACT diatomite, PT/INR, cTnl, CK-MB or BNP.
In addition, various aspects of the invention can be related to a kind of a plurality of types of biological samples evaluated and acquired from subject Method, which comprises (a) is received from being placed in subject's body or transmit with it or in the equipment of specified sample acquisition station Data, wherein the device configuration is for handling a plurality of types of biological samples as follows, these steps are as follows: (i) Receive a plurality of types of biological samples；(ii) biological sample is prepared for subsequent qualitative and/or quantitative assessment, described in generating Data necessary to the subsequent qualitative and/or quantitative assessment of a plurality of types of biological samples, and (iii) is electronically Data are transmitted to the analysis facility of authorization and/or its subsidiary body；And (b) in the analysis facility of authorization and/or its attached machine Structure analyzes the data transmitted from the equipment, to provide the subsequent qualitative of a plurality of types of biological samples and/or quantify Evaluation.
In above-mentioned or other any methods everywhere herein practices alone or in combination, the biological sample may be implemented Qualitative and/or quantitative assessment, and need not by the sample from acquisition sample website be physically transported to authorization analysis facility And/or its subsidiary body.
It is above-mentioned or can alone or in combination include such method in other methods everywhere herein --- wherein biology sample Product are selected from blood, serum, blood plasma, nose swab or nasopharynx washing lotion, saliva, urine, tear, gastric juice, spinal fluid, excrement, mucus, sweat Liquid, earwax, oil, glandular secretion object, celiolymph, tissue, sperm and vaginal fluid, breathing object, hair, refer to throat swab First, skin, biopsy article, placental fluids, amniotic fluid, Cord blood, heavy-fluid (emphatic fluid), chamber liquid, phlegm, mucus, purulence, microorganism Group, meconium, milk and/or other excretas.
Any of above or other methods everywhere can be practiced alone or in combination herein, wherein biological sample has 250 micro- Rise (uL) or smaller volume.
In above-mentioned or other methods everywhere herein the practices alone or in combination, the method may also include by authorizing The step of analyzing the health care professional of facility and/or providing supervision by software program.
In some embodiments, above-mentioned or other methods everywhere can further include at described point alone or in combination herein Before analysis, the insurance qualification of the subject is verified later or simultaneously.
It is above-mentioned or other methods everywhere can further include being based on described qualitative and/or quantitative assessment alone or in combination herein And generate the report of the analysis comprising the subject.
In above-mentioned or other methods everywhere herein practices alone or in combination, the analysis, which can determine, is present in biology The presence or concentration of analyte in sample.
Above or other methods for providing everywhere herein can include alone or in combination selected from protein, nucleic acid, drug, Drug metabolite, gas, ion, particle, small molecule and its metabolin, element, toxin, lipid, carbohydrate, prion, The analyte of visible component and their combination.
According to practices alone or in combination above or in other described any methods everywhere herein, specified sample acquisition Station can be retailer's website or doctor's office.In some embodiments, more than practice alone or in combination or at this Text other everywhere described any method when, specified sample acquisition station can be the family of subject.It is above-mentioned or herein its In the method alone or in combination of his everywhere, specified sample acquisition station may be the website of employer, supplier office or doctor Institute.
In above-mentioned or other methods everywhere herein practices alone or in combination, it is possible to provide aggregation number generates at any time accordingly Between the vertical analysis that elapses.
Above or herein other the method can utilize the biological sample acquired from fingerstick alone or in combination everywhere Product.
In above-mentioned or other methods everywhere herein practices alone or in combination, the processing of biological sample is in some cases Under be not related to selection for determine Applications of Cardiac Markers, chemical component, vim and vigour, electrolyte, lactate, hemoglobin, solidification or The presence of hematological one or more analytes or the display of concentration level.
Above or herein other the method can include a kind of device alone or in combination everywhere, which is configured to Verify subject whether for the biological sample described qualitative and/or quantitative assessment medical insurance scope of insurance coverage It is interior.
In above-mentioned or other any methods everywhere herein practices alone or in combination, which is configurable to verify Whether subject, which receives the prescription requirements from health care professionals, carries out the described qualitative of the biological sample and/or determines Amount evaluation.
It is in some embodiments, above-mentioned or other methods everywhere can include a kind of device alone or in combination herein, The device is configured to verify before receiving biological sample, the data that electronically transmission data or analysis are transmitted tested The identity of person.In some embodiments, the verifying of subject's identity may include the gene signature for receiving subject.Individually or Combination above-mentioned or other can be expanded by the nucleic acid of the biological sample from subject everywhere in the certain methods herein Increase to obtain gene signature.In above-mentioned or other methods everywhere herein practices alone or in combination, subject's identity is tested Card may include one or more biological characteristics measurement of subject.Other described sides everywhere in alone or in combination above-mentioned or herein In some embodiments of method, the verifying of subject's identity can be carried out by the technical staff authorized.
In above-mentioned or other methods everywhere herein practices alone or in combination, can receive biological sample, with electronics The identity of authorization technique personnel is verified before the data that mode transmits data or analysis is transmitted.
In above-mentioned or other methods everywhere herein practices alone or in combination, which is configurable to receive one Or multiple caskets, the cylinder casket are configured to qualitative as required by medical treatment and nursing professional and/or quantitative assessment.
In some embodiments, above-mentioned or other one or more methods everywhere can provide alone or in combination herein Cylinder casket with the readable one or more identifiers of described device.
It is above-mentioned or other methods everywhere can further include receiving identifier information from described device alone or in combination herein.
Above-mentioned or other methods everywhere herein execution alone or in combination may also include based on received identifier information The step of providing one or more schemes to described device, wherein the scheme realizes the preparation of biological sample.
In above-mentioned or other methods everywhere herein practices alone or in combination, described device may include in shell.
It is above-mentioned or herein other methods everywhere can include alone or in combination be related to biological sample clinical correlation or Lack the qualitative and/or quantitative assessment of the determination of correlation.
In above-mentioned or other methods everywhere herein practices alone or in combination, specified sample acquisition station may be zero Sell quotient place.Some embodiments of the present invention including other methods everywhere including alone or in combination above-mentioned or herein In, specified sample acquisition station is chain store, pharmacy, supermarket or department store.In alone or in combination above-mentioned or herein its In the method for his everywhere, specified sample acquisition station can be the family of subject.
It is above-mentioned or executing alone or in combination for other methods everywhere may include the electronic bits containing representative sample herein Data.In alone or in combination above-mentioned or herein in other methods everywhere, which can be assembled and can be used for pushing away at any time The vertical analysis of shifting is to promote screening, diagnosis, treatment and/or disease prevention.
In alone or in combination above-mentioned or herein in other methods everywhere, biological sample can have 250 microlitres (" uL ") Or smaller volume.In some embodiments, the biology in alone or in combination above-mentioned or herein in other methods everywhere Sample can be blood, serum, saliva, urine, tear, gastric juice and/or digestive juice, excrement, mucus, sweat, earwax, oil, gland Body secretion, sperm or vaginal fluid.In above-mentioned or other methods everywhere herein practices alone or in combination, biological sample Product can be tissue sample.It is above-mentioned or other methods everywhere can include the life acquired from fingerstick alone or in combination herein Object sample.
It is above-mentioned or other methods everywhere can include based on the described qualitative of the biological sample alone or in combination herein And/or quantitative assessment and generate report.In some embodiments, above-mentioned or other one or more methods everywhere herein Executing alone or in combination can further comprise that the report is transmitted to additional medical treatment and nursing professional.The additional doctor Treating care professional may provide that prescription requirements carry out alone or in combination above-mentioned or other are everywhere herein to subject The described qualitative and/or quantitative assessment of the biological sample in method.In some cases, it is above-mentioned or herein other everywhere Method execution alone or in combination in, additional medical treatment and nursing professional is in the different ground of analysis facility from authorization Point.
In above-mentioned or other methods everywhere herein practices alone or in combination, processing may include that addition is one or more Reagent or fixative.
In some embodiments, data are transmitted to base in other methods everywhere in alone or in combination above-mentioned or herein In the infrastructure of cloud computing.
Above-mentioned or other methods everywhere can include image alone or in combination herein, wherein the image is video image. In above-mentioned or other methods everywhere herein practices alone or in combination, which may include representative image and/or audio letter Number electronic data.
In above-mentioned or other methods everywhere herein practices alone or in combination, disburser can acquire from specified sample Station receives e bill.
In above-mentioned or other methods everywhere herein practices alone or in combination, the medical treatment and nursing of the analysis facility of authorization Professional can receive e-payment from specified sample acquisition station.
The device used in other methods everywhere in alone or in combination above-mentioned or herein can be configured to based on following In items at least one of extraly prepare biological sample, these are as follows: the analysis previously prepared, in authorization of biological sample The analysis of facility and/or its subsidiary body to data.
In above-mentioned or other methods everywhere herein execution alone or in combination, the analysis facility of authorization can be adopted with sample Collection station mutually separates.
When practicing above-mentioned or other one or more methods everywhere herein alone or in combination, the preparation of biological sample It can be automation.
It is above-mentioned or other methods everywhere can further include that supervision is described subsequent qualitative and/or quantitative alone or in combination herein Evaluation.In alone or in combination above-mentioned or herein in other methods everywhere, supervision step can be by the analysis facility authorized Medical treatment and nursing professional and/or pass through software program carry out.In some embodiments, from described device transmission data in list Solely or combination above-mentioned or it can also be used for supervising described subsequent qualitative in other certain methods everywhere herein and/or quantitatively comment Valence.It is above-mentioned or other methods everywhere can provide alone or in combination herein, wherein by the medical treatment and nursing of the analysis facility authorized Professional and/or supervision is provided by software program.
The data used in other methods everywhere in alone or in combination above-mentioned or herein can represent biological sample and/ Or its any part.In some embodiments, the data can represent the preparation of biological sample collected.Data may include The preparation of the biological sample of acquisition betides the information of one or more of conditions.One or more of conditions can wrap Include with one or more characteristics listed in the following group: the amount of biological sample, the concentration of biological sample, the quality of biological sample, Temperature or humidity.
In alone or in combination above-mentioned or herein in other certain methods everywhere, data representative is run anti-by device It answers.The data may include the information of reaction rate.In some cases, the data may include about being related to biological sample The information of control reaction and chemical reaction.
In above-mentioned or other methods everywhere herein practices alone or in combination, such method may also include (c) supervision (i) one or more steps in-(iii) are to improve the quality of the evaluation, wherein the supervision is in step (i)-(iii) Any step before, carry out later or simultaneously.
It is above-mentioned or other methods everywhere can further include one in (iv) supervision (i)-(iii) alone or in combination herein Or multiple steps to be to improve the quality of the evaluation, wherein the supervision is before any step in step (i)-(iii), it It carries out afterwards or simultaneously.
In some embodiments, above-mentioned or other methods everywhere herein can be provided alone or in combination, wherein described Supervision is the supervision to biological sample and/or its any portion of data progress is represented.Supervision can be to representing biological sample And/or the supervision that its any portion of data carries out.Supervision can be the data to the preparation for representing biological sample collected The supervision of progress.In some instances, supervision is the supervision carried out to the data for the preparation for representing biological sample collected.Prison Superintend and direct the supervision that can be the information progress to the one or more conditions at collected biological sample that prepare.Individually or Combination above-mentioned or herein in other methods everywhere, supervision can be to preparing at collected biological sample one Or the supervision that the information of multiple conditions carries out.Supervision can be the prison carried out to the data for representing the chemical reaction run by device It superintends and directs.In some embodiments, supervision can be the supervision carried out to the data for representing the chemical reaction run by the device.
In above-mentioned or other methods everywhere herein execution alone or in combination, medical treatment shield is provided by health insurance company Reason ensures covering.
It is above-mentioned or herein other methods everywhere can include alone or in combination be related to one or more types chemistry it is anti- The preparation step answered, the chemical reaction are selected from: immunoassays, nucleic acid determination, the measurement based on receptor, cell counting measuring, ratio Color measurement, enzymatic determination, electrophoretic determination, electrochemical gaging, spectroscopic assay, chromatographic determination, microcosmic measurement, landform measurement, calorimetric Measurement, turbidimetric assay, agglutination determination, radioactive isotope measurement, viscosimetric analysis, solidification measurement, coagulation time test, protein Synthesize measurement, Histological determining, culture measurement or osmometry.
Other methods everywhere, the equipment can also configure for by with electricity according to alone or in combination above-mentioned or herein Submode transmission represents the data of one or more biological characteristics measurement of subject to handle biological sample.
In alone or in combination some above-mentioned or herein in other methods everywhere, the processing of biological sample does not include to category In three or more analytes of the classifications such as cardiac marker, vim and vigour, electrolyte, lactate, hemoglobin and coagulation factor Presence or concentration level analysis.
In some embodiments, the processing of biological sample is above-mentioned or herein other methods everywhere are alone or in combination Do not include in practice to the presence for the three or more analytes for belonging to the following terms or the analysis of concentration level, these Are as follows: sodium, potassium, chloride, TCO2, anionic gap, ionized calcium, glucose, urea nitrogen, kreatinin, lactate, haemocyte ratio Appearance, hemoglobin, pH value, PCO2、PO2、HCO3, remaining alkali, sulfur dioxide, ACT kaolin, ACT diatomite, PT/INR, CTnl, CK-MB and BNP.
In above-mentioned or other certain methods everywhere herein practices alone or in combination, sample acquisition station can be following It is one or more: in hospital, clinic, military place or subject family.
In some embodiments, other methods everywhere for alone or in combination above-mentioned or herein, can be in analysis Data are shown on the touchscreen afterwards.
It is above-mentioned or other methods everywhere may include the imaging data of parts of body herein, the data can be used for it is biochemical It analyzes while being analyzed.
The system that one aspect of the present invention can be related to a kind of biological sample evaluated and acquired from subject, the system packet Include: (a) communication unit is configured to from being placed in subject's body or connect with it or in the equipment of specified sample acquisition station Data are received, wherein the device configuration is for handling biological sample, to generate the subsequent qualitative of the biological sample and/or quantify Data necessary to evaluating, and wherein the equipment includes that (i) is configured to receive the sample collection unit of biological sample；(ii) It is configured to prepare biological sample for subsequent qualitative and/or quantitative assessment sample preparation unit；And (iii) is configured to To the analysis facility of authorization and/or the transmission unit of its subsidiary body transmission data；(b) processor, in the authorization Analysis facility and/or its subsidiary body handle the data for the qualitative and/or quantitative assessment of the biological sample, and its Described in the database of record of processor and one or more medical records and/or insurance information comprising subject lead to Letter.
The system that other aspects of the present invention can be related to a kind of biological sample evaluated and acquired from subject, the system packet Include: (a) communication unit is configured to from being placed in subject's body or receive with it or in the equipment of specified sample acquisition station Data, wherein the device configuration is for handling biological sample, to generate the subsequent qualitative of the biological sample and/or quantitatively comment Data necessary to valence, and wherein the equipment includes that (i) is configured to receive the sample collection unit of biological sample；(ii) match It sets and is used to prepare biological sample for subsequent qualitative and/or quantitative assessment sample preparation unit；And (iii) be configured to The transmission unit of the analysis facility of authorization and/or its subsidiary body transmission data；(b) processor is set in the analysis of authorization It applies and/or subsequent qualitative and/or quantitative assessment that its subsidiary body handles the data for the biological sample, and wherein The processor is communicated with the database of record of one or more medical records comprising subject, and/or wherein The processor is communicated with disburser's database of the insurance information comprising subject.
According to another aspect of the present invention, it is possible to provide a kind of system for evaluating the blood sample acquired from subject.This is System can include: (a) communication unit is configured to from being placed in subject's body or with it or in specified sample acquisition station Equipment receives data, and wherein the device configuration is for handling blood sample, thus generate the subsequent qualitative of the blood sample and/ Or data necessary to quantitative assessment, and wherein the equipment includes that (i) is configured to receive the sample acquisition list of blood sample Member；(ii) it is configured to prepare biological sample for subsequent qualitative and/or quantitative assessment sample preparation unit, wherein the sample Preparation unit allows to add at least one reagent into blood sample；And (iii) be configured to authorization analysis facility and/ Or the transmission unit of its subsidiary body transmission data；(b) processor, analysis facility and/or its subsidiary body in authorization The data are handled for the subsequent qualitative and/or quantitative assessment of the blood sample, and the wherein processor access packet The database of record of one or more medical records containing subject, and/or wherein processor access includes subject Insurance information disburser's database.
According to other aspects of the invention, it is possible to provide a kind of biological sample acquired for Fast Evaluation from subject is with auxiliary The system for helping screening, the diagnosis, treatment or prevention of disease.The system can include: communication unit, for representing institute from equipment reception State the electron number of the image of biological sample and/or the chemical reaction carried out at least one component from the biological sample According to；The equipment is placed in subject's body or with it or in specified sample acquisition station, wherein the equipment is for handling life Object sample represents the biological sample to generate necessary to the subsequent qualitative and/or quantitative assessment of the biological sample The electronic data of image, and wherein the equipment includes the sample collection unit that (i) is used to receive biological sample in shell； (ii) it is used to prepare biological sample for subsequent qualitative and/or quantitative assessment sample preparation unit, wherein the system of biological sample Standby is automation；(iii) for record biological sample image and/or at least one component from the biological sample The imaging unit of the chemical reaction of progress, and (iv) are used for transmission the electronic data for representing described image and/or chemical reaction Transmission unit；And processor, handle the electronic data of the representative image for the subsequent qualitative of the biological sample and/or Quantitative assessment.
In above-mentioned or other systems everywhere herein practices alone or in combination, the processor can be configured to comprising Disburser's database of the insurance information of subject communicates.
Above or herein other the system can include following equipment alone or in combination everywhere, which is used for It receives information relevant to described qualitative and/or quantitative assessment and optionally shows the information on said device.
In above-mentioned or other systems everywhere herein practices alone or in combination, the equipment may include that following processing is single Member, the processing unit are configured to whether verifying subject has for the described qualitative and/or quantitative assessment of the biological sample Medical insurance guarantee covering.
It is in some embodiments, above-mentioned or other systems everywhere can include following equipment alone or in combination herein, Whether the device configuration receives the prescription requirements from medical treatment and nursing professional for verifying subject and carries out the biological sample Described qualitative and/or quantitative assessment.
In alone or in combination above-mentioned or herein in other systems everywhere, provided processor can provide it is described fixed Property and/or quantitative assessment before access database of record.Optionally, in alone or in combination above-mentioned or herein other everywhere be In system, which accesses disburser's database before providing described qualitative and/or quantitative assessment.
Before described qualitative and/or quantitative assessment is provided, above or herein other everywhere the system can individually or group Close which database of record ground determination will access.
In above-mentioned or other systems everywhere herein practices alone or in combination, which is configurable to receive one Or multiple caskets, the cylinder casket, which is configured to be prescribed by medical treatment and nursing professional, to be required the qualitative of progress and/or quantitatively comments Valence.
In some embodiments, which includes alone or in combination above-mentioned or herein in other systems everywhere In shell.
In alone or in combination above-mentioned or herein in other systems everywhere, described qualitative and/or quantitative assessment be can be related to To the clinical correlation of biological sample or its determination for lacking correlation.
In alone or in combination above-mentioned or herein in other systems everywhere, specified sample acquisition station be chain store, Pharmacy, supermarket or department store.In some embodiments, specified sample acquisition station is the family of subject.
It is above-mentioned or other systems everywhere can include the biological sample with 250uL or smaller volume alone or in combination herein Product.Biological sample can be blood, serum, saliva, urine, tear, gastric juice and/or digestive juice, excrement, mucus, sweat, ear Dirt, oil, glandular secretion object, sperm or vaginal fluid.In some cases, biological sample can be tissue sample.
In alone or in combination above-mentioned or herein in other some systems everywhere, which can adopt from fingerstick Collection.
In some embodiments, above-mentioned or other systems everywhere can be using specified sample acquisition station herein, it can To be retailer.In alone or in combination above-mentioned or herein in other systems everywhere, specified sample acquisition station may be to employ Main website, supplier office or hospital.
In alone or in combination above-mentioned or herein in other some systems everywhere, the analysis facility of authorization can be adopted with sample Collection station mutually separates.
In alone or in combination above-mentioned or herein in other systems everywhere, medical treatment and nursing professional be may have access to for institute State subsequent qualitative and/or quantitative assessment and/or supervision subsequent qualitative and/or quantitative assessment the user interface.
In alone or in combination above-mentioned or herein in other systems everywhere, processor can be further provided for described subsequent Qualitative and/or quantitative assessment supervision.
In alone or in combination above-mentioned or herein in other systems everywhere, sample preparation unit may include (i) pipette, And optionally include (ii) one or more of: centrifuge, magnetic separator, filter, vessel, container, determination unit, examination Agent unit, heater, heat controller, cell counter, electromagnet source, temperature sensor, motion sensor or for electrical property Sensor.
In some embodiments, above-mentioned or other systems everywhere can include image alone or in combination herein.The figure As can be static state.In some embodiments, which can be video image.Above-mentioned or other systems everywhere herein It can alone or in combination include the transmission unit for being configured to the electronic data of wireless transmission representative image.
In alone or in combination above-mentioned or herein in other systems everywhere, data may include representative image and audio signal Electronic data.
The equipment in other systems everywhere is configurable to receive one or more in alone or in combination above-mentioned or herein A casket, the cylinder casket are configured to qualitative and/or quantitative analysis.In some embodiments, can have can be by described for cylinder casket One or more identifiers that equipment is read.
In alone or in combination above-mentioned or herein in other some systems everywhere, at least one component be can be by carbon water Biological analyte composed by compound, lipid, protein or their combination.
In to above-mentioned or other systems everywhere herein utilizations alone or in combination, it can be changed without biological sample Learn reaction.
In some embodiments, other systems everywhere for alone or in combination above-mentioned or herein, can be in analysis Data are shown on the touchscreen afterwards.
It is above-mentioned or other systems everywhere may include the imaging data of parts of body herein, be treated for it is biochemical It analyzes while being analyzed.
Some aspects of the invention are related to a kind of method of the pathological research of biological sample acquire from subject, The method includes (a) receive from be placed in subject's body with it or specified sample acquisition station equipment, represent The electronic data of the biological sample and/or the image of the chemical reaction carried out at least one component of the biological sample, In the device configuration be used for: (i) receives the biological sample；(ii) preparation acquisition biological sample for it is subsequent it is qualitative and/ Or quantitative assessment, wherein the preparation generates the electronic data for representing the image of the biological sample and/or the chemical reaction； And the virologist of the analysis facility of (iii) Xiang Shouquan transmits the electronic data of the representative image；And (b) by authorizing The virologist of analysis facility analyzes the electronic data, to provide the subsequent qualitative and/or quantitative assessment.
One aspect of the present invention is related to a kind of method of biological sample evaluated and acquired from subject.This method includes (a) receive from be placed in subject's body with it or specified sample acquisition station the data transmitted of equipment, the wherein equipment It is configured to following steps processing biological sample, these steps are as follows: (i) receives biological sample；(ii) biological sample is prepared For subsequent qualitative and/or quantitative assessment, to generate number necessary to the subsequent qualitative and/or quantitative assessment of the biological sample According to；(iii) electronically sends data to analysis facility and/or its subsidiary body of authorization；And (b) in authorization Analysis facility and/or its subsidiary body analyze the data transmitted from the equipment, to provide the described subsequent of the biological sample Qualitative and/or quantitative assessment.This may be contrasted with traditional equipment --- traditional equipment may only transimiison analysis as a result, without It is subsequent qualitative and/or quantitative assessment the data for sample.Such traditional equipment for only transmitting result is possibly can not be in needle It is relied on by one or more medical treatment and nursing professionals in the medical diagnosis on disease of subject, treatment and/or prevention.
In some embodiments, the processing of biological sample does not include to belonging to cardiac marker, vim and vigour, electrolyte, cream The presence of three or more analytes of the classifications such as hydrochlorate, hemoglobin and coagulation factor or the analysis of concentration level.One In a little situations, the processing of biological sample does not include presence or concentration to the three or more analytes belonged in the following terms Horizontal analysis, these are as follows: sodium, potassium, chloride, TCO2, anionic gap, ionized calcium, glucose, urea nitrogen, kreatinin, Lactate, hematocrit, hemoglobin, pH value, PCO2、PO2、HCO3, remaining alkali, sulfur dioxide, ACT kaolin, ACT silicon Diatomaceous earth, PT/INR, cTnl, CK-MB and BNP.
A kind of method of biological sample evaluated and acquired from subject is provided according to another aspect of the present invention.This method packet Include (a) receive from be placed in subject's body with it or retailer's website the data transmitted of equipment, the wherein device configuration For handling biological sample as follows, these steps are as follows: (i) receives biological sample；(ii) biological sample is prepared to be used for Subsequent qualitative and/or quantitative assessment, to generate data necessary to the subsequent qualitative and/or quantitative assessment of the biological sample； (iii) electronically sends data to analysis facility and/or its subsidiary body of authorization；And (b) in point of authorization Analysis facility and/or its subsidiary body analyze the data transmitted from the equipment, to provide the described subsequent fixed of the biological sample Property and/or quantitative assessment.
Other aspects of the present invention are a kind of methods for evaluating biological sample, which comprises (a) by means of equipment, The biological sample acquired from subject is handled, wherein the equipment is placed in subject's body or acquires with it or in specified sample It stands, wherein the processing generates data necessary to the subsequent qualitative and/or quantitative assessment of the biological sample, and wherein should Device configuration receives biological sample for (i)；(ii) biological sample is prepared for subsequent qualitative and/or quantitative assessment, and (iii) data are transmitted in the analysis facility of Xiang Shouquan and/or its subsidiary body；(b) in the analysis facility of the authorization and/or its is attached Belong to mechanism and transmit the data from the equipment, to provide the subsequent qualitative and/or quantitative assessment of the biological sample；With And (c) verifying subject whether have medical insurance guarantee covering, wherein the verification step in step (a) and/or (b) before, It carries out later or simultaneously.
Another aspect of the present invention is a kind of method of biological sample evaluated and acquired from subject, the method includes (a) electronic data for representing the image of the biological sample and/or the chemical reaction carried out in equipment is received, wherein the electronics Data are from being placed in subject's body or transmitting with it or in the equipment of specified sample acquisition station, and wherein the device configuration is for leading to Cross following steps processing biological sample, these steps are as follows: (i) receives biological sample；(ii) biological sample is prepared for subsequent Qualitative and/or quantitative assessment, wherein the preparation generates the electricity for representing the image of the biological sample and/or the chemical reaction Subdata；(iii) will represent analysis facility and/or its subsidiary body of the electronic data transfer of described image to authorization；Its In the processing generate the electronic data of representative image necessary to the subsequent qualitative and/or quantitative assessment of the biological sample, with And the electronic data for the representative image (b) transmitted in the analysis facility of authorization and/or the analysis of its subsidiary body from the equipment, with The subsequent qualitative and/or quantitative assessment of the biological sample is provided.
A kind of system of biological sample evaluated and acquired from subject is provided according to another aspect of the invention.The system packet (a) communication unit is included, is configured to from being placed in subject's body or receive with it or in the equipment of specified sample acquisition station Data, wherein the device configuration is for handling biological sample, to generate the subsequent qualitative of the biological sample and/or quantitatively comment Data necessary to valence, and wherein the equipment includes that (i) is configured to receive the sample collection unit of biological sample；(ii) match It sets and is used to prepare biological sample for subsequent qualitative and/or quantitative assessment sample preparation unit；And (iii) be configured to The transmission unit of the analysis facility of authorization and/or its subsidiary body transmission data；(b) processor is set in the analysis of authorization It applies and/or subsequent qualitative and/or quantitative assessment that its subsidiary body handles the data for the biological sample, and wherein The processor is communicated with the database of record of one or more medical records comprising subject, and/or wherein The processor is communicated with disburser's database of the insurance information comprising subject.
Further it is provided that a kind of method for evaluating the biological sample acquired from subject.This method includes (a) receiving from being placed in The data of equipment transmission in subject's body or with it or in specified sample acquisition station, wherein the device configuration is used for by such as Lower step process biological sample, these steps are that (i) receives biological sample；(ii) prepare biological sample for it is subsequent it is qualitative and/ Or quantitative assessment, to generate data necessary to the subsequent qualitative and/or quantitative assessment of the biological sample, and (iii) will The data are transmitted to analysis facility and/or the health care provider of its subsidiary body of authorization；(b) it is set in the analysis of authorization Apply and/or its subsidiary body analyze data transmit from the equipment, with provide the biological sample it is described it is subsequent it is qualitative with/ Or quantitative assessment；And (c) whether verifying subject receives the progress of the prescription requirements from the medical treatment and nursing professional life The subsequent qualitative and/or quantitative assessment of object sample, wherein the verification step in step (a) and/or (b) before, later Or it simultaneously carries out.
Other aspects of the present invention are related to a kind of method for evaluating biological sample, and the method includes (a) by means of equipment, The biological sample acquired from subject is handled, which, which has received, requires to carry out the subsequent qualitative of biological sample and/or determine The prescription of evaluation is measured, wherein the equipment is placed in subject's body or with it or in specified sample acquisition station, wherein the place Reason generates data necessary to the subsequent qualitative and/or quantitative assessment of the biological sample, and wherein the device configuration is used for (i) biological sample is received；(ii) point of the biological sample for subsequent qualitative and/or quantitative assessment, and (iii) Xiang Shouquan is prepared It analyses facility and/or data is transmitted in its subsidiary body；(b) from the equipment transmission data, for authorization analysis facility and/or Its subsidiary body is analyzed, to provide the subsequent qualitative and/or quantitative assessment of the biological sample；And it (c) verifies For the biological sample subsequent qualitative and/or quantitative assessment the prescription whether in disburser or prescriber to described It is subsequent qualitative and/or quantitative assessment rule limitation in, wherein the verification step in step (a) and/or (b) before, later Or it simultaneously carries out.
A kind of method of biological sample evaluated and acquired from subject is illustrated according to an aspect of the present invention.This method Include (a) receiving the data from the equipment transmission in subject's body or with it or in specified sample acquisition station is placed in, wherein should For device configuration for handling biological sample as follows, these steps are that (i) receives biological sample；(ii) biological sample is prepared Product are used for subsequent qualitative and/or quantitative assessment, state letter necessary to the subsequent qualitative and/or quantitative assessment of biological sample to generate Breath, and (iii) electronically transmit data to the analysis facility of authorization and/or its subsidiary body；(b) in point of authorization Analysis facility and/or its subsidiary body analyze the data transmitted from the equipment, to provide the described subsequent fixed of the biological sample Property and/or quantitative assessment, wherein the subsequent qualitative and/or quantitative assessment of the biological sample is generated to belonging to selected from the following terms One of or a variety of analytes presence or concentration determination, these are as follows: sodium, potassium, chloride, TCO2, between anion Gap, ionized calcium, glucose, urea nitrogen, kreatinin, lactate, hematocrit, hemoglobin, pH value, PCO2、PO2、HCO3、 Remaining alkali, sulfur dioxide, ACT kaolin, ACT diatomite, PT/INR, cTnl, CK-MB or BNP.
In another aspect, the present invention provides a kind of system of blood sample evaluated and acquired from subject, the system Include (a) communication unit, is configured to from being placed in subject's body or connect with it or in the equipment of specified sample acquisition station Data are received, wherein the device configuration is for handling blood sample, to generate the subsequent qualitative of the blood sample and/or quantify Data necessary to evaluating, and wherein the equipment includes that (i) is configured to receive the sample collection unit of blood sample；(ii) It is configured to prepare biological sample for subsequent qualitative and/or quantitative assessment sample preparation unit, wherein the sample preparation list Member allows to add at least one reagent into blood sample；And (iii) is configured to the analysis facility of authorization and/or its is attached Belong to the transmission unit of mechanism transmission data；(b) processor handles institute in the analysis facility of authorization and/or its subsidiary body Data are stated for the subsequent qualitative and/or quantitative assessment of the blood sample, and wherein the processor access includes tested The database of record of one or more medical records of person, and/or wherein processor access includes the insurance of subject Disburser's database of information.
Provide the another method for a plurality of types of biological samples that evaluation is acquired from subject.This method includes (a) connecing It receives from the data for being placed in the equipment transmission in subject's body or with it or in specified sample acquisition station, wherein the device configuration is used In handling a plurality of types of biological samples as follows, these steps are as follows: (i) receives a plurality of types of biological samples； (ii) biological sample is prepared for subsequent qualitative and/or quantitative assessment, to generate the subsequent of a plurality of types of biological samples The data are electronically transmitted to the analysis facility of authorization by data necessary to qualitative and/or quantitative assessment, and (iii) And/or its subsidiary body；(b) data transmitted from the equipment are analyzed in the analysis facility of authorization and/or its subsidiary body, To provide the subsequent qualitative and/or quantitative assessment of a plurality of types of biological samples.
In some embodiments, the processing of biological sample is not related to for cardiac marker, chemical component, vim and vigour, electricity Xie Zhi, lactate, hemoglobin, solidification or hematological determination and presence or the concentration water of selected one or more analytes Flat display.In some embodiments, the processing of biological sample is not related to belonging to three or more points in the following terms The presence of object or the display of concentration level are analysed, these are as follows: sodium, potassium, chloride, TCO2, anionic gap, ionized calcium, grape Sugar, urea nitrogen, kreatinin, lactate, hematocrit, hemoglobin, pH value, PCO2、PO2、HCO3, remaining alkali, titanium dioxide Sulphur, ACT kaolin, ACT diatomite, PT/INR, cTnl, CK-MB and BNP.After subsequent analysis, this type of information can be transmitted The equipment is returned, such as showing, storing or analyze.
In addition, in some embodiments, the device configuration is for verifying whether subject has for the biological sample Described qualitative and/or quantitative assessment medical insurance guarantee covering.The equipment may include being configured to verifying subject to be The no processing unit for having described qualitative and/or quantitative assessment the medical insurance guarantee covering for the biological sample.The equipment It is configurable to whether verifying subject receives the institute that the prescription requirements from medical treatment and nursing professional carry out the biological sample State qualitative and/or quantitative assessment.
In some cases, processor accesses database of record before providing described qualitative and/or quantitative assessment.Processing Device can access disburser's database before providing described qualitative and/or quantitative assessment.In some embodiments, the system Which database of record determination will access before providing described qualitative and/or quantitative assessment.
In some embodiments, the device configuration be used for receive biological sample, electronically transmit data or The identity of subject is verified before analyzing transmitted data.The verifying of subject's identity may include the gene label for receiving subject Name.Gene signature can be obtained by the nucleic acid amplification of the biological sample from subject.The verifying of subject's identity can wrap Include one or more biological characteristics measurement of subject.The verifying of subject's identity can be carried out by the technical staff authorized.Authorization The identity of technical staff can be obtained before receiving biological sample, electronically transmitting the data that data or analysis are transmitted Verifying.
According to certain embodiments of the present invention, the equipment is configurable to receive one or more cylinder caskets, the cylinder Casket is configured to qualitative as required by medical treatment and nursing professional and/or quantitative assessment.The equipment is configurable to reception one A or multiple casket, the cylinder casket are configured to qualitative as required by medical treatment and nursing professional and/or quantitative assessment.It is described Cylinder casket can have the one or more identifiers that can be read by the equipment.In some cases, provided method may also include Identifier information is received from the equipment.Such method can also further comprise being set based on the identifier information received to described It is standby that one or more schemes are provided, wherein the scheme realizes the preparation of biological sample.Scheme can wirelessly be provided from server, To promote the preparation and/or processing of biological sample.The program can be provided from cloud or from any external equipment.
In some embodiments, which may include in shell.
Described qualitative and/or quantitative assessment can be related to the clinical correlation of biological sample or its lack correlation really It is fixed.
In certain embodiments of the present invention, specified sample acquisition station is retailer's website.Specified sample acquisition Station can be chain store, pharmacy, supermarket or department store.Specified sample acquisition station can be the family of subject.
In some embodiments, data include the electronic bits of representative sample.The data can be assembled and at any time The vertical analysis of passage, to promote screening, diagnosis, progress treatment and/or disease prevention.The data can also be used in and be found in Time passage vertical analysis, with promote screening, diagnosis, progress treatment and/or disease prevention, and more fully understand disease into Exhibition is subsided, or the effect of intervention of the understanding including treatment or lifestyle change.
Biological sample can have 250uL or smaller volume.Biological sample is blood, serum, saliva, urine, tear, stomach Liquid and/or digestive juice, excrement, mucus, sweat, earwax, oil, glandular secretion object, sperm or vaginal fluid.Biological sample can be with It is tissue sample.Biological sample can be acquired from fingerstick.
In some embodiments, a kind of method can further comprise described qualitative based on the biological sample and/or Quantitative assessment and generate report.This method, which may also include, is transmitted to additional medical treatment and nursing professional for the report.One In a little situations, the additional medical treatment and nursing professional provides its institute for carrying out the biological sample of prescription requirements to subject State qualitative and/or quantitative assessment.The additional medical treatment and nursing professional can be in the ground different from the analysis facility authorized Point.
In some embodiments, processing includes adding one or more reagents or fixative.
According to embodiment of the present invention, the infrastructure based on cloud computing can be sent data to.Image can be with It is video image.Data may include the electronic data of representative image and/or audio signal.Infrastructure based on cloud computing can be certainly I learns.The model that can be fitted and be readjusted again based on data collected can be supplied data to.Based on cloud The infrastructure of calculation can execute analysis.
In some embodiments, processor accesses disburser's database.Disburser can connect from specified sample acquisition station Receive e bill.The medical treatment and nursing professional of the analysis facility of authorization can receive e-payment from specified sample acquisition station.
The equipment can be configured to previously prepared, analysis facility in authorization or its subsidiary body pair based on biological sample At least one of the analysis of data, extraly to prepare biological sample.
In some embodiments, the analysis facility of authorization is mutually separated with sample acquisition station.
The preparation of biological sample can be automation.
Can provide further comprises supervision subsequent qualitative and/or quantitative assessment the method.Supervising step can be by awarding Power analysis facility medical treatment and nursing professional and/or by software program progress.It can also be used for supervising from equipment transmission data Superintend and direct the subsequent qualitative and/or quantitative assessment.The supervision can by authorize analysis facility medical treatment and nursing professional and/or It is provided by software program.Can provide it is being accessed by medical treatment and nursing professional, for described subsequent qualitative and/or fixed Subsequent qualitative and/or quantitative assessment the user interface is evaluated and/or supervised to amount.Processor can also be provided to described subsequent fixed The supervision of property and/or quantitative assessment.
