CN115541538A - Sample analysis device and sample detection method - Google Patents

Sample analysis device and sample detection method Download PDF

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Publication number
CN115541538A
CN115541538A CN202110728093.XA CN202110728093A CN115541538A CN 115541538 A CN115541538 A CN 115541538A CN 202110728093 A CN202110728093 A CN 202110728093A CN 115541538 A CN115541538 A CN 115541538A
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Prior art keywords
cleaning
detection
type
specific protein
sample
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刘海君
刘海
谢子贤
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Shenzhen Mindray Bio Medical Electronics Co Ltd
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Shenzhen Mindray Bio Medical Electronics Co Ltd
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47Scattering, i.e. diffuse reflection
    • G01N21/49Scattering, i.e. diffuse reflection within a body or fluid
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B08CLEANING
    • B08BCLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
    • B08B9/00Cleaning hollow articles by methods or apparatus specially adapted thereto 
    • B08B9/08Cleaning containers, e.g. tanks
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B08CLEANING
    • B08BCLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
    • B08B9/00Cleaning hollow articles by methods or apparatus specially adapted thereto 
    • B08B9/08Cleaning containers, e.g. tanks
    • B08B9/093Cleaning containers, e.g. tanks by the force of jets or sprays
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/59Transmissivity
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/57473Immunoassay; Biospecific binding assay; Materials therefor for cancer involving carcinoembryonic antigen, i.e. CEA
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/57476Immunoassay; Biospecific binding assay; Materials therefor for cancer involving oncofetal proteins
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6863Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors
    • G01N33/6869Interleukin
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/72Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
    • G01N33/721Haemoglobin
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
    • G01N33/76Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47Assays involving proteins of known structure or function as defined in the subgroups
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47Assays involving proteins of known structure or function as defined in the subgroups
    • G01N2333/4701Details
    • G01N2333/471Pregnancy proteins, e.g. placenta proteins, alpha-feto-protein, pregnancy specific beta glycoprotein
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47Assays involving proteins of known structure or function as defined in the subgroups
    • G01N2333/4701Details
    • G01N2333/4737C-reactive protein
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52Assays involving cytokines
    • G01N2333/54Interleukins [IL]
    • G01N2333/5412IL-6
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/575Hormones
    • G01N2333/585Calcitonins
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/575Hormones
    • G01N2333/59Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/575Hormones
    • G01N2333/61Growth hormones [GH] (Somatotropin)

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Abstract

A sample analysis device and a sample detection method are provided, which control the detection of specific protein in a reaction tank; obtaining the type of the specific protein detected in the reaction tank; and after the determination is finished, cleaning the reaction tank according to the type of the specific protein. The invention provides a new cleaning scheme, which is used for cleaning reaction tanks by adopting different cleaning parameters for different specific proteins according to different specific proteins or the adhesion strength of protein micelles of different specific proteins.

Description

Sample analysis device and sample detection method
Technical Field
The present invention relates to a sample analyzer and a sample detection method.
Background
A sample analyzer or an in vitro diagnostic apparatus refers to an apparatus for acquiring clinical diagnostic information by detecting a human sample (for example, blood, body fluid, tissue, etc.) in addition to a human body.
In order to avoid the inaccuracy of the test result of the project caused by the cross contamination of the sample measurement before and after the sample measurement, the related components in the sample analysis device are usually cleaned.
The detection of a specific protein is not exemplified.
The specific protein refers to some special kinds of proteins existing in human plasma, including C-reactive protein, serum amyloid, procalcitonin, interleukin-6, human chorionic gonadotropin, growth hormone, luteinizing hormone, alpha-fetoprotein, carcinoembryonic antigen and the like, and can reflect inflammatory conditions, postoperative rehabilitation states and the like of a human body, so that the specific protein has important clinical significance.