In some embodiments, data represent biological sample and/or its any part.The data can be represented and be acquired Biological sample preparation.The data may include carrying out preparing present one or more items to biological sample collected The information of part.One or more conditions may include with one or more characteristics listed in the following group: the amount of biological sample, biology Concentration, the quality of biological sample, temperature or humidity of sample.The data can represent the reaction run by equipment.The data It may include rate, quality and/or the information of execution of reaction.The data may include about control reaction and being related to biological sample Chemical reaction information.The data of acquisition can be the photon of the result as chemical reaction.Other examples of data can wrap Include electronics, photon, intensity, frequency, color, sound or temperature.
In some embodiments, provided method further comprises one or more of (c) supervision (i)-(iii) Step to improve the quality of the evaluation, wherein the supervision before any step in step (i)-(iii), later or with It is simultaneously carried out.In addition, provided method further comprise (iv) supervision (i)-(iii) in one or more steps with Improve the quality of the evaluation, wherein the supervision before any step in step (i)-(iii), later or simultaneously Ground carries out.The supervision can be the supervision to biological sample and/or its any portion of data is represented.The supervision can be Supervision to the data for the preparation for representing biological sample collected.The supervision can be to progress biological sample collected Preparation at one or more conditions information supervision.The supervision can be the reaction run to representative by equipment Data supervision.The supervision can be the supervision to the data that the operation of the reaction in system occurs are represented.
In some embodiments, medical treatment and nursing is provided by health insurance company and/or employer ensure covering.
In some embodiments, preparation step is related to the reaction of one or more types, which is selected from: immune to survey Fixed, nucleic acid determination, the measurement based on receptor, cell counting measuring, colorimetric estimation, enzymatic determination, spectrum analysis (for example, mass spectrum, Infrared spectroscopy, x-ray photoelectron spectroscopy), electrophoretic determination, nucleic acid sequencing, agglutination determination, chromatographic determination, coagulation function measurement, Electrochemical gaging, Histological determining or cell analysis (including dead cell and/or live cell assays), molecular biology measurement, When chemical assay, turbidimetric assay, coagulation function measurement, radioactive isotope measurement, viscosimetric analysis, coagulation function measurement, blood coagulation Between measurement, protein synthesis measurement, Histological determining, culture measurement, osmometry, it is microcosmic measure, landform measure, calorimetric Measurement and/or other kinds of measurement or their combination.
Equipment can also configure one or more biological characteristics measurement for representing subject by electronically transmission Data handle biological sample.
In some embodiments, sample acquisition station is one or more of: hospital, clinic, emergency ward, military place Or in the family of subject.
One aspect of the present invention can be related to a kind of biological sample acquired for Fast Evaluation from subject to assist disease The system of screening, the diagnosis, treatment or prevention of disease, the system comprises: communication unit, for representing the life from equipment reception The electronic data of object sample and/or the image of the chemical reaction carried out at least one component from the biological sample；Institute Equipment is stated to be placed in subject's body or with it or in specified sample acquisition station, wherein the equipment is for handling biological sample, To generate the electricity for representing the image of the biological sample necessary to the subsequent qualitative and/or quantitative assessment of the biological sample Subdata, and wherein the equipment includes the sample collection unit that (i) is used to receive biological sample in shell；(ii) for making Standby biological sample is for subsequent qualitative and/or quantitative assessment sample preparation unit, and wherein the preparation of biological sample is automation 's；(iii) chemistry for recording the image of biological sample and/or being carried out at least one component from the biological sample The imaging unit of reaction；And (iv) is used for transmission the transmission unit of the electronic data of representative image and/or chemical reaction；The place and Device is managed, handles the electronic data of representative image for the subsequent qualitative and/or quantitative assessment of the biological sample.
In some embodiments, sample preparation unit may include (i) pipette, and optionally include (ii) with next Kind or it is a variety of: centrifuge, magnetic separator, filter, vessel, container, determination unit, reagent unit, heater, heat controller, Cell counter, electromagnet source, temperature sensor, motion sensor or the sensor for electrical property.
Described image can be static and/or video image.The data may include representative image and audio signal Electronic data.
Biological sample can be selected from the one or more of the following terms: blood, serum, saliva, urine, tear, gastric juice And/or digestive juice, excrement, mucus, sweat, earwax, oil, glandular secretion object, sperm or vaginal fluid.In some embodiments In, biological sample has 250uL or smaller volume.The component of biological sample can be by carbohydrate, lipid, protein Or the biological analyte of their compositions composition.Chemical reaction can be carried out without biological sample.
Transmission unit is configurable to be wirelessly transmitted the electronic data of representative image.
Equipment is configurable to reception one or more and is configured to qualitative and/or quantitative assessment cylinder casket.In some realities It applies in mode, cylinder casket can have the one or more identifiers that can be read by the equipment.
According to the another aspect of method disclosed herein, system and equipment, evaluate applicant discloses a kind of from subject The method of the biological sample of acquisition, which comprises
(a) data transmitted from the equipment with shell are received in laboratory site, the equipment is placed in subject's body Or with it or it being placed in specified sample acquisition station, the data include the initial data from the biological sample, the biology Sample includes cell, wherein the device configuration is used to handle the biological sample in the shell as follows, this A little steps are as follows: (i) receives the biological sample；(ii) biological sample is prepared in the shell and generates original number According to for the subsequent qualitative and/or quantitative assessment to the biological sample, the initial data includes that (1) representative is set by described The numerical value and (2) of the standby physical process executed or chemical reaction represent the electron number of the image of the cell in the biological sample According to；And (iii) electronically by the initial data from the sample acquisition station be transmitted to authorization analysis facility and/or Its subsidiary body, for executing the subsequent evaluation in the laboratory site；
(b) initial data transmitted from the equipment is analyzed in the analysis facility of authorization and/or its subsidiary body, to provide The evaluation of the biological sample, wherein the analysis individually or with the personal of analysis facility for being attached to the authorization is assisted It is executed with ground using processor；And
(c) supervision of the integrality of the operation to the analysis and the equipment is provided, so that being given birth to by the analysis At result can be come screening, diagnosis or the treatment subject by health care professionals' utilization, wherein the supervision exists The laboratory site individually or with the individual for the analysis facility for being attached to the authorization is synergistically executed using processor.? In embodiment, the sample analysis facility of the authorization be not physically transported to from the website for acquiring the sample or its is attached The evaluation to biological sample is realized in the case where belonging to mechanism.The analysis facility of authorization and/or its subsidiary body, which can be to meet, to face Improve the laboratory of amendment (CLIA) in bed laboratory.In embodiments, specified sample acquisition station can be retail trade station Point, military place, the family of subject, health evaluating place or health treatment place.
In the embodiment of such method, the biological sample is prepared in the shell and generates initial data can A part including transporting reagent, the biological sample or the biological sample with the intracorporal pipette of the shell；And it can Including being centrifuged in the shell to biological sample or part of it.In the embodiment of such method, cell is represented The electronic data of image may include to the histology of the cell, the morphology of the cell, hematology or cell The electronic data of the optical evaluation of counting.In the embodiment of such method, receiving data may include from by the equipment benefit The image of the physical process or chemical reaction that are executed with some or all of biological samples receives data.In the embodiment party of such method In formula, produced by initial data can be measured as more than one, the more than one measurement includes surveying selected from immunoassays, nucleic acid At least two measurements in the fixed, measurement based on receptor and enzymatic determination.In embodiments, initial data can be exempted from by being selected from Produced by least three measurements in epidemic disease measurement, nucleic acid determination, the measurement based on receptor and enzymatic determination.
The optional autoblood of biological sample, serum, blood plasma, nose swab, nasopharynx washing lotion, saliva, urine, tear, gastric juice, spinal cord Liquid, excrement, mucus, sweat, earwax, oil, glandular secretion object, celiolymph, tissue, sperm and vaginal fluid, throat swab, Breathe object, hair, nail, skin, biopsy article, placental fluids, amniotic fluid, Cord blood, lymph, chamber liquid, phlegm, mucus, purulence, microorganism Group, meconium, milk and other excretas.Biological sample can be the fluid sample with 250 μ L or smaller volume.
In embodiments, the method includes evaluating a plurality of types of biological samples acquired from subject, wherein from The data of the equipment transmission include the initial data from a plurality of types of biological samples, wherein the biology sample At least one of product include cell.It is including in the embodiment for evaluating a plurality of types of samples, generating initial data can wrap It includes according to the biological sample of at least two types and at least two measurements and generates initial data, at least two measurement is selected from Immunoassays, nucleic acid determination, the measurement based on receptor and enzymatic determination.Can not by any sample from acquire the sample The website of product be physically transported to the authorization analysis facility and/or its subsidiary body in the case where realize it is such to multiple types The evaluation of the biological sample of type.Fluid sample in such a plurality of types of biological samples can respectively have 250 μ L or smaller Volume.In the embodiment for evaluating a plurality of types of samples, supervision may include for a plurality of types of biological samples In every kind of biological sample and selection analysis method and regulation.
In the embodiment of these methods, supervision includes selection analysis method and regulation.In embodiments, these sides Method includes the steps that the insurance qualification for verifying the subject before the analysis, later or simultaneously.In embodiment party In formula, these methods include generating the report of subject based on the evaluation.
According to the various aspects of method disclosed herein, the equipment can be clinical labororatory and improve amendment (CLIA) Exempt equipment.According to other aspects of method disclosed herein, the equipment can be meet CLIA equipment, can be by meeting The mode of CLIA operates, can be by meeting the laboratory operation of CLIA, or can operate in the place for meeting CLIA；Or It can be CLIA authenticating device, can be operated by CLIA accredited laboratory, or can be operated in CLIA authentication location；Or It can be and ratify the equipment used by United States Food and Drag Administration；Or it can be by U.S.'s food and drug control Office is classified as inspection-free equipment；Or it can be the equipment not yet ratified or checked and approved through any regulatory agency.The equipment may include Sample-processing equipment, or may include sample treatment unit.The equipment may include being classified as sample treatment by regulatory agency The equipment of equipment or sample treatment unit.The equipment can be sample-processing equipment, or may include sample treatment unit.Institute Stating equipment can be the equipment for being classified as sample-processing equipment or sample treatment unit by regulatory agency.
According to the various aspects of method disclosed herein, the analysis facility of the authorization and/or its subsidiary body be can be Meet clinical labororatory and improve the laboratory of amendment (CLIA), and can be CLIA accredited laboratory.According to disclosed herein Method various aspects, the equipment can operate under the control or supervision in the laboratory for meeting CLIA, and can be The lower operation of the control or supervision of CLIA accredited laboratory.For example, the equipment can according to the various aspects of method disclosed herein To be that the CLIA operated under the control for meeting the laboratory of CLIA or CLIA certification exempts equipment.According to disclosed herein The various aspects of method, the equipment can be to be operated under the supervision in the laboratory or CLIA accredited laboratory that meet CLIA CLIA exempt equipment.According to other aspects of method disclosed herein, the equipment can in the laboratory for meeting CLIA or The lower operation of the supervision or control of CLIA accredited laboratory, wherein the equipment can be the equipment for meeting CLIA or CLIA certification is set It is standby；Or it can be and ratify the equipment used by United States Food and Drag Administration；Or it can be by U.S.'s food and medicine Product management board is classified as inspection-free equipment；Or it can be the equipment not yet ratified or checked and approved through any regulatory agency.
According to system disclosed herein, the another aspect of method and apparatus, evaluate applicant discloses a kind of from subject The system of the biological sample of acquisition, the system comprises:
(a) communication unit being placed at laboratory site, the communication unit are configured to from being placed in subject's body or body Equipment that is upper or being placed in specified sample acquisition station receives data, wherein the equipment includes shell and is configured at this Biological sample is handled in shell, the biological sample includes cell, and the processing carried out by the equipment is generated for institute Subsequent qualitative and/or quantitative assessment the initial data of biological sample is stated, and wherein the equipment includes: described in (i) is located at The intracorporal sample collection unit of shell, the sample collection unit are configured to receive the biological sample；(ii) it is located at the shell Interior sample preparation unit, the sample preparation unit are configured to prepare the biological sample in the shell and generate use In the initial data of the evaluation, wherein the raw data packets, which include (1), represents the physical process or change executed by the equipment The numerical value and (2) of learning reaction represent the electronic data of the image of the cell in the biological sample；And (iii) transmission is single Member is configured to for the initial data to be transmitted to the analysis of the authorization from the laboratory site from the sample acquisition station Facility and/or its subsidiary body；
(b) processor being located at the laboratory site, the processor individually or with the analysis for being attached to authorization are set The individual applied synergistically handles the data, and institute is evaluated at the analysis facility of the authorization and/or its subsidiary body for (a) Biological sample is stated, and (b) supervises the integrality of the evaluation and the operation of the equipment, so that being generated by the evaluation Result can be come screening, diagnosis or the treatment subject by health care professionals' utilization.The analysis facility of authorization can To be the laboratory for meeting clinical labororatory and improving amendment (CLIA).Specified sample acquisition station can be retailer's website, Military place, the family of subject, health evaluating place or health treatment place.Can not by the sample from acquire the sample Website be physically transported to the authorization analysis facility or its subsidiary body in the case where realize evaluation to biological sample.
In embodiments, the sample preparation unit of such system may include fluid handling system, the fluid handling system Including being located at the intracorporal pipette of the shell；It and may include being located at the intracorporal centrifuge of shell.It represents in the biological sample The electronic data of the image of cell may include to the histology of the cell or the electron number of morphologic optical evaluation According to, and the initial data may include the physics mistake coming biological sample described in the freely equipment utilization or part of it and executing The initial data of journey or the image of chemical reaction.Initial data may include surveying from least two measurements or from least three Fixed initial data, the measurement are selected from immunoassays, nucleic acid determination, the measurement based on receptor and enzymatic determination.
According to the various aspects of system disclosed herein, the equipment can be clinical labororatory and improve amendment (CLIA) Exempt equipment.According to other aspects of system disclosed herein, the equipment can be meet CLIA equipment, can be by meeting The mode of CLIA operates, can be by meeting the laboratory operation of CLIA, or can operate in the place for meeting CLIA；Or It can be CLIA authenticating device, can be operated by CLIA accredited laboratory, or can be operated in CLIA authentication location；Or It can be and ratify the equipment used by United States Food and Drag Administration；Or it can be by U.S.'s food and drug control Office is classified as inspection-free equipment；Or it can be the equipment not yet ratified or checked and approved through any regulatory agency.
According to the various aspects of system disclosed herein, the analysis facility of the authorization and/or its subsidiary body be can be Meet the laboratory that clinical labororatory improves amendment (CLIA).According to the various aspects of system disclosed herein, the equipment It can be operated under the control or supervision in the laboratory or CLIA accredited laboratory that meet CLIA.For example, according to being disclosed herein System various aspects, the equipment can be to be operated under the control for meeting CLIA's or CLIA certification laboratory CLIA exempts equipment.According to the various aspects of system disclosed herein, the equipment can be in the laboratory for meeting CLIA or The CLIA operated under the supervision of person's CLIA accredited laboratory exempts equipment.It is described according to other aspects of system disclosed herein Equipment can meet CLIA's or CLIA certification laboratory supervision or control under operate, wherein the equipment can be symbol Close the equipment or CLIA authenticating device of CLIA；Or it can be and ratify the equipment used by United States Food and Drag Administration； Or it can be and be classified as inspection-free equipment by United States Food and Drag Administration；Or it can be not yet through any regulatory agency batch Equipment that is quasi- or checking and approving.
In the embodiment of system disclosed herein, the processor at laboratory site is configurable to generate report It accuses；It is configurable to communicate with the database of record of one or more medical records or insurance information comprising subject； And it is configurable to communicate with disburser's database of the insurance information comprising subject.
According to the another aspect of method disclosed herein, system and equipment, evaluate applicant discloses a kind of from subject The method of the biological sample of acquisition, which comprises (a) is from laboratory to the equipment transmission plan for being placed on sample acquisition station Information, the equipment include shell, wherein scheme information mark, update or the action executed including management by the equipment And the scheme of the data acquired by the equipment；(b) according to the scheme, make to acquire in the sample acquisition station from subject Biological sample is in contact with more than first a reagents in reagent a more than second, wherein the reagent more than described second in a reagent The number be greater than more than described first a reagents in reagent number；(c) number is transmitted from the equipment to the laboratory According to wherein the data packet includes the number obtained in the shell of the equipment from the biological sample according to the scheme According to；(d) it is analyzed at the laboratory and the data of the evaluation to the biological sample transmitted effectively is provided, wherein described point Analysis is executed using the processor at the laboratory or by individual associated with the laboratory；And (e) provide prison It superintends and directs, wherein the supervisory packet includes at the integrality for supervising the transmitted data of the analysis or the supervision sample acquisition station The operation of the equipment effectively to be suitable for according to the result analyzing transmitted data and generating by health care professional people Member uses, for screening, diagnosis or the treatment subject, wherein the supervision using at the laboratory processor or It is executed by individual associated with the laboratory.So that biological sample is in contact with more than first a reagents may include using liquid relief Pipe transports at least part of reagent or biological sample.In embodiments, can in the shell to biological sample extremely Few a part carries out obtaining transmitted data after centrifugation.
In embodiments, biological sample the laboratory site be not physically transported to from the sample acquisition station In the case of realize evaluation to the sample.In embodiments, sample acquisition station can selected from the intracorporal website of the subject, Website, retail site with the subject, military place, the family of subject, health evaluating place and health treatment Point.
It in embodiments, may include transmitting initial data to laboratory to laboratory transmission data.In embodiments, Analyze transmitted data can effectively determine the analyte being present in the biological sample presence or concentration or with institute State the associated disease condition of biological sample.In embodiments, such method includes from the sample acquisition station to the reality Test room transmission identification information；And described set is transmitted to including selecting or generating based on the identification information from the laboratory The standby scheme information.Laboratory can be authorization analysis facility, authorization analysis facility subsidiary body or meet The laboratory of CLIA.
In embodiments, equipment is configurable to receive cylinder casket, this tin casket may include a reagent more than second and can match It sets for allowing more than described first a reagents being delivered to the equipment.Cylinder casket is configurable to deliver biological sample to the equipment Product.Identification information may include subject's identification information, the information based on signal relevant to the sample generated, based on institute Generate signal relevant to the reaction executed with the sample information, based on the signal relevant with the sample detected Information, the information based on the signal relevant to the reaction executed with the sample detected, equipment identification information, cylinder casket mark Know information, component identification information and the other information transmitted from the equipment.
In embodiments, scheme may include the instruction about one or more of the following items: the system of a sample It is standby；The preparation of multiple samples；Execute a chemical reaction；Execute multiple chemical reactions；Carry out the sequence of multiple chemical reactions；It holds One clinical trial of row；Execute multiple clinical trials；Execute the sequence of multiple clinical trials；Detect a kind of presence of analyte； Detect the presence of multiple analytes；Detect the existing sequence of multiple analytes；Detect a kind of concentration of analyte；It detects a variety of The concentration of analyte；Detect the sequence of the concentration of multiple analytes；Preprocessed data；And the step sequence in processing data. In embodiments, scheme information can be changed according to the data transmitted, the data of the transmission are according to the scheme It is obtained in the shell of the equipment from the biological sample.
In embodiments, biological sample can have 250 μ L or smaller volume.In embodiments, biological sample can Including cell, wherein the device configuration is used to handle the biological sample in the shell, effectively to obtain from the sample Initial data, the initial data can include: represent from the group to the cell at least part of the biological sample Knit the electronic data of, morphology, kinematics or the image in dynamic (dynamical) optical evaluation；And (2) are derived to the life The data for the measurement that at least part of object sample executes, wherein the measurement is selected from immunoassays, nucleic acid determination, is based on receptor Measurement, enzymatic determination and spectroscopic assay.In embodiments, initial data can from selected from immunoassays, nucleic acid determination, Two or more or three or more measurements among measurement, enzymatic determination based on receptor and spectroscopic assay obtain ?.In embodiments, obtaining initial data may include obtaining the figure represented from two or more optical evaluations The electronic data of picture or multiple images, the group of cell of the optical evaluation at least part to the biological sample Knit, morphology, kinematics and dynamic (dynamical) optical evaluation.
In embodiments, transmission data may include transmission from a plurality of types of biological samples acquired from subject Data, at least one of described biological sample include cell.
The embodiment of method disclosed herein includes such embodiment: wherein obtaining sample and is included at the first time It obtains the first sample and obtains subsequent sample in the subsequent time.
In embodiments, providing supervision may include providing to set to described by the processor at the laboratory site The supervision of standby operation；It and may include selecting analyzing analysis method and regulation used in transmitted data.Implementing In mode, these methods may include verifying the insurance qualification of the subject；Such verifying can be in certain before the analysis A time executes with described some time of analysis simultaneously or some time after the analysis.
In embodiments, method disclosed herein may also include based on the evaluation to the biological sample and generate Report about the subject.
In the embodiment of method disclosed herein, system and equipment, equipment may include temperature sensor, wherein the biography Sensor is configurable to detect and measure the temperature in the equipment or outside the equipment.Temperature in the equipment may include this The temperature of sample, reagent, apparatus assembly, region, surface or compartment in equipment.In method disclosed herein, system and equipment Embodiment in, equipment may include temperature-controlling module, the temperature-controlling module effectively by the equipment temperature keep At a desired temperature or it is maintained within the temperature range of expectation.It can be on the surface of the equipment or the equipment Temperature is measured in region, compartment or component or can keep the temperature.In the implementation of method disclosed herein, system and equipment In mode, equipment is configurable to laboratory report temperature, wherein the temperature can be the temperature on the surface of the equipment, be somebody's turn to do Temperature in equipment, the temperature in the region of the equipment, the equipment every indoor temperature, the equipment component in temperature or Temperature outside person's equipment.
When considering in combination with the following description and drawings, it will further understand and understand other targets of the invention And advantage.Although being described below may include describing the detail of only certain exemplary embodiments of this invention, this should not be explained To limit the scope of the invention, but it should be construed as the example of preferred embodiment.For each aspect of the invention, such as originally Proposed by text, many change known to persons of ordinary skill in the art be all possible to.It within the scope of the invention can be with Numerous changes and modifications can be made, without being away from each other with its spirit.
It quotes and is incorporated to
The all publications, patents and patent applications referred in this specification are incorporated to this by reference with same degree Text is pointed out as particularly and individually being incorporated by reference into like each single publication, patent or patent application.
Detailed description of the invention
Novel feature of the invention is specifically described in appended claims.By reference to using this wherein The features as discussed above that the Illustrative embodiment of inventive principle is illustrated, can to feature of the invention and Advantage is better understood from, in the accompanying drawings:
Figure 1A, which is shown, is related to the operation scheme in laboratory, sample acquisition station and health care professionals.
Figure 1B shows the retailer with the processing equipment communicated with laboratory (for example, CLIA accredited laboratory).
Fig. 2 shows processing equipment, which can be placed in specified sample acquisition station, and be configured to pass through net Network is communicated with one or more other equipment.
Fig. 3 A illustrates the various example components of processing equipment.
Fig. 3 B illustrates another example of equipment.
Fig. 4 shows the example of sample acquisition, processing and analysis method.
Fig. 5 shows the laboratory welfare management person communicated with disburser and sample acquisition station.
Fig. 6 shows embodiment according to the present invention and the laboratory welfare system that provides.
Fig. 7 shows laboratory welfare management person/whole seller's model example of embodiment according to the present invention.
Fig. 8, which is shown, provides sample treatment, the example of the system of analysis and supervision.
Fig. 9, which is shown, provides sample treatment, the further example of the system of analysis and supervision.
Figure 10 A shows embodiment according to the present invention and the example of laboratory welfare system that provides.
Figure 10 B shows embodiment according to the present invention and the example of laboratory welfare system that provides.
Figure 10 C shows embodiment according to the present invention and the example of laboratory welfare system that provides.
Figure 10 D shows embodiment according to the present invention and the example of laboratory welfare system that provides.
Specific embodiment
It is aobvious and easy for those skilled in the art although the preferred embodiment of the present invention has been illustrated and described herein See, such embodiment only provides in an illustrative manner.Those skilled in the art will now occur many changes, change and replace Generation, without being away from each other with the present invention.It should be understood that the implementation of invention described herein can be used in the practice of the invention The various alternative solutions of mode.
The present invention provides for acquiring and transmitting about the data of sample and frequent representative sample so as to sample Further analysis do not need the system and method to the physical transportation of sample.Each fermentation of invention described herein can fit Diagnosis or measurement system for any specific application set forth below or applied to any other type.The present invention can be used as Independent system or method are applied, or as a part of integrated system, such as in laboratory, health care professionals It is applied in system between sample acquisition station.It should be appreciated that different aspect of the invention can individually, jointly or each other Understand in combination.
It must be noted that in the specification and the appended claims used in singular "one", "an" " described " includes plural reference object, unless the context otherwise clear meaning.Therefore, for example, finger is referred to " reagent " Single reagent and also refer to multiple reagents, and the finger that refers to of " measurement " is individually measured and also refers to multiple measurements.
In description herein and used in appended claims " ... in " meaning include " ... In " and " ... on ", it is clear signified unless the context otherwise.
Meaning in description herein and through "or" used in appended claims not only included connectivity but also It is clear signified unless the context otherwise including Compartmentalization.Therefore, term "or" includes "and/or", clear unless the context otherwise It is signified.
Term " embodiment " and phrase " in embodiments " and its language used in description herein become Body refers to devices disclosed herein, the example feature of system and method, element, ability and their combination.To specific spy The disclosure of the specific combination of sign or element or ability or feature, element or ability is not restrictive, but to such spy Sign, element and ability illustrate, and may include other combinations and other aspects of this category feature, element and ability.
In the present specification and in appended claims, it will refer to multiple terms, these terms should be defined as It has following meanings:
Term as used herein " analyte " and its plural form and other forms include but is not limited to drug, prodrug, Medicament, drug metabolite, the protein such as expressed and cell marker etc biomarker, antibody, antigen, albumen Matter, hormone, polypeptide, glycoprotein, polysaccharide, lipid, virus, cholesterol, polysaccharide, nucleic acid, gene, nucleic acid and combinations thereof.
Term as used herein " cell count " refers to thin in sample or in volume or in the visual field or on surface The qualitative or quantitative assessment of born of the same parents' number.(cell in sample is passed through for example, passing through to the estimation of the cell number in sample The absorbance of light or the light for being scattered by the cell in sample or otherwise being changed is estimated；By by expression fluorescence Or otherwise detectable protein or by dyestuff, radionuclide or other label substance markers cell launch Light or other radiation estimated)；To image (for example, the blood obtained by camera, microscope or other optical imaging apparatus Or the image of urine sample, histotomy or other biological sample) in cell number calculating, and to being adhered to surface The quantitative measurment of the number of cell is all the example of cell count.
Term as used herein " cell counting " refers to observation relevant to the cell of biological sample, analysis, method With as a result, wherein cell is substantially stationary in a fluid or in substrate.It is detected by cell counting and the cell analyzed can be by Any fluorescence detector, photodetector or acoustic detector detection and analysis.Cell counting may include preparation and analysis biology In sample or come biological sample cell image (for example, two dimensional image).Cell can be marked (for example, benefit With fluorescent marker, chemiluminescent labels, enzyme marker or other markers), plate apply (plate) (for example, being allowed to fall to In substrate) and detection.Such as cell can be imaged by camera.Microscope can be used for the cell in cell counting at Picture；For example, cell can be by camera and microscope imaging, such as forms by using microscope the camera of image and be imaged.By Cell counting is formed and the image for cell counting generally includes more than one cell.Term as used herein " cell counting " refers to the measurement carried out relative to equipment without significant cell movement (for example, opposite in cell It is observed and is imaged when the rest of equipment).In this regard, term as used herein " cell counting " is no It is same as the term referred to by more restrictive term " flow cytometry ", and refers to different observation, analysis, side Method and result.
Term as used herein " flow cytometry " refers to observation and analysis to cell, wherein cell in equipment or Apparent motion of the person relative to equipment.Flow cytometry is usually using mobile liquid medium, and the medium is sequentially by individual cells It carries to fluorescence detector, photodetector or acoustic detector, for example, in typical flow cytometry, cell is by moving Fluid is carried by static detector.
Term as used herein " microscopy ", which refers to using amplifying lens and other optical means, provides such as one The image of the targets such as cell or multiple cells.Microscopy generally detects static cell using optics or acoustic means, generally It is the image by record at least width amplification.The image formed by microscopy usually provides and checks target by visually than only When the bigger resolution ratio of the resolution ratio that is likely to be obtained；For example, image can be amplified.In addition to use for refraction lens it Outside, optical means and technology used in microscopy include using reflective mirror, prism, polarizer, grating, grid, light source, sweep Retouch methods and techniques (for example, such as methods and techniques used in confocal microscopy), special aperture (for example, pin hole) and Other methods.
" spectrum analysis " used herein refers to the measurement and measurement for carrying out testing and evaluation sample using luminous intensity, described Luminous intensity includes the luminous intensity of the function as optical wavelength.Spectrum analysis includes measurement electromagnetic wave (including visible light, UV and infrared Line) reflection or transmission.Spectrum analysis includes generating any and all measurements for shining or changing light (for example, colour chemistry). This may include one or more of: spectrophotometry, fluoremetry, photometering, turbidimetry, turbidimetric analysis turbidimetry, refraction measurement, Polarimetry and agglutination measurement.
Term as used herein " fluoremetry " refers to measurement when exciting fluorescent molecule with incident light by being coupled to master The light of the fluorescent molecule transmitting of body.
Term as used herein " photometering " refers to without using exterior lighting method, but detects by or from interested Object, chemical reaction or the electromagnetic radiation of field emission measurement and observation.The light of transmitting may be faint, therefore luminosity Measurement may need to detect low light or other radiation levels；Extremely sensitive sensor can be used to detect in such signal, example Such as use photomultiplier tube (PMT).Photometering includes generating chemiluminescent measurement, such as survey using those of luciferase Some measurements fixed or using peroxidase.
Term as used herein " turbidimetry ", which refers to by illuminating the component in sample and sample with white light backlight, to be examined It surveys, the reaction in measurement or observation sample or sample, result is sensed with imaging sensor.Measure the intensity of the light of transmission It reduces (known to the intensity of incident light).Turbidimetry is for example determined for the cell concentration in solution.In some embodiments In, turbidimetry is measured by turbidimetric analysis turbidimetry.
Term as used herein " turbidimetric analysis turbidimetry " refers to that measurement is passing through suspension (for example, target point in the solution Analyse object suspension) after transmit or scattering light.For example, can be measured by turbidimetric analysis turbidimetry and such as IgM, IgG and IgA The amount for the substrate that equal immunoglobulins combine.
Term as used herein " polarimetry " refer to measurement light or other electromagnetic radiation reflection, refraction or with master Polarization after other contacts of body target or main body field.Polarimetry analysis include can provide structural information circular dichroism and It can provide the determination of light scattering of the information of the size and/or shape about main body.One non-limiting example of determination of light scattering It uses dynamic light scattering (DLS).
Term as used herein " coloring agent " and " chromogen " refer to generation or provide color, the absorbance, turbidity of medium Or the compound of the detectable variation in other optical properties.Chromogen can be used for signal indicate chemical reaction generation, Progress or as a result, the signal can be measured by colorimetric device or other devices (for example, by photometer, spectrophotometer or its His photo-detector measurement).
Term as used herein " product is formed ", " color products ", " color products are formed " etc. are for referring to solution The product for adding the behavior of coloring agent and being generated and adding coloring agent to solution.For example, can to solution addition coloring agent Lead to the reaction for effectively changing the optical property of solution.Such reaction can lead to the shape for the molecule being initially not present in solution At, perhaps can lead to the previously polymerization of molecule or compound in the solution or can lead to previous in the solution molecule or The degradation of compound or other variations, thus effectively change the color of solution for adding coloring agent thereto, absorbance and/or Other optical properties.
Term as used herein " reflection " and " reflection measurement ", which refer to, to be based on obtaining after initial measurement, measurement or analysis Information or result and start, modify or iteration scheme, measurement, measuring method or analysis.Reflection measurement can be in following feelings Executed under condition: by initial measurement (it can be supplemented by further testing) obtained information suggestion should execute it is more accurate or More specifically measurement, or suggesting should be for the relevant or analyte as proposed by initial measurement or condition to initial measurement And execute additional testing.Reflection measurement is executed generally, based on the result of initial testing；Initial testing is usually than reflection measurement spirit Sensitivity is low, cheap or quick.For example, reflection measurement can occur when detecting possible exception with initial Pap smear, Later, it is tested more accurately to assess that more specific or more accurate test (such as using the test of foranalysis of nucleic acids) can be executed The situation of person.Another example of reflection measurement may include being based on finding lower hematocrit levels in initial sample of blood And measure the folate level in the blood of subject.
Term as used herein " sample " and " biological sample " include entire sample and one including entire sample Part or multiple portions, it is clear signified unless the context otherwise." sample " may include but be not limited to sample selected from the group below: blood Liquid, serum, blood plasma, nose swab, nasopharynx washing lotion, saliva, urine, tear, gastric juice, spinal fluid, excrement, mucus, sweat, earwax, Oil, glandular secretion object, celiolymph, tissue, sperm, vaginal fluid, throat swab, breathing object, hair, nail, skin, biopsy Tissue or fluid, placental fluids, amniotic fluid, Cord blood, lymph, chamber liquid are (for example, the stream for acquiring or being discharged from the body cavity of subject Body), phlegm, mucus, purulence, micropopulation, meconium, milk and other secretion and excreta.
" processing " sample used herein refers to receive, modify, test, represent and characterize sample and the row taken It is dynamic, and may include dilute sample, sample is made to be processed (for example, centrifugation, filtering or other processing), classification separation or separation Sample composition contacts sample with reagent, makes sample coloring or dyeing, observation sample, test sample or other action, for example, For determining the action of the feature or property of sample；Processing sample may include image or the expression for obtaining sample or sample composition.
Term as used herein " sample acquisition station " refers to the place that sample can be obtained from subject.Sample acquisition station Such as it can be retailer place (for example, chain store, pharmacy, supermarket or department store), supplier office, doctor's office Room, hospital, the family of subject, military place, employer website or other websites or website combination.Term as used herein " sample acquisition station " can also refer to the owner or the representative of the business for being located at or being attached to the website, service or mechanism.Therefore, For example, phrase " e bill from specified sample acquisition station " and " the electronics branch from specified sample acquisition station Pay " refer to the bill or payment of the representative from the owner or the owner for being located at or being attached to the sample acquisition station.
Term as used herein " retailer ", " retailer's website ", " retail site " etc., which refer to, occurs retail operations (pin Sell and other business transactions) place.These terms used herein can also refer to the industry for being located at or being attached to retail site Business, service or the owner or the representative of mechanism.
Phrase " not handling sample by subject or operator " used herein and language equivalent item mean that sample is (all Such as blood sample, urine sample, fecal specimens or other samples) it can be placed directly in container for further processing, and Mean not needing any action other than realizing those required to the placement of sample in a reservoir action.
" numerical value " used herein (for example, such as represents the physical process or chemical reaction executed by equipment Numerical value) refer to the output of sensor, detector or other assemblies or equipment, for measure physical parameters, such as luminous intensity, extinction Degree, temperature, pH or the other parameters useful for measurement physical process or chemical reaction.Such numerical value can be the analogue value (that is, continuous variable) or digital value (that is, discrete variable), and can according to need or convenient for measurement and logarithm is asked Be averaged, normalize, branch mailbox or otherwise manipulated.
" electronic data of representative image " used herein refers to camera, microscope, charge-coupled device or can There is provided data other sensors, can be used to form image or the electronics of the expression of image output.When being configured for being formed Or when image (for example, in the form of an array provide) is provided, including photodiode, photomultiplier tube, photovoltaic element and other The sensor and component of photosensitive electronic building brick can be used for wholly or partly providing the electronic data of representative image.
Term as used herein " data " include it is any type of, to sample (part including sample) or sample All information that test, measurement or the observation that the reaction participated carries out obtain or associated.Data include original Data, pretreated data and processed data.
" initial data " used herein includes coming sensor, the camera of the property or characteristic of self-test or measurement sample With the signal of other assemblies and instrument and directly reading.For example, initial data includes coming from sensor, detector, counter, phase The output of the voltage or electric current of machine or other assemblies or device；Initial data includes coming from sensor, detector, counter, phase Machine or other assemblies or the output of the number or simulation value of device；And initial data may include from sensor, detector, The digitlization of counter, camera or other assemblies or device or filtered output.For example, initial data includes photometric Output, which may include the output of " relative light unit " relevant to the number of photon detected by photometer.Original number According to may include by camera generate JPEG, bitmap or other image files.Initial data may include cell count；Luminous intensity ( Certain wave strong point, or the luminous intensity at wave-length coverage or in wave-length coverage)；The change rate of the output of detector；In two times Difference between the similarity measure of progress；The number of the event detected；It is detected in the preset range for meeting pre-set criteria Event number；The minimum value measured within a certain period of time or in the visual field；Within a certain period of time or in the visual field The maximum value inside measured；And other data.It, can be without the case where being further processed or analyze when initial data is abundant It is lower to use initial data；In general, initial data is further processed, or for sample, subject is relevant further divides Analysis, or it is used for other purposes.
" pretreated " data used herein include from by baseline correction, filtering, sum, be averaged, The data of normalization, scaling or the initial data otherwise manipulated.Pretreated data may include branch mailbox data or change Data (for example, being converted to the time domain data in frequency domain by Fourier transformation) is changed, or can be combined with other data. Data can be become desired form by pretreatment, and can be related to the format of change data；However, data prediction does not execute reality Border data are analyzed or compared with any threshold values, and do not change the content of data.
" processed data " used herein includes by initial data, pretreated data or other are processed Combination, manipulation or the analysis of data and the data and analysis generated.Processing may include comparing (for example, with baseline, threshold value, standard Curve, historical data or the data from other sensors compare), combination, mathematical manipulation or correction, curve matching, general Data are used as mathematical reasoning or other analysis ratiocinations (including deduction, induction, Bayesian inference or other reasonings) The processing of basis and other forms well known by persons skilled in the art.
As used herein, term " immunoassays " refers to such test, which utilizes antibody (including antibody piece Section) and the combination of they and target molecule mark, identify, quantitatively or otherwise provide about target molecule and contain target molecule The presence of sample, amount and property information.A kind of useful immunoassays that can be run in device disclosed herein are ELISA (enzyme linked immunosorbent assay (ELISA)).Immunoassays further include, for example, competitive binding assay, sandwich assay, Western print Mark method uses the measurement of antibody and antibody fragment with other.
As used herein, term " nucleic acid " refers to the molecule formed by nucleotide chain, such as DNA point Son (DNA), ribonucleic acid molecule (RNA), and including locked nucleic acid, " peptide nucleic acid " (PNA) and it is other similar in or simulation DNA Or the nucleic acid analog of RNA.
As used herein, term " nucleic acid determination " is referred to using any and complete of the nucleic acid in nucleic acid or test sample Portion's measurement.Nucleic acid hybridizes with complementary nucleic acid, and property can be used for identifying target nucleic acid and for identifying sample, either contains target Fluid, tissue or other samples of nucleic acid.Nucleic acid determination is using and including for (for example, pass through the copy for generating target nucleic acid Or the copy with the nucleic acid of complementary target) amplification target nucleic acid technology.Nucleic acid determination includes, for example, anti-using polymerase chain The measurement answered, Southern blotting, Northern blotting and other can identify and allow the survey of the nucleic acid in test sample It is fixed.
As used herein, term " measurement based on receptor " refer to utilizing or detecting receptor and its ligand combination or Measurement of the ligand from the dissociation on its receptor.This can be used directly in conjunction with detecting or quantitative receptor or ligand in such measurement In the presence of or amount, competitive binding technology can be used to detect or the presence or amount of quantitative sample target, or can be by making With other methods detection or the presence of quantifying target target or amount based on the combination between receptor and a kind of ligand or multiple ligands.
As used herein, term " enzymatic determination " refers to utilizing or detecting the measurement of presence or the effect of enzyme.For example, The substrate of target enzyme is provided and detects the presence or the quantitative active survey of the enzyme in the sample of the enzyme after adding the substrate It is fixed, it is a kind of enzymatic determination.It is another example of enzymatic determination using the measurement that the enzymatic of detectable substance generates；For example, (for example, wherein generating detectable product by enzyme, which can be endogenous enzymes or can mention together with measurement reagent for colorimetric estimation For), such as use horseradish peroxidase or alkaline phosphatase to generate color products as reaction progress or the existing finger of target The measurement for showing object is enzymatic determination.
" clinical labororatory improves amendment " used herein and " CLIA " refer to the 42nd part F of United States Code Clause (for example, the 2nd subdivision, the 263a articles to the 263a7 articles), (the 493.1st article extremely for " federal regulations " the 42nd section IV 493.2001st article) and relevant law, regulation and amendment.Regulation according to CLIA is by US Health and Public Service Department Medical insurance and Medicaid Service center (CMS) execute.
Term as used herein " meeting CLIA " means that equipment, regulation, operation, laboratory or other facilities meet through repairing Positive CLIA.
Term as used herein " CLIA certification " means equipment, regulation, operation, laboratory or other facilities by having the right The appropriate regulatory agency certification of certification is made to meet the CLIA being corrected.
Term as used herein " laboratory for meeting CLIA " mean the laboratory for meeting the CLIA being corrected or other Facility.
Term as used herein " CLIA accredited laboratory " means to be recognized by the appropriate regulatory agency for having the right to make certification Card is laboratory or other facilities for meeting the CLIA being corrected.CLIA accredited laboratory is the laboratory for meeting CLIA.
It is used herein be referred to as " equipment for meeting CLIA " equipment be meet be corrected CLIA's or its make Equipment with the CLIA being corrected is met.
" CLIA exempt equipment " used herein be meet the CLIA being corrected, by having the right issue the suitable of exemption certificate When regulatory agency according to CLIA issue exemption certificate equipment or its use the appropriate prison met by having the right to issue exemption certificate Pipe mechanism is according to the equipment of the CLIA exemption certificate issued.It is to meet the equipment of CLIA that CLIA, which exempts equipment,.
" CLIA authenticating device " used herein means: being symbol by the appropriate regulatory agency certification for having the right to make certification It closes the equipment of CLIA that is corrected or it is issued by the appropriate regulatory agency for certificate of having the right according to CLIA using meeting The equipment of certificate.CLIA authenticating device is the equipment for meeting CLIA.
The equipment meaning of " according to " U.S.'s food, drug and cosmetics bill " the 510th (k) article of approval " used herein Refer to: by United States Food and Drag Administration or its continuity mechanism according to " U.S.'s food, drug and cosmetics bill " the 510th (k) equipment that item approval is sold or used in the U.S..
" according to the 510th (k) article of " U.S.'s food, drug and cosmetics bill " without substantial equivalence " used herein is set It is standby to mean: to there is no for it and sold according to " U.S.'s food, drug and cosmetics bill " the 510th (k) article of approval in the U.S. Substantial equivalence equipment equipment.
The equipment of " not yet ratify or check and approve through any regulatory agency " used herein means: not yet obtaining according to CLIA Certificate and United States Food and Drag Administration are not yet received or it continues mechanism approval according to " U.S.'s food, drug and change Cosmetic bill " the 510th (k) article of equipment sold or used in the U.S..
Phrase " operating under the control in the laboratory for meeting CLIA " used herein means: equipment, method or system Control of the operation by the laboratory for meeting CLIA.
Phrase " operating under the supervision in the laboratory for meeting CLIA " used herein means: equipment, method or system Operation under the supervision in the laboratory that meets CLIA.
Phrase " operating under the control or supervision in the laboratory for meeting CLIA " used herein means: equipment, method Or control of the operation of system by the laboratory for meeting CLIA；The operation of equipment, method or system is in the reality for meeting CLIA It tests under the supervision of room；Alternatively, the operation of equipment, method or system by the laboratory for meeting CLIA control and in its prison It superintends and directs down.
Figure 1A shows the system including laboratory 110, designated samples acquisition station 120 and health care professionals 100. Equipment 130 may be provided in designated samples acquisition station.Sample acquisition station can be the first place, and laboratory may be provided in the second ground Point.First place and the second place can be different place.First place and the second place can be positioned such that them each other It keeps off.Health care professionals may be provided in third place, although he/her can be attached to laboratory, be employed by laboratory Or contract is signed with laboratory.Third place can be the place different from the first place and the second place.Third place can determine Position is at making it keep off the first place or the second place.Laboratory, health care professionals and sample acquisition station can be all It is in place different from each other.In one example, laboratory, health care professionals and/or sample acquisition station can be located At individual facility.Alternatively, one or more of which can be in same place.
Laboratory can be the entity for being able to carry out clinical trial or the collected data of analysis or facility or system or set It is standby.Laboratory can provide controlled condition, and scientific research, experiment and measurement can be carried out under the controlled condition.It laboratory can To be medical laboratory or clinical labororatory, can wherein carry out the test about clinical sample or can occur it is related from The analysis of the data of clinical sample acquisition, to obtain the screening for being related to disease, diagnosis, prognosis, treatment and/or prevention, pass In the information of patient health.Clinical sample can be the sample acquired from subject.Preferably, if other each places herein are into one Step is described in detail, and can acquire clinical sample from subject in the sample acquisition station being located at the facility separated with laboratory.It can be used It is placed on specified sample acquisition station or subject or intracorporal equipment from subject acquires clinical sample.
In some embodiments, laboratory can be accredited laboratory.Accredited laboratory can be authorized analysis Facility.In some embodiments, authorized analysis facility may include the analysis facility of signing.For example, accredited laboratory or Other laboratories can send image to the expert for being in another laboratory (it can be accredited laboratory) for analysis.
Authorized analysis facility may be applicable to any description in laboratory herein, and vice versa.In some feelings Under condition, laboratory can be authenticated by government organs or professional association.Laboratory is subjected to the certification or supervision of regulatory agency.At one In example, laboratory can be by entity authentication, all for example medical insurances of the entity and Medicaid Service center (CMS), the U.S. Pathology association (College of American Pathologists), iso standard 15189 or 17025 or its equivalent entities. For example, it is authorized analysis facility can be the U.S. clinical labororatory improve amendment (CLIA) certification laboratory or its Equivalent entities in foreign administrative area.
Authorized analysis facility is usually supervised or is supervised.For example, laboratory can have the reality authenticated by the committee The supervision that body (it may include the personnel of one or more committee's certifications) is made.In some embodiments, supervision may include Verify one or more clinical trials.Supervision, which may also include, assesses the execution of one or more clinical trials, to this or more A clinical trial makes correction, calibration, operation control, repeats, adjusts or analyze.Supervision may include to one or more groups of data Evaluation, to provide the quality control for clinical trial.Authorized analysis facility can have one or more qualified people Member provides supervision.For example, one or more virologists or other health care professionals can check by facility processing Data and/or analysis.In the analysis facility of authorization, trained virologist or other authentication of medical health professional can Supervision is provided.In some cases, the authentication of medical health professional for providing supervision can be one or more of: pathology Learn certification doctor, the professional service field that health care professionals are responsible for have laboratory training or experience doctor or Profession has the individual of experience or laboratory training herein.
Supervision can further comprise following authentication of medical health professional: it can establish regulation and rule in the lab Then, the problem and/or training/evaluation experimental room personnel are handled.Supervision may also include that selection test method, validation test Regulation and the test execution characteristic for establishing laboratory, registration participate in the proficiency testing plan of HHS approval, and foundation is suitable for performed Test quality control planning, establish analysis execute acceptable level parameter, it is ensured that in entire test process always These levels are kept, technical problem is solved and ensure to take remedial action when test macro deviates the execution specification established, really Guarantor does not report patient's test result before having taken all correct actions, determines training demand and ensures to execute each of test Individual receives regular in-service training and education, evaluates the competent ability of all testers and ensures that employee keeps it to execute test (for example, there are also the regulations for being used for Stakeholder Evaluation: directly observation routine test executes the competent ability of regulation, the note of monitored results Intermediate Test Results, record etc. are checked in record/report, and test execution is assessed in the execution of optical viewer maintenance, and evaluation problem solves Ability), and/or evaluate and record the personal performance of responsible intermediate complexity test (for example, every half a year one during First Year It is secondary；Hereafter at least annual, unless test method or instrument change).Supervision may include checking and/or validation laboratory's regulation Or the functionality of equipment, and/or the validity of data acquire and/or generation.Supervision can ensure that the matter of remaining item Amount and/or data are placed in such situation: at this time health care professionals can be provided by it screening, diagnosis, Treatment, including but not limited to prophylactic treatment.Supervision may include testing by rule of thumb to check.Supervision may include herein other everywhere The one or more of description, two or more or any number of project.
In some cases, supervision can be provided by supervisor software program rather than authentication of medical health professional.? Under some cases, provide one, two more or the supervision of multiple types can be realized by supervisor software program.It can be using prison The combination of software program and health care professionals are superintended and directed to provide supervision.In some cases, one, two or more class The supervision of type can be realized in software program by health care professionals.For example, health care professionals can determine with it is soft The associated regulation of part program and rule.In some cases, software program can be self learning type.Software program may have access to Constantly increase the rule or regulation of data pool and/or continuous evolution.
In some embodiments, supervisor software program may be provided in equipment.Supervisor software program can be acquired in sample It stands offer, in equipment or not in equipment.Software program may be provided in laboratory, the analysis facility such as authorized.One In a little situations, equipment can receive the update to supervisor software program.Update can by or can not be provided by laboratory.Supervision Software can store in memory, and may include computer-readable medium, which includes that can hold Code, instruction or the logic of row step.
In some cases, supervisor software may include one or more algorithms, and the algorithm can check executable sample Product are qualitative and/or quantitative assessment.Supervisor software program can find outlier, it may be determined that whether qualitative and/or quantitative assessment is appropriate Execute, can be performed with record or data point it is one or more relatively, can be performed the statistical analysis to evaluation, or such as this paper its His described any other supervision action everywhere.Supervisor software may be able to carry out one or more calibrations and/or diagnosis.
The health care professionals of the analysis facility of authorization can receive and/or check data.The analysis facility of authorization Health care professionals can be attached to or be associated with the analysis facility of authorization.In some cases, health care professionals It can be employed by the analysis facility authorized or be signed with contract with it.Health care professionals can be located at the analysis facility of authorization, can It is located remotely from place of the analysis facility of authorization, or (such as hospital, center of excellence, profession lead path/small in another analysis facility Group) among.In some cases, health care professionals are in test execution or when the analysis facility of authorization receives data It does not need always at the scene, but can get in touch on the basis of as needed, in order to provide consulting.It can relate to Health care professionals, in order to provide scene, phone and/or electronic consultation.
The health care professionals supervised are provided and report can be received from the analysis facility of authorization to examine for subject The health care professionals of disconnected, treatment, monitoring or prevention disease can be different personal or identical individual.For example, awarding The virologist of the analysis facility of power can be the individual different from the prescriber of subject.The medical treatment of the analysis facility of authorization Health professional, which can be, checks health care professionals or supervision health care professionals.It can receive the medical treatment of report Health professional can be the health care professionals for having subscribed to the test that subject is subjected to.Different health cares is special Industry personnel can provide analysis, and different health care professionals can provide supervision.Alternatively, identical health care is special Industry personnel can provide analysis and supervision simultaneously.
Specified sample acquisition station can be the place service point (POS).Herein to any disclosure of sample acquisition station Also it is applicable to service point place, and vice versa.It can wherein acquired from subject or provide the service of sample by subject Point place can be the place far from laboratory.Sample acquisition station can have the facility separated with laboratory.Sample can or Person can not be in sample acquisition station from the fresh acquisition of subject.Alternatively, sample can be acquired and be brought to from subject elsewhere Sample acquisition station.Sample acquisition station in service point place can be blood collection center or any other biological fluid extracting center. Sample acquisition station can be biological sample collection center.In some embodiments, sample acquisition station can be retailer.Retail The example of quotient is in other further offers in detail everywhere herein.Other examples of sample acquisition station may include hospital, clinic, medical treatment Office, school, Day Care Center, health center, auxiliary life residence, the government bodies, flowing doctor of health professional Treat nursing unit, mobile unit, emergency vehicle (for example, aircraft, ship, ambulance) or house.For example, sample is adopted Collection station can be the house of subject.Sample acquisition station can obtain place and/or health evaluating and/or treatment place in sample (it may include other described any sample acquisition stations everywhere herein, including but not limited to emergency ward, doctor's office, first aid Stand, screening canopy (it can be in remote site), come into someone house provide residential care health care professionals).Sample Acquisition station can be in any place for wherein receiving the sample from subject by equipment.Any place can be designed to sample Acquisition station.Specified to be made by any party concerned, the party concerned includes but is not limited to laboratory, the reality for being associated with laboratory Body, government organs or regulatory agency.Any description herein in regard to sample acquisition station or service point can be related to or be suitable for zero Quotient, hospital, clinic or any other example provided herein are sold, and vice versa.
It can provide equipment in sample acquisition station.The equipment is configurable to receive sample.The equipment can be referred to sample and adopt Collect equipment.The equipment is also referred to as sample-processing equipment.The equipment also can be referred to reader.To reader Any description may be applicable to any equipment that can be received sample and/or handle sample.Equipment may be received in sample acquisition The sample stood from subject's acquisition, or the agent of subject or subject is received to carry to the sample of service location.Equipment Sample directly can be acquired from subject, or intermediate equipment or technology can be used and acquire sample from subject.Acquisition technique and In this paper, other are more fully described the example of mechanism everywhere.
In some cases, equipment can be placed in subject's body or with.For example, equipment can swallow (example by subject Such as, referring to U.S. Patent Publication No. 2006/0182738, U.S. Patent Publication No. 2006/0062852, U.S. Patent Publication No. 2005/0147559, U.S. Patent Publication No. 2010/0081894, above-mentioned document are integrally incorporated by reference hereby).Equipment It can be pill, or with the gastral another shape that may pass through subject.Equipment can plant in subject's body.For example, Equipment can be implanted in subject's body.In another example, equipment can be by subject wears.Equipment can pass through tape, bonding Agent, be integrated into clothes or any other technology and be attached to subject.It is tested that equipment may include that one or more can penetrate The needle or micropin of person's skin.Equipment can be the patch that can be worn by patient.Equipment may include automatic blood sampling cylinder casket.Cylinder casket can be with It is disposable.One or more disposable assemblies can be used and acquire sample from subject.Disposable assembly can be by the sample It is supplied to non-disposable equipment.Alternatively, disposable assembly can be sample-processing equipment.
Equipment once can receive sample from subject.Alternatively, equipment periodically can receive sample from subject.This It can be carried out with the interval being periodically ranked, or be carried out in response to one or more situations detected.Equipment optionally may be used Subject is applied and is treated.Equipment can apply one or more therapeutic agents to subject.Therapeutic agent can be applied with the interval being ranked With, or apply in response to the situations that detect of one or more.Therapeutic agent may be in response to from sample detection to one or Multiple conditions and apply.
In some cases, equipment can be supplied to subject in specified sample acquisition station.Alternatively, subject can be in office What his place obtains or contact arrangement.
The example of sample may include various fluids or solid sample.In some cases, sample can be from subject Humoral sample.Sample can be aqueous specimen or gaseous sample.In some cases, it is possible to provide solid or semisolid sample. Sample may include the tissue and/or cell acquired from subject.Sample can be biological sample.The example of biological sample can wrap It includes but is not limited to blood, serum, blood plasma, nose swab, nasopharynx washing lotion, saliva, urine, gastric juice, spinal fluid, tear, excrement, glue Liquid, sweat, earwax, oil, glandular secretion object, celiolymph, tissue, sperm, vaginal fluid, the interstitial from tumor tissues Liquid, intraocular liquid, spinal fluid, throat swab, breathing object, hair, nail, skin, biopsy article, placental fluids, amniotic fluid, Cord blood, lymph Liquid, chamber liquid, phlegm, purulence, micropopulation, meconium, milk and/or other excretas.Sample may include nasopharynx washing lotion.Nose swab, Throat swab, fecal specimens, hair, nail, earwax, breathing object and other solids, semisolid or gaseous sample analysis before, One fixed or variable time can be for example processed in Extraction buffer.It if necessary, can be then similar Extraction buffer or its aliquot are handled like that in other fluid samples.The example of subject group tissue samples may include but unlimited In connective tissue, musculature, nerve fiber, epithelial tissue, cartilage, carcinous sample or bone.Sample can provide from people or move Object.Sample can provide from mammal, vertebrate, such as muroid, ape and monkey, people, farm-animals, sport animals or pet.Sample Product can be acquired from subject live or dead.Sample can from subject it is fresh acquisition or can undergo it is some form of it is pre- from Reason, storage or transport.
Can be acquired from subject it is one or more, two or more, three or more, four kinds or more, five kinds Or more, six kinds or more, seven kinds or more, eight kinds or more, ten kinds or more, 12 kinds or more, 15 kinds or more or 20 kinds or more different types of samples.It can be simultaneously or in different time from subject Acquire the sample or a plurality of types of samples of single type.The sample of single type or a plurality of types of samples can be simultaneously or not It is received by the device or can be received with the time.A plurality of types of samples can concurrently and/or in turn be handled by equipment.Example Such as, equipment can receive simultaneously body fluid and tissue or fecal specimens and body fluid.In another example, equipment may energy Enough receive a plurality of types of body fluid, such as blood and urine.For example, equipment can receive one or more types, two kinds Or more type, three kinds or more seed types, four kinds or more types, five kinds or more types, six kinds or more Type, seven kinds or more types, eight kinds or more types, ten kinds or more types or 20 kinds or more The body fluid of type.
The different acquisition mechanism or identical collecting mechanism that equipment can be used acquire a plurality of types of samples.
Subject can provide sample and/or sample and can acquire from subject.Subject can be human or animal.By Examination person can be mammal, vertebrate, such as muroid, ape and monkey, people, farm-animals, sport animals or pet.Subject can Be live or it is dead.Subject can be patient, clinical trial subjects or preclinical subject.Subject can undergo sieve It looks into, diagnose, treating, monitoring and/or disease prevention.Subject can by or can not be by the shield of health care professionals Reason.Subject can be people, baby, child, adult or the elderly at any age.
The sample of any volume can be provided from subject.The example of volume may include but be not limited to: about 10mL or smaller, 5mL or smaller, 3mL or smaller, 1 μ L or smaller, 500 μ L or smaller, 300 μ L or smaller, 250 μ L or smaller, 200 μ L or more Small, 170 μ L or smaller, 150 μ L or smaller, 125 μ L or smaller, 100 μ L or smaller, 75 μ L or smaller, 50 μ L or smaller, 25 μ L Or smaller, 20 μ L or smaller, 15 μ L or smaller, 10 μ L or smaller, 5 μ L or smaller, 3 μ L or smaller, 1 μ L or smaller, 500nL or Smaller, 250nL or smaller, 100nL or smaller, 50nL or smaller, 20nL or smaller, 10nL or smaller, 5nL or smaller, 1nL or Smaller, 500pL or smaller, 100pL or smaller, 50pL or smaller or 1pL or smaller.The amount of sample can be about one drop sample Product.The amount of sample can be the finger by puncturing or the amount of fingerstick acquisition.The amount of sample can be by micropin or vein pumping The amount of blood device acquisition.Any volume including volume described herein can be provided to equipment.
Health care professionals may include personnel associated with health care system or entity.Health care professional people Member can be health care provider.Health care professionals can be doctor.Health care professionals can be to be Systemization mode provides preventative, therapeutic, publicity property or rehabilitation Health Care Services to subject, family and/or community Personal or mechanism.The example of health care professionals may include doctor (including general practitioner and specialist), dentist, Ear specialist, speech pathologist, physician extenders, nurse, midwife, pharmacist/pharmacists, nutritionist, therapist, psychology doctor Life, masseur, clinical medical official, Physical Therapist, blood drawing teacher, occupational therapist, optist, emergency medical technicians, medical assistance personnel, Medical laboratory technician, medical prostheses technician, radiographer, social worker and some type of health care clothes of trained offer Other numerous human resources of business.Health care professionals may have qualification or may prescribe without qualification.Health care Professional may operate in or be under the jurisdiction of hospital, health care place and other service provision points, or can also work in Academic training, research and administrative department.Some health care professionals can provide nursing in private residence for patient and control Treat service.Community health worker can be in the local work other than formal medical health institution.Health Care Services manager, Medical records is also possible to health care professionals or is under the jurisdiction of medical treatment with health and fitness information technician and other support staff Healthcare provider.
In some embodiments, health care professionals may already be familiar with subject or carry out with subject It links up.Subject may be the patient of health care professionals.In some cases, health care professionals may give Subject, which prescribes, enjoins it to be subjected to clinical trial.Health care professionals may instruct or suggest that subject is subjected in sample Product acquisition station or the clinical trial carried out by laboratory.In one example, health care professionals can be subject's Primary care doctor.Health care professionals can be any kind of doctor (including general practitioner and the training of subject Doctor).
Health care professionals can receive from the analysis facility of authorization and report.Receive the health care professionals of report It can be the health care professionals for making reservation or the health care professional people in analysis facility and/or sample acquisition station Member.
Laboratory 110 can be communicated with sample acquisition station 120 and health care professionals 100.It laboratory can be with any number Purpose sample acquisition station and health care professionals' communication.For example, laboratory can with one or more, 2 or more, 3 Or more, 5 or more, 10 or multiple, 15 or more, 20 or more, 30 or more, 50 or More, 100 or more, 200 or more, 500 or more, 1000 or more, 5000 or more A, 10000 or more, 100000 or more or 1000000 or more sample acquisition stations and/or medical treatment Health professional's communication.In some systems, 1,2,3,4 or more laboratory, the experiment can be provided Room can be communicated with any number of sample acquisition station and/or health care professionals.Laboratory can communicate with one another or can Not communicate with one another.Sample acquisition station, laboratory and/or health care professionals geographically can be dispersed in any place. In some embodiments, the sample acquisition station communicated with laboratory and/or health care professionals can be in same geographic regions Domain (for example, cities and towns, city, state, area, country).Alternatively, the sample acquisition station communicated with laboratory and/or health care Professional is dispersed in the whole world Anywhere.
Laboratory can communicate in any manner known in the art with health care professionals and sample acquisition station.One In a little embodiments, laboratory can directly be communicated with equipment in sample acquisition station or subject's body or with it.It is such Communication can be via electronic signal, radiofrequency signal, optical signal, mobile phone signal or its any that can be transmitted via wired or wireless connection The signal of his type.Any transmission of data can be through to the description of other described electronic data or transmission everywhere herein By electronic signal, radiofrequency signal, optical signal, mobile phone signal or it is any can via it is wired or wireless connection transmission it is other kinds of Signal and occur.For example, data can be from sample acquisition station electron-transport to laboratory, and vice versa.Data can be from Ke Chu In sample acquisition station or in subject's body or with equipment be transferred to laboratory, and vice versa.Similarly, data can Health care professionals are transferred to from lab e, and vice versa.Communication can be carried out by network, and the network is all Such as are as follows: local area network (LAN), the wide area network (WAN) of such as internet etc, personal area network, such as telephone network etc Telecommunication network, cellular phone network, mobile network, wireless network, data provide network or the network of any other type.Communication Using wireless technology, such as bluetooth or RTM technology.Alternatively, using various communication means, modem is such as utilized Dialing wired connection, such as TI, ISDN etc direct link or cable run.In some embodiments, wirelessly connect The example wireless network that such as cellular network, satellite network or pager network, GPRS etc can be used is connect, or using all Local data's conveyer system of token ring such as Ethernet or on LAN etc.In some embodiments, equipment can be used red Outer communication component carries out wireless communication.In order to provide communication, equipment 130, personal computer, server, on knee can be used Computer, tablet computer, mobile phone, cellular phone, satellite phone, smart phone (for example, iPhone, Android, Blackberry, Palm, Symbian, Windows), personal digital assistant, bluetooth equipment, pager, fixed-line telephone or other The network equipment.Such equipment can be communication enabled device.
Laboratory can in sample acquisition station or in subject's body or with equipment communicate.From sample acquisition station Equipment can be communicated with any communication enabled device in laboratory.Equipment can provide data, the cloud meter to cloud computing infrastructure Calculating infrastructure can be accessed by any communication enabled device in laboratory.Equipment can transmit data to laboratory.
By the data that the data that equipment provides may include about the sample from subject.The data can be for sample Qualitative and/or quantitative assessment for necessary and/or sufficient information.Data may include the information for supervision.Data may include For the information of analysis.Data can be the electronic representation of sample.The electronic representation of sample may include entire sample and/or its is any Partial electronic representation.Data can be electronic data.In some cases, data can be representative sample or reaction or reagent Electronic bits.Data can be digital and/or simulation.Data can represent it is one or more about, be based on or belong to sample Measurable parameter.
Data can representative sample and/or its any part.In some embodiments, data represent the biological sample of acquisition Preparation.Data can acquire before, during and/or after sample preparation.Data can acquire over time.Data may include The preparation of the biological sample of acquisition betides the information of one or more of conditions.The example of such condition may include The one or more characteristics listed in the following group: biological sample amount, biological sample concentration, biological sample quality, temperature or humidity.This The condition of sample may include environmental condition.Environmental condition can refer to the condition around sample and/or sample.Environmental condition can be in sample By equipment receive, by equipment preparation and/or data transmitted by equipment before, during and/or after provide.
Data may include the sample that may relate in sample preparation in equipment, reaction and/or control/calibration, reagent, dilution Agent, detergent, dyestuff or any other materials amount, concentration, ratio, purity or other information.Sample and/or other materials Physically and/or chemically property and/or chemical reaction can be in one or more point in time measurement, and can be gathered into data. In some embodiments, data can determine sample, reagent, diluent, detergent, dyestuff or any other materials if appropriate for For the sample preparation and/or allow subsequent qualitative and/or quantitative assessment for equipment.For example, data can indicate any mistake Accidentally condition, and the error condition can indicate that sample and/or any other materials have degenerated, or improper in other respects. In some cases, data acquire during any process that equipment executes.
In some embodiments, data can represent the chemical reaction that can be run by equipment.Chemical reaction may include with Sample or not with the chemical reaction of sample.Chemical reaction may include it is one or more can be with the reagent of example reaction.It is chemical anti- It should may include control or calibration reactions.The data for representing reaction may include one or more measurements of chemical reaction.Data may be used also Rate or speed including chemical reaction, and/or the acceleration of chemical reaction.Data may include the completion journey of chemical reaction (for example, whether chemical reaction has started, whether chemical reaction is carrying out degree, and whether chemical reaction is completed, chemical reaction progress How far --- for example, 10%, 50%, etc.).Data may include about control reaction and being related to the chemical reaction of biological sample Information.These reactions can while and/or occur in proper order.Data may can occur simultaneously about one or more or may not Simultaneous chemical reaction.Data may can occur simultaneously about one or more or may not simultaneous sample system Standby step.Data may also include physical treatment, and such as centrifugation, crushing or any other action as described herein can pass through number It is indicated according to bit.Data can be used for the functionally supervision of onboard execution, the prison remotely executed by health care professionals It superintends and directs and/or by being configured to give the supervision of such external equipment execution supervised.
Generation, progress or the result of chemical reaction can be detected and be measured by colorimetric or other means.For example, can be with Chromogen that system, apparatus and method provided herein are used together (referred to herein as, for example, coloring agent, color products and Other terms) may include, for example, the substrate that can i) be oxidized is (for example, such as by peroxidase and peroxidating hydrogen-oxygen Change the molecule of color when change), such as: anil [for example, 2- amino-4-hydroxy benzene sulfonic acid (AHBS) (in oxidation shape Yellowly dyestuff can be monitored at 415nm)；N- (2- hydroxyl -3- sulfopropyl) -3,5- dimethoxyaniline is (in oxygen Dyestuff is formed when change, can be monitored at 610nm)]；Dianisidine (yellowish orange dyestuff is formed in oxidation, it can be Be monitored at 405nm), 10- acetyl group -3,7- dihydroxy phenoxazine (ADHP) (oxidation when form dyestuff, for example, it can With at 570nm carry out colorimetric monitoring or EX/EM=535/587nm at progress fluorescence monitoring), ii) kinases substrate (example Such as, change the molecule of color in phosphorylation), such as: iii) substrate of phosphatase is (for example, change color in dephosphorylation Molecule), such as: p-nitrophenyl phosphate (pNPP) (forms p-nitrophenol in dephosphorylation, can pass through 405nm The absorbance at place measures)；Iv) the substrate (for example, the molecule for changing color in hydrolysis) of hydrolase, such as: adjacent nitro (it is galactolipin and o-nitrophenol that galactoside enzyme hydrolysis can be crossed by β to phenyl-base benzene galactoside (ONPG)；O-nitrophenol It can be measured by the absorbance at 420nm)；V) substrate of color can be changed when forming compound, such as: o-cresolphthalein (forming compound with calcium, can measure by the absorbance at 575nm)
In horseradish peroxidase and such as amino-antipyrine (for example, 4-AA) and containing the chemical combination of aniline In the presence of the coloring agent of object (for example, N- ethyl-N- (2- hydroxyl -3- sulfopropyl) -3,5- dimethoxyaniline) etc, peroxide Changing hydrogen can react to form coloured product (for example, Trinder (for example, quinone imines) dyestuff as illustrated in the drawing).
For example, HRP can be with such as N- ethyl-N- of the compound containing aniline (2- hydroxyl -3- sulfopropyl) -3,5- dimethoxy Aniline (ALPS) is reacted with amino-antipyrine compound such as 4-AA or with phenolic compound.Therefore, example Such as, peroxidase (for example, HRP, myeloperoxidase or other peroxidase), the compound containing aniline and amino peace are replaced It is more equal than woods to be referred to as " coloring agent " or " chromogen ".In further example, HRP can be with the compound (example containing benzidine Such as, with diaminobenzidine (DAB)；Tetramethyl benzidine (TMB)；2,2'- azine group-bis- (3- ethyl benzo thiazole phenanthroline -6- sulphur Acid) (DABS)；3- dimethylaminobenzoic acid (DMAB)；Quinhydrones；O-tolidine；O-phenylenediamine；Orthomonochlorphenol；Para hydroxybenzene sulphur Acid；Paraphenetidine；Trinder reagent (such as 4-AA, methylbenzothiazole quinoline ketone hydrazone (MBTH) or other For generating the compound of Trinder dyestuff)；And derivative and related compound) reaction, to form coloured product.HRP Or other peroxidase can also be reacted to form Chemiluminescent light production with other compounds；For example, HRP or other peroxide Enzyme can react that (other molecules may be present and can enhance such reaction to form Chemiluminescent light production with luminol；For example, HRP What is mediated is enhanced in the presence of 4- iodine phenol by luminol generation luminescent products).
Other chromophore includes, for example, alkaline phosphatase；Resazurin (7- hydroxyl -3H- phenoxazine -3- ketone -10- oxidation Object)；10- acetyl group -3,7- dihydroxy phenoxazine (Amplex is red) and similar compound are (for example, Amplex UltraRed (A36006 comes from Life Technologies, Carlsbad, CA 92008)；Resorufin compound is (for example, 7- ethyoxyl tries Halogen spirit)；Dyestuff, for example, fluorescein, calcein, rhodamine and second ingot dyestuff；N- methyl -4- diazanyl -7- nitro benzo furan We；It acridine (acridine -9- carboxylic acid) ester and is reacted with these compounds to change the compound of the optical property of solution；Phenol and phenol spread out Biology (for example, p-iodophenol and to phenyl phenol)；Shine amine, including amine additives (for example, can be such as derived by copper cyanider) And other molecules.It is appreciated that other enzymes and reactant can be used to form color products or for detecting such as blood sample Biological sample in analyte.
In some instances, data can be the one or more images and/or audio data of representative sample.Image can be with It is digital picture or analog image.Audio data can be digital and/or simulation.Data may include the video of representative sample. Image may include video image.Data may include the digital picture of representative sample and/or the electronic data of audio data.At one In example, data may include video imaging, which can capture variation over time.Such as, it is possible to provide video, with Just provide cracking, agglutination, mixing, movement to cell or other molecules in sample or matrix etc. dynamic action evaluation or Measurement.
Data one or many can acquire.Data can acquire at discrete time point, or can continuously adopt over time Collection.The data acquired over time can be assembled and/or be analyzed.In some cases, data can assemble, and can be used In vertical analysis over time, to promote screening, diagnosis, treatment and/or disease prevention.
Data can be acquired from equipment over time.The aggregation data from single equipment of designated samples are for promoting sample The qualitative and/or quantitative assessment of product may be useful.For example, its for determine sample how over time and react and/ Or variation may be useful to provide screening, diagnosis, treatment and/or disease prevention.
In some embodiments, data can be displayed in laboratory report, medical records or any other type display it In.By the vertical analysis to high integrality data, display can show patient health, the nursing level of supplier, disease regression, Progress and/or breaking-out, the data more frequently can be obtained or continually be obtained by the architecture of description over time.
Data can be acquired from multiple equipment.Aggregated data from multiple equipment is for promoting the qualitative of sample and/or determining Amount evaluation may be useful.Aggregated data may include received about the sample acquired from single subject in multiple equipment Data.Alternatively, aggregated data may include in the received data about the sample acquired from other subjects of multiple equipment.It is poly- Closing data can acquire and/or store in the database.The accessible database is executed with providing data by past acquisition The vertical analysis that data are taken into account.Trend and variation over time can be monitored.Multiple equipment can standardize, and So as to aggregated data and thus and/or person can provide with enough quality, accuracy and/or the data of accuracy, execute longitudinal direction Analysis.It can provide very small variation between equipment or do not change.Equipment can also be created can occur sample preparation wherein Standardized environment.Standardized environment can also provide during chemical reaction.Step before standardized analysis can also be provided in equipment. Multiple equipment can distribution on global.This can provide Global Evaluation architecture, the architecture can preferably allow to disease into Exhibition and/or the detection subsided.By enabling Standardization instrument, can be watched in one or more subjects with vertical analysis data The speed of marker at any time.The available analysis of data, and/or with laboratory report or electronic medical record or decision branch Hold system form be shown to consumer, supplier and/or disburser (for example, health plan, employer, government-payer, etc. Deng).Such display may include showing data at any time, may include the variation about numerical value, change rate or change rate The trend analysis of rate or other analyses.
Data can have the quality for being suitble to vertical analysis at any time.The appropriate mass of data pushes away at any time for may be incorporated into The laboratory report and/or electronic medical record for moving the data of acquisition may be useful.This may include long period (for example, Multiple interview, or it is based on multiple samples) or shorter time period (in single interview, or being based on single received sample) interior acquisition Data.Data can have enough quality, accuracy and/or the accuracy for vertical analysis.For example, sample can be more from subject Secondary acquisition.Sample can be acquired in different time from subject.Sample can be acquired in predetermined space or according to predetermined schedule. It is alternatively possible to acquire sample from subject in one or more conditions or event triggering collection.The multi collect of sample can Allow to analyze sample whithin a period of time, to allow for vertical analysis.In some embodiments, in order to allow longitudinal point Analysis, data can have the accuracy and/or accuracy of height.In one example, data can have 20% or smaller, 15% or It is smaller, 10% or smaller, 9% or smaller, 8% or smaller, 7% or smaller, 6% or smaller, 5% or smaller, 4% or smaller, 3% or smaller, 2% or smaller, 1% or smaller, the 0.5% or smaller or 0.1% or smaller coefficient of variation at any time.? Under some cases, multiple equipment can provide with 20% or smaller, 15% or smaller, 10% or smaller, 9% or smaller, 8% or It is smaller, 7% or smaller, 6% or smaller, 5% or smaller, 4% or smaller, 3% or smaller, 2% or smaller, 1% or smaller, The data of the 0.5% or smaller or 0.1% or smaller coefficient of variation at any time.
It can be with the data of vertical analysis over time.This may include data change with time, the change of data at any time Rate, data change with time the change rate or its any derivative of rate.For example, data variation can be acquired and/or be analyzed Speed and/or acceleration.Data value increase and or reduce and/or various change rate determine screening, diagnosis, treatment and/ Or it can be in disease prevention beneficial.
Equipment is capable of handling the sample acquired from subject, and the data of subsequent analysis are used for output.Equipment is configurable to be used In promotion acquisition of the sample from subject.Equipment is configurable to receive sample from subject.Equipment is configurable to prepare sample Product are for clinical trial, to detect and/or quantify interested analyte.Equipment may include one or more having for clinical trial Reagent.Preparation or clinical trial may include the chemical reaction with reagent.Equipment may include one or more detectors, described Detector may be able to detect the signal generated by processing sample.Equipment can transmit the data about sample.Number about sample According to may include the initial data from the signal detected, such signal is relevant to unreacted sample, has been subjected to reaction Sample and/or device configuration.In some cases, equipment can pre-process some initial data to become desired format, And transmit pretreated data.In some cases, the executable one or more analytical procedures of equipment, and transmit analysed Data.Alternatively, equipment does not execute any pretreatment and/or analysis.Pretreatment and/or analysis can occur in laboratory.One In a little situations, pretreatment and/or analysis can occur simultaneously in equipment and laboratory.Laboratory can also include using sick to it The hospital of neo-confucian, therefore data can be for transmission to center of excellence to analyze different types of specific situation.