The concentration of a specific protein in blood can be detected by immunoturbidimetry (turbidimetric inhibition immunoassay). Specifically, immunoturbidimetry is an antigen and antibody binding kinetic assay; immunoturbidimetry is classified into immunotransmission turbidimetry and immunoscattering turbidimetry. The antibody-antigen complex has the functions of scattering and shielding light. The amount of the antibody-antigen complex is therefore proportional to the change in the intensity of transmitted light or scattered light. When the amount of antibody is constant, the intensity of light changes proportionally to the amount of antigen. Therefore, under certain conditions, the concentration or amount of the antigen, i.e., the specific protein, in the sample can be determined by measuring the intensity change of the transmitted light or the scattered light and the calibration curve.
One process may be such that:
referring to fig. 1, a sample and a hemolytic agent are added to a reaction cell, and after the sample is dissolved and incubated, a latex reagent of a specific protein is added, wherein the latex reagent is a suspension composed of latex particles (antibodies) with a nanometer scale, and under a certain condition, the latex particles can be combined with the surrounding specific protein (antigen) to form micelles with larger scales. When the latex particles are continuously combined with the specific protein, the volume of formed micelles is increased, the scattering signal formed after the latex particles are irradiated by the light with the specific wavelength is gradually enhanced, and the transmission signal is gradually weakened. The content of the specific protein in the original sample can be obtained by monitoring the change rate of the scattering or transmission signal and certain calculation.
It can be seen that the nature of the reaction for the determination of a particular protein is the process by which the particular protein antigen and latex particle antibody are continually bound to form larger micelles (not referred to as protein micelles). These protein micelles are very likely to adhere to the wall of the reaction cell during the formation process, and many adverse effects are caused if the protein micelles are not cleaned in time, so that the reaction cell and other parts need to be cleaned after each sample or item is measured.
How to specifically clean is a matter of constant concern and ongoing research by those skilled in the art.
Disclosure of Invention
The invention provides a new cleaning scheme aiming at the cleaning problem of a reaction tank.
According to a first aspect, an embodiment provides a sample analysis apparatus including a sampling part, a reagent supply part, a reaction part, a detection part, a washing member, and a controller;
the sampling part is used for obtaining a sample so as to convey the sample to the reaction part;
the reagent supply part is used for storing a reagent and supplying the reagent to the reaction part;
the reaction part at least comprises a multiplex type reaction tank; the multiplex reaction tank can be at least used for preparing a first specific protein sample and a second specific protein sample; the first-type specific protein sample is prepared by the multiplex-type reaction cell by receiving the sample transported by the sampling section and the first-type reagent supplied by the reagent supplying section, and is used for measurement of a first-type specific protein detection item; the second type specific protein sample is prepared by the multiplex-type reaction cell by receiving the sample transferred by the sampling section and the second type reagent supplied by the reagent supply section, and is used for measurement of the second type specific protein detection item;
the detection part comprises a specific protein detection part which can be used for detecting the first specific protein sample and the second specific protein sample so as to obtain the detection result of the first specific protein and the detection result of the second specific protein;
the cleaning component is at least used for cleaning the multiplex reaction tank; the cleaning assembly at least has a post-detection cleaning mode, and the post-detection cleaning mode at least has a first cleaning parameter and a second cleaning parameter, wherein the cleaning force of the first cleaning parameter is stronger than that of the second cleaning parameter;
after the detection items of the multiplex-type reaction tank are determined, the controller controls the cleaning assembly to execute the cleaning mode after detection so as to clean the multiplex-type reaction tank; wherein:
the controller acquires detection items of the multiplex reaction tank; when the detection items of the multiplex reaction tank are the first-class specific protein detection items, after the detection items are determined, the controller controls the cleaning component to execute the post-detection cleaning mode according to the first cleaning parameters so as to clean the multiplex reaction tank; when the detection items of the multiplex reaction tank are the second type specific protein detection items, after the detection items are determined, the controller controls the cleaning component to execute the post-detection cleaning mode according to the second cleaning parameters so as to clean the multiplex reaction tank.
In one embodiment, the cleaning assembly further has a post-item-switching cleaning mode, the post-item-switching cleaning mode has a third cleaning parameter, and the cleaning strength of the third cleaning parameter is stronger than the cleaning strength of the second cleaning parameter;
the controller judges whether to control the cleaning component to execute the item switching cleaning mode to clean the multiplex type reaction tank or not according to the currently measured detection item and the next item to be detected of the multiplex type reaction tank;
when the currently determined detection item of the multiplex-type reaction tank is the second-type specific protein detection item and the next-to-be-detected item is the first-type specific protein detection item, the controller controls the cleaning component to execute the post-detection cleaning mode according to the second cleaning parameter and execute the item-switching cleaning mode according to the third cleaning parameter to clean the multiplex-type reaction tank after the currently determined detection item and before the next-to-be-detected item are determined; or,
when the currently measured detection item of the multiplex-type reaction tank is the second-type specific protein detection item and the next item to be detected is the first-type specific protein detection item, the controller controls the cleaning component not to execute the post-detection cleaning mode but to execute the item-switching cleaning mode according to the third cleaning parameter to clean the multiplex-type reaction tank after the currently measured detection item and before the next item to be detected is measured.
In one embodiment, the cleaning assembly further has a pre-detection cleaning mode, the pre-detection cleaning mode has a fourth cleaning parameter, and the cleaning force of the fourth cleaning parameter is stronger than the cleaning force of the second cleaning parameter; preferably, the cleaning strength of the fourth cleaning parameter is stronger than that of the first cleaning parameter, and/or the cleaning strength of the fourth cleaning parameter is stronger than that of the third cleaning parameter;
before the multiplex type reaction tank detection items are measured, the controller obtains a blank voltage of the multiplex type reaction tank, and when the blank voltage is in a non-preset range, the cleaning component is controlled to execute the cleaning mode before detection according to the fourth cleaning parameter so as to clean the multiplex type reaction tank, and the blank voltage is in a preset range.
According to a second aspect, an embodiment provides a sample analysis apparatus including a sampling part, a reagent supply part, a reaction part, a detection part, a washing member, and a controller;
the sampling part is used for obtaining a sample so as to convey the sample to the reaction part;
the reagent supply part is used for storing a reagent and supplying the reagent to the reaction part;
the reaction part at least comprises a first type reaction tank and a second type reaction tank; the first type reaction cell is used for receiving the sample conveyed by the sampling part and the first type reagent supplied by the reagent supplying part to prepare a first type specific protein sample for determining a first type specific protein detection item; the second type reaction cell is used for receiving the sample conveyed by the sampling part and a second type reagent supplied by the reagent supplying part so as to prepare a second type specific protein sample for measuring a second type specific protein detection item;
the detection part comprises a first specific protein detection part and a second specific protein detection part; the first specific protein detection part is used for detecting the first specific protein sample to obtain a detection result of the first specific protein; the second specific protein detection part is used for detecting the second specific protein sample to obtain a detection result of the second specific protein;
the cleaning component is used for cleaning the first type reaction tank and the second type reaction tank; the cleaning assembly at least has a post-detection cleaning mode, the post-detection cleaning mode at least has a first cleaning parameter and a second cleaning parameter, wherein the cleaning force of the first cleaning parameter is stronger than that of the second cleaning parameter;
after the detection items of the first-class reaction cells are determined, the controller controls the cleaning component to execute the cleaning mode after detection according to the first cleaning parameters so as to clean the first-class reaction cells; and after the detection items of the second type reaction tank are determined, the controller controls the cleaning component to execute the cleaning mode after detection according to the second cleaning parameters so as to clean the second type reaction tank.
In one embodiment, the cleaning assembly further comprises a pre-detection cleaning mode, the pre-detection cleaning mode has a fourth cleaning parameter, the cleaning strength of the fourth cleaning parameter is stronger than the cleaning strength of the second cleaning parameter, preferably, the cleaning strength of the fourth cleaning parameter is stronger than the cleaning strength of the first cleaning parameter;
before the detection items of the first-class reaction tank are measured, the controller acquires a blank voltage of the first-class reaction tank, and when the blank voltage is in a non-preset range, the cleaning component is controlled to execute a cleaning mode before detection according to the fourth cleaning parameter so as to clean the first-class reaction tank, so that the blank voltage is in a preset range; and/or the presence of a gas in the gas,
before the detection items of the second type reaction tank are measured, the controller obtains a blank voltage of the second type reaction tank, and when the blank voltage is in a non-preset range, the cleaning assembly is controlled to execute the cleaning mode before detection according to the fourth cleaning parameter so as to clean the second type reaction tank, so that the blank voltage is in a preset range.