In embodiments, equipment can monitor its environment, including its internal environment and external environment.In embodiment In, equipment can provide facility environment information to laboratory.Facility environment information is for example including internal temperature, external temperature, interior Portion's humidity, outer moisture, time, the state of component, error code, the image from inner camera, the figure from external camera Picture, air pressure (atmospheric pressure) and other information.In embodiments, inner camera can be fixed on interior location.Implementing In mode, inner camera can be fixed on interior location and be configurable to rotation, scanning or otherwise provide to set The view in standby interior multiple areas or region.In embodiments, inner camera can move in equipment；For example, inner camera can On the displaceable element (such as pipette) that is mounted in equipment.In embodiments, can be can be in equipment for inner camera Interior movement, and be configurable to rotation, scan or otherwise provide from multiple positions in equipment the area in equipment Multiple views in domain.In embodiments, external camera can be fixed in external position.In embodiments, external camera can It is fixed in external position and is configurable to rotation, scanning or multiple views in device external region are otherwise provided Figure.In embodiments, external camera can be and can move on the outside of equipment or around it.In embodiments, outside Portion's camera can be moveable and be configurable to rotation, scanning or otherwise from device external or surrounding Multiple positions provide multiple views in the region except equipment.
Therefore, in embodiments, monitoring device environment and report the result of such monitoring of facility environment can be Supervise the operation of equipment and a part of result and the integrality of analysis.Such monitoring provide with equipment and its output (condition, The data of operation, the result generated and transmission) related information, supervision and quality control.Such monitoring can include: measurement and Control temperature；Measurement and control liquid (volume, temperature, mixing etc.)；Monitor sample acquisition；Cylinder casket is imaged to determine cylinder The position of casket in a device；Cylinder casket is imaged to correct its position (if necessary, to each of the cylinder casket in equipment Its position is all corrected in such imaging)；Tip is imaged, to confirm the correct engagement with liquid relief ozzle；To in tip Liquid volume is imaged；Bubble in liquid is imaged (if yes)；Sample is imaged to assess sample body Product, sample quality and (haemolysis situation, the piarhemia situation, jaundice of such as sample the case where may interfere with correct processing or analysis Situation) existence or non-existence；State to the motor on pipette and situation carry out feedback control and error detection, for Relevant control and supervision are accurately drawn and distribute to liquid；Feedback control and error detection are carried out to centrifuge, for accurate Centrifugal force controlled, determine position and about the state of centrifuge and the other information of situation；To door frame, robot and shuttle Position carries out feedback control and error detection, including to pipette, cylinder casket and the tip/tank for handling and analyzing sample Positioning is exercised supervision and is controlled；Control reaction (reacting between sample and reagent) is to confirm normal equipment operation (for example, making With sensor, pipette, door frame, heat sensor and control etc.)；Monitor and control the correct status of reagent；It is same with sample analysis When or before this or later operation control reaction；Replicate analysis is executed to improve accuracy to sample；Blank reading is carried out, In possible variation and sensor performance to control the background signal in sample and light source output in possible minor swing.
In embodiments, the result for monitoring and reporting such monitoring may include calibration.To equipment, reagent, disposable use The calibration of product and its manufacture and assembling can be the operation of supervision equipment and a part of result and the integrality of analysis.It is making During making, by each equipment Alignment to one group of controlled standard.During manufacture, by reagent and disposable product (for example, point End, tank and other elements) calibrate to one group of controlled standard, and with include each of these reagents and disposable product casket Relevant identification information includes the information about these standards.This class standard can include: calibrate each liquid relief of each pipette Ozzle --- for example, for each liquid relief ozzle, measurement is converted to the liquid of specified rate on how to the given displacement by motor The information of volume, and the information is provided in the information recorded for each motor, for for (wherein should with equipment Motor is its component) in the scheme that is used together；According to one group of controlled standard come in calibrator (-ter) unit each sensor and illumination Source, and be provided in the information for each equipment, so that the signal generated from all the sensors in all devices Lead to identical measurement；Each motor control algorithm is calibrated during manufacture, so that the speed of the motor in each equipment and position It sets and similar control can be obtained；Characterize (including flat field correction) each camera and each light source；During manufacture, calibration batch Each reagent in reagent, so that any variation in the effect of reagent still generates identical analysis result.Therefore, because logical It crosses on equipment (for the equipment, this class component and equipment particular calibration information are known) and is handled to analyze each sample Product, it is possible to be calibrated and be corrected from sample treatment according to the information and calibration of every kind of reagent and each equipment and its component The initial data of generation.Such supervision and calibration ensure the integrality of result obtained, and therefore also provide to such result Analysis integrality.By analyzing the original number from equipment using equipment particular calibration and reagent lot particular calibration According to obtain result.Therefore each result for obtaining in this way is accurate, accurate and reliable, and can be with The similar results obtained from other samples in same instruments compare and compared with other instruments and sample, to reduce It makes a variation and diagnosis or deduction wrong and that allow preferably analysis to obtain from sample analysis with preferably trust.
Quality control operation can periodically carry out equipment and reagent, for example, exercised supervision by CLIA, with ensure reagent and The performance of equipment is still in specification.If it find that difference, then can determine that reagent and/or equipment need to recalibrate.Pass through fortune Scheme defined in row, can at the scene recalibrate equipment, this may need or may not be needed into equipment Insertion calibration cylinder casket.Calibration function to generate standard curve and is derived by using same a collection of reagent, weight can be carried out to reagent New calibration.Such reagent, which is recalibrated, to be executed in any one equipment in the apparatus, and is applicable to own Equipment.
Transmission of the facility environment information to laboratory is useful for supervising and controlling equipment, including for supervising and controlling The operation of control equipment is useful.Transmission from facility environment information to laboratory for keep equipment operation and control it is complete Property, the operation of equipment and control quality control be useful, and acquired by the data that equipment executes and sample for reducing Variation or mistake in processing are useful.Facility environment information can be for example by use for laboratory in modification, correction or update pair The scheme of equipment or other instructions or order.Facility environment information can be for example by use for laboratory in modification, correction or update pair From the analysis of the received data of equipment.For example, transmission from temperature information to laboratory for supervise and control equipment be it is useful, It and is useful in the analysis carried out from laboratory to equipment to the data that laboratory provides.
In embodiments, equipment is configurable to control the temperature in a part of the temperature or the equipment in the equipment Degree.Such control improves the reproducibility for the measurement made in equipment, can unify the condition of all samples or provide the rule of condition Rule property, and reduce the variability (for example, as measured by coefficient of variation of multiple measurements or duplicate measurements) of measured value and data. Temperature information may be useful for quality control.In embodiments, equipment with monitoring temperature and can control its internal temperature Degree.Temperature control may be useful for quality control.It monitors and the equipment for controlling its temperature can transmit temperature to laboratory Spend information；Such temperature information can be used to control the operation of instrument, supervise instrument and analysis from instrumental transmission by laboratory Data.
In embodiments, equipment is configurable to from the inside of equipment or the interior acquisition image of a part of equipment.This Class image can provide with about in equipment component, reagent, supply or sample position, situation, availability or other information have The information of pass, and may be provided in information used in the control to equipment operation.Such image controls quality Useful.The equipment that image is obtained out of equipment can transmit image information to laboratory；Laboratory can believe such image Cease the data of operation, supervision instrument and analysis for controlling instrument from instrumental transmission.
In one scenario, sample preparation steps can be performed without executing any analysis or receiving any supervision in equipment.Come Can be transmitted from the data of sample preparation steps to laboratory, the executable analysis in the laboratory, and the laboratory can be including The analysis facility of the authorization of supervision.In another scene, the executable one or more sample preparation steps of equipment, and can be onboard Ground executes analysis.The analysis facility of authorization can be transmitted in data from analysis, and the analysis facility of the authorization can provide supervision. Alternatively, supervision can occur in equipment onboardly.
In some embodiments, supervision may include to the data after primitive form, preprocessed form or analysis Check.Qualitative and/or quantitative assessment to sample can occur for supervision.The example of the qualitative evaluation of sample may include but be not limited to Image, video or audio file are checked.The example of the quantitative assessment of sample may include indication signal, a series of signal or divide Analyse the presence of object or the numerical value of concentration level.Supervision may include one or more or two or more other are everywhere herein The example of offer.Supervision can be provided by the health care professionals of the analysis facility authorized.In some other cases, it supervises System can be checked by software program or automation to provide by superintending and directing.Software program and/or automation the system of checking can by or can not It is checked or is looked after by qualified persons such as health care professionals (such as laboratory supervisor).
The reproducible manual analyzing regulation of equipment.In some cases, equipment can execute multiple steps automatically, such as liquid relief, Prepare filtrate, heating and/or measurement colouring intensity.Equipment can cooperate with use with material, to measure one or more analytes.If The standby presence or concentration that can measure one or more analytes.Equipment may include the component comprising reagent, and the component may act as Reaction member.Apparatus assembly other can be more fully described everywhere with example the step of being taken by equipment in this paper.
Laboratory can be communicated with health care professionals.Laboratory can the data based on analysis and generate report.One In a little situations, laboratory can analyze the initial data or pretreated data provided from equipment.Alternatively, laboratory can be from setting It is standby to receive analysed data.Laboratory can execute further analysis and/or supervision from the analysed data received from equipment, Or further analysis and/or supervision can not be executed.
Laboratory and/or equipment produce report, and this report can be presented in a manner of significant or is desired through analyzing Data.Report can have such format: it can enable the viewer of report make medicine decision by report.It is real Report can be transferred to health care professionals (or laboratory supervisor) by testing room and/or equipment.In some embodiments, sick Neo-confucian, other health care professionals or other qualified persons can report transmitting to the health care professionals This report is checked before reporting to.Report can checked to before subscribing health care professionals' transmission by checking health care professionals It accuses or for generating the useful qualitative and/or quantitative assessment of this report.Checking or supervising can occur in laboratory analysed In data and/or report.Alternatively, check or supervise to occur in equipment onboardly.Receive the health care profession of report Personnel can rely on or can make screening, diagnosis, treatment and/or disease prevention to subject not against report.
Laboratory and/or equipment can also provide report to subject.The report for being supplied to subject can be cured with being supplied to The report for treating health professional is identical or different.The report for being supplied to health care professionals can have more details, or Vice versa.Being supplied to format between subject and the report of health care professionals can be different or can phase Together.Alternatively, laboratory and/or equipment do not provide report to subject.Subject can be based on from health care professionals Report receive information.Equipment or laboratory when executing test and/or making analysis, or be sent to doctor check and/or After doctor checks, laboratory report automatically can be directly provided to consumer.
Any transmission of data and/or report may include the use to cloud computing foundation structure.Sender can be to cloud computing Foundation structure provides data or has data on it.One and/or multiple recipients (for example, health care professionals or Patient) it may have access to cloud computing foundation structure.Cloud computing foundation structure may be provided in sender side and/or recipient side.It is standby Selection of land can use traditional fixed data storage technology.
Figure 1B shows retailer 170, has the processing equipment 172 communicated with laboratory 160.Laboratory or reader Equipment can be communicated with health care professionals 150.As it was earlier mentioned, herein to other examples of retailer or sample acquisition station Any discussion may be applicable to any kind of sample acquisition station, and vice versa.Retailer may be provided in the first place, and Health care professionals may be provided in the second place.First place and the second place can be different place.In some realities Apply in mode, the first place and the second place each other not close to.Laboratory may be provided in third place.Third place can be with The different place in first place and/or the second place.For example, the first, second, and third place do not need each other close to.The first, Second and/or third place can be located at different facilities in.Alternatively, first, second and/or third place can be all same One place (service point).
Retailer can be the entity for selling product or service.In some embodiments, product or service can be related to be good for Health or medical treatment and nursing.For example, retailer can sell drug or medical health care products and/or insurance.In some embodiments, zero Selling quotient can be pharmacy (for example, retail pharmacy, clinical pharmacy, hospital pharmacy), pharmacy, chain store, supermarket or grocery store.Zero Sell quotient example may include but be not limited to Walgreens, CVS Pharmacy, Duane Reade, Walmart, Target, Rite Aid, Kroger, Costco, Kaiser Permanente or Sears.
Retailer may be provided in retailer place.In some embodiments, retailer can be in and health care profession Personnel and/or the different geographic location of laboratory site.Alternatively, health care professionals may be provided in retailer place.
Retailer 170 can have sample-processing equipment 172 in the place of retailer.In some embodiments, retailer Can retailer place have one or more, 2 or more, 3 or more, 4 or more, 5 or more, 6 A or more or 10 or more sample-processing equipments.Sample-processing equipment can be service point device.Sample treatment Equipment can be communicated with enabled device is communicated.For example, the sample-processing equipment in retailer place can communicate with one another.Alternatively Ground, sample-processing equipment can be in other sample acquisition stations or subject's body or equal different locations with it other Reader communication.Sample-processing equipment can in other classes such as the computer in laboratory and/or biometric device The communication enabled device of type communicates.Such communication can be wired or wireless.
Sample-processing equipment 172 is configurable to receive sample.Sample-processing equipment is configurable to directly from subject Acquire sample.Sample-processing equipment is configurable to execute subject one or more sample preparation steps.Sample treatment is set It is standby to be configurable to operation measurement.In some embodiments, sample-processing equipment is configurable to run one or more surveys It is fixed.Sample-processing equipment can execute multiple assay to simple sample.When needed, device configuration is for executing at least 2 It is a, 3,4,5,6,7,8,9,10,20,30,40,50,100,200,500, 1000 or more measurements.Multiple measurements can be run parallel simultaneously.If necessary, one or more blank determinations and/ Or calibrator (e.g., including have compare to measurement/test calibrator configuration) can also be incorporated in equipment and execute parallel. It in some cases, can be based on sample and in turn or successively to run measurement with parallel any combination.Reader Equipment can realize one, two or more chemical reaction or other processing tests (for example, crushing).Sample-processing equipment can match It sets for detecting one or more signals about sample.Sample can be humoral sample, biological sample or other are each such as this paper Any other example provided is provided.
In some embodiments, sample-processing equipment 172 may include a casket 174.Cylinder casket can be can be from sample treatment What equipment removed.In some embodiments, sample can provide the cylinder casket of sample-processing equipment.Alternatively, sample can provide To another part of sample-processing equipment.Cylinder casket and/or equipment may include sample collection unit, and the sample collection unit is configurable For receiving sample.In this paper, other are described in further detail sample-processing equipment everywhere.Cylinder casket and equipment can be integrated into single Equipment, or can be separable equipment.Equipment may include pill or patch, and the pill or patch may link to movement and set Standby or other network equipments are for handling.
Subject 176 may be provided in retailer 170.Subject humoral sample can be provided sample-processing equipment 172 and/ Or the cylinder casket 174 of equipment.Body fluid can be extracted in many ways from subject and be provided to equipment, and the mode includes but unlimited In fingerstick, blood sampling, injection and/or liquid relief.Vein or the acquisition of non-vein method can be used in body fluid.Body fluid can be used to adopt for body fluid Storage provides.Body-fluid collector may include lancet, micropin, perforated membrane (such as pill), capillary, pipe, pipette, note Emitter, vein haemospasia device or other any other collectors for describing everywhere herein.In one embodiment, lancet pierces Broken skin skin simultaneously for example fetches sample using gravity, capillarity, absorption or vacuum power.Lancet can be sample treatment and set The a part of cylinder casket, a part of system or independent component of standby a part, equipment.When needed, lancet can pass through A variety of mechanical, electrical, electromechanics activate any combination of mechanisms or such method to activate known to any other.In an example In, the finger (or other parts of subject's body) of subject can be punctured with output body fluid.Body fluid can be used capillary, move Liquid pipe or any other mechanism known in the art acquire.Capillary or pipette can be separated with equipment and/or cylinder casket, or It can be a part of equipment and/or cylinder casket.Transfer equipment can not need additional processing step, and can be in single step Precoating anti-coagulants or other pretreatments.In another embodiment for not needing Active mechanism wherein, subject can example As can occurring saliva sample, or allow the direct contact surface of the body part punctured, and simply to equipment and/or Cylinder casket provides body fluid.The fluid of acquisition can be placed in equipment.Body-fluid collector can be attached to equipment, can removedly be attached to Equipment, or can be provided separately with equipment.
Cylinder casket 174 can be plugged into sample-processing equipment 172, or otherwise connect with sample-processing equipment.Cylinder Casket can be removed from sample-processing equipment.In one example, sample can provide the sample collection unit of cylinder casket.Sample can be direct Cylinder casket is provided.Sample can via or can not provide via body-fluid collector to sample collection unit.Body-fluid collector A casket can be attached to, can removedly be attached to a casket, or can be provided separately with cylinder casket.Body-fluid collector can be adopted with sample Collection unit is integrally formed, or can not be integral with.Cylinder casket is then inserted into sample-processing equipment.Alternatively Ground, sample can be directly provided to sample-processing equipment, and sample-processing equipment is available or can not utilize a casket.Cylinder casket can wrap Containing one or more reagents, the reagent can be used for the operation of sample-processing equipment.Alternatively, one or more reagents may be It is provided on sample-processing equipment onboardly.
Cylinder casket may or may not be disposable.Cylinder casket can be special for the clinical trials of one or more types It does not configure.For example, first casket can have the first configuration to support first group of test, and second casket can have the second configuration To support second group of test.Alternatively, it is possible to provide general cylinder casket is configurable to identical one group of test selected.One In a little situations, general cylinder casket can be directed to certain test dynamic programmings by long-range or onboard scheme.
When cylinder casket is inserted into sample-processing equipment, the one or more components of cylinder casket can with sample-processing equipment its He is in fluid communication component.For example, the sample can be transferred to other portions of sample-processing equipment if sample is acquired in cylinder casket Point.Similarly, if one or more reagents provide on cylinder casket, can by the agent transfer to sample-processing equipment its His part, or the other assemblies of sample-processing equipment can be brought to reagent.The one or more components of cylinder casket can be with automatic Change mode is transferred to the other parts of sample-processing equipment, and vice versa.In some embodiments, the group of reagent or cylinder casket Part can stay in onboardly on casket.It in some embodiments, does not include that tubulature or maintenance is needed (such as manually or automatically to tie up Shield) jet stream.
Sample-processing equipment be configurable to be placed in subject's body or with.Sample-processing equipment can pass through equipment Shell receives sample from subject.For example, if sample-processing equipment can be swallowed or is implanted in subject's body, it can Including shell or biocompatible coating.Biocompatible coating, which can be, can allow the desired sample to penetrate.Sample can penetrate The coating or shell of sample-processing equipment, to be received by sample-processing equipment.If sample-processing equipment is in subject With, then sample can be received by the shell and/or coating of equipment.It is alternatively possible to use one may be provided in equipment A or multiple needles or micropin (it can be provided on the cylinder casket part of equipment, or can not provide on the portion) receive Sample.
Sample-processing equipment is configurable to promote sample acquisition, prepares sample for clinical trial, and/or may include The useful reagent of one or more pairs of clinical trials.In some embodiments, sample-processing equipment be configurable to operation from One or more tests of sample.It can execute using sample or without using the chemical reaction of sample or other processing steps.? In some embodiments, measurement, such as immunoassays or nucleic acid determination can be run.The step of being prepared or be run by equipment And/or test example may include but be not limited to: immunoassays, nucleic acid determination, the measurement based on receptor, cell counting measuring, Colorimetric estimation, enzymatic determination, electrophoretic determination, electrochemical gaging, spectroscopic assay, chromatographic determination, microcosmic measurement, landform measurement, amount Heat determination, turbidimetric assay, agglutination determination, radioactive isotope measurement, viscosimetric analysis, solidification measurement, coagulation time test, albumen Matter synthesizes measurement, Histological determining, culture measurement, osmometry and/or other kinds of measurement, centrifugation, separation, mistake Filter, dilution, enrichment, purifying, precipitating, crushing, incubation, liquid relief, transport, cell cracking or other sample preparation steps, Huo Zheqi Combination.Sample treatment may include chemical reaction and/or physical treatment.Sample treatment may include histology, morphology, kinematics, The assessment of dynamics and/or sample state may include such assessment for cell.These step/tests can be performed in equipment In one or more, 2 or more, 3 or more or 4 or more step/tests.
The processing of biological sample may include pretreatment (for example, preparation of sample, for subsequent processing or measurement), place Reason (for example, sample change so that its be different from its original or previous state) and post-processing (for example, fix sample, Or all or part of sample is disposed after its measurement or use).It can be by biological sample part, such as blood or urine The aliquot of sample, such as by slicing tissue samples, shred or be divided into two parts or more part.To blood sample etc. The processing of biological sample may include the mixing to a part of sample or sample, stirring, sonication, homogenizing or other processing.It is right The processing of the biological samples such as blood sample may include the centrifugation of sample or part thereof.To biological samples such as blood samples Processing may include provide the time of separation or precipitating for the component of sample, and may include filtering (for example, making sample or its portion Divide across filter).Processing to biological samples such as blood samples may include allowing or blood sample being caused to solidify.To all If the processing of blood sample biological sample may include the concentration of a part of sample or sample (for example, by blood sample Sedimentation or centrifugation, or sedimentation or centrifugation to the solution for including the tissue homogenate from tissue sample) to provide sediment and upper Clear liquid.Processing to biological samples such as blood samples may include the dilution to a part of sample.Dilution can be to whole The dilution of a sample or a part to sample, including the dilution to sediment or supernatant from sample.Biological sample can To be diluted with water, or with saline solution such as buffered saline solution.Biological sample may include or can not include and fixes The solution of agent (for example, reagent of formaldehyde, paraformaldehyde or other cross-linked proteins) dilutes.Biological sample can be dilute with solution It releases, which effectively to generate osmotic gradient between surrounding medium and the inside or interior compartment of this kind of cell, thus Effectively change cell volume.For example, the solution concentration generated after the dilution is less than cell interior or internal cellular compartment Effective concentration in the case where, the volume of such cell will will increase (that is, cell will expand).Biological sample is available can be with Include or penetrant can not included (such as, for example, glucose, sucrose or other sugar；Salt, such as sodium, potassium, ammonium or other salt； Or other osmotically active compounds or ingredient) solution dilute.In embodiments, penetrant can for example, by stablize or Reduce possible osmotic gradient between surrounding medium and the inside or interior compartment of this kind of cell, effectively to remain thin in sample The integrality of born of the same parents.In embodiments, penetrant can effectively provide or increase the inside or interior of surrounding medium and this kind of cell Osmotic gradient between portion's compartment effectively makes cell at least partly shrink (inside or interior compartment concentration in cell Lower than surrounding medium concentration when), or cell expansion is effectively made (to be higher than week in the inside of cell or interior compartment concentration When enclosing the concentration of solution).
Biological sample can be dyed, marker can be perhaps added in sample or can made in other ways Standby sample for sample, a part of sample, the component part of sample or sample inner cell or a part of structure detection, Visualization or quantization.For example, biological sample can be in contact with the solution comprising dyestuff.Dye capable of dyeing color otherwise makes sample A part of cell or cell in product or substance associated with cell or molecule are visible.Dyestuff can be with element, compound Or the other components of sample combine or are changed by it；For example, dyestuff can be in response to the change or difference of the pH value of solution present in it It is different and change color, or otherwise change one or more property, including its optical property；Dyestuff can be in response to Element present in solution present in the dyestuff or compound are (for example, sodium, calcium, CO2, glucose or other ions, element or Compound) concentration change or difference and change color, or otherwise change one or more property, including its optics Property.For example, biological sample can be in contact with the solution comprising antibody or antibody fragment.For example, biological sample can with include The solution of grain is in contact.The particle being added in biological sample may act as standard (for example, particle size or size distribution It may act as may act as concentration mark under size criteria, or the situation known to the number, amount or concentration of particle in the case where knowing It is quasi-), or may act as marker (for example, being bonded or adhered to specific cells or certain types of cell, specific cells mark in particle In the case where remembering object or cellular compartment, or in the case where particle is bound to all cells in sample).
Sample-processing equipment is configurable to execute small humoral sample one, two or more measurement.As herein its He is described everywhere, and one or more chemical reaction can occur on the sample with certain volume.For example, one or more chemistry Reaction can occur in having the pill for being less than and ascending to heaven (femtoliter) volume.In an example, sample collection unit is matched The humoral sample for receiving certain volume is set, single drop or less blood or interstitial fluid are equivalent to.Sample collection unit can Skin of the humoral sample of certain volume without puncturing subject can be acquired.In one example, can with irradiation light, so as to Optical measurement sample.In additional example, ultrasonic wave, MRI or scanning can be used to execute non-invasive analysis.
Equipment can execute all onboard steps within a small amount of time.For example, from from subject acquire sample to Transmission data and/or about 3 hours or less, 2 hours or less, 1 hour or less, 50 minutes can be spent or more to analyze Less, 45 minutes or less, 40 minutes or less, 30 minutes or less, 20 minutes or less, 15 minutes or less, 10 minutes or Less, 5 minutes or less, 4 minutes or less, 3 minutes or less, 2 minutes or less, 1 minute or less, 50 seconds or less, 40 seconds or less, 30 seconds or less, 20 seconds or less, 10 seconds or less, 5 seconds or less, 3 seconds or less, 1 second or less, 500ms or less, 200ms or less or 100ms or less time.Sample is received to transmit to by equipment from equipment Data and/or the time quantum analyzed can spend about 3 hours or less, 2 hours or less, 1 hour or less, 50 minutes or Less, 45 minutes or less, 40 minutes or less, 30 minutes or less, 20 minutes or less, 15 minutes or less, 10 minutes Or less, 5 minutes or less, 4 minutes or less, 3 minutes or less, 2 minutes or less, 1 minute or less, 50 seconds or more Less, 40 seconds or less, 30 seconds or less, 20 seconds or less, 10 seconds or less, 5 seconds or less, 3 seconds or less, 1 second or less, 500ms or less, 200ms or less or 100ms or less.
Laboratory, equipment or other entities or software can execute analysis to data in real time.Analysis may include to sample Qualitative and/or quantitative assessment.Laboratory, equipment or other entities can at 48 hours or less, 36 hours or less, 24 hours or Less, 12 hours or less, 8 hours or less, 6 hours or less, 4 hours or less, 3 hours or less, 2 hours or more Less, 1 hour or less, 45 minutes or less, 30 minutes or less, 20 minutes or less, 15 minutes or less, 10 minutes or more Less, 5 minutes or less, 3 minutes or less, 1 minute or less, 30 seconds or less, 15 seconds or less, 10 seconds or less, 5 seconds or Data are analyzed in less or 1 second or less time.Analysis may include data compared with one or more threshold values.Analysis It may include or may not include and checked by virologist or other qualified persons.Be included in analysis time may include or Person may not include the time that report is generated based on data.The time for being included in analysis may include or may not include special to health care Industry People report the time it takes.
Equipment 172 can be supplied to sample acquisition station 170 by laboratory 160.Equipment can be sold to sample acquisition station, by sample Acquisition station is leased/is rented, or can be used as sample acquisition station can allow laboratory to carry out sample acquisition and/or other steps herein Place.
Similarly, one or more cylinder caskets 174 can be provided by laboratory 160 to sample acquisition station 170.Alternatively, cylinder casket It can be provided by another source.Cylinder casket can be sold to sample acquisition station, be leased/rented by sample acquisition station, or can be used as and can allow Laboratory acquires sample herein and/or executes a part in the place of other steps to utilize.Cylinder casket may be from identical as equipment Or different source.
Laboratory 160 can have processor 162 and communication unit 164.Laboratory may be provided in facility.Processor and logical Letter unit may be provided in facility.Laboratory can have one or more processors and one or more communication units.
Processor 162 is configurable to generate for health care professionals 150 and report.Processor, which can be in have, to be held The server end of the software of row processing.Processor can based on generating report from the received data of sample-processing equipment 172, or It can provide supervision or analysis.The qualitative and/or quantitative assessment of sample can be performed in processor.In some embodiments, processor Data received from sample-processing equipment can be compared with threshold value.Threshold value can be directed to one or more analytes.It is described Compare may include data value whether greater than, equal to or less than threshold value comparison.Compare may include data value whether qualitatively and/or It is quantitatively identical as threshold value.Compare may include data related one or more storage values one or more forms statistics or Physiological Analysis.Example may include best fit analysis, and/or such as curve matching, extrapolation, interpolation, regression analysis, The analysis such as least square method, mean value calculation, multivariable, simulation analysis or Variational Calculation.Processor can be analyzed from sample treatment The received data of equipment.Processor is configurable to execute the one or more steps of the statistical analysis of data.
In some embodiments, threshold value can refer to single value.Threshold value can be numerical value or alphanumeric values.Threshold value can be with It is character string or the data of any other form.Threshold value can refer to a series of values and/or a class value.Threshold value can refer to single value or Multiple values.Multiple values can be fallen in one or more continuous spectrums.Alternatively, multiple values can be discrete.Threshold range shows Example may include 1-100 unit or 5-10 unit, and the example of sets of threshold values may include falling in selected from 1 unit, 3 units, 5 units, 8 Unit, 13 units, 20 units or 50 units list in value.Unit can refer to any size or measurable amount.It is such Value is provided by way of example only.In some cases, the comparable one or more images of processor, video or audio file or other Data.Processor can make such comparison for one or more reference pictures, video or audio file or other data.Algorithm It can evaluate file or the one or more features of other data.In some cases, processor can be automatically by file Classification, so that health care professionals check.
Processor may be able to access that one or more data storage cell 166a, 166b, and the data storage cell can Information comprising storage.The information of storage may include the threshold value for one or more analytes.Threshold value described for determination one The presence of kind or multiple analytes or concentration may be useful.Threshold value can the case where alarm comes in handy wherein for detection It can be useful.Data storage cell may include any other about sample preparation or the letter for the clinical trial that can be run to sample Breath.Data storage cell may include for generating the record that comes in handy of report or his information for health care professionals.Number Computer-readable medium may can also be stored according to storage unit, the computer-readable medium may include for allowing processor to hold Code, logic or the instruction of row one or more steps.
In some embodiments, data storage cell 166a can be provided in laboratory 160.Processor may be able to access that Local data store.In another embodiment, data storage cell 166b can be provided far from laboratory.For example, data Storage unit may be provided in sample acquisition station 170, or provide with health care professionals 150.Data storage cell can mention For in equipment.Alternatively, data storage cell may be provided in any other place.Processor can use data storage cell Any combination in place.For example, the accessible data storage cell that may be provided in except laboratory and laboratory of processor.
In some embodiments, data storage cell can be electronic medical record (EMR) or EMR data library.Data Storage unit may include being associated with the information of subject.Be associated with subject information may include the medical records of subject, by The health history of examination person, the identification information for being associated with subject, the payment information for being associated with subject or it is associated with subject's Any other information.Data storage cell can be disburser's database.Data storage cell may include being associated with such as health The information of the disburser of insurance company or government-payer etc.Such information may include being associated with the treatment note of subject Record, insurance record or financial information.
One or more communication units 164 can be provided in laboratory 160.Laboratory can acquire or handled with sample Center the identical place of supplier or hospital office/place or different places or can actually perhaps be adopted with sample Collection or processing center or supplier or hospital office/place are identical.Any description in laboratory may be applicable to herein Any other place provided herein, and vice versa.Communication unit is configurable to receive data from equipment 172.Communication unit Member can receive the data of the sample about subject from the equipment for being in sample acquisition station 170.Communication unit can from equipment and/or Sample acquisition station receives the information about subject.Communication unit can receive the identification information about subject.Communication unit can From equipment and/or any other machine (for example, biometric device, mobile device) associated with sample acquisition station or entity Receive information.
Communication unit 164 is configurable to equipment 172 and/or any other machine associated with sample acquisition station 170 Device or entity transmitting data.In some embodiments, communication unit can provide one or more schemes to equipment.In addition to receiving Other than data, communication can provide scheme.The program can realize that sample acquires, and prepare sample for clinical trial, or allow setting The chemical reaction of one or more reagents is used on standby.Scheme can realize operation of the clinical trial in equipment.Scheme can be realized To the detection of the presence of analyte and/or concentration in equipment.Detection to presence and/or concentration about analyte and/or Any description of analysis may each comprise and/or be suitable for assessment disease condition.Scheme may be implemented in equipment to initial data Pretreatment and/or the analysis to data.
Communication unit allows the bidirectional communication unit between sample acquisition station and laboratory.Communication unit is allowed in sample Product acquisition station or in subject's body or with sample-processing equipment and the two-way communication between the processor in laboratory. In some embodiments, one or more schemes can be sent to equipment based on the data sent from equipment.It is sent out by equipment The data sent may include subject's identification information, based on generate and/or detect about the information of sample or the signal of reaction, Equipment identification information, cylinder casket identification information or any other information sent from equipment.According to the scheme provided to equipment, It can be from devices collect data.The action that scheme can manage the data type of acquisition and be executed by equipment.In some embodiments In, based on the data acquired from equipment, subsequent one group, two or more groups scheme can be sent to equipment.From equipment Data can provide feedback, the feedback can Managed Solution order the further action to be taken by equipment.
In alternate embodiment of the invention, laboratory is not needed to equipment transmission scheme.Scheme can it is locally-stored In equipment.Alternatively, system can provide scheme to equipment.Scheme can be provided from the entity except equipment.Scheme can be in cylinder casket On.
Laboratory can have output unit, and the output unit can show or transmit report to health care professionals. Output unit can be video display.Alternatively, output unit can be communication unit.In one example, output unit It can be touch screen.Touch screen can by built-in sensors have intrinsic imaging capability, the sensor may include LED or Other light sources.
Equipment can have one or more identifiers.Device identifier can be transmitted to laboratory by equipment.Equipment One or more components can have identifier.For example, cylinder casket can have one or more identifiers.Cylinder casket identifier can be Device-readable.For example, equipment can read a casket identifier automatically when providing cylinder casket to equipment.Equipment can be by cylinder casket mark Know symbol or other assemblies identifier is transferred to laboratory.Equipment, cylinder casket or other assemblies identifier can be provided correspondingly about setting The configuration of standby, cylinder casket or other assemblies and/or the information of ability.For example, identifier can indicate which reagent or apparatus assembly It is available.Scheme can be transferred to based on identification information that is receiving or Gong checking from equipment to laboratory from laboratory Equipment.Scheme can be run in equipment based on identification information.
Identifier can be formed at the physical objects in equipment, cylinder casket or other assemblies.For example, identifier can be swept by light Retouch device reading.In some embodiments, camera can capture the image of identifier, and the image can obtain analyzing to identify Equipment, cylinder casket or other assemblies.In one example, identifier can be bar code.Bar code can be 1D or 2D bar code. In some embodiments, identifier can emit one or more signals, which can identify equipment, cylinder casket or component.For example, Identifier can provide infrared, ultrasonic wave, optics, audio, electricity or other signals, and the signal can indicate that equipment, cylinder casket or group The identity of part.Identifier can utilize radio frequency identification (RFID) label.Identifier can be stored in depositing for equipment, cylinder casket or other assemblies On reservoir.In one example, identifier can be computer-readable medium.
Communication unit 164 is configurable to transmit data to health care professionals 150.In some embodiments, Communication unit can transmit the report or analysis generated based on data related with sample.Communication unit can be with health care profession Network device communications used in personnel.For example, communication unit can computer, plate with health care professionals Computer or mobile device communication.
Alternatively, another entity or source produce report and/or transmit to health care professionals and report.For example, Laboratory can analyze by be in sample acquisition station perhaps in subject's body or with equipment provide or by testing The data that room, hospital, sample acquisition center or any other place described herein provide.Laboratory, equipment or another entity Can the data based on analysis and generate report or analysis.Report may include longitudinal data over time, may include one kind Or the concentration or presence or morbid state of multiple analytes change with time.Report and/or analysis can be commented using clinical effectiveness Estimate, such as the clinical effectiveness described in U.S. Patent Publication No. 2009/0318775 is assessed, and it is complete that the document passes through reference hereby Text is incorporated to.Report can be transmitted to health care professionals by laboratory, equipment, other entities or additional entity.Multiple times The analysis or data processing of conjunction can be occurred by one or more entities.Each entity may be provided in different facilities.It is standby Selection of land, some entities in each entity may be provided in identical facility.
In some embodiments, processor, communication unit and data storage cell can provide on the same machine.It is standby Selection of land, two or more in processor, communication unit and data storage cell can provide on the same machine.Machine can Be computer or as herein other everywhere described in any other network equipment.In processor, communication unit and data storage Two or more can be located at be located on the computer in laboratory.Alternatively, processor, communication unit and data storage can All on different machines.In some cases, it is possible to provide multiple processors, communication unit and data storage cell, it Can be distributed on one or more machines.
Fig. 2 shows the sample-processing equipments communicated by network 202 with one or more other equipment 204a, 204b 200。
Sample-processing equipment other can further describe everywhere in this paper.Sample-processing equipment is configurable to receive one Or multiple caskets.Sample-processing equipment is configurable to receive sample from subject.Sample-processing equipment is configurable to promote The acquisition of sample prepares sample for clinical trial, and/or realizes using the chemical reaction of one or more reagents or other changes Or physical treatment.Sample-processing equipment is configurable to the one or more signals about sample of detection.Sample-processing equipment It is configurable to operation test.Test may include running one or more chemical reactions.Sample-processing equipment is configurable to know One or more properties of other style product.In some embodiments, equipment can not be configured to execute sample in equipment onboardly The qualitative and/or quantitative assessment of product.Alternatively, the executable such qualitative and/or quantitative assessment of equipment.For example, sample treatment Equipment is configurable in test sample the one of (for example, in body fluid, secretion, tissue or other samples or pass through them) The presence of kind analyte or multiple analytes or concentration or disease condition.Alternatively, sample-processing equipment is configurable to examine Survey signal, which can obtain analyzing that (it can indicate that disease with the presence of analytes one or more in test sample or concentration Prevalence) or disease condition.Signal can be onboardly in equipment or in another ground point analysis.Operation clinical trial may include or Person may not include any analysis to the data of acquisition or compare.
Sample-processing equipment 200 is configurable to be communicated by network 202.Sample-processing equipment may include can be with The communication module that network connects.Sample-processing equipment can be via being wired connection or wirelessly connected to network.Network can be office Domain net (LAN) or wide area network (WAN), such as internet.In some embodiments, network can be personal area network.Net Network may include cloud.Sample-processing equipment can be connected to network without intermediate equipment.Any other to network provided herein It describes applicable.
In some embodiments, sample-processing equipment 200 can be communicated by network 202 with another equipment 204a, 204b. Another equipment can be communication enabled device.For example, another equipment can be client computer or show comprising video The mobile device of device, wherein at least one show that page includes data.Other equipment can be any kind of networked devices, including But it is not limited to: personal computer, server computer or laptop computer；Personal digital assistant (PDA), such as based on Palm Equipment or Windows CE equipment；Phone, such as cellular phone, smart phone (for example, iPhone, Android, Blackberry etc.) or location aware portable phone (such as GPS)；Peripatetic device such as connects the peripatetic device of network； Wireless device, such as wireless e-mail devices or the other equipment that can be wirelessly communicated with computer network；Or it is any its The network equipment that electronic transaction is communicated and handled possibly through network of his type.To any of any equipment referred to Discussion is also applicable to other equipment, including other equipment described everywhere herein.Sample-processing equipment can with it is one or more, Two or more, the communication of three or more or any number of other equipment.Such communication can be or can not Be at the same.Such communication may include the data that can be accessed by other equipment to cloud computing foundation structure or any other type It stores foundation structure and data is provided.