In one embodiment, the first cleaning parameter and the second cleaning parameter at least include different cleaning time periods, different types of cleaning agents, and/or different concentrations of cleaning agents.
In one embodiment, the cleaning duration of the first cleaning parameter is longer than the cleaning duration of the second cleaning parameter; and/or the cleaning intensity of the cleaning agent type of the first cleaning parameter is greater than the cleaning intensity of the cleaning agent type of the second cleaning parameter; and/or the concentration of the cleaning agent of the first cleaning parameter is greater than that of the second cleaning parameter.
In one embodiment, the first specific type of protein comprises at least C-reactive protein and the second specific type of protein comprises at least serum amyloid.
In one embodiment, the cleaning agent comprises a hemolytic agent.
In one embodiment, the first reagent type comprises a hemolytic agent; the second class of reagents comprises hemolytic agents; the hemolytic agent included in the first type of reagent and the second type of reagent is the same type of hemolytic agent.
In one embodiment, the reaction part further comprises a blood routine reaction part, and the detection part further comprises a blood routine detection part;
the blood routine reaction part is used for receiving the sample conveyed by the sampling part and the third type reagent supplied by the reagent supply part so as to prepare a blood routine sample for measuring a blood routine detection item;
the blood routine detection part comprises one or more of a DIFF detection part, an RBC detection part, an HGB detection part, an NRBC detection part and an RET detection part; the DIFF detection part is used for detecting four classes of white blood cells, the HGB detection part is used for detecting hemoglobin concentration, and the RBC detection part is used for detecting red blood cell count and/or platelet count; the RET detection part is used for detecting reticulocyte count, and the NRBC detection part is used for detecting nucleated red blood cell count, white blood cell count and basophil count.
In one embodiment, the third type of reagent comprises a hemolytic agent; the washing component uses hemolytic agent in the third type of reagent for washing.
According to a third aspect, an embodiment provides a sample detection method applied to a sample analysis device that can be used for assaying a plurality of specific proteins, the sample detection method including:
controlling the detection of any one of the plurality of specific proteins in the reaction pool;
acquiring the type of the specific protein currently detected in the reaction tank;
acquiring cleaning parameters corresponding to the type of the specific protein detected currently; wherein at least two specific proteins in the plurality of specific proteins correspond to different cleaning parameters, and different cleaning parameters correspond to different cleaning forces;
and after the measurement is finished, cleaning the reaction tank according to the acquired cleaning parameters.
In one embodiment, the cleaning parameters include cleaning duration, type of cleaning agent, and/or concentration of cleaning agent.
In one embodiment, the sample detection method further includes:
acquiring a specific protein type which is detected in a reaction tank at present and a specific protein type to be detected next;
acquiring cleaning parameters corresponding to the next specific protein type to be detected;
and when the cleaning intensity of the cleaning parameter corresponding to the currently detected specific protein type is weaker than the cleaning intensity of the cleaning parameter corresponding to the specific protein type to be detected next, controlling to additionally clean the reaction tank, or adjusting the cleaning parameter corresponding to the currently detected specific protein type to enable the cleaning intensity to be larger than or equal to the cleaning intensity of the cleaning parameter corresponding to the specific protein type to be detected next, and cleaning the reaction tank according to the adjusted cleaning parameter.
In one embodiment, the plurality of specific proteins includes at least two of C-reactive protein, serum amyloid, procalcitonin, interleukin-6, human chorionic gonadotropin, growth hormone, luteinizing hormone, alpha-fetoprotein, and carcinoembryonic antigen.
According to a fourth aspect, an embodiment provides a computer readable storage medium comprising a program executable by a processor to implement a method as described in any of the embodiments herein
According to the sample analysis device and the sample detection method as well as the computer readable storage medium of the above embodiments, a new cleaning scheme is proposed, which performs the cleaning of the reaction chamber by using different cleaning parameters for different specific proteins, or according to the strength of the adhesion of the protein micelles of different specific proteins.
Drawings
FIG. 1 is a schematic illustration of the determination of a specific protein according to one embodiment;
FIG. 2 is a schematic structural diagram of a sample analyzer according to an embodiment;
FIG. 3 is a schematic diagram of a sample analyzer according to an embodiment;
FIG. 4 is a schematic structural diagram of a sample analyzer according to an embodiment;
FIG. 5 is a schematic diagram of an exemplary cleaning assembly;
FIG. 6 is a flow chart of a sample detection method according to an embodiment;
FIG. 7 is a flowchart showing the washing of the reaction cell according to the kind of the specific protein after the completion of the measurement according to an embodiment;
FIG. 8 is a flow chart of a sample detection method according to an embodiment.
Detailed Description
The present invention will be described in further detail with reference to the following detailed description and accompanying drawings. Wherein like elements in different embodiments are numbered with like associated elements. In the following description, numerous details are set forth in order to provide a better understanding of the present application. However, those skilled in the art will readily recognize that some of the features may be omitted or replaced with other elements, materials, methods in different instances. In some instances, certain operations related to the present application have not been shown or described in detail in order to avoid obscuring the core of the present application from excessive description, and it is not necessary for those skilled in the art to describe these operations in detail, so that they may be fully understood from the description in the specification and the general knowledge in the art.
Furthermore, the features, operations, or characteristics described in the specification may be combined in any suitable manner to form various embodiments. Also, the various steps or actions in the method descriptions may be transposed or transposed in order, as will be apparent to one of ordinary skill in the art. Thus, the various sequences in the specification and drawings are for the purpose of describing certain embodiments only and are not intended to imply a required sequence unless otherwise indicated where such sequence must be followed.
The numbering of the components as such, e.g., "first", "second", etc., is used herein only to distinguish the objects as described, and does not have any sequential or technical meaning. The term "connected" and "coupled" when used in this application, unless otherwise indicated, includes both direct and indirect connections (couplings).
As mentioned in the background art, the protein micelles are very easy to adhere to the wall surface of the reaction tank in the process of generation, and can cause a lot of adverse effects if not cleaned in time; for example, carry contamination, thereby affecting the detection result of the next sample; for another example, the protein micelles adhered to the wall of the reaction cell can reduce the transmittance of the reaction cell, and the corresponding scattering or transmission signals can change, which directly affects the detection result of the sample or item.
Therefore, after the sample or item is visually determined, the components (such as the relevant pipelines) such as the reaction cell need to be cleaned to restore the initial state, so as to avoid affecting the detection result of the next sample.
At present, for instruments capable of measuring various specific proteins, reaction tanks and the like are cleaned by adopting the same set of cleaning strategies and fixed parameters after each reaction measurement.
The applicant found that different specific proteins have different adhesions due to their physicochemical properties and the differences of the corresponding latex reagents, and for example, the applicant found that the adhesions of the protein micelles of C-reactive protein (CRP) are stronger than those of serum amyloid protein (SAA). The existing measurement aiming at different specific proteins is cleaned by adopting the same cleaning mode, namely the cutting cleaning mode is effective only for weak adhesion proteins and has little cleaning effect for strong adhesion proteins, or is effective for strong adhesion proteins, but the cleaning process takes a long time, the cleaning efficiency is low, and the reagent consumption is large. The applicant has therefore conceived to use different washing modalities for different specific proteins, or to divide specific proteins into at least two groups according to their protein micelle adhesivity, and then to use different washing modalities, for example different washing durations, different kinds or concentrations of washing agents, after the detection of the different groups of specific proteins.