Other equipment 204a, 204b that can be communicated with sample-processing equipment 200 can have video display.Video display It may include the component that can show information in such a way that user is appreciable on it, for example, such as computer monitor, yin Extreme ray pipe, liquid crystal display, light emitting diode indicator, Trackpad or touch-screen display and/or known in the art For emit visual perception output other means.Video display can according to hardware and software known in the art and It is electronically connected to client computer.
In realizing at of the invention one, display page may include the computer documents resided in memory, the computer File can pass through network transmission to client computer or the other equipment that can be stored in memory from server.Client Computer is held to can receive visible computer readable medium, the medium may include instruction, logic, data or code, described instruction, Logic, data or code can be stored in the long-time memory or scratchpad memory of client computer, or can be with certain The action that mode influences or initial is carried out by client computer.Similarly, one or more equipment can across a network and one or The communication of multiple client computer, and the computer documents resided in memory can be transmitted.One or more equipment can To transmit the computer documents or the link that can provide to the access right of other computer documents.
Client computer 204a, mobile device 204b or herein other everywhere as described in any other network equipment Place, display page can be interpreted by the software resided in the client computer, mobile device or the memory of the network equipment, It is shown on a video display in a manner of it can be perceived by user so as to cause computer documents.Display page described herein can make It is created with software language known in the art, for example, the software language is all if any hypertext markup language (" HTML "), Dynamic Hyper Text Makeup Language (" DHTML "), extensible HyperText Markup Language (" XHTML "), extensible markup Language (" XML "), or in terms of can be used to create and being shown in the way of it can be perceived by user on video or other displays Another software language of calculation machine file.Any computer-readable medium with logic, code, data, instruction can be used to realize Any software or step or method.When network includes internet, display page may include the webpage of type known in the art.
Display page according to the present invention may include embedded functional, and told embedded functional includes to be stored in memory devices On software program, for example, such as VBScript routine, JScript routine, JavaScript routine, Java, ActiveX component, ASP.NET, AJAX, Flash small routine, Silverlight small routine or AIR routine.
Display page may include graphical user interface technology well-known characteristic, for example, such as frame, form, scroll bar, Button, icon and hyperlink, and the well-known characteristics such as " indication " interface or touch screen interface.It is directed toward and in graphical user circle It is clicked in face button, icon, menu option or hyperlink and also referred to as " selects " button, option or hyperlink.According to this hair Bright display page can also be incorporated into characteristics of the multimedia, multi-point touch, pixels sense, the surface based on IR LED, with or without The interaction of the view-based access control model of camera.
User interface can be shown on video display and/or display page.User interface can be shown based on analysed pass In sample data and the report that generates.Report may include the information of the presence or concentration about one or more analytes.With Family interface can show about the initial data of sample or through analyzing data.Data may include depositing about one or more analytes Or concentration information.User interface can show alarm.If an example of alarm can be detects mistake in equipment, Or if analyte concentration is more than scheduled threshold value.
In some embodiments, the one or more network equipment 204a, 204b can be provided in laboratory facility.In reality The data that the network equipment for testing room can receive or access is provided by sample-processing equipment 200.In some other implementations, may be used To provide one or more network equipments in health care professionals place.In some embodiments, laboratory equipment and Health care professionals' equipment all can receive or access the data provided by sample-processing equipment.In additional example In, one or more of network equipments can belong to subject.One in laboratory, health care professionals or subject Or it is multiple have can receive or access by sample-processing equipment provide data the network equipment.One or more laboratories The network equipment in health care professionals and/or subject or laboratory, health care professionals and/or subject, It can be before obtaining power access data by certification.For example, in order to access data, lab assistant, health care professionals and/ Or subject can have login ID and/or password.In some embodiments, data can be sent to lab assistant, medical treatment The E-mail address of health professional and/or subject.
In some embodiments, sample-processing equipment can provide data to cloud computing foundation structure.The network equipment (example Such as, the network equipment of laboratory, health care professionals or other entities) it may have access to cloud computing foundation structure.In some realities Apply in mode, can via computer network rather than from local computer occur computing resource (data, software) on-demand offer. The network equipment may include few software or data (perhaps containing only the operating system and web browser of bottom line), to fill When the basic display terminal for being connected to internet.Since cloud can be basal delivery mechanism, application and service based on cloud It can support any kind of software application or service.The information for being provided by sample-processing equipment and/or being accessed by the network equipment can It is distributed in each computing resource.Alternatively, they can be stored in one or more fixed data storage units or database.
Fig. 3 A illustrates the high-rise example of sample-processing equipment 300.Sample-processing equipment may be provided in be acquired including sample Any place including standing.Sample-processing equipment can in subject's body or with, or can be carried by subject.Sample treatment Equipment can be easily moved either transportable.Sample-processing equipment can be mobile with subject.Sample-processing equipment can be with It is bench device or handheld device.Sample-processing equipment can be located remotely from place of laboratory.Any number of sample-processing equipment It can geographically be distributed in any way.For example, one or more sample acquisition stations can have one or more equipment.
Sample-processing equipment 300 is configurable to receive removable cylinder casket 350.Removable cylinder casket and/or equipment can With as herein other everywhere described in any other characteristic or component.Removable cylinder casket be configurable to receive sample and/ Or deliver the sample into equipment.Removable cylinder casket can have the one or more reagents provided thereon.For example, Fig. 3 B is provided The diagram of the one or more reagents provided on removable cylinder casket.Alternatively, such as it is shown in figure 3 a, it is a kind of or more Kind reagent 370 can provide in equipment onboardly.Equipment may include one or more reagent units, and the reagent unit may include And/or the one or more reagents of constraint.Reagent can be originally provided in equipment, reagent can provide come from or be on a casket or Person is in the reagent unit in equipment and in cylinder casket onboardly simultaneously.
In other embodiments, sample-processing equipment is not needed with removable cylinder casket.One or more is such as directed to The function of cylinder casket description can be provided by equipment itself.
Herein other everywhere as described in, sample-processing equipment and/or cylinder casket may include executing one or more chemical reactions And/or all reagents, liquid-phase reagent and solid-phase reagent needed for other processing steps including physical treatment.For example, right It is measured in luminous ELISA, the reagent in equipment may include diluents, (such as three kinds of enzymes labels is anti-for detector conjugate Body), the surface that is marked with antibody conjugates, washing solution and zymolyte.
Enzyme linked immunosorbent assay (ELISA) (" ELISA ") is the survey for carrying out the target analyte in binding soln or in substrate using antibody It is fixed.A kind of useful immunoassays that can be run in devices disclosed herein are ELISA.For example, have adherency antibody or The tip of target antigen can use in the ELISA carried out according to method disclosed herein by equipment.
Progress ELISA is usually directed at least one can be in conjunction with interested antigen (that is, indicating influenza infection Analyte) antibody.Include or the doubtful sample comprising interested antigen non-specifically (for example, via surface is adsorbed onto) Or specifically (for example, in " sandwich " ELISA, via the capture of another antibody to same antigen with specificity) It is fixed on support (for example, tip or other supports with surface for fixing).It is added after immobilized antigen Antibody is detected, to form compound with antigen.Detection antibody can be coupled with enzyme or itself can be by transferring and enzyme coupling Secondary antibody detection.In substrate of the addition for the enzyme of coupling, generate indicate the presence of antigen in sample and/or amount can Detect signal.The selection of substrate will depend on the enzyme of coupling.Suitable substrate includes fluorogenic substrate and chromogenic substrate.This field skill Art personnel will be understood that and can determine which parameter of this kind of measurement can be modified to increase the signal detected and sheet Other variations of ELISA known to field
In some ELISA, solid-phase capture surface may include attachment first antibody, sample (for example, diluted blood, Blood plasma or biological sample) first antibody can be added to.If it does, the analyte in sample can be in conjunction with first antibody And it is fixed.Enzymatic reagent can be added, including is for example coupled or sews with enzyme (for example, alkaline phosphatase or horseradish peroxidase) The antibody of conjunction, the enzyme generate detectable product or can otherwise detect.If the antibody moiety of enzymatic reagent can be with In conjunction with analyte, then the enzymatic reagent is also secured on catch surface.The substrate of addition enzyme can lead to a kind of product, which produces It comes into force and answers, for example, the light that can measure and mark and draw as shown.In this way it is possible to measure the amount of analyte present in sample.
Therefore, for example, the exemplary ELISA that devices disclosed herein, system or method can be used to carry out is included in The solid phase capture surface (for example, tip) of first antibody is fixed thereon.First antibody to test antigen be it is specific (for example, There is specificity to the target bloods analyte such as cholesterol or to the neuraminic acid on the shell of virus for example interested Enzyme or other antigens have the antibody of specificity).If on being exposed to surface fixed antibody test sample (for example, Whole blood, blood plasma or serum) it is middle in the presence of test antigen, then the test antigen can fix (capture) on capture surface.Addition and the (for example, wherein first antibody has biotin labeling, and secondary antibody is with anti-for the antibody for the second label that one antibody combines Biotin protein label and detectable label；Or wherein first antibody is the sheep antibody for including the part Fc, secondary antibody It can be the antibody for being directed to sheep Fc and being marked with alkaline phosphatase (AP), can be detected after adding AP substrate) Allow to detect and quantify the amount of antigen in sample.First antibody in conjunction with substrate will not due to secondary antibody addition and washed Fall.By provide alkaline phosphatase substrate, so as to cause generate can be detected and measure it is coloured, fluorescence, shine (for example, chemiluminescent) or otherwise detectable compound, may be implemented such detection and quantization.
Alternatively, blood sample is made (to generate first with catalysis with first antibody with fixation, for the first antigen The enzyme of the reaction of detectable compounds marks) surface be in contact after, can add for the second antigen and with can produce The secondary antibody of the second enzyme label of second detectable compounds.First antibody in conjunction with substrate will not be due to secondary antibody It adds and is washed off, and can be by providing substrate and appropriate to generate the first detectable product by the enzyme for being connected to first antibody Reaction condition and be detected.The combination of the antibody of the second label and subsequent detection indicate in test sample on capture surface The presence of both first and second test antigens.The first and second detectable compounds that enzyme by being connected to antibody generates all may be used Detected by any desired means, including detection fluorescence, shine, chemiluminescence, absorbance or other for detect because attached Enzyme and the means of the product of enzyme reaction that occur.
For example, photomultiplier tube, charge-coupled device, photodiode, camera, spectrophotometer and other assemblies and Equipment can be used for measuring the light for emitting during carrying out ELISA or influencing.For example, being detected during carrying out ELISA to sample The amount (for example, other measured values for being expressed as relative light unit or luminosity) of light can be with standard curve (for example, being The calibration curve that particular assay, equipment, cylinder casket or reagent prepare) it is compared, to calculate the concentration of target analytes in sample. It has used the ELISA carried out in devices disclosed herein and system detect and has measured it in blood sample Horizontal analyte includes: vitamin B-12, folic acid, thyroxine, testosterone, estradiol, cotinine, vancomycin, blood red egg It is white A1c, prostate-specific antigen, human chorionic gonadotrophin, metakentrin, parathormone, alpha-fetoprotein, preceding white Albumen, cardiac troponin T, c reactive protein, hepatitis B surface antigen (HBsAg), immunoglobulin E (IgE), immunoglobulin G (IgG), dengue virus IgG, rheumatoid factor IgM, west nile virus IgM, 1 antibody of AntiHIV1 RT activity, 2 antibody of AntiHIV1 RT activity, anti-core are anti- Body, Flu-A, influenza B and streptococcus (streptococcus).
For example, ELISA can also be used in competitive binding experiment, wherein can pass through the analyte of the label of addition known quantity And measure analyte in conjunction with and measure the concentration of analyte in solution.Sample analytes (its do not include label) it is increased Concentration interferes the combination of the analyte of (" competition ") label, to allow to calculate the amount of analyte in sample.
It can provide additional reagent as needed.In some embodiments, reagent may be incorporated into equipment to be supplied to sample Product pretreatment.The example of pretreating reagent includes but is not limited to leucocyte lytic reagent, discharges and divide from the binding factor in sample Analyse reagent, enzyme and the detergent of object.Pretreating reagent can also be added in the diluent for including in equipment.
Reagent includes but is not limited to washing buffer, zymolyte, dilution buffer, conjugate, enzyme label according to the present invention Conjugate, DNA cloning agent, diluents, washing solution, sample pretreatment reagent, including it is additive such as detergent, poly- Close object, chelating agent, albumin binding reagents, enzyme inhibitor, enzyme, anti-coagulants, erythrocyte agglutination agent, antibody or other in equipment Material necessary to upper operation measures.The conjugate of enzyme label can be the polyclonal antibody marked with enzyme or monoclonal antibody, It can produce detectable signal when the enzyme and substrate reactions appropriate.The non-limiting example of this fermentoid is alkaline phosphatase and horseradish Peroxidase.In some embodiments, reagent includes immunoassay reagent.It can provide the reagent for limiting measurement specificity, It optionally may include for example affine base of such as monoclonal antibody, polyclonal antibody, protein, nucleic acid probe or other polymers Matter, carbohydrate or lipid.In general, reagent, especially those of relatively unstable reagent when being mixed with liquid, point It opens in the limited area (such as reagent unit) being limited in equipment and/or cylinder casket.
In some embodiments, reagent unit may include the reagent of small size.For example, reagent unit can be substantially comprising about 5 microlitres or less to about 1 milliliter of liquid.In some embodiments, unit can include about 20-200 microlitres of liquid.At it In his embodiment, reagent unit includes 100 microlitres of fluid.In one embodiment, reagent unit includes about 40 microlitres Fluid.Reagent unit may include other any volumes for describing everywhere herein, may include sample volume.Liquid in reagent unit The volume of body can change according to the type of operation or the humoral sample of offer.In one embodiment, the body of reagent Product need not be predetermined, but must exceed known minimum value.In some embodiments, the initial stored dry of reagent, and work as Dissolution when the measurement initial run in equipment.
Sample-processing equipment may include display 310.Display can be video display or other kinds of user circle Face.Display can play the function of user interface.Display allows user to operate sample-processing equipment.Display is configurable For receive from user with subject's identity, the other information about subject, the information about sample, about one Or the information of multiple clinical trials, the information about sample preparation steps, the information about laboratory and/or about health care The relevant input of the information of supplier.
Display can be to device operator output information.In the operation of equipment, display can prompt operator to execute one A or multiple steps.Display can show the sample about acquisition, subject and/or the preparation step executed with one or more Or the information of the relevant data of chemical reaction of operation.Display is exportable can be by the automatic of equipment realization about one or more The information of change process.Display can be for the mistake detected or when meeting one or more parameters (for example, certain detect Signal be more than scheduled threshold value) one or more alarms are provided.Display can show the result in equipment.
Sample-processing equipment 300 may include it is one or more for acquisition sample, prepare sample for clinical trial and/or The component that operation chemical reaction or other tests or analysis come in handy.Sample-processing equipment also may include it is one or more for The component that the one or more signals about sample or apparatus assembly of detection come in handy.For example, sample-processing equipment may include But it is not limited to sample collection unit, centrifuge, magnetic separator, filter, pipette or other fluid handling systems, vessel, appearance Device, determination unit, reagent unit, heater, heat block, cell counter, spectrophotometer, imaging system, micro- station, light source, Photodetector, photometer, temperature sensor, motion sensor or the sensor for electrical property.Fluid can be via such as liquid relief The fluid handling system of pipe, channel or pump etc is transferred to another component from a component.
In some embodiments, fluid handling system can be pipette.Pipette can be bull pipette.One It is that each head of pipette can be identical type or can be different type in a little situations.For example, head of pipette can be with It is exhaust pipette and/or positive displacement pipette.In some cases, fluid handling system can be picked up and/or be moved Except one or more pipette tips.Pipette tip can be added individually or be removed from head of pipette.Head of pipette can will move Liquid pipe tip is transferred to the second position from first position.Pipette tip may be connectable to head of pipette and it is formed not The sealing of leakage current body, or be screwed to and wherein or be otherwise attached.Sample or other fluids can be drawn by pipette tip and/ Or distribution.
Pipette tip can have the inner surface and the outer surface.Pipette tip can have first end and opposite second end. In some embodiments, first end and second end can be unlimited.In some embodiments, first end can have ratio The bigger diameter of the diameter of second end.Pipette tip can be coated with or can be not coated by reagent and/or such as antibody etc Capture conjugate.In some cases, the inner surface of pipette tip can be coated with reagent and/or capture conjugate.Chemistry Reaction can occur in pipette tip.Chemical reaction can be when tip be attached to head of pipette, or at tip and head of pipette Occur in pipette tip when separation.Alternatively, chemical reaction can occur in one or more vessel.Pipette can be to device Ware delivers sample or other fluids, or from vessel pipette samples or other fluids.Pipette tip can be at least partly It is inserted into vessel.
It can use the sample or other fluids that pipette comes in transfer equipment.Pipette can assist the preparation of sample.It moves Liquid pipe can assistant chemical reaction operation.
Sample-processing equipment may be able to carry out at least one sample preparation steps, and/or run one or more, 2 It is a or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or More, 9 or more, 10 or more, 20 or more, 30 or more or 50 or more changes Learn reaction.Equipment may be able to carry out one or more, two or more, 3 kinds or more, 4 kinds or more, 5 kinds or more A variety of, 6 kinds or more, 7 kinds or more, 8 kinds or more, 9 kinds or more, 10 kinds or more, 20 kinds or more Kind, 30 kinds or more or 50 kinds or more different types of measurements.These can while and/or successively occur.It can send out Raw sample preparation and/or chemical reaction can be managed by scheme, and the program can be individualized for the demand of subject, with And/or person sends back and forth from server and/or locally-stored or input.The demand of subject can have been protected from medical treatment based on subject The prescription or instruction that strong professional receives.Equipment is configurable to the extensive sample preparation and/or chemical reaction of adaptation range.
Sample-processing equipment 300 may include one or more detectors 360, the detector may be able to detect one or Multiple signals about sample.Detector may be able to detect all transmittings from electromagnetic spectrum.Alternatively, detector may It is able to detect the transmitting of the selected range from electromagnetic spectrum.For example, photodetector is detectable about having occurred in equipment The optical signal of chemical reaction.Electrical property sensor or other sensors can detect appointing for voltage, electric current, impedance, resistance or sample What his electrical property.Temperature sensor can determine that sample can be placed in the temperature of heat block thereon.Sensor can determine centrifugation The speed of machine.Sensor can determine position, speed and/or the acceleration of pipette and/or the successful execution of scheme.
One or more detectable signals can be detected by detector 360.Detectable signal can be luminous signal, including but It is not limited to luminescence generated by light, electroluminescent, chemiluminescence, fluorescence, phosphorescence or any transmitting from electromagnetic spectrum.In some implementations It, can be during chemical reaction using one or more markers in mode.Marker allows the generation of detectable signal.Detection The method of marker is known in those skilled in the art.Therefore, for example, when marker is radioactively labelled substance, Detection means may include scintillation counter or the photographic film such as in radioautography.When marker is fluorescent marker When, it can detect in this way: by exciting fluorescent dye with the light of appropriate wavelength, and for example pass through microscopy, visual inspection, warp It is examined by photographic film, by using digital camera, charge-coupled device (CCD) or the electronics such as photomultiplier tube and photoelectric tube Device or other detection devices are surveyed, to detect the fluorescence of generation.In some cases, camera can use CCD, CMOS, can be with It is no lens camera (such as Franken camera (Frankencamera)), open source camera, or can use or known in the art Or any other vision detection technology of Future Development.In some embodiments, 2D imaging, 3D imaging can be used in imaging device And/or 4D imaging (including variation over time).Similarly, enzyme marker is by providing substrate appropriate for enzyme and detecting The reaction product of generation and detected.Finally, simple colorimetric marker is associated with the color of marker frequently by observation And it is simply detected.For example, the frequent pinkiness of coupling gold, and various coupling pearls are then in the color of microballon.
In some embodiments, it is possible to provide imaging unit.The example of imaging unit may include as other are retouched everywhere herein Any detector and/or light sensing device stated.For example, imaging unit can be the camera using CCD, CMOS, can be No lens camera (such as Franken camera (Frankencamera)), open source camera, or can use or it is known in the art or Any other vision detection technology of Future Development.Imaging unit can capture still image and/or can capture moving image. For example, imaging unit can capture a series of digital pictures.Imaging unit can captured video image.Imaging device can be detection And/or record the camera or sensor of electromagnetic radiation and associated space and/or time dimension.
In one example, imaging unit can capture one or more digital pictures of sample.For example, imaging unit can be caught Catch the image of tissue sample.The photo of tissue sample can be transferred to virologist or other health care professionals.It can send out The analysis and/or supervision of the raw image to tissue sample.Analysis and/or supervision can occur onboardly, or remotely pass through doctor It treats health professional or software program and occurs.In other examples, imaging unit can capture the image of sample, and/or The image of any type of sample preparation of chemical reaction or physical treatment step etc that person such as occurs with sample.Example Such as, the video of chemical reaction can be shot.The data of representative image are also applicable to any description of data herein, and on the contrary ?.
Imaging can be used for, for example, the cell in detection, inspection, identification, characterization and quantization sample, such as in such as blood Cell in liquid sample, urine sample, biopsy or other samples.Imaging and this application of other technologies are referred to alternatively as " cell counting ".Cell counting includes observing and measuring cell, such as red blood cell, blood platelet, leucocyte, including cell Number, other features of cell type, cell surface marker object, internal cell marker and interested cell it is qualitative and fixed Amount observation and measurement., can be by the sample part when biological sample includes blood sample or blood sample, and can incite somebody to action It dilutes (for example, to provide bigger volume in order to handle, to change the density of the cellular component in sample or dense Degree, to provide desired dilution density, concentration or cell number or these range, etc.).Sample can use influence solidification Reagent is handled, or can be handled or be disposed to which concentration or deposit sample component into sample (for example, can add second Ethylenediamine tetraacetic acid (EDTA) (EDTA) or heparin, or the sample can be centrifuged or make cell settlement).Can by addition can be with certain detail Born of the same parents or specific cells component reaction and the dyestuff marked or other reagents handle sample.For example, the dye of label nucleus Material (for example, hematoxylin dyestuff, cyanine dye, draq dyestuff such as Draq5 and other), the cytoplasmic dyestuff of label is (for example, eosin Dyestuff, including fluorescein(e) dye and other) can be used alone or be used together visualization, identification and amount to help cell Change.More specific marker, including to cell target such as cell cortex protein, intracellular protein and compartment and other targets The antibody and antibody fragment with specificity are marked, is also useful in cell counting.
Biological sample can be used Optical devices and measure and analyze by cell counting, and the Optical devices include, For example, photodiode detector, photomultiplier tube, charge-coupled device, laser diode, spectrophotometer, camera, micro- Mirror or measurement (optical wavelength of Single wavelength a, multi-wavelength or range or multiple ranges) luminous intensity form image or two Other devices both with person.The visual field for including sample can be imaged, or it can be carried out using such detector Scanning, or both has both.Biological sample can be before processing, dilution, separation, centrifugation, solidification or other changes by thin Born of the same parents' counting method is measured and is analyzed.It can be logical during or after the processing of sample, dilution, separation, centrifugation, solidification or other changes Cell counting is crossed to measure and analyze biological sample.For example, can be measured immediately by cell counting after receiving sample And analyze biological sample.It in other examples, can be in the processing of sample, dilution, separation, centrifugation, solidification or other change phases Between or measured later by cell counting and analyze biological sample.
For example, blood sample can be prepared to be used for cell counting by sedimentation or centrifugation.The sedimentation of such sample or Sediment fraction can be in the buffer for being resuspended in selection before cell count analysis (for example, passing through suction, stirring, sonication Or other processing).Biological sample can dilute before cell count analysis with water or with saline solution such as buffered saline solution Or resuspension.Solution for such dilution or resuspension may include or can not include fixative (for example, formaldehyde, low Other of polyformaldehyde or cross-linked proteins reagent).Solution for such dilution or resuspension can be in surrounding medium and sample Osmotic gradient is provided between the inside or interior compartment of cell in product, to effectively make some or all of cells in sample Cell volume change.For example, the solution concentration generated after the dilution is less than cell interior or internal cellular compartment In the case where effective concentration, the volume of such cell will will increase (that is, the cell will expand).Biological sample is available can be with Include or penetrant can not included (such as, for example, glucose, sucrose or other sugar；Salt, such as sodium, potassium, ammonium or other salt； Or other osmotically active compounds or ingredient) solution dilute.In embodiments, penetrant can for example, by stablize or Reduce possible osmotic gradient between surrounding medium and the inside or interior compartment of this kind of cell, effectively to remain thin in sample The integrality of born of the same parents.In embodiments, penetrant can effectively provide or increase the inside or interior of surrounding medium and this kind of cell Osmotic gradient between portion's compartment effectively makes cell at least partly shrink (inside or interior compartment concentration in cell Lower than surrounding medium concentration when), or cell expansion is effectively made (to be higher than week in the inside of cell or interior compartment concentration When enclosing the concentration of solution).
For example, can measure or analyze biological sample after with the solution dilute sample comprising dyestuff.For example, can be With measurement after a part comprising antibody or the solution dilute sample of antibody fragment or analysis biological sample.For example, can be With measurement after the solution dilute sample comprising particle or analysis biological sample.The particle added to biological sample may act as standard (for example, may act as size criteria in the situation known to the size or size distribution of particle, or the number in particle, amount or May act as concentration standard in situation known to concentration), or may act as marker (for example, being bonded or adhered in particle specific In the case where cell or certain types of cell, specific cells marker or cellular compartment, or it is bound in sample in particle All cells in the case where).
For example, biological sample can be measured or be analyzed after treatment, which can be by one or more cell types and another Outer one or more cell types separate.Such separation can pass through gravity (for example, sedimentation), centrifugation, filtering and substrate (example Such as, surface, such as wall or pearl, it includes antibody, agglutinin or can prior to another cell type and with a kind of cell class Type combines or the other components of adherency) contact or other means realize.By changing a kind of cell type or various kinds of cell class Type can help or realize separation.For example, solution can be added into biological sample such as blood sample, this cause some in sample or Whole cell expansions.When a kind of cell type is quickly expanded than another cell type or various kinds of cell type, can pass through The sample is observed or measured after adding the solution to distinguish cell type.Such observation and measurement can carry out one Secondary or multiple, selection is to protrude the difference of response (for example, size, volume, concentration inside or by this expansion effects Other properties), and so as to improve the sensitivity and accuracy observed and measured.In some cases, a seed type or more The cell of seed type may be in response to such expansion and burst, to allow to one or more cell types remaining in sample Observation and measurement.
It may include photometric measurement by observation, measurement and analysis that cell counting carries out biological sample, such as using Photodiode, photomultiplier tube, laser diode, spectrophotometer, charge-coupled device, camera, microscope or other dresses It sets or equipment.Cell counting may include the image (for example, two dimensional image) of preparation and the cell in analysis biological sample, wherein Cell can be marked (for example, using fluorescent marker, chemiluminescent labeling, enzyme label or other label) and plate painting (for example, It is allowed to settle in substrate) and be imaged by camera.Camera may include camera lens, and can be attached on microscope or It is used in conjunction with microscope.The label that cell can be attached in two dimensional image according to it is (for example, according to by label transmitting Light) Lai Jianding.
The image for the cell for being prepared and being analyzed with cell counter disclosed herein can not include cell, including one thin Born of the same parents or multiple cells.It can mark as disclosed above thin in the image of cell or cell counter disclosed herein Born of the same parents.The cell in the image of cell or cell counter disclosed herein can be marked, as disclosed above with effective It identifies image and therefrom obtains the subject of sample in ground.
It is made using the equipment, system and method for embodying feature disclosed herein to the cell from blood sample The count measurement of cell.For example, being counted to the number of cell using cell count image (for example, providing every volume The cell number of blood), the size and size distribution for determining cells in sample (including survey by average value, standard deviation and other sizes Degree), and the identification of cell type based on cell surface marker object.In general, the total concentration of red blood cell and blood platelet is at every microlitre About 1-3x106(for example, every microlitre of about 2x 10 in the range of a cell6A cell).Allow channel of the cell settlement in tank Bottom on, to allow to shoot the image of single focal plane, which is enough to detect all in the volume in image-region Cell；Therefore the counting of the cell in blood volume represented by the cell count in single image is provided by the image.By Size in channel is known, therefore the blood volume on the region shown in described image allows to the cell in the volume The accurate calculating of density.Also by the inclusion of as indicant, known concentration microballon, (its image can be different from blood cell figure Picture) measure volume；Due to the concentration of microballon be it is known, the number of the microballon in the visual field count allow it is accurate Ground calculates the volume for therefrom shooting the sample of image.
Optical imagery includes for detecting the fluorescent image of red wavelength, blue wavelength and green wavelength (for example, for inspection Survey and measurement the fluorescence from the dyestuff for being connected to specific cell surface markers object be useful) and dark field images it is (right It is useful in detection cell shape and profile and for measurement cell size and volume).Fluorescent image can for example be used to reflect Different cell types in fixed and quantitative sample.Dark field images are based on the light from the object scatter in tank, and it is provided Information related with the size of the object in tank, shape and number.Forward scattering measurement is used for quantization cell size.It is lateral to dissipate Measurement is penetrated for determining, identifying and cellular morphology of classifying.
Data from image are handled by being associated with the controller of sample-processing equipment.Following measurement can be calculated: 1) The number of red blood cell in tank；2) in tank red blood cell average external volume；3) in tank red blood cell erythrocyte distribution width (RDW)；4) in tank blood platelet number；5) in tank blood platelet average external volume；And 6) in tank the blood of blood platelet is small The plate dispersion of distribution.
The microscopy methods that can be used together with devices disclosed herein with system include but is not limited to the bright visual field, inclined-plane Illumination, dispersion dyeing, difference, differential interference comparison (DIC), polarised light, epi-fluorescence, interference reflection, fluorescence, is total to dark field Burnt (including CLASS), confocal laser scanning microscopy (CLSM), stimulated emission detraction, electronics, scan probe, are red structured illumination Outside, laser, wide-angle, light field microscopy, without holographic microscopy, number and conventional photographic microscopy on lens chip, extension field depth Microscopy, defocuses microscopy, quantifies phase microscopy, diffraction phase microscopy, is total to light scattering imaging microscopy, deconvolution microscopy Burnt Raman microscopy, scan-type sound wave microscopy and X-ray microscopy.As unrestricted example, what microscopy used is put Big level may include up to 2x, 5x, 10x, 20x, 40x, 60x, 100x, 100x, 1000x or higher amplification factor.It is feasible Amplification level will change with the microscopy type used.For example, the image generated by some form of electron microscopy can relate to And the amplification factor of up to hundreds of thousands times.Several micro-images can record to same sample, to generate time resolution data, including Video.By parallel imaging or by recording the piece image comprising multiple cells, single or multiple cells can be imaged simultaneously.It is aobvious Objective can soak in the medium to change its optical property, such as pass through oil immersion.Micro objective can be by the convex of rotation Wheel is mobile to change focus relative to sample.Cell count data can automatic or manual processing, and can further comprise for example It is diagnostic purpose to the morphologic analysis of cell or tissue by virologist.
Can be by actuator, such as subtly position finding microscope object lens of the cam by being connected on motor, to focus Image.Object lens can focus in one or more planes of sample.By the figure for calculating digital picture by image analysis regulation Image sharpness and other methods can make to focus automation.
Cell counting can be used, such as with or without the imaging of microscopy, Lai Zhihang cell count.It bright can regard In the case where wild illumination body, preferred embodiment is to illuminate main body from front with white light and sensed with imaging sensor thin Born of the same parents.Subsequent digital processing will count cell.Cell poor or it is smaller when, preferred embodiment be connection specificity or it is non- The fluorescent marker of specificity, and then main body field is illuminated with laser or other suitable light sources.Cofocus scanning imaging can be used. In embodiments, the cell of up to 500 or 1000 any given types can be counted.It in other embodiments, can be with Various several aim cells of any given type are counted, about 1 cell, 5 cells, 10 are including but not limited to than or equal to Cell, 30 cells, 50 cells, 100 cells, 150 cells, 200 cells, 300 cells, 500 cells, 700 A cell, 1000 cells, 1500 cells, 2000 cells, 3000 cells, 5000 cells.It can be used available Counting algorithm count cell.Cell can be identified by the distinctive fluorescence of cell, size and shape.
In some microscopy embodiments, Koehler can be created by using white light source and classification condenser and shone It is bright to realize the illumination of the bright visual field.The cell bright vision image for detecting similar property with the forward scattering in flow cytometry can be with Coloration attributes in display cell size, intracellular phase dense material and cell (if cell is previously dyed).? In one example embodiment, Wright-Giemsa colouring method can be used to dye people's whole blood smear.Bright visual field imaging is shown The distinctive staining pattern of human leukocytes.Special shaped red blood cell can also identify in these images.
In some microscopy embodiments, can by using based on ring light illumination scheme or other are available outer dark Darkfield image is realized through dark field illumination scheme in the visual field.Darkfield image can be used for for example determining the light scattering of cell Matter, the sidescattering being equivalent in flow cytometry, such as when human leukocytes are imaged.In dark field images, scattering The cell interior and surface of more light seem brighter, and the feature for scattering less amount of light seems darker.Cell such as grain Cell has the internal particle of certain particle size range (100-500nm), these particles can scatter a large amount of light, and in dark field figure Usually seem brighter as in.In addition, the outer boundary of any cell can scatter light, and it can behave as the ring of light.The diameter of the ring The size of cell can be directly given.In addition, microscopy methods may further be used to measurement cell volume.For example, can measure red blood cell Volume.To increase accuracy, red blood cell can be transformed by sphere by using anion or zwitterionic surfactant, and make The size of each sphere is measured with darkfield image, thus can calculate cell volume.
In some microscopy embodiments, it can be marked with fluorescent marker and be likely lower than microscope by diffraction limit The limit of resolution cellule or visible component；Sample can be excited with the light of appropriate wavelength, and image can be captured.The cell of label The diffraction pattern of the fluorescence of transmitting can be used computer analysis to quantify, and associated with cell size.For these implementations The computer program of mode is described in this paper other parts.It, can be by using anion and two for the accuracy for improving this method Property ionic surface active agent is by cells switch at sphere.
Cell imaging can be used in the information (but being not limited to these following information) of the following type of each cell extraction One or more information: cell size；What cellular granularity or light scattered and (is commonly called as lateral scattering, be based on flow cytometry term) determines Measurement degree；The quantitative measure or glimmering of fluorescence in each spectrum channel being imaged after crosstalk between compensated spectrum channel Light or the distribution pattern intracellular of other dyeing；Cell shape such as passes through standard and custom-shaped attribute (such as length-width ratio, Feret Diameter, kurtosis, rotary inertia, circularity, degree of packing etc.) cell shape that is quantified；Color, distribution of color and the shape of cell, In the case where cell dyestuff (being not connected to antibody or other kinds of receptor) dyeing；The mould intracellular of dyeing or scattering Formula, is defined as the color or fluorescence of the quantitative target of biological property, which is, for example, morphology, such as dark field Core in the Giemsa-Wright dye image of intracellular grain density or polymorphonuclear neutrophisls in image Number and size of benevolence leaflet, etc.；The common location of shown cell characteristic in the image obtained in different channels；Individual Spatial position (the example of cell, eucaryotic cell structure, cell colony, intracellular protein, ion, carbohydrate and lipid or secretion Such as it is used to determine the source of the protein of secretion).
The information being collected by cell count widely can be used based on the measurement of cell with scope of design.For example, It can provide the measurement for executing 5 part leukocyte differentials.In this case can report value can be it is for example following kind of white The cell number of cell/microlitre blood: monocyte, lymphocyte, neutrophil leucocyte, basophilic granulocyte and acidophil granules are thin Born of the same parents.Can report value can also be used to classification leucocyte differentiation, or identification T and B cell group.
Fluorescence microscopy, which is usually directed to fluorescent marker, marks cell or other samples, retouches in further detail below It states.The micro-imaging of the sample of fluorescent marker collects depositing about the target marked in given time or whithin a period of time , amount and position information.Fluorescence can also be used to the sensitivity of enhancing detection cell, eucaryotic cell structure or cell function.In fluorescence In microscopy, fluorescent molecule is excited using light beam, then which emits the light of different wave length for detection.Excitation The light source of fluorogen is well known in the art, including but not limited to xenon lamp, laser, LED and photodiode.Detector include but It is not limited to PMT, CCD and camera.
Spectrum analysis includes generating any and all measurements for shining or changing light (such as colour chemistry).This may include with Under it is one or more: spectrophotometry, fluoremetry, photometering, turbidimetry, turbidimetric analysis turbidimetry, refraction measurement, polarimetry and Agglutination measurement.
Spectrophotometry refers to reflection or transmission of the measurement main body to electromagnetic wave (including visible light, UV and infrared ray).Example Such as, spectrophotometry can be used to for example determine the nucleic acid concentration in sample by measuring absorbance at the wavelength of about 260nm； Protein concentration is determined by measuring absorbance at the wavelength of about 280nm；And/or by being surveyed at the wavelength of about 230nm Absorbance is measured to determine salinity.
Other examples of spectrophotometry may include infrared (IR) spectrum analysis.The example of infrared spectrum analysis includes close red External spectrum analysis, far red light spectrum analysis, Laser Roman spectroscopic analysis of composition, the spectrum analysis of Raman confocal laser, Fourier transformation are red External spectrum analysis and any other Infrared Spectrum Technology.Below about 650cm-1Frequency be generally used for far-infrared spectrum point Analysis, greater than about 4000cm-1Frequency be generally used for near-infrared spectrum analysis, and the frequency between about biomedical applications, packet The frequency in the screening and diagnosis of cancer, arthritis and other diseases is included, the chemical component of biofluid is measured, measures septicopyemia Symptom state etc..IR spectrum analysis can be used for solid sample, such as tissue biopsy, cell culture or Pap smear；Or it is used for Fluid sample, such as blood, urine, synovia, mucus etc..IR spectrum analysis can be used to distinguish normal and cancerous tumor cell, as the U.S. is special Benefit number 5, described in 186,162, is incorporated herein by reference.IR spectrum analysis can also be used for blood sample, to detect a variety of entities The label of organ cancer.IR spectrum analysis can also be used to determine the cellular immunity in patient, such as diagnoses immune deficiency, itself exempts from Epidemic disease, infectious disease, allergy, hypersensitivity and tissue transplantation compatibility.