Therefore, the invention designs a specific protein intelligent cleaning scheme, which adopts different cleaning modes for different specific proteins, for example, for strong-adhesion proteins, a high-strength cleaning mode is adopted after the measurement is completed to ensure the cleaning effect of a sample pool, and for weak-adhesion proteins, a low-strength cleaning mode is adopted after the measurement is completed to save the cleaning time and reagents.
Referring to fig. 2, in some embodiments of the present invention, a sample analyzer is disclosed, which may include a sampling unit 10, a reagent supplying unit 20, a reaction unit 30, a detecting unit 40, a washing assembly 50, and a controller 60, which will be described in detail below.
The sampling part 10 is used to take a sample to deliver the sample to the reaction part 30. For example, the sampling part 10 may include a sampling needle for sucking a sample from a sample tube located at a sample sucking site to transfer the sucked sample to the reaction part 30.
In the present invention, the term "sample" generally refers in the context of a blood sample, in particular a whole blood sample. Herein, the sample is typically a peripheral or venous blood sample derived from a mammal, in particular a blood sample derived from a human. The sample may have been subjected to necessary treatments including, but not limited to, anticoagulation, etc., prior to the immunological reaction.
The reagent supply unit 20 stores a reagent and supplies the reagent to the reaction unit 30. For example, the reagent supplying section 20 may supply the first type reagent and the second type reagent to the reaction section 30.
In some embodiments, the first type of reagent may include a hemolysis reagent, and the first type of reagent may also include a latex reagent. In some embodiments, the second type of reagent may include a hemolysis reagent, and the second type of reagent may also include a latex reagent. In some embodiments, the hemolytic agent included in the first type of reagent and the second type of reagent may be the same type of hemolytic agent.
The first type of reagent and the second type of reagent comprise at least the same type of hemolytic agent.
The reaction part 30 will be described below.
Referring to fig. 3, from a functional perspective, the reaction part 30 may include any one or more of a first type specific protein reaction part 31, a second type specific protein reaction part 33, and a blood general reaction part 35.
The first specific protein reaction unit 31 is configured to receive the sample transferred from the sampling unit 10 and the first reagent supplied from the reagent supply unit 20, and to prepare a first specific protein sample for measurement of a first specific protein detection item. The second specific protein reaction unit 33 is configured to receive the sample transferred from the sampling unit 10 and the second reagent supplied from the reagent supply unit 20 to prepare a second specific protein sample, which is used for measurement of the second specific protein detection item.
The blood routine reaction portion 35 is for receiving the sample delivered by the sampling portion 10 and the third type reagent supplied by the reagent supply portion 20 to prepare a blood routine test sample for measuring a blood routine test item. In some embodiments, the third type of reagent may include at least a hemolytic agent. In some embodiments, the third type of agent may further comprise a fluorescent agent.
From a structural point of view, the reaction part 30 may include one or more reaction cells for receiving the sample and the reagent delivered from the sampling part 10 and the reagent supplying part 20 to prepare corresponding samples. For example, in some embodiments, the reaction portion 30 includes a reaction cell for receiving the sample delivered by the sampling portion 10 and the first type of reagent supplied by the reagent supplying portion 20 to prepare a first type of specific protein sample for measuring the first type of specific protein detection item. For another example, in some embodiments, the reaction portion 30 includes a reaction cell for receiving the sample delivered by the sampling portion 10 and the second type of reagent supplied by the reagent supplying portion 20 to prepare a second type of specific protein sample for measuring the second type of specific protein detection item. For example, in some embodiments, the reaction portion 30 includes a reaction cell for receiving the sample delivered by the sampling portion 10 and the third type of reagent supplied by the reagent supplying portion 20 to prepare a blood routine test sample for measuring a blood routine test item.
In designing the sample analyzer, a first-type reaction cell for receiving the sample delivered from the sampling unit 10 and the first-type reagent supplied from the reagent supplying unit 20 to prepare a first-type specific protein sample for assaying a first-type specific protein assay item and a second-type reaction cell; the second type reaction cell is used for receiving the sample delivered by the sampling part 10 and the second type reagent supplied by the reagent supplying part 20 to prepare a second type specific protein sample for measuring a second type specific protein detection item.