IR spectrum analysis can be used to measure the glucose level in blood, this is useful to diabetic, such as with In monitoring insulin response.IR spectrum analysis further can be used to measure other substances in blood sample, such as alcohol is horizontal, fat Acid content, cholesterol levels, hemoglobin concentration.IR spectrum analysis can also distinguish between the cunning from Healthy People and arthritic Liquid.
Fluoremetry refer to incident light excite fluorescent molecule when measurement by be coupled with main body fluorescent molecule transmitting Light.Fluoremetry can be used as above in face of any fluorescent molecule, label and target described in cell counting measuring.In some implementations In mode, fluoremetry uses the substrate molecule based on enzyme activity change fluorescence, such as is converted to NADH or vice versa also from NAD+ So, or by precursor molecule beta galactosidase is generated.Fluoremetry can be used together with Polarized Excitation source, to measure main body Fluorescence polarization or anisotropy can provide the information about size and/or reference state.
Colorimetric method refers to that the transmitted colors of measurement main body absorb, preferably by illuminating main body with white light backlight, with imaging Sensor detection results.Example includes some use oxidizing ferment or peroxidase and becomes have face in the presence of hydrogen peroxide The measurement that the dyestuff of color combines.A method of measuring peroxidase activity in the intact cell suspension of human leukocytes It discloses in Menegazzi etc., J.Leukocyte Biol 52:619-624 (1992), is incorporated herein by reference of text. Such measurement can be used to test and analyze object, including but not limited to alcohol, cholesterol, lactate, uric acid, glycerol, triglycerides, paddy ammonia Hydrochlorate, glucose, choline, NADH.The some enzymes that can be used include horseradish peroxidase, lactoperoxidase, micro- peroxide Compound enzyme, alcohol oxidase, cholesterol oxidase, nadh oxidase.Other non-limiting examples of colorimetric estimation include being based on The measurement of dyestuff, to measure protein concentration, such as Bradford, Lowry, biureat and nanometer-orange method.The pH of sample It can also be determined by colorimetric estimation indicator dye, including but not limited to phenolphthalein, thymolphthalein, alizarin yellow R, Indigo Carmine A Red, m-cresol purple, cresol red, thymol blue, xylenol blue, 2,2 ', 2 ", 4,4 '-pentamethoxyl triphenylcarbinols, benzopurpurin 4B, tropeolin G, 4- phenylazo diphenylamines, malachite green, quinaldine red, orange IV, thymol blue, xylenol blue and combinations thereof.
Photometering does not use means of illumination, and the photon of its own is emitted because based on.The light of transmitting may be weaker, and Very sensitive sensor detection, such as photomultiplier tube (PMT) can be used.Photometering includes generating chemiluminescent survey It is fixed, such as using the measurement of those of luciferase or use some measurements of peroxidase.
For turbidimetry, the preferred embodiment of detection is to illuminate main body with white light backlight, is detected and is tied with imaging sensor Fruit.For turbidimetry, the decline of transmitted intensity is measured.Turbidimetry can be used to for example measure the cell concentration in solution.One In a little embodiments, turbidimetry is measured by turbidimetric analysis turbidimetry.
Turbidimetric analysis turbidimetry measurement after the main body in suspension transmit or scatter light, the main body be usually and immune globulin The substrate that white such as IgM, IgG and IgA are combined.
The polarization of electromagnetic wave of polarimetry general measure main body.Polarimetry analysis includes the circle two that can provide structural information The determination of light scattering of color and the information that can provide the size and/or shape about main body.One of determination of light scattering is unrestricted Property example use dynamic light scattering (DLS).Main body for these measurements does not need to mark.
Sample-processing equipment 300 can have processor 330, which can provide to the one or more components of equipment refers to It enables.Processor may act as can be with the controller of the one or more components of commander equipment.For example, processor can provide instruction to shifting Liquid pipe, to draw or distribute fluid.Processor can provide to heater (it optionally can be and heats and/or cools equipment) The instruction that temperature is controlled.Processor can provide instruction to photodetector, to detect one or more signals.Processor may be used also Receive the data of instruction and/or acquisition.For example, processor can take action according to one or more schemes.Scheme can mention onboardly For in equipment, or can be provided from the source except equipment.Processor also can receive about the signal detected by equipment Data.The signal detected by equipment can be analyzed or can not be analyzed to processor.What processor can detect one or more Signal is compared with threshold value, or can be without comparing.
It can provide communication module 340 in equipment 300.Communication unit can be laboratory or the setting including equipment A part.Communication module allows equipment to communicate with external mechanical.For example, communication module can from external source receive one or Multiple schemes or instruction set.In some embodiments, external source can be laboratory.Communication module may also allow for equipment to External mechanical transmits data.Data can be transmitted via transmission unit.For example, equipment can be to laboratory or health care professionals Transmit data.Equipment can be by laboratory, health care to cloud computing infrastructure transmissions data, the cloud computing foundation structure Professional or the access of other entities.Communication module allows wireless and/or wire communication.
Sample-processing equipment 300 also may include power module 320.Power module can connect devices to external power supply, or Person is provided as inside local power supply.For example, power module can connect devices to power transmission network or communal facility.Equipment can To include the plug that may be connected to electrical socket.Equipment may be connected to any other external power supply, and the external power supply may include all Such as generator generating equipment perhaps any renewable energy (for example, solar energy, wind energy, water energy, geothermal energy) or energy Storage source (for example, battery, supercapacitor).Power module can be local power supply.It is set for example, power module can be energy storage It is standby, such as battery or supercapacitor.Any known in the art or Future Development battery chemistries can be used.Alternatively, originally Ground power supply may include local power plant, such as utilize the equipment of renewable energy.Power module can provide electric power to run The rest part of sample-processing equipment.
The one or more components of equipment may include in shell.Shell can partially or even wholly enclosing equipment group Part.It can provide display on shell, so that the display be made to may be visible.
Equipment can be bench device.Equipment can be portable or Worn type.Multiple equipment can be in a room. Equipment, which can have, to be less than, greater than or equal to about 4m3、3m3、2.5m3、2m3、1.5m3、1m3、0.75m3、0.5m3、0.3m3、0.2m3、 0.1m3、0.08m3、0.05m3、0.03m3、0.01m3、0.005m3、0.001m3、500cm3、100cm3、50cm3、10cm3、5cm3、 1cm3、0.5cm3、0.1cm3、0.05cm3Or 0.01cm3Total volume.Equipment can have the occupy-place of the horizontal area of overlay device Area.In some embodiments, equipment footprints can be less than, greater than or equal to about 4m2、3m2、2.5m2、2m2、1.5m2、 1m2、0.75m2、0.5m2、0.3m2、0.2m2、0.1m2、0.08m2、0.05m2、0.03m2、100cm2、80cm2、70cm2、60cm2、 50cm2、40cm2、30cm2、20cm2、15cm2、10cm2、7cm2、5cm2、1cm2、0.5cm2、0.1cm2、0.05cm2Or 0.01cm2.Equipment can have be less than, greater than or equal to about 4m, 3m, 2.5m, 2m, 1.5m, 1.2m, 1m, 80cm, 70cm, 60cm, 50cm, 40cm, 30cm, 25cm, 20cm, 15cm, 12cm, 10cm, 8cm, 5cm, 3cm, 1cm, 0.5cm, 0.1cm, 0.05cm or The lateral dimension (such as width, length or diameter) or height of 0.01cm.Lateral dimension and/or height can be different from each other.Alternatively Ground, they can be identical.In some cases, equipment can be high and thin equipment, or can be short and wide set It is standby.Height and the ratio of lateral dimension can be greater than or equal to 100:1,50:1,30:1,20:1,10:1,9:1,8:1,7:1,6: 1,5:1,4:1,3:1,2:1,1:1,1:2,1:3,1:4,1:5,1:6,1:7,1:8,1:9,1:10,1:20,1:30,1:50 or 1: 100。
Equipment can have any weight.Equipment can manually be lifted by people.Equipment can on the person or In vivo.Equipment can be molded or be installed to ground, wall, ceiling and/or wall.The size and/or shape of equipment can be can It is swallowed by people.The example of weight of equipment may include but be not limited to be less than, greater than or equal to about 20kg, 15kg, 10kg, 8kg, 6kg、5kg、4kg、3kg、2kg、1kg、0.7kg、0.5kg、0.3kg、0.1kg、0.05kg、0.01kg、5g、1g、0.5g、 0.1g, 0.05g or 0.01g.
In some embodiments, the above method one or more by means of being provided in following documents alone or in combination System or equipment is realized: patent cooperation application number PCT/US2011/53188；Patent cooperation application number PCT/US2011/ 53189；Patent cooperation application number PCT/US2012/57155；U.S. Patent application 13/244,946；U.S. Patent application 13/ 244,947；U.S. Patent application 13/244,949；U.S. Patent application 13/244,950；U.S. Patent application 13/244,951； U.S. Patent application 13/244,952；U.S. Patent application 13/244,953；U.S. Patent application 13/244,954；United States Patent (USP) Application 13/244,956；Entitled " the Systems and Methods for Multi- submitted on 2 18th, 2013 The U.S. Patent application 13/769,779 (also requiring the priority to PCT/US2011/53188) of Analysis ", it is all above-mentioned The content of application is integrally incorporated by reference in this hereby.
Fig. 4 shows the example of sample acquisition, processing and analysis method.One or more can occur in such method Following steps.The sequence of step can change perhaps one or more steps can be it is optional or can be by another step It is substituted.The step of being illustrated in Fig. 4 by the box numbered from 400 to 440 indicates the step of step before can be considered as analyzing. Analyze before step include sample acquisition, verifying, preparation, including supervision, calibration, the operation of control, the acquisition of initial data and Other steps as shown in the figure and as disclosed herein.In embodiments, the supervision of step can be acquired in sample before analyzing It is one or many with being executed before and after, during test, or can acquire in sample and continue with before and after, during testing One or more snippets time.The step of being illustrated in Fig. 4 by the box numbered from 450 to 460 indicates to can be considered as analytical procedure The step of.Analytical procedure includes as indicated in FIG. with as disclosed herein, is received to the equipment from sample acquisition station Data analysis.In embodiments, the supervision of analytical procedure can before analysis, during and after execute it is primary or more It is secondary, or can before analysis, during and after continue one or more snippets time.Side in Fig. 4 by being numbered from 470 to 480 The step of block diagram shows indicates the step of step after can be considered as analyzing.Step includes checking to data analysis after analysis, with Control, calibration, equipment and sample mark and information comparison, to report generation and for fc-specific test FC generate report examine It tests, and other steps as indicated in FIG. and as disclosed herein.In embodiments, the supervision of step can after analysis Executed before and after, during post analysis it is one or many, or can continue before and after, during post analysis one section or Multi-section time.Method disclosed herein and useful equipment in the practice of such method and system can be laboratory certainly Dynamicization system (LAS) or laboratory information system (LIS) or electronic medical record system (EMR), or can therewith make With, or can be part of it.In the embodiment of method disclosed herein, system and equipment, as disclosed herein Method, system or equipment can be integrated with LAS, LIS or EMR.In embodiments, EMR can be with LAS, LIS and such as this paper institute Disclosed method, system or equipment are integrated.
This method may include acquiring sample 400 from subject, prepares sample for operation chemical reaction 410, allows and one The chemical reaction 420 of kind or plurality of reagents detects the signal 430 about sample, chemical reaction and/or apparatus assembly, pretreatment The signal detected analyzes data 450 without executing analysis, generates report 460 based on data, transmission report 470 provides report To health care professionals 480, and/or report is shown in equipment and/or screen or other display equipment.
One or more steps in these steps can be provided by any equipment or entity.The division illustrated in figure is only to show Example mode provides, and restrictive by no means.For example, sample can acquire 400 except equipment 490.Alternatively, sample can be straight It connects and is acquired in equipment, or can be acquired by equipment.This can occur in sample acquisition station.Sample preparation 410, chemical reaction 420 or letter Number detecting step 430 can be executed by equipment 490.
In some embodiments, sample can be prepared for subsequent qualitative and/or quantitative assessment.It is such to be used to comment The sample preparation steps of valence may include one or more in sample preparation 410, chemical reaction 420 and/or 430 step of signal detection It is a.In some embodiments, sample can be handled in this way: by reception sample 400, and/or prepare sample for subsequent qualitative And/or quantitative assessment, with data necessary to output is subsequent qualitative and/or quantitative assessment.Sample treatment may also include transmission and come From the data of equipment.In some cases, data can be transferred to the health care professionals of the analysis facility of authorization.
1,2 in the step of 1,2 in these steps or all steps can occur, and occurred Or all steps can occur at the equipment of sample acquisition station.Alternatively, they can occur in such as laboratory etc At another entity.It can be laboratory close to or at the service point place in the main body (such as house) of subject or sample adopted Collection station.
Equipment data collected can be at reset condition.This is included in equipment signal detected.Data can be optional Ground is subjected to pretreatment 440.Data prediction does not execute actual data analysis or compared with any threshold value.Data prediction can relate to And the format of change data.In some cases, data prediction can occur at the equipment 490 of sample acquisition station.Through Pretreated data can then be transferred to laboratory.Alternatively, data prediction 440 can occur in laboratory 492.Initial data Pretreatment can be sent to from equipment can be in the laboratory wherein occurred.Alternatively, occur in this method without pretreatment.
The example of initial data includes but is not limited to the following terms: light data, including luminous intensity, wavelength, polarization and other About the data of light, for example, coming from such as photomultiplier tube, photodiode, charge-coupled device, photometer, spectrophotometric The output of the fluorescence detectors such as meter, camera and other optical sensing subassemblies and equipment, including absorbance data, transmisivity data, Turbidity data, luminosity data, wavelength data are (including strong under one, two or more wavelength or across wave-length coverage Degree), reflectivity data, refractive index data, birefringence data, polarization and other light datas.Light data can provide about sample, Tissue, container or analyte in the visual field, cell, the presence of particle or other interested main bodys, number or other characteristics Information.Light data can provide the information about chemical reaction or the presence of physical process, progress or completion.
Initial data includes image data, for example, the data from number or analogue camera, the image including tissue, institute Stating tissue includes histotomy and biopsy samples；Cell, particle, crystal or other be likely to be present in the element in sample；Image It may include fluorescent marker or the cell granulations such as chemiluminescent cell or crystal two dimensional images；By cell, particle or The two dimensional image of the light of crystal scattering；Using difference, the bright visual field, dark field, interference comparison or other technologies shooting cell, The two dimensional image of grain or crystal；The two dimensional image of histotomy or the cell in other histological specimens, wherein cell can be by Dyeing can not be colored.Image may include cell granulations or the crystal such as fluorescent marker or chemiluminescent cell 3-D image；By the 3-D image of the light of cell, particle or crystal scattering；Use difference, the bright visual field, dark field, interference pair Than or the cell of other technologies shooting, particle or crystal 3-D image；Cell in histotomy or other histological specimens 3-D image, wherein cell can be colored or can not be colored.Initial data include cell count, cell shape, The cell number and dyeing of dyeing or label or the intensity of label.
Initial data includes temperature measurement, duration measurement, pH measurement, ion and other analysis measurements, particle meter Number, hematocrit measurement and other measurements of the chemically or physically characteristic to sample or sample composition.Initial data includes The data for measuring or indicating the progress of chemical reaction or physical change, including due to the enzymatic catalysis on chemical reaction product and The color change of generation.Such initial data provides the data from chemical assay, including to chemical reaction, association reaction, The measurement of light emit during or after competitive reaction and other reactions and measurement or absorption.Such initial data can mention For directly estimating to chemical reaction or measurement, or being further processed based on initial data may be needed or analyzed to provide Desired measurement.
Initial data can be pre-processed before being transferred to laboratory site by equipment.In embodiments, original number Laboratory site is transferred to from sample collection location according in not pretreated situation.
Data analysis 450 can occur for embodiment according to the present invention.Data analysis may include to the subsequent fixed of sample Property and/or quantitative assessment.Quantitatively and/or qualitatively analysis can be related to the determination to the clinical correlation of biological sample or its missing. Data analysis may include data compared with the one or more of threshold value.The comparison can be used for determining one or more analytes In the presence of or concentration, or may to herein other the analysis method and/or pathological analysis is useful everywhere.Data analysis It can occur in laboratory 492.In some embodiments, the laboratory can be accredited laboratory.Analyzable data It can be initial data or pretreated data.Equipment can handle sample in the case where not analyzing sample.Data are analyzed not Occur in the equipment in this scene.In some embodiments, sample being handled in equipment will not generate to one or more Analyte, two or more analytes, 3 kinds or more analytes, 4 kinds or more analytes, 5 kinds or more analyses Object, 6 kinds or more analytes, 7 kinds or more analytes, 8 kinds or more analytes, 9 kinds or more analytes, 10 Kind or more analyte, 12 kinds or more analytes, 15 kinds or more analytes or 20 kinds or more analyte Presence or concentration level determination.In some cases, in equipment handle sample will not generate to belong to cardiac marker, One or more or any number of the analyte (packet of vim and vigour, the classification of electrolyte, lactate, hemoglobin or coagulation factor Include herein that other are those of described everywhere) presence or concentration determination.In some embodiments, sample is handled in equipment Will not generate to belong to the following terms one or more, two or more, 3 kinds or more or any number of analyte The presence of (other are those of described everywhere including this paper) or the determination of concentration, these are as follows: sodium, potassium, chloride, TCO2, yin Ion gap, ionized calcium, glucose, urea nitrogen, kreatinin, lactate, hematocrit, hemoglobin, pH, PCO2、PO2、 HCO3, remaining alkali, sO2, ACT kaolin, ACT diatomite, PT/INR, cTnl, CK-MB and BNP.In some cases, sample is handled Product do not include to belonging to one or more or any number of analyte of following classification (including other described those everywhere herein The display of presence or concentration a bit), these classifications are as follows: cardiac marker, vim and vigour, electrolyte, lactate, hemoglobin or blood coagulation The factor.Similarly, in some cases, processing sample do not include to belong to the following terms one or more or it is any number of The presence of analyte (including other are those of described everywhere herein) or the display of concentration, these are as follows: sodium, potassium, chloride, TCO2, anionic gap, ionized calcium, glucose, urea nitrogen, kreatinin, lactate, hematocrit, hemoglobin, pH, PCO2、PO2、HCO3, remaining alkali, sO2, ACT kaolin, ACT diatomite, PT/INR, cTnl, CK-MB and BNP.
Data analysis may include the qualitative and/or quantitative assessment to sample.The qualitative and/or quantitative assessment to sample Can produce to one or more, two or more, 3 kinds or more, 4 kinds or more, 5 kinds or more, 6 kinds or more Kind, the presence of 10 kinds or more, 15 kinds or more or 20 kinds or more analytes or the determination of concentration.Some In example, analyte can belong to the classification involved in one or more following kind of researchs and/or analysis, these researchs And/or analysis are as follows: immunoassays, nucleic acid determination, the measurement based on receptor, cell counting measuring, colorimetric estimation, enzymatic determination, Electrophoretic determination, spectroscopic assay, chromatographic determination, microcosmic measurement, landform measurement, calorimetry, turbidimetric assay, coagulates at electrochemical gaging Collect measurement, radioactive isotope measurement, viscosimetric analysis, solidification measurement, coagulation time test, protein synthesis measurement, histology Measurement, culture measurement, osmometry and/or other kinds of measurement or their combination.The analyte tested Can be related to the reaction of one or more types selected from the following: chemistry-conventional chemical, hematology (including based on cell measurement, Solidification and virile diesae), microbiology-bacteriology (including " molecular biology "), chemistry-endocrinology, microbiology-disease Poison is learned, the general immunology of diagnostic immunology-, chemistry-urinalysis, immunohematology-abo blood group group and Rh type, diagnosis are immunized - serological syphilis, chemistry-toxicology, immunohematology-antibody test (blood transfusion), immunohematology-antibody test are (non-defeated Blood), histocompatbility, microbiology-branch bar mycology, microbiology-mycology, microbiology-parasitology, immune blood - antibody identification, immunohematology-compatibility test, pathology-histopathology, pathology-oral pathology, pathology- Cytology, radiobioassay, and/or clinical cytogenetics.One or more measurements can include: protein, nucleic acid (DNA, RNA, its hybrid, microRNA, RNAi, EGS, antisense strand), it is metabolin, gas, ion, particle (it may include crystal), small Molecule and its metabolin, element, toxin, enzyme, lipid, carbohydrate, prion, visible component are (for example, cellular entities (example Such as, entire cell, cell fragment, cell surface marker object)).In some embodiments, one or more analytes belong to the heart Dirty marker, vim and vigour, the classification of electrolyte, lactate, hemoglobin or coagulation factor.In some embodiments, Yi Zhonghuo Multiple analytes may include sodium, potassium, chloride, TCO2, anionic gap, ionized calcium, glucose, urea nitrogen, kreatinin, lactic acid Salt, hematocrit, hemoglobin, pH, PCO2、PO2、HCO3, remaining alkali, sO2, ACT kaolin, ACT diatomite, PT/INR, CTnl, CK-MB and/or BNP.
Analyzable data can be provided from equipment 490, or can before analysis in laboratory 492 or other entities into Row modification.In another embodiment of the present invention, data analysis 450 can occur in equipment, without in the lab. Alternatively, data analysis can occur simultaneously in equipment or in laboratory or equipment can be laboratory.Analysis can occur In service point place, such as house, office, doctor's office/hospital, retailer's website or other service point places.Herein Other described any other service points everywhere herein may be applicable to any description of laboratory site or other places Point.
Report 460 is produced based on data.Report can be based on analysed data 450, or can be based on original at its Or the data in pretreated form.Report can be generated based on the qualitative and/or quantitative assessment to sample.Report can be all It is generated in the laboratory 492 of analysis facility such as authorization etc.Alternatively, report can generate at equipment, or by it is any its He generates entity.Report 470 can be transmitted.Report can be by generating the same entity transmission of this report.Alternatively, different entities can Transmit this report.Report can be by laboratory 492, equipment 490, cylinder casket or any other reality of the analysis facility etc such as authorized Body transmits.
Report can be received by health care professionals 480.Health care professionals may be provided in equipment 490 and/ Or the place of 492 phase of laboratory separation.Health care professionals can in order to diagnose, treat subject and/or for by Examination person provides the purpose of disease prevention and depends on this report.
Therefore, as it was earlier mentioned, any one or more of these steps step can be optionally.In these steps Any one or more steps can by equipment 490 in sample acquisition station or in subject's body or with execute, or can be Laboratory 492 executes in any other entity.In some embodiments, the place that data analyze 450 steps can be performed It can be certified, or acceptable check or supervise.
Equipment is configurable to processing sample.Sample treatment may include receiving sample 400 and/or preparation for subsequent qualitative And/or the sample of quantitative assessment, to generate necessary to subsequent qualitative and/or quantitative assessment.Preparation for subsequent qualitative and/or The sample of quantitative assessment may include one or more sample preparation steps 410, chemical reaction step or physical treatment step 420, And/or detecting step 430.Handling sample may include adding one or more reagents or fixative.Sample treatment optionally may be used also To include electron-transport data.Data can be transferred to the health care professionals of the analysis facility of authorization and/or be shown in screen On curtain.Data can simultaneous transmission and/or display.
Can by herein other any mode acquires sample 400 from subject everywhere.For example, fingerstick can be from Subject acquires sample.In other examples, excreta, urine or tissue can be acquired in operating room and/or casualty department, or Person can utilize other described any other sample collecting mechanisms everywhere herein.Sample collected is provided to equipment 490.Sample Product acquisition can occur in sample acquisition station or other places.Sample is provided to the equipment at sample acquisition station.
It is alternatively possible to prepare sample 410 for chemical reaction and/or physical treatment step.Sample preparation steps may include It is below one or more: centrifugation, separation, filtering, dilution, concentration, purifying, precipitating, incubation, liquid relief, transport, chromatography, Cell cracking, cell count, crushing, grinding, activation, ultrasonication, microtrabeculae are handled, are handled with magnetic bead or nano particle, or Other sample preparation steps of person.Sample can shift in equipment.Sample preparation may include one or more for separating blood The step of being separated into various components for serum and/or particle part or by any other sample.Sample preparation may include one Or multiple the step of being used for dilution and/or concentrate blood or other biological sample.Sample preparation may include anticoagulant to sample addition Agent or other compositions.Sample preparation may also include the purifying of sample.Sample preparation can be related to change the density and/or creation of sample The Density Distribution of sample.In some cases, the higher density part of sample can be divided with the lower density portion phase of sample From.Sample preparation may include that the solid component of sample is isolated from the aqueous components of sample.In some instances, sample preparation It can be related to centrifugation, incubation and/or cell cracking.Sample preparation may include promoting sample flow, such as laminar flow.Sample preparation can wrap It includes and sample is transported to another part from a part of equipment.Sample preparation may include incubated samples.Sample preparation may include using In the process for causing biological sample that can be applicable in front of being chemically reacted and/or being run measurement.Sample preparation steps can cause Biological sample is ready for running one or more clinical trials, and the clinical trial may include adding a series of reagents, fortune Row scheme and/or operation measurement.
Optionally, sample can undergo the chemical reaction with reagent 420.Chemical reaction can occur sample preparation steps it Afterwards.Alternatively, chemical reaction need not be after sample preparation steps.Sample preparation steps can before chemical reaction, later and/ Or occur at the same time.In some embodiments, preparation for qualitative and/or quantitative assessment sample may include allow into Row chemical reaction.Can occur herein other everywhere as described in one or more types measurement.For example, sample preparation steps (such as can be in the chemical reaction of preparation for occurring when qualitative and/or quantitative assessment sample) may include selected from following One of chemical reaction type or a variety of: immunoassays, nucleic acid determination, the measurement based on receptor, cell counting measuring, ratio Color measurement, enzymatic determination, electrophoretic determination, electrochemical gaging, spectroscopic assay, chromatographic determination, microcosmic measurement, landform measurement, calorimetric Measurement, turbidimetric assay, agglutination determination, radioactive isotope measurement, viscosimetric analysis, solidification measurement, coagulation time test, protein Synthesize measurement, Histological determining, culture measurement, osmometry and/or other kinds of measurement or their combination. In some embodiments, heater and/or heat block can be used.Chemical reaction may include providing sample at a desired temperature. Chemical reaction maintains and/or changes the temperature of sample before, during and/or after may additionally include chemical reaction.Herein to change Any description for learning reaction may each comprise any kind of reaction that can occur in a device.For example, chemical reaction may include object Reason interaction, chemical interaction, and/or other Physical interactions or transformation.In some embodiments, in equipment Display (such as screen) or sensor can be imaged in outside.For example, equipment may be able to carry out MRI, ultrasound or other Scanning.
Sample preparation and/or chemical reaction may be in response to one or more instructions and occur.Instruction, which can be locally stored in, to be set It is standby upper, or can be provided from external source.In some embodiments, external source is laboratory.In some embodiments, Sample preparation and/or chemical reaction regulation can be baking with Self-study Ability.For example, they can acquistion different mode prepare It sample and/or makes it ready for for analyzing.In some embodiments, pass through one group of given parameter, sample preparation regulation Can self-control with utilize various sample preparation technologies.Sample preparation adjusts or maintains to can be dependent on or can not depend on In detected related with sample, and/or with parameter provided by operator and/or the related signal of instruction.Sample system Standby regulation can be self learning type.One or more can provide the control for carrying out the instruction of sample preparation and/or chemical reaction Device can self study.
It can be in response to can locally generate or can be adjusted from the new instruction that external source provides in equipment.Example Such as, new instruction can from external source update and/or under push away.There may be such dynamic processes: sample preparation wherein and/ Or chemical reaction and/or physical treatment step are executed according to changeable instruction.It is anti-herein in regard to sample preparation and/or chemistry Any description answered also may include any physical treatment step.
One or more signals 430 can be detected from equipment.The signal can after sample preparation steps are completed and/ Or it is detected after chemical reaction and/or physical treatment step have occurred.Signal can be based on may live through or may be without Went through the reading of the sample of measurement.Signal can be based on device-dependent measurement.
In some cases, one or more additional sample preparation steps can occur.For example, can occur for fixed The additional sample preparation of property and/or quantitative assessment.Such preparation can be carried out based on following at least one: before biological sample Phase prepares and/or makes data analysis by health care professionals.Reflection measurement can occur based on Previous results.Reflection measurement It can occur in a manner of automatically and dynamically before, during or after test/analysis.It may be automatic that previous evaluation, which can produce, The further test changed.
Optionally, data can undergo pretreatment 440.The initial data of the signal detected can undergo or can be without Go through pretreatment.Pretreatment can influence the format of initial data.For example, pretreatment can make the format specification of data.Pretreatment can Data are become into desired form.Pretreatment can be in the case where not executing any data and analyzing.In some embodiments In, pre-process the form of changeable data, the content without changing data.In some cases, pretreatment not by data with Any valuation judgement is made comparisons or executed to any threshold value.
Herein other everywhere as described in, analysis 450 can be carried out to data.Data analysis may include to the subsequent qualitative of sample And/or quantitative assessment.It is alternatively possible to generate report based on initial data, pretreated data or analysed data. Report and/or data can be transferred to health care professionals.Chemical analysis and/or pathological analysis can be performed in software systems, or Person these analysis can be distributed in laboratory, clinic and recommendation/signing professional combination among (for example, being supplied to The laboratory of the professional expert of some diseases and John Hopkins laboratory (John ' s Hopkins laboratory) or Make they as accredited laboratory a part/work is participated in accredited laboratory).
In some embodiments, will report be transferred to health care professionals before report can be checked. In some cases, data can be checked before or after generating report.Checking can be by one or more virologist Or other qualified persons execute.Virologist can be associated with laboratory 492.Virologist can or can not be in Laboratory facility.Virologist can be employed by laboratory.For the analysis facility of authorization, supervision can be provided via regulatory agency. In some embodiments, laboratory can be the laboratory authenticated through CLIA.Through the committee certification entity (its may include through The personnel of committee's certification) data/report can be checked and the measurement and verifying controlled quality is provided.In some embodiments In, the entity authenticated through the committee may include one or more virologists.
In some embodiments, equipment can be certified equipment.Equipment can be under the supervision of regulatory agency. Through the committee authenticate entity can check equipment data/report and provide to quality control, calibrator performance, test measurement And verifying.Health care professionals can check data/report from equipment and/or provide to the number from equipment According to/report supervision.It is alternatively possible to provide the software program that can check equipment data generated.Software program can be by curing Treat health professional's creation or the creation under the checking of health care professionals.Software program can be special by such as health care The authorized person of industry personnel etc safeguards.
Fig. 8, which is shown, provides sample treatment, the example of the system of analysis and supervision.
Fig. 8 (i) shows the example that may be able to carry out the equipment 800 of 802 step of sample treatment.The equipment can It is communicated with laboratory 810.The laboratory may be able to carry out 812 steps of subsequent analysis and can provide supervision 814.Supervision And/or analysis can be provided by health care professionals and/or software program.The equipment can by include herein other everywhere Network 850 including any network is communicated with laboratory.It can provide cloud computing foundation structure.The equipment may be provided in by In examination person's body or with subject, or provide in sample acquisition station.Laboratory can be the analysis facility of authorization, such as through The facility of CLIA certification, can be equipment or cylinder casket.
Fig. 8 (ii) shows the example that may be able to carry out the equipment 820 of sample handling procedure 822 and analytical procedure 824. The equipment can be communicated with laboratory 830.The laboratory may be capable of providing supervision 832.Supervision can be by health care Professional and/or software program provide.The equipment can by including herein other everywhere including any network Network 860 is communicated with laboratory.It can provide cloud computing foundation structure.Cloud computing foundation structure can be system/infrastructure/and set Standby a part.Equipment may be provided in subject's body or with subject, or provide in sample acquisition station.Laboratory can be with It is the analysis facility of authorization, the facility such as authenticated through CLIA.
Fig. 8 (iii), which shows to be able to carry out sample handling procedure 842, analytical procedure 844 and provide, supervises 846 The example of equipment 840.In some embodiments, supervision can be provided by the supervisor software program in equipment.The equipment can be with It is communicated including other networks 870 everywhere including any network herein.It can provide cloud computing foundation structure.Equipment can mention For in subject's body or with subject, or provide in sample acquisition station.In some embodiments, which can be by supervising Pipe agency qualification.In some embodiments, which can authenticate through CLIA.
In devices disclosed herein, the embodiment of system and method, the processing to sample may include following three ranks One of section: it can be described as the first stage in stage " before analysis "；It can be described as " analyzing " second stage in stage；And it can be described as The phase III in " after analysis " stage.In embodiments, the analysis last stage may include such action or step: for example, sample Product acquisition, sample preparation, sample test, the detection to the signal from sample or observation or imaging to sample；Data are pre- It handles (if yes), and other action carried out before analyzing the data obtained about sample and step.For example, Analysis before action may include starting test, and may include so that sample is in contact with reagent, test sample is in contact with reagent Later from the light quantity of electromagnetic radiation or by the light quantity of sample absorption or other such action or step.In embodiments, divide The analysis stage may include such action or step: for example, the analysis data obtained about sample, generate about sample and its The report of analysis and other action relevant to the data obtained about sample are analyzed and step.For example, analysis action Or step may include correcting based on facility environment data and/or to the calibration specific to the equipment or reagent that are used to check sample Initial data；A certain value is calculated, for example, concentration value, hematocrit value, cell volume or other values；Determine one in sample Kind or a plurality of types of cells, particle or other main bodys；Or other steps or action.In embodiments, the stage after analysis It may include such action or step: for example, transmission is about the report of sample, connection or receives from health care professionals Or communication of other suppliers about such report, and other rows after analyzing the data obtained about sample Dynamic and step.For example, take action after analysis or step may include for example by by outlier, control and repeat with the result of analysis into Row compares, and tests whether accurately to determine.For example, taking action after analysis or step may include highlighting to be outlier or may draw Rise concern (for example, be higher or lower than normal range (NR) or tolerance interval, either indicate unusual condition) value or as a result, It can indicate that there are the combinations of the result of unusual condition together.It is transmitted to doctor or such analysis of other health care providers Afterwards action can better ensure that make doctor or other health care providers know the problem of and recognize it is possible, therefore or can be More likely take appropriate action.
In devices disclosed herein, the embodiment of system and method, the test of sample can be executed in equipment.
In devices disclosed herein, the embodiment of system and method, the test of sample can be started in equipment, and Can by from sample original data transmissions to different location, for example, laboratory site.The transmission of initial data can be via Cloud or other networks.Can be in starting the test of sample in equipment and by original data transmissions to the embodiment in another place In, test can be completed in the place other than in equipment；It is, for example, possible to use via cloud or via another network transmission in fact The initial data for testing room place completes test at laboratory site.In such an embodiment, the test of sample starts from Sample acquisition station (in equipment) simultaneously ends at laboratory site.In embodiments, the test of sample can be adopted positioned at sample Collect and starts in the equipment at station and complete.In embodiments, it can start and complete the test of sample in equipment, and can incite somebody to action Original data transmissions from sample are to different location, for example, laboratory site.
In devices disclosed herein, the embodiment of system and method, equipment can be placed in and be physically remote from laboratory At sample acquisition station, and sample is handled in the case where sample not being physically transported to laboratory from the equipment.It is public herein In the embodiment for the equipment, system and method opened, although equipment is placed at the sample acquisition station for being physically remote from laboratory, but It is to be operated under the control in laboratory, and operated under the supervision in laboratory.In devices disclosed herein, system and method In embodiment, control and supervision to the equipment at sample acquisition station can be by the processors of laboratory site or by being attached to The individual in laboratory realizes.Laboratory can be the analysis facility of authorization, and can be the laboratory for meeting CLIA, CLIA Accredited laboratory or CLIA exempt laboratory.
Equipment as disclosed herein can be or including sample-processing equipment.Equipment as disclosed herein can be or Including sample treatment unit.
In embodiments, the equipment for executing sample handling procedure as disclosed herein can be CLIA certification and set It is standby；It can be the laboratory in CLIA certification or the equipment of site operation；It can be the equipment for meeting CLIA；It can be and meeting The laboratory of CLIA or the equipment of site operation；It can be the equipment operated by the operator of CLIA certification；It can be by meeting The equipment of operator's operation of CLIA；It can be the equipment operated in a manner of meeting CLIA；It can be CLIA and exempt equipment；It can To be the equipment for ratifying to use by having the right to make the regulatory agency of approval；Can be is made by United States Food and Drag Administration approval Equipment；It can be and be classified as inspection-free equipment by United States Food and Drag Administration；Can be for example according to " U.S.'s food, Drug and cosmetics bill " equipment that uses of the 510th (k) article of approval；It can be according to " U.S.'s food, drug and cosmetics law Case " the 510th (k) article of equipment without substantial equivalence；Or the equipment can not have governmental certification.
In embodiments, equipment as disclosed herein can be or including CLIA exempt equipment, and can pair or use Sample execute meet CLIA's or CLIA certification test.In embodiments, equipment as disclosed herein can be or including CLIA exempt equipment, and can pair or with sample execute CLIA exempt test.In embodiments, equipment as disclosed herein Can be or including meeting CLIA's or CLIA certification equipment, and can pair or meet CLIA's or CLIA with sample execution The test of certification.In embodiments, equipment as disclosed herein can be or set including meeting CLIA's or CLIA certification It is standby, and can pair or with sample execute CLIA exempt test.In embodiments, equipment as disclosed herein can be located at symbol Close CLIA's or CLIA certification laboratory or place among or place, and can pair or with sample execution meet CLIA's or The test of CLIA certification.In embodiments, equipment as disclosed herein can be located at meet CLIA's or CLIA certification reality Test among room or place or place, and can pair or execute CLIA with sample and exempt test.
In embodiments, equipment as disclosed herein can operate under the supervision or control in laboratory.For example, as herein Disclosed equipment can handle sample in sample acquisition station under the supervision in laboratory, and wherein laboratory, which is located at, is physically remote from sample and adopts Collect the laboratory site at station.Therefore, in embodiments, although equipment is physically remote from laboratory, but since its operation is by reality Test room control and it is operated as a part in laboratory.In embodiments, although equipment is physically remote from laboratory, but by In its operation be to be operated under the supervision in laboratory as a part in laboratory.In the lab, sample can be located at Test is executed in equipment at product acquisition station, and initial data and/or result can be transferred to the reality positioned at laboratory site Test room.Such initial data and/or result can be analyzed in the laboratory for being located at laboratory site.Laboratory, which can be, awards The analysis facility of power, and can be CLIA accredited laboratory.Therefore, reality can be obtained from the test executed at sample acquisition station Test the result of room certification.