When designing the sample analysis device, a multiplex reaction tank can be designed, and the multiplex reaction tank can be at least used for preparing a first specific protein sample and a second specific protein sample; in other words, the first-type specific protein sample is prepared by the multiplex-type reaction cell by receiving the sample delivered by the sampling section 10 and the first-type reagent supplied by the reagent supplying section 20, and is used for measurement of the first-type specific protein detection item; the second specific protein sample is prepared by the multiplex reaction cell by receiving the sample transferred from the sampling unit 10 and the second reagent supplied from the reagent supplying unit 20, and is used for measurement of the second specific protein detection item.
Whether they are first type reaction cells, second type reaction cells or multiplex type reaction cells, they may also be used for preparing blood routine samples in some cases.
The above is some description of the reaction section 30.
The detection unit 40 detects a sample to obtain a detection result.
In some embodiments, the detection portion 40 includes a blood routine detection portion 41 and/or a specific protein detection portion 43, as described in detail below.
The blood routine detecting portion 41 is used to detect a blood routine sample to obtain a blood routine result. Blood routine results, for example, may include, but are not limited to, one or more of white blood cell count, white blood cell classification (tri-, tetra-, or penta-classification), red blood cell count, reticulocyte count, nucleated red blood cell count, platelet count, hemoglobin concentration. Therefore, in some embodiments, the blood routine detecting unit 41 may include one or more of a DIFF detecting unit, an RBC detecting unit, an HGB detecting unit, an NRBC detecting unit, and an RET detecting unit; the DIFF detection part is used for detecting four classes of white blood cells, the HGB detection part is used for detecting hemoglobin concentration, and the RBC detection part is used for detecting red blood cell count and/or platelet count; the RET detection part is used for detecting reticulocyte count, and the NRBC detection part is used for detecting nucleated red blood cell count, white blood cell count and basophil count.
The specific protein detecting portion 43 can be used to detect a specific protein sample to obtain a corresponding detection result, i.e., the concentration of the specific protein. For example, the specific protein detecting section 43 can be used to detect a first specific protein sample and a second specific protein sample to obtain a detection result of the first specific protein and a detection result of the second specific protein. In some embodiments, referring to fig. 4, the specific protein detecting portion 43 includes a first specific protein detecting portion 44 and a second specific protein detecting portion 45, the first specific protein detecting portion 44 is used for detecting a first specific protein sample to obtain a detection result of the first specific protein; the second specific protein detection unit 45 detects the second specific protein sample to obtain a detection result of the second specific protein.
In some embodiments, the specific protein detecting part 43, the first specific protein detecting part 44 and the second specific protein detecting part 45 may be implemented by a photometer, which may be a turbidimeter and/or a turbidimeter.
The cleaning assembly 50 is used at least for cleaning the reaction cell. For example, the cleaning module 50 cleans the multiplex-type reaction cell. The first type reaction cell is cleaned by, for example, the cleaning assembly 50. The second type reaction cell is cleaned by, for example, the cleaning assembly 50.
In some embodiments, referring to fig. 5, reference numeral 39 in the figure denotes a reaction tank, which may be a multiplex-type reaction tank, a first-type reaction tank, or a second-type reaction tank. The reaction tank 39 is provided with a waste liquid discharge port 39a and a first wash port 39b. The waste liquid discharge port 39a is used for discharging a waste liquid such as a sample after detection, for example, a waste liquid generated by washing or the like. Specifically, a waste liquid channel 38a and a waste liquid driving part 38 may be introduced; one end of the waste liquid channel 38a is connected to a waste liquid discharge port 39a of the reaction tank 39, and the other end of the waste liquid channel 38a is connected to the waste liquid driving member 38; the waste liquid driving member 38 is used to discharge the liquid in the reaction cell 39 through the waste liquid channel 38a, for example, the waste liquid driving member 38 may include a pressure source to provide a negative pressure so that the waste liquid in the reaction cell 39 can flow into the waste liquid channel 38a through the waste liquid discharge port 39a and be discharged. In some examples, the waste discharge port 39a or the waste passage 38a can be controllably opened and closed, for example, by a solenoid valve. In some examples, the waste liquid discharge port 39a is provided at the bottom of the reaction chamber 39.