In embodiments, test can start in the equipment being located at sample acquisition station, and can be in laboratory site Continue in the laboratory at place and (for example, using the initial data transmitted from equipment) can be completed wherein.In embodiments, it surveys Therefore examination can be completed at laboratory site, and can be at laboratory site by sample acquisition station and completing from starting Result that test in laboratory at the laboratory site obtains executes analysis.The analysis that laboratory can be authorization is set It applies, and can be CLIA accredited laboratory.It therefore, can be from the starting at sample acquisition station and the experiment at laboratory site The test completed in room obtains the result of laboratory certification.
In embodiments, the supervision of equipment operation can be it is lasting, for example, may include the operation phase in equipment Between repeatedly supervise, and may include the continuous surveillance during the operation of equipment to equipment operation.For example, supervision may include It to the multiple supervision of equipment operation during the test of sample, and may include during the test of sample to equipment operation Continuous surveillance.During the test of sample to for equipment operation scheme progress supervision may include with new processing step, Corrected processing step updates the program about the newer command of processing step.Processor can be used to provide or execute Supervision.Can be used at sample acquisition station (for example, in equipment) processor, using at laboratory site processor, make Being used as cloud or network, (cloud or network may or may not include the processing in equipment or at laboratory site Device) the processor of a part provide or execute supervision.It can be by personal (for example, being attached to of the analysis facility of authorization People) Lai Zhihang or provide supervision.Supervision may include cooperateing with to make with personal (for example, the individual for being attached to the analysis facility of authorization) With one or more of such processor.
Scheme can receive or using mark use in equipment, cylinder casket, sample, the mark data of patient and information and Other information and data.Identification information and data can identify particular device, its past history, current state, the present situation, pass In the equipment and surrounding environmental information and other data and information.For example, in embodiments, it can be with each sample Retain Patient identification in the start and ending of sample acquisition, test, analysis and result report.It in embodiments, can be with every A sample retains Patient identification in the start and ending of sample acquisition, test, analysis, result report and charging.Identification information and Data can identify specific cylinder casket, its content (including reagent, disposable product and sample message), its past history, current State, the present situation, about this tin casket and surrounding environmental information and other data and information.Identification information and data can To identify particular patient, identity, age, gender, medication, medical history including patient, test history, current state, the present situation with And other data and information.Identification information and data can identify specific sample, acquisition mode, the patient in institute source, situation (sample volume, if be in contact with heparin, EDTA, if filtered, solidified, if there are bubble, whether blood sample may It is subjected to haemolysis or whether is piarhemia) and other data and information.Identification information and data may specify to or Analysis through being executed to the data from sample.Identification information and data are taken action after may specify to the analysis executed, are such as closed In the action of report, it is compared with other test datas or analysis or other are taken action or step.
Scheme can be updated and be customized for the environmental condition in or around particular device or the equipment, for example, by single Sensor, motor, the special properties of physical size and the characteristic of a equipment and other properties and characteristic account for；By equipment Temperature, humidity, air pressure, the position and movement of interior internal module or component account for；Motor, sensor or other assemblies Situation and state；The calibration of motor, sensor and other assemblies will be accounted for；And other properties and characteristic.Scheme can Update and customize for particular agent and disposable product, for example, by contrast agents, the calibration of reagent, cylinder casket reagent, The special properties and characteristic of the temperature at tip, cylinder casket in cylinder casket or other characteristics or property account for.Supervision can wrap Include the supervision during or after analysis of data, and can provide to sample or the additional samples from patient it is further It tests or retests.
Using include the information specific to equipment, the information specific to cylinder casket or the sensor specific to sample test, The scheme of the other information or data (including calibrating and controlling information) of device, reagent and other assemblies or element provides pair The correction and conversion of initial data, with guarantee from the value that such initial data obtains and from be correct, consistent and can It reproduces.Such value obtained and observation be striding equipment and can be reproduced across the time (for example, from subsequent sample), thus Allow to compare patient's result with group and history value, for carrying out better screening, diagnosis based on test result and analysis And treatment.Supervision provides the supervision to the integrality and test result of test execution as disclosed herein, including to every the same The supervision of product, the supervision to the test of every a sample, the supervision to conversion and the calibration of the initial data obtained during test are right The supervision of test completeness, the supervision for using and analyzing in view of control, calibrator, repetition and outlier to data, in view of setting Supervision standby and that reagent environment and calibration information are to the analysis of data, the supervision to the analysis of test result, to test result and The supervision of the report of analysis, and the supervision to taking action and communicating after analysis.Equipment and cylinder casket information can be retained in cloud or other In network；It can be retained on each equipment or cylinder casket or be retained with it；Or it can partially or even wholly be retained in whole two In a place.
Equipment, system, method and scheme as disclosed herein provide multi-function capability, to allow at sample acquisition station Single equipment multiple tests, including a plurality of types of tests are executed to sample；Such test can quickly be run, it is only necessary to few It measures sample (for example, it will only be necessary to the available blood volume of fingerstick), and can reliably and accurately run, to allow across setting Standby and sample reproducibility and reliable comparison.Therefore, devices disclosed herein is multi-functional；Measurement performed by it is more function Can；Control is multi-functional；And it is multi-functional for supervising.Multi-functional includes holding on single equipment and from simple sample Row includes nucleic acid determination, general chemistry measurement, cell count (for example, cell imaging, flow cytometry) measurement, ELISA measurement And other measurements are (for example, such as 18 days 2 months 13/244,947 and 2013 year entitled " the Systems and submitted of U.S. Patent application The U.S. Patent application of Methods for Multi-Purpose Analysis " _ _ _ _ _ _ _ _ _ _ _ disclosed in measurement) etc. The ability of a plurality of types of measurements.
Equipment, system, method and scheme as disclosed herein provide fast results from testing small volumes sample；Such survey Examination and result can be automation, and the quick offer of such result, such as are provided by laboratory to health care and mentioned Donor provides quick and reliable information for better patient care.Laboratory, such as meets CLLA's and CLLA is authenticated Laboratory, can possess and be in therein or ready-to-use virologist, so as to carry out result check and interpretation, carry out Further analysis, and make about the further possible suggestion tested and/or handle.As disclosed herein, equipment, be System, method --- the embodiment including scheme as disclosed herein and supervision may include disclosed feature, element and energy Some or all of features, element and ability in power, and can be with some or all of in such feature, element and ability Any combination of feature, element and ability is including these features, element and ability.
In embodiments, supervision may include at least following procedure: 1) sample acquires；2) data are received (for example, test number According to, initial data, device data, cylinder casket data, sample data, patient data etc.)；3) it identifies state associated with the data or asks Topic；In view of sample, the test being carrying out, the equipment, the reagent that execute test etc., to analyze state or problem；And it 4) is based on Data and analysis are sent out to equipment, operator or doctor (for example, general practitioner, virologist or other health care providers) Instruction is sent, for further taking action or modification or suspension to currently taking action.It is such supervise can be interval (for example, Before test, occur once or several times during or after), perhaps can be it is lasting (persistently carry out dduring test or Time before test persistently carry out or it is sustainable by or beyond the testing time).In embodiments, supervision can be with It is dynamic supervisory, to allow the update of scheme, in the event of generation or acquisition data to guarantee correct regulation, correct matter Amount, correct integrality and the correct result from such test.Such supervision and test can be and " know patient ", that is, it can be by identity relevant to the patient tested, characteristic (for example, age, gender, medical history, medication, shape Condition, doctor, insurance coverage) or other factors account for.In this way, sample and sample analysis, which can run through, tested Journey --- before analysis the stage, the stage is associated with patient always in the analysis phase and after analysis.As disclosed herein, Ke Yi All these tests and analysis are provided in the case where sample not being physically transported to laboratory site.By setting for sample acquisition station The standby sample acquisition carried out and processing and initial data are not transporting sample physics then to the transmission permission of laboratory site Test, analysis and the report to result are executed in the case where being sent to laboratory site.Transmission of the initial data to laboratory site " number " transmission or actual " virtual sample " of sample is provided, to eliminate for sample to be physically transported to test The demand in room place.It is by cloud or other networks or directly being provided from laboratory site, the sample carried out by scheme is adopted The supervision and control of the operation of equipment at collection station allow to control and operate equipment by laboratory.It is such to control and operate It can be carried out by the laboratory for meeting CLIA, which can be CLIA accredited laboratory.
For example, can be provided by laboratory as equipment scheme used in processing sample, or can be updated by laboratory, and And its correct application can be supervised by laboratory.Scheme may include following instruction and regulation, commander: the place to apply to sample The form of reason and test；Execute the sequence of such sample treatment and test；The timing of such sample treatment and test；To logical Cross the pretreatment (if yes) of the data obtained to sample treatment and test；To obtained by sample treatment and test, packet Include the compiling of the data including initial data (and pretreated data, if yes)；It is obtained by sample treatment and test Including transmission of the data to laboratory including initial data (and pretreated data, if yes)；To from experiment Room, data in response to being transferred to laboratory from the equipment reception further instructed；According to it is from laboratory, in response to It is transferred to any instruction of the data in laboratory from equipment, is further processed or tests to what sample carried out；And such Disposition after sample treatment and test to sample and other wastes.
It in embodiments, may include supervising the operation of equipment by the supervision that laboratory carries out；Supervise the sensing in equipment Operation；Supervise the analysis to the data for being transferred to laboratory by equipment；Supervise the report generated according to the analysis to such data It accuses；Supervise the charging to service provided；And other supervision.In embodiments, may include by the supervision that laboratory carries out The sample acquisition supervised at sample acquisition station, the sample supervised in the cylinder casket at sample acquisition station are placed, are supervised in sample Cylinder casket in equipment at acquisition station is placed or other supervision.Such supervision may include that confirmation has been provided for this The right instructions of the regulation of sample, and the correct regulation of confirmation have been complied with.In embodiments, supervision may include that supervision exists Handle sample before, when or the confirmation to the insurance coverage of subject later.For example, can be all via electronic communication It (may include such as microwave or multiple component units, for example, via cellular phone chain via cloud computing foundation structure, other telephone communications Connect), radio communication, infrared link, and the communication of the electromagnetic radiation using other forms, come realize control to equipment or Supervision.The electronic communication between the laboratory at equipment and laboratory site at sample acquisition station may include the downloading of scheme； The transmission or update of scheme；Facility information is (for example, device identification；Equipment state；Temperature or other environmental information；Date, time Or order information；Supply status (for example, supply of reagent, the supply of cylinder casket or other materials)；And other equipment information) Communication；The communication of patient or subject information；Sample message is (for example, identification information relevant to sample；The number obtained from sample According to；Information about the processing applied to sample；About the information for obtaining equipment and regulation used in data from sample；And Other about or from sample data) communication；The communication of insurance information；The communication of payment information；And other information Communication.Processor can be used to provide or execute in such supervision, and the processor is, for example, the processing at sample acquisition station Processor at device, laboratory site, as cloud or network a part processor；It can be by individual (for example, being attached to authorization Analysis facility individual) provide or execute；It and may include collaboration individual (for example, being attached to the analysis facility of authorization It is personal) use processor.
It in embodiments, may include supervision to equipment operation by the supervision that laboratory carries out.In embodiments, right The supervision of equipment operation may include checking the state of equipment.It in embodiments, may include execution pair to the supervision of equipment operation The calibration of equipment.It in embodiments, may include knowledge of the supervision to subject before handling sample to the supervision of equipment operation Not.Supervision to equipment operation may include supervising to the identification of operator before handling sample (for example, about correctly recognizing Card, qualification etc.).It in embodiments, may include supervising to for handling and the cylinder casket of test sample to the supervision of equipment operation Identification.In embodiments, to the supervision of equipment operation may include offer scheme, supervision the reception or update of scheme are used for The scheme of processing and test sample.It in embodiments, may include supervising by equipment to sample to the supervision of equipment operation It manages and tests, the sample treatment and survey in reagent and sample transport, equipment in selection and use, equipment including supervising reagent The execution of examination is acquired from the acquisition of the data of sample, from control or calibrating reagent and the data of test；And relevant sample treatment And test operation.It in embodiments, may include the data supervised to being obtained by test sample to the supervision of equipment operation Any pretreatment.In embodiments, to the supervision of equipment operation may include retest sample or test control, duplication or its The instruction of his material.Supervision to equipment operation may include acquisition facility information, including device identification, equipment state, temperature and Other information.It in embodiments, may include acquisition by equipment (for example, from camera in equipment) biography to the supervision of equipment operation Defeated image.It in embodiments, may include analytical equipment information or the figure that analysis is transmitted by equipment to the supervision of equipment operation Picture.In embodiments, to the supervision of equipment operation may include transmission, receive or analysis quality control information, equipment state or Condition information, measurement information, control information or data, calibration information or data or other information.Such operation supervision can It is provided or is executed using processor, the processor is, for example, the processor at sample acquisition station, the place at laboratory site Manage device, as cloud or network a part processor；Can by personal (for example, the individual for being attached to the analysis facility of authorization) Lai It provides or executes；It and may include that collaboration personal (for example, the individual for being attached to the analysis facility of authorization) uses processor.
It in embodiments, may include transmitting to instruct to equipment to the supervision of equipment operation.Instruction may include scheme, basis Scheme starts the instruction of operation, interrupted according to scheme or the instruction of tentative operation, stopped according to scheme or the instruction of end operation, Dynamic regulation or modification operation or the instruction of scheme and other instructions.In embodiments, the supervision of equipment operation can be wrapped Equipment from including from from laboratory site to sample acquisition station transmits instruction.In embodiments, the supervision of equipment operation can be wrapped It includes according to regulatory agency, the analysis facility of authorization or the regulation and requirement of CLIA accredited laboratory, from laboratory site to sample Equipment at acquisition station transmits instruction.In embodiments, supervision may include that laboratory or CLIA by such as meeting CLIA are recognized The supervision that the personnel in the laboratories such as the laboratory of card carry out.In embodiments, supervision may include the reality by such as meeting CLIA Test the remote supervisory that the personnel in the laboratories such as the laboratory of room or CLIA certification carry out.In embodiments, by the people in laboratory The supervision that member carries out may include supervision to guarantee to take sample acquisition, sample treatment and other steps appropriate.In embodiment In, the supervision to equipment operation may include the forward direction equipment transmission instruction in processing sample.In embodiments, to equipment operation Supervision may include test sample forward direction equipment transmission instruction.In embodiments, may include to the supervision of equipment operation To equipment transmission for the instruction from sample acquisition data.In embodiments, to the supervision of equipment operation may include supervision to The data in laboratory are transmitted, and the data include initial data and pretreated data (if yes).In embodiments, Supervision to equipment operation may include the instruction from control, duplication, facility information or other information acquisition data.In embodiment In, the supervision to equipment operation may include receiving instruction from laboratory to according to sample is transmitted after processing and test sample Supervision.In embodiments, to the supervision of equipment operation may include according to the data or information that laboratory is transferred to from equipment from Laboratory retests sample with realizing to equipment transmission instruction.In embodiments, the supervision of equipment operation can be wrapped Supervision is included to handle and the disposition after test sample to sample and any waste.In embodiments, to the prison of equipment operation Superintending and directing may include other equipment operation.Processor can be used to provide or execute in such supervision, and the processor is, for example, sample The processor at processor, laboratory site at acquisition station, as cloud or network a part processor；It can be by individual (for example, the individual for being attached to the analysis facility of authorization) provides or executes；It and may include collaboration individual (for example, being attached to The individual of the analysis facility of authorization) use processor.
It can be in the physics at laboratory (its analysis facility that can be authorization, and can be CLIA accredited laboratory) Place far from sample acquisition station executes the analysis to sample.Sample acquisition can be physically remote from according to the requirement of regulatory agency The place stood executes the analysis to sample.Regulatory agency can be CLIA regulatory agency, can be U.S.'s food and drug control Office or other regulatory agencies.Regulatory agency can be American regulation mechanism, can be international regulatory bodies, or can be except beauty The regulatory agency of country except state.
It in embodiments, may include the data supervised to laboratory is transferred to by equipment by the supervision that laboratory carries out Analysis.In embodiments, supervision may include analyzing preceding supervision, analysis supervision and analysis to the analysis for the data transmitted by equipment After supervise.In embodiments, supervision may include supervising initial data to laboratory to the analysis for the data transmitted from equipment Transmission.In embodiments, supervision may include supervising pretreated data to experiment to the analysis for the data transmitted from equipment The transmission of room.In embodiments, supervision may include supervising to execute in laboratory to the analysis for the data transmitted by equipment Analysis to the data including initial data, pretreated data and other data.In embodiments, data are passed Defeated supervision may include the timing or sequence of the encryption of monitoring data, the mode of monitoring data transmission, monitoring data transmission, and Confirmation is completed data transmission or is received.In embodiments, supervision to the analysis for the data transmitted by equipment may include supervision by Point to the data including initial data, pretreated data and other data that processor at laboratory carries out Analysis.In embodiments, supervision may include supervision cooperative experiment room to the analysis for the data transmitted by equipment or be attached to reality The analysis to the data including initial data, pretreated data and other data testing the individual of room and executing.? In embodiment, supervision may include being supervised according to the regulation of regulatory agency and requirement pair to the analysis for the data transmitted by equipment The analysis of data including initial data, pretreated data.In embodiments, supervision is to the number transmitted by equipment According to analysis may include supervised according to the regulation of the analysis facility of authorization and requirement to include initial data, pretreated number According to the analysis of data inside.In embodiments, supervision may include being recognized according to CLIA to the analysis for the data transmitted by equipment Regulation and the requirement in laboratory are demonstrate,proved to supervise the analysis to the data including initial data, pretreated data.In this way Analysis supervision processor can be used to provide or execute, the processor is, for example, processor at sample acquisition station, experiment Processor at the place of room, as cloud or network a part processor；It can be by individual (for example, being attached to the analysis of authorization The individual of facility) it provides or executes；It and may include that personal (for example, the individual for being attached to the analysis facility of authorization) is cooperateed with to make Use processor.
In embodiments, supervision may include executing to divide in laboratory site to the analysis for the data transmitted by equipment Analysis.In embodiments, to data analysis supervision can be executed by processor, and may include software monitor, by or collaboration People (for example, be attached to authorization analysis facility individual) carry out supervision, by or cooperative experiment room automated system (LAS) into Capable supervision, by or cooperative experiment room information system (LIS) carry out supervision, by or coelectron medical record system (EMR) The supervision of progress.In embodiments, supervision may include from laboratory site to sample to the analysis for the data transmitted from equipment Equipment at acquisition station transmits instruction；Such instruction transmission of equipment from from from laboratory site to sample acquisition station can basis Regulatory agency, the analysis facility of authorization or the regulation and requirement of CLIA accredited laboratory.In embodiments, supervision is to by equipment The analysis of the data of transmission may include at laboratory receiving device information, cylinder casket information, patient identification, calibration information and Other information from equipment.Processor can be used to provide or execute in such supervision；It (can be awarded for example, being attached to by individual The individual of the analysis facility of power) it provides or executes；It and may include collaboration individual (for example, being attached to the analysis facility of authorization Individual) use processor.
In embodiments, supervising the report generated according to the analysis for the data for being transferred to laboratory by equipment may include Compile institute's data to be reported and analysis；Supervision includes checking and monitor procedure, operation and the survey for generating institute's data to be reported Fixed integrality, including check and monitoring data integrality, test completeness and analysis integrality；It prepares a report；For accurate Degree and completeness check report；Report is checked via the processor at laboratory site；Individual by being attached to laboratory checks Report；Transmission of the supervision report to recipient, the transmission including supervision report to recipient, including the correct confidentiality of confirmation and Confirm its reception；And other supervision.In embodiments, supervision according to the analysis for the data for being transferred to laboratory by equipment and The report of generation can be executed according to regulatory agency, the regulation of the analysis facility of authorization or CLIA accredited laboratory and requirement.This The report generation supervision of sample can be automated using technology and operating procedure, and therefore effectively make possible mistake minimum Change.Processor can be used to provide or execute in such report supervision；It can be by individual (for example, being attached to the analysis facility of authorization Individual) provide or execute；It and may include collaboration personal (for example, the individual for being attached to the analysis facility of authorization) at Manage device.
In embodiments, the processor at laboratory site can be used to execute for the charging for supervising service provided.? In embodiment, the charging for supervising service provided can be executed by being attached to the individual in laboratory.In embodiments, it supervises The charging of service provided can be held according to regulatory agency, the regulation of the analysis facility of authorization or CLIA accredited laboratory and requirement Row.Processor can be used to provide or execute in such charging supervision；It can be by individual (for example, being attached to the analysis facility of authorization Individual) provide or execute；It and may include collaboration personal (for example, the individual for being attached to the analysis facility of authorization) at Manage device.
For example, in devices disclosed herein, the embodiment of system and method, for example, as illustrated in fig. 8, sample Equipment at acquisition station can be from the laboratory reception scheme from laboratory site.It in embodiments, can be by coming from laboratory It is further instruction come update scheme.Scheme may include the finger about the one or more cylinder caskets that can be used according to the program It enables.Subject can be desirable to provide sample for testing.It is tested in devices disclosed herein, the embodiment of system and method Person can to equipment or to the operator of equipment at sample acquisition station provide identification information or test information (for example, from doctor or Other medical suppliers, orders about the one or more tests to be executed；Identification information etc. about operator).If It is standby such mark or test information to be provided to laboratory.Such mark or test information can be used to determine for laboratory The subject of test for the qualification of the test or appropriateness (for example, by determine subject safety position and coverage area, Charge information, gender, age or health status or other means).In view of identifying or test information, laboratory can be to tested Person or operator provide (for example, providing via apparatus user interface, equipment audio url, phone or other means) about sample The instruction of the acquisition of product, correct cylinder casket to be used or other information.The acquisition of sample can not need by subject or by operating Person handles sample.For example, sample acquisition can be automation, sample treatment can be automation, and other function can To be automation, to provide the better control and integrality of sample acquisition, processing and analysis；Such control can be such as A possibility that by reducing operator's variation or mistake, helps to meet CLIA or other supervision standards.In view of mark or test Information, laboratory can provide instruction, including but not limited to scheme to equipment.Such instruction can cause equipment (for example, via with Family interface, audio output or other means) subject or operator of the request at sample acquisition station confirmation or further Information.Sample can be obtained from the subject from sample acquisition station.Sample can be placed in a device, or can be by sample It is placed in a casket and can place the cylinder casket with sample in a device.Equipment can be to laboratory transmission state, test Or identification information.In view of cylinder casket, state, test or identification information, laboratory can transmit to equipment and instruct, including but not limited to just Case.For example, if sample, cylinder casket, scheme, identification information or other information mismatch or otherwise incompatible by equipment pair Correct operation, processing or the test of sample, either if subject lacks insurance coverage or if tests with its other party Formula is not suitable for subject, cylinder casket or equipment, then laboratory can be transmitted to equipment realizes refusal sample or the cylinder casket with sample Instruction.In view of cylinder casket, state, test or identification information, laboratory can be to equipment transmission plan or update scheme.It laboratory can The instruction for realizing processing and test sample is transmitted to equipment.It can be via cloud, phone, wireless to the instruction of equipment transmission from laboratory Electricity, network, LAN, other electronics or electromagnetic means or any other communication link.Realize processing and the instruction of test sample It may include realizing the instruction that sample or reagent or apparatus assembly are transported in equipment or to equipment；May include realize mixing sample with The instruction of reagent；It may include the instruction for realizing processing and/or test sample；It may include the instruction for realizing observation or measurement sample, The instruction of data is obtained from sample including realizing；It may include realizing that (data may include original from equipment to laboratory transmission data Beginning data and pretreated data) instruction；It and may include realizing disposition sample and derived from the useless of processing and test sample The instruction of object.These instructions enable a device to handle sample in the case where sample not being physically transported to laboratory from equipment. Laboratory can be analyzed from the received data of equipment.It can be dynamic analysis (example to from the lab analysis of the received data of equipment Such as, can in view of with or about sample or test provide information or data come confirm, change or replacement analysis).Laboratory can press It is further instructed according to provide to equipment from the analysis of the received data of equipment.Such further instruction may be implemented in sample and adopt Collect being further processed or testing to sample in the equipment at station.It laboratory can be quasi- based on the data from sample and its analysis Standby report.Laboratory can about sample processing and test and notify subject, medical supplier, insurance company or disburser. Laboratory can about sample processing and test and to subject, medical supplier, insurance company or disburser send report.It is real Test room can about sample processing and test and prepare bill information or be ready for bill.It laboratory can be about the processing of sample With test and to subject, insurance company or disburser send bill.Therefore, the control to the equipment at sample acquisition station and prison Superintending and directing can be realized by the processor at laboratory site, the individual by being attached to laboratory or whole the two.Laboratory can be The analysis facility of authorization, and can be laboratory that is CLIA certification or meeting CLIA.
In embodiments, to the supervision of equipment operation, to analysis the data from sample supervision or other supervision can Including the supervision carried out by software.Such supervisor software can be according to " U.S.'s food, drug and cosmetics bill " the 510th (k) item is ratified, or according to other regulations or the software ratified or checked and approved by another regulatory agency, and such software can By meeting CLIA's or CLIA certification laboratory or place operation or wherein running.Such supervisor software can be basis " U.S.'s food, drug and cosmetics bill " the 510th (k) article of approval, or according to other regulations or by another regulatory agency Approval or the software checked and approved, and such software can be by being not the laboratory or place for meeting CLIA or CLIA certification Place runs or runs wherein.Such supervisor software can be according to " U.S.'s food, drug and cosmetics bill " the 510th (k) item is ratified, or according to other regulations or the software ratified or checked and approved by another regulatory agency, and such software can It runs by cloud or other network operations or wherein；Such software operation in cloud or other networks can be by meeting CLIA's CLIA certification laboratory or place operation perhaps run under its supervision or can not be authenticated by meeting CLIA's or CLIA Laboratory or place operation or do not run under its supervision.
In some embodiments, it is possible to provide the method for evaluating biological sample.This method may include setting onboardly For upper reception and/or prepare sample.This method may include executing analysis in equipment onboardly.Alternatively, this method may include Analysis is executed except equipment and/or in place of separate equipment.For example, analysis can occur in laboratory or by the attached machine in laboratory Structure carries out.In some embodiments, analysis can occur simultaneously in equipment and outside equipment.
Analysis can be executed by the health care professionals in laboratory or any other subsidiary body in laboratory.Analysis can It is executed by software program.The one or more steps of software program can be performed in processor, to realize this alanysis.In some realities It applies in mode, the analysis of a kind, two or more types can be provided by analysis software program.In some embodiments, it analyzes It can be executed simultaneously by health care professionals and software program.In some instances, the software that analysis can be contained by equipment Program, by equipment outside health care professionals, and/or by equipment outside software program execute.
This method may also include the supervision provided to analysis.This method may include executing supervision in equipment onboardly.It is standby Selection of land, this method may include executing supervision except equipment and/or in place of separate equipment.For example, supervision can occur in laboratory Or it is carried out by the subsidiary body in laboratory.Laboratory can be the analysis facility of authorization, and can be CLIA accredited laboratory. In some embodiments, supervision can occur simultaneously in equipment and outside equipment.
In some embodiments, can be carried out and be supervised by health care professionals can be special by health care for analysis Industry personnel carry out, and analysis can be carried out and be supervised be carried out by software program by health care professionals, analysis can It is carried out by software program and is supervised to be carried out by health care professionals, or analysis can be carried out by software program And supervising can be carried out by software program.Identical health care professionals or different health cares profession can be used Personnel analyze and/or supervise.Identical software program or different software programs can be used carry out analysis and/or Supervision.Also may be used for any description of the laboratory of executable supervision, health care professionals, software, and/or infrastructure Suitable for analyzing, or vice versa.
Supervision can be executed by the health care professionals in laboratory or any other subsidiary body in laboratory.Supervision It can be executed by software program.The one or more steps of software program can be performed in processor, to realize such supervision.One In a little embodiments, supervision can be executed by health care professionals and software program simultaneously.In some instances, supervision can By onboard in the software program in equipment, by the health care professionals except equipment, and/or by the software journey except equipment Sequence executes.Any combination of analysis and supervision can be provided.
Supervision may include analyzing preceding supervision, it may include analysis supervision, and may include being supervised after analyzing.Supervision can before analysis Including the supervision to equipment acquisition and processing sample by sample acquisition station.Such supervision can be by processor or by being attached to The individual in laboratory executes at laboratory site.Laboratory can be sample acquisition station, and sample acquisition station can be manually Or can be automation.Laboratory can be the analysis facility of authorization, and can be CLIA accredited laboratory.
Analysis supervision may include the supervision to data are obtained from sample by equipment.Such supervision can be by processor or by attached The individual for belonging to laboratory executes at laboratory site, and the laboratory can be the analysis facility of authorization, and can be CLIA accredited laboratory.Analysis supervision may include to the supervision from equipment to laboratory transmission data.Supervision to data transmission It may include the timing or sequence of the encryption of monitoring data, the mode of monitoring data transmission, monitoring data transmission, and confirmation is completed Data transmission receives.Such supervision can be executed by processor or by being attached to the personal of laboratory in laboratory site, The laboratory can be the analysis facility of authorization, and can be CLIA accredited laboratory.Analysis supervision may include supervision pair The analysis for the data transmitted from equipment to laboratory.Supervision may include from right to the analysis for the data transmitted from equipment to laboratory According to, duplication, facility information or other information acquisition data instruction.Supervise the analysis to the data transmitted from equipment to laboratory May include using on the same device can be used or use, perhaps simultaneously can be used or use or substantially simultaneously may be used With or the various analysis that uses, control for analyzing, calibrating and control.It supervises to transmitting from equipment to laboratory The analysis of data may include with compare, replicate, facility information or other information are compared, or use control, duplication, equipment Information or other information.Such supervision can be substantially simultaneously performed simultaneously including the supervision to many measure method.This The supervision of sample can be executed by processor or by being attached to the personal of laboratory in laboratory site, and the laboratory, which can be, awards The analysis facility of power, and can be CLIA accredited laboratory.
Supervision may include the analysis about the data and data obtained from sample and prepare a report after analysis.It is supervised after analysis It may include identifying outlier or other data or information for requiring further to check.Supervision may include about clinical different after analysis Constant value or other data for further checking of requirement or information and mentioned using processor for further analysis.Supervision can after analysis The individual for being attached to laboratory is notified including data or the information further checked about outlier or other requirements.Analysis Supervision may include to be attached to the individual in laboratory and providing the data further checked with outlier or other requirements or letter afterwards Cease related data, analysis or information.After analysis supervision can by processor or by be attached to laboratory it is personal in laboratory It is executed at point, the laboratory can be the analysis facility of authorization, and can be CLIA accredited laboratory.
Fig. 5 shows laboratory welfare management (LBM) entity 510 communicated with disburser 500 and sample acquisition station 520. LBM can be communicated with the disburser for being in disburser place and the sample acquisition station for being in service point place.LBM, which may be provided in, to be in At the facility in the place LBM.LBM can be in the place different from disburser and sample acquisition station.In some embodiments, sample Acquisition station can be herein other everywhere as described in any retailer, insurance company, entity or sample acquisition station.For example, can Disburser, LBM and service point are provided in different facilities.
LBM 510 can be entity.For example, LBM can be company and enterprise, tissue, partnership business, industrial and commercial enterprises, or One or more can form the individual of entity.LBM be configurable to about financial transaction and service one or more other Entity communication.LBM can provide instruction and managerial finance process about financial transaction and service.
Disburser 500 can be can for subject one or more and healthy or medical relevant service make pay or The entity of partial payment.Disburser can sign a contract with the sponsor of subject or subject or reach an agreement to provide some shapes The medical insurance of formula.Disburser can be public disburser or private payments person.In some cases, disburser can be government Disburser or health insurance companies.The example of government-payer may include but be not limited to medical insurance, medical subsidy, federal government Employee's health welfare plan, veteran's health control office, national children's health insurance plan, military health departments/ The health insurance plan that TRICARE, Indian health service or other public expenses are subsidized.Various types of private payments persons' Example may include but be not limited to Health Maintenance Organization (HMO), preferably medical services tissue (PPO), free-standing clinic association (IPA), Service point (POS) plan or management history or indemnity insurance.The example of health insurance companies may include but be not limited to Aetna、Blue Cross Blue Shield Association、CIGNA、Kaiser Permanente、Humana、 Health Net, UnitedHealth Group or Wellpoint.
Sample acquisition station 520 can be service point place.Sample acquisition station can be provided in service point place.To service point Any discussion be also applicable to be in the sample acquisition station in service point place.Service point place can be the place far from LBM, It can be acquired from subject at this or provide sample by subject.In some embodiments, sample acquisition station can be retail Quotient.In this paper, other are provided the example of service point place and retailer in further detail everywhere.In some embodiments, sample Product acquisition station may include equipment that other are described in further detail everywhere such as this paper.
LBM can receive the information from sample acquisition station, and/or can receive the information from disburser.LBM can be to Sample acquisition station provides information, and/or can provide information to disburser.LBM can be with known in the art or from now on open Any mode of hair including but not limited to uses sample-processing equipment, the network equipment, mobile device, phone, mail, express delivery, throwing It passs or other described any other communication technologys everywhere herein, is communicated with disburser and sample acquisition station.Communication can pass through Including herein other everywhere the network including any latticed form and occur.Can between LBM and disburser and One-way communication or two-way communication are provided between LBM and sample acquisition station.LBM, disburser and sample acquisition station can have one or Multiple communication units.Communication unit is configurable to provide communication between LBM, disburser and sample acquisition station.Communication unit Member is configurable to provide wireless communication or wire communication.
LBM can also carry out the financial transaction with disburser and with sample acquisition station.In some cases, financial transaction can To be two-way financial transaction, or it can be unidirectional financial transaction.In one example, the payable LBM of disburser.LBM can be propped up Pay sample acquisition station.The payment that LBM is supplied to sample acquisition station can be from the payment that LBM is received from disburser.
LBM, disburser and sample acquisition station can have the processor and memory of recordable communication and/or payment. LBM, disburser and sample acquisition station can be interacted with the third party of one or more recordable communications and/or payment.Described one A or multiple third parties can be financial institution.The accessible one or more memories of processor, the memory may include Information about payment receive or expenditure.For example, LBM can have the one or more memories of access or data storage cell Processor, the memory or data storage cell include about the payment received from disburser and to be supplied to sample acquisition The information for the payment stood.
Payment can be provided based on the use to the equipment for being provided in sample acquisition station.LBM can be based on making equipment With and require the payment from disburser.LBM can provide payment to sample acquisition station based on the use to equipment.Alternatively, LBM can require the payment from sample acquisition station based on the use to equipment.
LBM may include one or more data storage cells comprising subject information, or can have access tested The ability of the information of person, the information includes: the insurance situation of the subject, the sum that previously carries out have pending one or The common payment status of multiple clinical trials, the medical records about subject, the payment information about subject, subject Identity information, or with subject or be associated with the associated other information of the financial transaction of subject.
In some alternate embodiments, disburser can receive the e bill from sample acquisition station and/or LBM.? Under some cases, health care professionals can receive the electronic cash from sample acquisition station and/or LBM.
Fig. 6 shows embodiment according to the present invention and the laboratory welfare system that provides.Service point 620 can be with experiment Room 630 communicates.Service point can be sample acquisition station, and also be applicable to sample acquisition to any description of service point herein It stands, and vice versa.Service point can also be communicated with LBM 610, and LBM 610 can also be communicated with disburser 600.LBM and experiment Room can be communicated with health care professionals 640.Subject 650 can provide sample to service point.
Service point 620 can be sample acquisition center, can have and be configurable to promote to acquire biology from subject 650 The equipment of sample.As it was earlier mentioned, sample can be acquired in service point from subject, or can be provided to the equipment at service point.
Sample acquisition center can be communicated with laboratory 630.Laboratory can be accredited laboratory.In sample acquisition The heart can be communicated via the sample-processing equipment for being located at sample acquisition center with laboratory.Sample acquires center can be with additional side Formula is communicated with laboratory.Equipment data collected can be transferred to laboratory from service point 620.Such data may with from tested The sample of person's acquisition is related.Can provide to laboratory includes that initial data, pretreated data or analysed data exist Interior any kind of data described previously herein.
Laboratory can provide equipment to service point place.In one example, laboratory can by equipment sell or hire out/ It is leased to sample acquisition center.Laboratory can be required to sale and/or the taxi at sample acquisition center from sample about equipment The payment at product acquisition center.Sample, which acquires center, to provide payment according to the ownership of equipment or using and to laboratory.Equipment It can be operated by device operator.Operator can be attached to service point place.Operator can be employee or otherwise attached Belong to sample acquisition center.Operator may receive or may not receive the training used about equipment.Sample acquisition Center can be another entity mutually separated with laboratory.Sample acquisition center can be attached to service point place, or can be by list Only entity operation.Sample acquisition center can be other described any service point places everywhere herein, including but not limited to Retailer (for example, Blue Cross, Blue Shield, Health Net, Aetna, Cigna), hospital, medical facilities and Any other service point.In one example, equipment can by technical staff associated with retailer or other service points or its His individual operates.Laboratory can play the function of the whole seller as equipment.It can be from it is alternatively possible to provide one or more Laboratory purchase of equipment simultaneously transfers to provide/sell the intermediate entities of equipment to service point place.
In an alternative example, laboratory can provide equipment about at the sample acquisition center that can be located at service point place And payment services point place.Laboratory can be about allowing in service point place using equipment and about allowing to set up in service point Sample acquires center and payment services point place.For example, laboratory is allowed to lease space in retailer, laboratory can be at this Set up the sample acquisition center with one or more equipment in place.Equipment can use training by receiving or not receiving equipment Personnel operate.Device operator can be attached to laboratory.Device operator may or may not be the employee in laboratory. Equipment and device operator can be used service point place as the sample acquisition station far from laboratory.
Laboratory can provide cylinder casket to service point place.The cylinder casket is configurable to be inserted into equipment or with its other party Formula connects with equipment.Cylinder casket may or may not be disposable.Laboratory can to or can not be to service location Disposable product is provided, for being used together with equipment.Disposable is also applicable to any description of cylinder casket herein, and Vice versa.In one example, cylinder casket can be sold to sample acquisition center by laboratory.Sample acquisition center can be attached to clothes Business point place and/or corpus separatum.Sample acquisition center can be managed by service point place and/or corpus separatum.It laboratory can The payment that center is acquired from sample is required to the sale at sample acquisition center about cylinder casket.Sample acquires center can be about cylinder Casket provides payment to laboratory.The operator of equipment can be attached to service point place.Laboratory can play the whole seller's of a casket Effect.It is alternatively possible to which cylinder casket can be bought from laboratory and transfer to service point place offer/sale by providing one or more The intermediate entities of cylinder casket.
In an alternative example, laboratory need not require to adopt from sample about cylinder casket is provided at sample acquisition center The payment at collection center.Equipment can be operated by receiving or not receiving equipment using the personnel of training.Device operator can be attached Belong to laboratory.Device operator may when or may not be laboratory employee.Clothes can be used in equipment and equipment operator Business point place is as the sample acquisition station far from laboratory.For the equipment that can be operated by the individual for being attached to laboratory, Cylinder casket can be used as to a part in the sample acquisition service in service point place.
Laboratory 630 can be communicated with health care professionals 640.Health care professionals can be located at and reality Test the place that room is mutually separated with service point.Health care professionals may have or may not have with subject's 650 Existing relationship.Health care professionals may be subject's prescription, allow it to go to service point place and execute one A or multiple tests.Health care professionals can have or can not have with service point or with the relationship in laboratory. In some embodiments, laboratory can send to health care professionals and report.Medical report can based on from be in service The collected data of equipment of point.Medical report can be based on the analysis to the data acquired from equipment.In some embodiments, Data analysis may include by data collected compared with one or more thresholds with the presence of at least one analyte of determination Or concentration.In some embodiments, laboratory can have such processor: the processor, which is configurable to access, to be had The data storage cell of information relevant to one or more of threshold values.Analysis can occur in laboratory 630, and reporting can It is generated in laboratory.Alternatively, analysis can occur in a device, and report and can generate by equipment or in laboratory.
In some embodiments, report is provided to subject 650.Be transferred to subject report can be supplied to The report of health care professionals 640 is identical, or can not be identical.Report can be sent simultaneously or health care profession Personnel can be firstly received report, or vice versa.
The LBM 610 that can be communicated with disburser 600 and service point 620 can be provided.LBM can be with health care profession Personnel 640 and/or laboratory 630 communicate, or can not communicate with.
Laboratory 630 and LBM 610 can be independent entity.Laboratory and LBM can be independent enterprise, company, It is tissue, mechanism, partnership business, one or more personal, or the entity of other described any other types everywhere herein.It is real It tests room and the registrable establishment of LBM is independent legal entity.LBM can be laboratory welfare management person, and laboratory can be Whole seller.Laboratory and LBM can be occupy in independent facility.Alternatively, they can share facility.
LBM 610 can be charged based on the use to the equipment at service point 620 to disburser 600.For example, every use is set Standby primary, LBM can collect the certain expense of disburser.The size of expense may depend on one or more factors, for example equipment makes With type (for example, existing to it and the number of analyte that concentration is detected, the number of chemical reaction, sample preparation Amount, type, the number of used apparatus assembly of reaction occurred), point that is carried out about the data acquired from equipment Analyse relationship, the branch of (for example, more complicated analysis can produce the expense different from simpler analysis), disburser and subject The relationship (if yes) of Fu Zheyu service point.LBM and disburser can reach the payment meter that can determine between disburser and LBM The agreement drawn.
LBM 610 can provide payment to service point 620 based on the use to the equipment for being in service point.For example, often making Primary with equipment, LBM can provide payment to service point.In another example, LBM can be located at the time of service point according to equipment Amount provides payment to service point.The size of expense may depend on one or more factors, the usage type of such as equipment (for example, Exist to it and the number of analyte that concentration is detected, the number of chemical reaction, the amount of sample preparation, occurred it is anti- The number of the type, used apparatus assembly answered), the analysis that carries out about the data acquired from equipment is (for example, more multiple Miscellaneous analysis can produce the expense different from simpler analysis).LBM and service point, which can be reached, can determine service point and LBM And the agreement of the payment plan between LBM.In the alternative, LBM can provide payment to laboratory 630, opposite herein Any description that service point provides payment is also applicable to laboratory.LBM to laboratory can provide payment rather than to service point Payment is provided；Or other than providing payment to service point, payment is provided to laboratory.
In some embodiments, the payment collected from disburser 600 can be divided into technical fee and professional expense by LBM 610 With.In one example, LBM can provide payment to health care professionals 640 based on profossional fee.LBM can be based on technology Expense provides payment to sample acquisition center 620.In some embodiments, sample acquisition center can be by such as retailer, doctor The service point of institute or any other service point etc is runed.In some embodiments, sample acquisition center can be by laboratory To run.Payment is provided to the entity in service point place, or be supplied to may the sample just in operating service point place adopt The laboratory at collection center.
LBM can make the decision for how dividing the payment from disburser.Technical fee and/or profossional fee can be based on The agreement that LBM may reach with health care professionals, service point and/or laboratory.Profossional fee is acceptable or alternative The agreement that ground may be reached based on health care professionals with disburser and/or laboratory.
Payment from disburser further can be divided into tranaction costs by LBM.Tranaction costs can be the gold for going to LBM Volume.LBM can retain a part for the payment that disburser is paid.
Fig. 7 shows laboratory welfare management person/whole seller's model example of embodiment according to the present invention.Such as The retailer 700 (or other service points) in pharmacy etc can have one or more sample treatments for being located at retailer's website to set It is standby.Retailer technical staff can operate sample-processing equipment, and can into equipment 710 placing tube casket.Cylinder casket may include or The sample acquired at retailer's website from subject can be not included in.
Laboratory welfare management person 720 can be herein other everywhere as described in LBM.Laboratory welfare management person can be with It is entity.
Laboratory welfare management person 720 and whole seller 730 can be provided in model.Laboratory welfare management person and whole seller It can be independent entity.Laboratory welfare management person and whole seller can be independent corporate entity, business entity, enterprise, Partnership business, tissue and/or the group being made of one or more individuals.Laboratory welfare management person and whole seller can occupy not In same facility or in identical facility.
Laboratory welfare management person 720 can communicate with one or more disbursers 740.Laboratory welfare management person can be to branch It pays person and issues the invoice about service.The payable laboratory welfare management person of disburser.For example, laboratory welfare management person can be from Disburser requires the expense (for example, providing numerical example --- $ 28) of $ a, which pays $ to laboratory welfare management person a.Laboratory welfare management person can retain LBM expense.For example, $ b (for example, providing numerical example --- $ 1) expense can be by testing Room welfare management person retains.
Laboratory welfare management person 720 can repay the remaining sum of 700 amount of money of retailer.For example, laboratory welfare management person Remaining $ c (for example, $ 27) can be paid to retailer.For example, $ c, which can be equal to $ a, subtracts $ b.
Retailer can also have expense associated with laboratory welfare management person and/or whole seller.For example, retailer can With the agency fee that can be paid to laboratory welfare management person with the retailer.In one example, agency fee be $ d (for example, There is provided numerical example --- $ 8).Retailer can also provide order form or payment product.For example, retailer is payable to retailer The purchase or use of equipment and/or cylinder casket at website.Retailer can pay to laboratory welfare management person.Alternatively, it is sold Quotient can pay about the purchase of equipment and/or cylinder casket or using and to whole seller.It in one example, can for the payment of product To be $ e (for example, providing numerical example --- $ 9).
For the angle of laboratory welfare management person, it then follows the model may have financial benefit.For example, laboratory good fortune Sharp manager can be used based on equipment and collect LBM expense.For example, LBM expense can be every transaction $ b.Laboratory welfare pipe Reason person can also collect agency fee from retailer.For example, laboratory welfare management person can collect the administration fee of $ d.In some cases Under, laboratory welfare management person can also collect product expense from retailer.For example, laboratory welfare management person can collect the product of $ e Take.
For the angle of retailer, it then follows the model may have financial benefit.For example, retailer can collect the clothes of $ c Business income.Service income can be provided by laboratory welfare management person.Laboratory welfare management person can be based on receiving from disburser The payment that takes and service income is provided.Laboratory welfare management person can deduct LBM expense from the amount of money of disburser from collecting, and And remaining amount of money can be passed to retailer as service income.In additional embodiment, laboratory welfare management person The also deductible profossional fee that may be supplied to health care professionals or other entities, and the rest part of remaining sum is given to Retailer is as service income.Therefore, as shown in Figure 7, total income can be provided from the service income of $ c.Retailer is born Cost include administration fee (expense of $ d shown in for example) and/or product expense (expense of $ e shown in for example).Cost can About $ f (for example, numerical example --- $ 17 is provided).$ f can be equal to $ d and add $ e.The cost that retailer is undertaken can be lower than service Income.For example, illustrating the gross profit of the $ g (for example, providing numerical example --- $ 10) of retailer.In some cases, $ g=$ C subtracts $ f.
Following table illustrates the example of model.
Any U.S. dollar amount only provides by way of example, and is understood not to restrictive.It can be with Any numerical value is inserted into for each dollar.
In some embodiments, subject may be associated with disburser.For example, such as health insurance companies, political affairs Mansion disburser or the as described herein disburser of any other disburser etc can provide insurance covering for subject.Disburser The some or all of medical bills of payable subject.In some embodiments, it when subject reaches service point, can test Demonstrate,prove the identity of subject.Equipment can be used to verify and/or be verified by the personnel of service point in the identity of subject.For example, clothes The personnel of business point can check the identity card and/or insurance card of subject.Equipment can or can not capture the image of subject And/or one or more biometric parameters are acquired from subject.Verifying can occur in equipment onboardly.Alternatively, The identity of subject can be acquired in service point, and can further be verified in another entity or place.For example, laboratory, medical treatment Health professional or disburser can verify that subject's identity.Equipment, laboratory, health care professionals and/or disburser It may be able to access that subject information, such as electric health record.Verifying can occur quickly and/or in real time.For example, verifying can be 10 minutes or less, 5 minutes or less, 3 minutes or less, 1 minute or less, 45 seconds or less, 30 seconds or less, 20 seconds or Less, 15 seconds or less, 10 seconds or less, 5 seconds or less, 3 seconds or less, 1 second or less, 0.5 second or less or 0.1 Occur in second or less time.Verifying can be automation, without any human intervention.
System can for the record of system, insurance coverage and verify the identity of subject, to prevent from cheating or to use In any other purpose.Verifying can be executed by equipment.Verifying can occur at any time.In one example, can preparation by Identity of the sample of examination person for verifying subject before test.It can be verified before providing sample to equipment and/or cylinder casket tested The identity of person.Can verifying subject insurance coverage before, testing for subject's identity is provided later or at the same time Card.Can verifying subject have been received by be subjected to described qualitative and/or quantitative assessment prescription before, later or at the same time The verifying of subject's identity is provided.Verifying can by with health care provider, laboratory, disburser, laboratory welfare management The communication of person or any other entity and carry out.Verifying can be occurred by accessing one or more data storage cells.Data Storage unit may include electronic medical records database and/or disburser's database.Verifying can occur quickly and/or in real time.Example Such as, verifying can at 10 minutes or less, 5 minutes or less, 3 minutes or less, 1 minute or less, 45 seconds or less, 30 seconds or Less, 20 seconds or less, 15 seconds or less, 10 seconds or less, 5 seconds or less, 3 seconds or less, 1 second or less, 0.5 second or more Occur less or in 0.1 second or less time.Verifying can be automation, without any human intervention.
Verifying may include the information provided by subject.For example, verifying may include identity card and/or the guarantor for scanning subject Danger card.Verifying may include the photo for shooting subject and/or subject's face.For example, verifying may include shoot subject two Dimension or three-dimensional snapshot.The two-dimensional digital image that can provide subject can be used and/or can formulate the three-dimensional of subject Or the camera of four-dimensional image.The four-dimensional image of subject may include changing with time.Verifying may include shooting subject's face Photo for identification.Verifying may include shoot subject's face another part photo for identification, the part includes But it is not limited to any other part of the whole body of patient, arm, hand, leg, trunk, foot or body.Verifying can be used and can be captured The video camera and/or microphone of additional vision and/or audio-frequency information.Verifying may include comparing the movement of subject (for example, step State) or sound.
Verifying may include typing personal information related with subject, the name of such as subject, insurance single numbers, key The answer of problem and/or any other information.Verifying may include the one or more biometrics reading for acquiring subject.Example Such as, verifying may include fingerprint, impression of the hand, footprint, retina scanning, temperature reading, weight, height, audio-frequency information, electronical reading or Any other information.Biometric information can be acquired by equipment.For example, equipment can have touch screen, subject can be by subject Palm it is placed on it to be read by equipment.Touch screen can scan one or more physical feelings of subject, with And/or person receives temperature reading, electric reading and/or pressure reading from subject.Alternatively, equipment, which can receive, comes from other The biometric information of equipment.For example, equipment can receive the weight of subject from the weighing apparatus mutually separated with equipment.Information can (for example, by wired or wireless connection) is directly transmitted from other equipment or can be manually entered.
Verifying may also include the information based on the sample acquired from subject.For example, verifying may include the gene of subject Signature.When sample is supplied to equipment, at least part of sample is can be used to determine the gene signature of subject in equipment.Example Such as, the executable one or more nucleic acid amplification steps of equipment, and can determine the key gene marker of subject.This can be formed The gene signature of subject.The gene signature of subject can be before handling sample in equipment, later or at the same time obtain ?.The gene signature of subject can be stored on one or more data storage cells.For example, the gene signature of subject can store up There are in the electronic medical record of subject.The gene signature of subject collected can with have been stored in record in subject Gene signature (if it exists) compare.Any other unique identification feature of subject is used equally for verifying tested The identity of person.
Method for nucleic acid (including DNA and/or RNA) amplification is as known in the art.Amplification method can be related to Temperature change, such as denaturation step；Or it can be the constant temperature process for not needing thermal denaturation.Polymerase chain reaction (PCR) makes With the annealing and primer extend of the denaturation of multiple circulations, primer pair and opposite strand, to exponentially increase the copy number of target sequence. It can be by applying heat, increasing localized metallic ion concentration (such as US6277605), ultrasonic radiation (such as WO/2000/ 049176), apply voltage (for example, US5527670, US6033850, US5939291 and US6333157) and apply electromagnetic field And the primer (for example, US5545540) in conjunction with magnetic response material is combined to realize the denaturation of the nucleic acid chains of annealing, above-mentioned patent And patent application passes through reference hereby and is integrally incorporated.In the referred to as version of RT-PCR, using reverse transcriptase (RT) from RNA Generate complementary DNA (cDNA), then by PCR amplification cDNA with generate DNA multiple copies (for example, US5322770 and US5310652 passes through reference hereby and is integrally incorporated).
One example of constant-temperature amplification method is strand displacement amplification, commonly referred to as SDA, it uses following circulation: primer pair Sequence anneals are to the opposite chain of target sequence, and primer extend is in the presence of dNTP to generate half thiophosphorylation primer extend product Duplex, endonuclease mediate semi-modified restriction endonuclease recognition site notch generate and it is polymerase-mediated The end slave notch 3' primer extend with replace existing chain and generate for next round primer annealing, notch generate and strand displacement Chain, cause the geometry of product to expand (for example, US5270184 and US5455166, passes through reference hereby and be integrally incorporated).It is thermophilic Hot SDA (tSDA) is in essentially identical method at higher temperatures using thermophilic endonuclease and polymerase (Europe The patent No. 0 684315 passes through reference hereby and is integrally incorporated).
Other amplification methods include rolling circle amplification (RCA) (for example, Lizardi, " Rolling Circle Replication Reporter Systems ", U.S. Patent number 5,854,033)；Rely on amplification (HDA) (example of unwindase Such as, Kong etc., " Helicase Dependent Amplification Nucleic Acids ", U.S. Patent Application Publication No. US 2004-0058378A1)；And the isothermal duplication (LAMP) that ring mediates is (for example, Notomi etc., " Process for Synthesizing Nucleic Acid, " U.S. Patent number 6,410,278), pass through reference hereby and be integrally incorporated.Some In the case of, isothermal duplication is using the transcription by RNA polymerase since promoter sequence, such as can be introduced into antisense oligonucleotide primer In object.Commonly the amplification method based on transcription includes the amplification based on nucleic acid sequence in the art, also referred to as NASBA (example Such as US5130238)；Dependent on the method for using rna replicon enzymatic amplification probe molecule itself, commonly known as Q β replicates enzyme method (for example, Lizardi, P. etc. (1988) Biotechnol.6,1197-1202)；It is automatic maintain sequence replicating (for example, Guatelli, J. etc. (1990) Proc.Natl.Acad.Sci.USA 87,1874-1878；Landgren(1993)Trends in Genetics 9,199-202；With HELEN H.LEE etc., NUCLEIC ACID AMPLIFICATION T ECHNOLOGIES(1997))；With the method (for example, US5480784 and US5399491) for generating additional transcription templates, It passes through reference hereby and is integrally incorporated.Further isothermal nucleic acid amplification method include using containing non-standard nucleotide (such as Uracil or RNA nucleotide) primer at non-standard nucleotide cut nucleic acid with exposed needle to the bound site of other primers The combination (for example, US6251639, US6946251 and US7824890) of the enzyme (such as DNA glycosylase or RNaseH) of point, It is integrally incorporated hereby by reference.Isothermal duplication process can be linear or index.
Nucleic acid amplification for subject's identification may include multiple nucleic acid sequences, for example, about, be less than about or be greater than About 10,11,12,13,14,15,20,25,30,35,40,50,100 or more target sequence it is continuous, in parallel or concurrently expand. In some embodiments, the whole gene group of subject or entire transcript profile are non-specifically expanded, and product is needle To the probe of one or more identification sequence signatures.Identify that sequence signature includes that can be used as the basis distinguished between individuals Nucleic acid sequence any feature.In some embodiments, using about, be less than about or more than about 10,11,12,13,14, 15,20,25,30,35,40,50,100 or more identification sequence uniquely identifies individual with selected statistical significance.? In some embodiments, statistical significance is about or less than about 10-2、10-3、10-4、10-5、10-6、10-7、10-8、10-9、10-10、10-11、10-12、10-13、10-14、10-15Or it is smaller.The example for identifying sequence includes restriction fragment length polymorphism (RFLP；Botstein, etc. Am.J.Hum.Genet.32:314-331,1980；WO 90/13668), single nucleotide polymorphism (SNPs；Kwok, etc. Genomics 31:123-126,1996), randomly amplified polymorphic DNA (RAPD；Williams etc., Nucl.Acids Res., 18:6531-6535,1990), simple sequence repeats (SSRs；Zhao and Kochert, Plant Mol.Biol.21:607-614,1993；Zietkiewicz, waits .Genomics 20:176-183, and 1989), amplified fragments are long Spend polymorphism (AFLP；Vos, etc. Nucl.Acids Res., 21:4407-4414,1995), Short tandem repeatSTR (STRs) can be changed Number tandem repeats (VNTR), microsatellite (Tautz, Nucl.Acids Res., 17:6463-6471,1989；Weber and May, Am.J.Hum.Genet.44:388-396,1989), amplification polymorphism (IRAP) between retrotransposon, long interspersed element (LINE), long tandem sequence repeats (LTR), displaceable element (ME), retrotransposon microsatellite amplification polymorphism (REMAP), base In the insertion polymorphism (RBIP) of retrotransposon, short interspersed element (SINE) and sequence specific amplification polymorphism (SSAP).The other example of identification sequence is well known in the art, such as in US20030170705, by drawing With being incorporated herein.Gene signature can be made of multiple identification sequences of single type (for example, SNPs), or may include any number The combination of the different types of identification sequence of two or more of mesh or combination.
Gene signature can be used for the process of the identification of any required one or more subjects, such as paternal or maternal Paternity test, immigrant and succession dispute, animal breeding test, the detection of twins' ovum type, the inbreeding of human and animal test； Transplant Matching estimate, such as bone-marrow transplantation；The identification of the remains of human and animal；Cultivate the quality control of cell；Legal medical expert's detection Such as semen sample, the forensic analysis of bloodstain and other biological material；By detection loss of heterozygosity to the Gene effect of tumour Characterization；With the gene frequency for determining specific identification sequence.Sample for generating gene signature includes from scene of a crime Evidence, blood, bloodstain, sperm, seminal stain, bone, tooth, hair, saliva, urine, excrement, nail, muscle or other soft group It knits, cigarette, stamp, envelope, dandruff, fingerprint, project and their combination containing any of these materials.In some realities It applies in mode, generation and more two or more gene signatures.In some embodiments, one or more gene label Name is such as compared comprising gene signature in the database with gene signature known to one or more.
System can also verify the instruction whether subject has received clinical trial to be subjected to from health care professionals. System therefore can verify that subject whether received from health care professionals to carry out to the qualitative of biological sample and/or The reservation of quantitative assessment.For example, system, which can verify that whether subject receives from health care professionals, wants acceptance test Prescription.System, which can verify that whether subject receives from health care professionals, to provide the instruction of sample to equipment. System can also verify subject whether be authorized to go to special services point through tested person.Verifying can be occurred by means of equipment.It tests Card can occur at any time.In one example, it verifying subject can be connect before the sample for preparing subject is for test The authorization of tested person.The authorization of subject's acceptance test can be verified before providing sample to equipment and/or cylinder casket.To subject Authorization verifying can verifying subject identity after provide.It can be in verifying subject's tool to the verifying of the authorization of subject Have and is provided before or after the insurance covering for clinical trial.System can verify that subject whether by health insurance for sample Qualitative and/or quantitative assessment the covering of product, wherein verification step handling biological sample by equipment or transmits number from equipment According to executing before, later or at the same time.Verifying can by with health care provider, laboratory, disburser, laboratory good fortune The communication of sharp manager or any other entity and carry out.Verifying can occur quickly and/or in real time.For example, verifying can be at 10 points Clock or less, 5 minutes or less, 3 minutes or less, 1 minute or less, 45 seconds or less, 30 seconds or less, 20 seconds or more Less, 15 seconds or less, 10 seconds or less, 5 seconds or less, 3 seconds or less, 1 second or less, 0.5 second or less or 0.1 second Or occur in the less time.Verifying can be automation, without any human intervention.
System can also verify whether subject there is the insurance to clinical trial to cover.System can verify that whether subject has Have for providing the insurance covering of sample to equipment.System can also verify whether subject has for going to service point and being subjected to The insurance of test covers.Verifying can occur at any time.It in one example, can be in the sample for preparing subject for test The insurance coverage of subject is verified before.The insurance of subject can be verified before providing sample to equipment and/or cylinder casket Coverage area.The verifying of the insurance coverage of subject can be provided after the identity of verifying subject.To subject's The verifying of insurance coverage can provide before or after verifying subject and having received the prescription of clinical trial to be received.It tests Card can be and the communication with medical service provider, laboratory, disburser, laboratory welfare management person or any other entity It carries out.Verifying can be occurred by means of equipment.Verifying can occur quickly and/or in real time.For example, verifying can at 10 minutes or more Less, 5 minutes or less, 3 minutes or less, 1 minute or less, 45 seconds or less, 30 seconds or less, 20 seconds or less, 15 seconds Or less, 10 seconds or less, 5 seconds or less, 3 seconds or less, 1 second or less, 0.5 second or less or 0.1 second or less Occur in time.Verifying can be automation, without any human intervention.
System can also verify clinical trial and be appropriate for subject.System can verify that qualitative and/or quantitative assessment It subscribes whether within one group of rule limitation.The limitation of this rule-like can form guilding principle.The limitation of this rule-like can be payment Person, the doctor to prescribe or other make health care professionals, laboratory, government or the regulatory agency or any of reservation The rule limitation of other entities.It is such to verify the one or more known features that may depend on subject, including but not limited to property Not, age or medical history.Clinical Decision Support Systems can be provided.The system may be able to access that associated with subject One or more medical records or information.System may be able to access that with the identity of subject, subject insurance coverage, Subject in the past with current therapeutic treatment, subject biological characteristic and/or be supplied to the relevant record of the prescription of subject. System may be able to access that electric health record and/or recall patient's record and history.System may can also recall disburser Record, insurance such as related with subject and financial information.Verifying can be occurred by means of equipment.
In some embodiments, before providing qualitative and/or quantitative assessment, system may be able to access that one or more A database of record and/or disburser's database.In some cases, system can provide described qualitative and/or determine Before amount evaluation, and/or before accessing the database, determination will access which database of record and/or disburser Database.System can identity based on subject, disburser's information of subject, the information collected about sample, mentioned View qualitative and/or quantitative assessment and/or any other information and make such determination.
In one example, it is unsuitable test may be for male subject pregnancy tests or for women it is tested PSA (prostate-specific antigen) horizontal checkout of person.Such test may the rule limit beyond disburser or prescribing doctor Except system.Such reservation error can be by examining that the test subscribed and the information for being associated with subject are detected.It is such The information being associated with may include the medical records of subject or the identification information about subject.In one example, it is preparing The appropriateness of validation test before the sample of subject is used to test.The test appropriateness of subject can be to equipment and/or cylinder Before casket offer sample, verify later or at the same time.The verifying of the test appropriateness of subject can be verifying subject's It is provided after or before identity and/or insurance coverage.The verifying can by with health care provider, laboratory, payment Person, laboratory welfare management person or any other entity communication and carry out.Clinical Decision Support Systems can be rapidly and/or real When run.For example, verifying can be 10 minutes or shorter, 5 minutes or shorter, 3 minutes or shorter, 1 minute or shorter, 45 seconds Or it is shorter, 30 seconds or shorter, 20 seconds or shorter, 15 seconds or shorter, 10 seconds or shorter, 5 seconds or shorter, 3 seconds or shorter, 1 second or Shorter, 0.5 second or shorter or 0.1 second or the interior generation of shorter time.Clinical Decision Support Systems can be automation, and nothing Need any manual intervention.
In some embodiments, competent person can assist acquisition subject identity and/or to equipment provide from by The sample of examination person.Competent person can be the technical staff being authorized for having lived through the training using equipment.Competent person can To be the specified operator of equipment.Competent person may or may not be medical treatment and nursing professional.In some embodiment party In formula, the identity of competent person can be verified.The identity of competent person can receive biological sample, electronically transmit number from equipment According to and/or the transmitted data of analysis before, later or at the same time verify.The identity of competent person can be in verifying subject Identity before, verify later or at the same time.The identity of competent person can be used herein other everywhere described one kind or Multiple technologies are verified.
Fig. 9, which is shown, provides sample treatment, the further example of the system of analysis and supervision.The number in box in Fig. 9 Word number corresponding with Fig. 8 has identical meanings.As shown in Figure 9, the arrow for carrying out self-supervisory box indicates that supervision can be with It is supervision to analysis, to the supervision of the communication by network (such as cloud, as exemplified by the cartoon cloud in attached drawing) and to processing Supervision, for example, to equipment processing sample operation supervision.As discussed above, the supervision of equipment operation can be and holds Continuous supervision, for example, continuing during handling sample, and may include in view of facility information relevant to equipment, cylinder casket, sample (including device identification, equipment state and other equipment information), cylinder casket information, sample message, patient information, environmental information or Other environmental information and other about equipment or from equipment transmit information and data supervision.Such supervision is for every One can be located at the example of laboratory site or sample acquisition station in wherein supervision, may include supervision to analysis, to communication Supervision and supervision to processing.In embodiments, supervision can be located in cloud or other networks.In further embodiment In, supervision may include to action after analysis or the supervision of step.
Figure 10 A, Figure 10 B, Figure 10 C and Figure 10 D show the laboratory welfare pipe of embodiment according to the present invention offer The example of reason system.As illustrated in Figure 10 A, Figure 10 B, Figure 10 C and Figure 10 D and the advantage of scene as discussed herein includes The ability of the confirmation income when for example receiving payment is provided for retailer.Such payment can be received from customer, such as Figure 10 A, figure Shown in 10B, Figure 10 C and Figure 10 D；It can be received from laboratory, as shown in Figure 10 A and 10 B；Or received from LBM, such as scheme Shown in 10C and Figure 10 D.As illustrated in the accompanying drawings, laboratory welfare management person (LBM) can communicate with laboratory either tests A part of room.It (respectively indicates the dashed rectangle around the box of laboratory and LBM and indicates that laboratory and LBM can be together One entity, or can be independent entity).Test can be provided in the samples acquisition station such as retail site.Labeled as " retail The box of quotient " indicates sample acquisition station, for example, can be shop, another business site, pharmacy, medical health facility or other Sample acquisition station.By the customer that indicates of box labeled as " customer " can it is expected such as blood testing, urine test or other The service such as test；Customer can pay such test to retailer；Alternatively, customer can only pay such test amount payable A part (for example, paying volume altogether).In embodiments, customer not to retailer pay, and retailer from another party (for example, Laboratory, LBM, insurance company, health plan, government organs or other disbursers) receive payment.Laboratory can provide service (for example, executable test to biological sample) can provide equipment, can provide disposable product, and can carry out other can be pre- The action of phase payment.As label is bill in attached drawing " arrow indicated by, laboratory or LBM can send request to disburser and pay The invoice (for example, bill) of money.Dollar mark () indicates payment.The head of arrow indicates the indicated directionality taken action；Example Such as, the label pointed up in Figure 10 A be bill " arrow indicate that LBM can be to disburser's charging；And it is being labeled as " account Downwardly directed arrow near the arrow of list " indicates that disburser can provide payment to LBM.As shown, laboratory can be from Disburser receives payment.Laboratory can provide payment or other funds to LBM.Laboratory can share payment or other moneys with LBM ?.LBM can be received from disburser and be paid the bill.LBM can provide payment or its fund to laboratory.Laboratory can share payment with LBM Or other funds.In embodiments, laboratory can be together with payment or fund, independently of payment or fund or be additional to Payment or fund and information is provided, for example, identification information, test information, insurance information or other information.LBM can managing payment Person's relationship and connection.The payable retailer of LBM.For example, LBM for example can repay the certain amount of money of retailer according to the test of execution Fund.In embodiments, laboratory can repay retailer.Retailer can pay expense to LBM or provide other payment (examples Such as, payable service charge, agency fee or other fees).In embodiments, laboratory or LBM can be from being paid by retailer Retain an expense in fund.In embodiments, laboratory or LBM can retain an expense from the fund paid by disburser With；In embodiments, LBM can pay expense to laboratory.Laboratory can be the laboratory of authorization, and can be and meet CLIA's or CLIA certification laboratory.
As indicated by the dotted square block, laboratory and LBM can be same entity, or can be independent entity.In addition, Laboratory can be whole seller, that is, can provide equipment, supply etc. (for example, equipment, cylinder casket and other facilitate practice herein Disclosed method or the material for helping to obtain equipment and system as disclosed herein).In embodiments, such object It can be provided by the third party for needing not to be laboratory.
As indicated by Figure 10 A, customer can directly trade with retailer, and can provide payment to retailer.Retailer Can trade with laboratory, and payable laboratory or to laboratory transmitting payment (for example, for service, equipment, material or its He pays the bill)；The payable retailer in laboratory (for example, expense).Laboratory can trade with LBM, and pay the bill (including expense, repay Pay or other payments) can either between LBM and laboratory to or whole both direction on transmit.LBM can be with disburser (for example, health plan, insurance company, government organs or other disbursers) transaction, for example, by being directed to service (for example, being directed to Be supplied to the service of customer) or for other costs or can charging action trade to disburser's charging.Disburser can It is paid by each such bill to LBM.In embodiments, LBM and laboratory can be same entity, prop up in the case It pays person and retailer and the entity is traded.
As indicated by Figure 10 B, customer can directly trade with retailer, and can provide payment to retailer.Retailer Can trade with laboratory, and payable laboratory or to laboratory transmitting payment (for example, for service, equipment, material or its He pays the bill)；The payable retailer in laboratory (for example, expense).Laboratory can trade with LBM, and pay the bill (including expense, repay Pay or other payments) can either between LBM and laboratory to or whole both direction on transmit.It laboratory can be with payment Person (for example, health plan, insurance company, government organs or other disbursers) transaction, for example, by being directed to service (for example, needle Service to customer is supplied to) or for other costs or can charging action trade to disburser's charging.Disburser It can be paid by each such bill to laboratory.In fig. 1 ob in illustrated scene, LBM is not direct to trade with disburser, And retailer is not direct to trade with LBM.In embodiments, LBM and laboratory can be same entity, prop up in the case It pays person and retailer and the entity is traded.
As indicated by Figure 10 C, customer can directly trade with retailer, and can provide payment to retailer.Retailer Can trade with LBM, and payable LBM or to LBM transmitting payment (for example, for service, equipment, material or other pay the bill)； The payable retailer of LBM (for example, expense).Laboratory can trade with LBM, and pay the bill (including expense, reimbursemen or other pairs Money) can either between LBM and laboratory to or whole both direction on transmit.It laboratory can be with disburser (for example, strong Health plan, insurance company, government organs or other disbursers) transaction, for example, by (being supplied to Gu for example, being directed to for service The service of visitor) or for other costs or can charging action trade to disburser's charging.Disburser can by it is each this The bill of sample is paid to laboratory.In fig 1 oc in illustrated scene, retailer and LBM trade, without direct and laboratory Transaction；And disburser and laboratory are traded, without directly trading with LBM.In embodiments, LBM and laboratory can be Same entity, disburser and retailer and the entity are traded in the case.
As indicated by Figure 10 D, customer can directly trade with retailer, and can provide payment to retailer.Retailer Can trade with LBM, and payable LBM or to LBM transmitting payment (for example, for service, equipment, material or other pay the bill)； The payable retailer of LBM (for example, expense).Laboratory can trade with LBM, and pay the bill (including expense, reimbursemen or other pairs Money) LBM can be transmitted to from laboratory.In figure 10d in illustrated scene, laboratory pays LBM, but LBM does not pay experiment Room (laboratory receives from disburser and pays the bill).Laboratory can with disburser (for example, health plan, insurance company, government organs or Other disbursers) transaction, for example, by for service (for example, for the service for being supplied to customer) or for other costs Or can charging action trade to disburser's charging.Disburser can be paid by each such bill to laboratory.Scheming In 10D in illustrated scene, LBM is not direct to trade with disburser；And laboratory is not direct to trade with retailer.Implementing In mode, LBM and laboratory can be same entity, and disburser and retailer and the entity are traded in the case.
The publication for being discussed herein or quoting is only because its disclosure was provided before the submission date of the application. Any statement of this paper, which is not necessarily to be construed that, recognizes that the present invention haves no right by formerly invention and prior to such publication.In addition, Provided publication dates may be different from the practical publication date that may need individually to confirm.All publication being mentioned herein Object is incorporated by reference into herein, with open or description structure related with cited publication and/or method.Following Shen It is please incorporated herein also by reference for all purposes: Application U.S. Serial No 61/766,076 and 13/769,779.
From hereinbefore it will be appreciated that though illustrate and describe specific implementation, but it can be made and herein It is susceptible to various modifications.It is not intended to the limitation by the specific example provided in this specification herein.Although the present invention is Described with reference to description above, but the preferred embodiment of this paper description and diagram be not intended to manage with restrictive sense Solution.In addition, it will be appreciated that all aspects of this paper be not limited to it is set forth herein, dependent on the specific of a variety of conditions and variable Description, configuration or relative scale.The various modifications in form and details of embodiments of the present invention are for those skilled in the art Member will be obvious.It is therefore contemplated that the present invention should also cover any such modification, variation and equivalent.

Claims (10)

1. a kind of method for evaluating the biological sample acquired from subject, which comprises
(a) data transmitted from the equipment with shell are received in laboratory site, the equipment is placed in subject's body or body Above or it is placed in specified sample acquisition station, the data include the initial data from the biological sample, the biological sample Including cell, wherein the device configuration, for handling the biological sample in the shell as follows, these are walked Suddenly are as follows:
(i) biological sample is received；
(ii) biological sample is prepared in the shell and generates initial data, for the subsequent of the biological sample Qualitative and/or quantitative assessment, the initial data include that (1) represents the physical process or chemical reaction executed by the equipment Numerical value and (2) represent the electronic data of the image of the cell in the biological sample；And
(iii) electronically by the initial data from the sample acquisition station be transmitted to authorization analysis facility and/or its Subsidiary body, for executing the subsequent evaluation in the laboratory site；
(b) initial data transmitted from the equipment is analyzed in the analysis facility of authorization and/or its subsidiary body, described in providing The evaluation of biological sample, wherein the analysis individually or with the analysis facility that is attached to the authorization it is personal synergistically It is executed using processor；And
(c) supervision of the integrality of the operation to the analysis and the equipment is provided, so that generated by the analysis As a result it can be come screening, diagnosis or the treatment subject by health care professionals' utilization, wherein the supervision is described Laboratory site individually or with the individual for the analysis facility for being attached to the authorization is synergistically executed using processor.
2. according to the method described in claim 1, wherein preparing the biological sample in the shell and generating original number According to including transporting reagent or biological sample with the intracorporal pipette of the shell.
3. according to the method described in claim 1, wherein preparing the biological sample in the shell and generating original number According to including being centrifuged in the shell to biological sample.
4. according to the method described in claim 1, wherein the equipment is that clinical labororatory's improvement amendment (CLIA) exemption is set It is standby.
5. according to the method described in claim 1, wherein the equipment meets clinical labororatory's improvement amendment (CLIA) Equipment is operated in a manner of meeting CLIA, the laboratory operation by meeting CLIA or is operated in the place for meeting CLIA.
6. a kind of system for evaluating the biological sample acquired from subject, the system comprises:
(a) communication unit being placed at laboratory site, the communication unit be configured to from be placed in subject's body or with it or The equipment for being placed in specified sample acquisition station receives data, wherein the equipment includes shell and is configured in the shell Interior processing biological sample, the biological sample include cell, and the processing carried out by the equipment is generated for the life Subsequent qualitative and/or quantitative assessment the initial data of object sample, and wherein the equipment includes:
(i) it is located at the intracorporal sample collection unit of the shell, which is configured to receive the biological sample；
(ii) it is located at the intracorporal sample preparation unit of the shell, which is configured to prepare institute in the shell It states biological sample and generates the initial data for being used for the evaluation, set wherein the raw data packets include (1) representative by described The numerical value and (2) of the standby physical process executed or chemical reaction represent the electron number of the image of the cell in the biological sample According to；And
(iii) transmission unit is configured to the initial data from the sample acquisition station with being transmitted to the laboratory The analysis facility of authorization at point and/or its subsidiary body；
(b) processor being located at the laboratory site, the processor individually or with the analysis facility that is attached to authorization It is personal to handle the data in combination, evaluate for (a) at the analysis facility of the authorization and/or its subsidiary body place described in Biological sample, and the integrality evaluated with the operation of the equipment (b) is supervised, so that generated by the evaluation As a result it can be come screening, diagnosis or the treatment subject by health care professionals' utilization.
7. system according to claim 6, wherein the sample preparation unit includes fluid handling system, fluid processing System includes being located at the intracorporal pipette of the shell.
8. system according to claim 6, wherein the sample preparation unit includes being located at the intracorporal centrifuge of the shell.
9. system according to claim 6, wherein the equipment is that clinical labororatory's improvement amendment (CLIA) exemption is set It is standby.
10. system according to claim 6, wherein the equipment, which meets clinical labororatory, improves amendment (CLIA) Equipment is operated in a manner of meeting CLIA, the laboratory operation by meeting CLIA or is operated in the place for meeting CLIA.
CN201910172255.9A 2013-02-18 2014-02-14 System and method for acquiring and transmitting measurement result Pending CN109813923A (en)

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US61/766,095 2013-02-18
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