In some embodiments, the cleaning assembly 50 can be used to flush the reaction cell with a cleaning agent. In some embodiments, the cleaning assembly 50 includes a cleaning agent supply member 51. The cleansing agent supplying means 51 includes a cleansing agent supplying passage 51a connected to the first cleansing port 39b of the reaction chamber 39, and the cleansing agent supplying means 51 is for supplying the cleansing agent to the reaction chamber 39 through the cleansing agent supplying passage 51 a. In some examples, the first cleaning port 39b is provided on a side wall of the reaction chamber 39. In a specific cleaning process, the cleaning agent supply part 51 feeds the cleaning agent into the reaction tank 39 through the first cleaning port 39b by, for example, positive pressure power, washes the tank wall or the like, and discharges the waste liquid through the waste liquid discharge port 39 a. The flushing action can be repeated for a plurality of times, and a better flushing effect is achieved.
The wash assembly 50 can be used to rinse and/or soak the reaction cells with a cleaning solution. The cleaning agent may be a hemolytic agent, such as a hemolytic agent in the multiplexing reagent supply 20.
The above are some of the descriptions of the sample analysis device of the present application. The following is a description of how to specifically clean the reaction cell.
The multiplex reaction cell is not exemplified.
In some embodiments, the cleaning assembly 50 has at least a post-detection cleaning mode having at least a first cleaning parameter and a second cleaning parameter, wherein the cleaning power of the first cleaning parameter is different from the cleaning power of the second cleaning parameter, for example, the cleaning power of the first cleaning parameter is stronger than the cleaning power of the second cleaning parameter. In some embodiments, the first cleaning parameter and the second cleaning parameter include at least a different cleaning duration, a different type of cleaning agent, and/or a different concentration of cleaning agent.
Each time the measurement of the measurement items of the multiplex reaction chamber is completed (e.g., after the measurement of the first specific protein measurement item or the second specific protein measurement item), the controller 60 controls the cleaning module 50 to perform a post-measurement cleaning mode to clean the multiplex reaction chamber. In some embodiments, the controller 60 obtains the detection items of the multiplexing-type reaction cell; when the detection item of the multiplexing-type reaction tank is the first-class specific protein detection item, after the detection item is determined, the controller 60 controls the cleaning component 50 to execute a post-detection cleaning mode according to the first cleaning parameter so as to clean the multiplexing-type reaction tank; when the detection items of the multiplex reaction chamber are the second specific protein detection items, the controller 60 controls the cleaning component 50 to perform the post-detection cleaning mode according to the second cleaning parameters to clean the multiplex reaction chamber after the detection items are determined.
For example, the viscosity of the protein micelles of the first specific protein type is greater than the viscosity of the protein micelles of the second specific protein type, then the cleaning power of the first cleaning parameter is stronger than the cleaning power of the second cleaning parameter. Specifically, the cleaning duration of the first cleaning parameter is longer than that of the second cleaning parameter; and/or the cleaning intensity of the cleaning agent type of the first cleaning parameter is greater than the cleaning intensity of the cleaning agent type of the second cleaning parameter; and/or the concentration of the cleaning agent of the first cleaning parameter is greater than that of the second cleaning parameter.
In some embodiments, both the purging agent in the first cleaning parameter and the purging agent in the second cleaning parameter may be LH hemolytic agents. In some embodiments, the wash agent in the first wash parameter is an LN hemolytic agent and the wash agent in the second wash parameter is an LH hemolytic agent.
In some embodiments, the cleaning assembly 50 further has a post-item-switch cleaning mode, wherein the post-item-switch cleaning mode has a third cleaning parameter with a cleaning intensity stronger than the cleaning intensity of the second cleaning parameter. The controller 60 determines whether to control the cleaning assembly 50 to execute the cleaning mode after the item switching to clean the multiplex type reaction tank according to the currently measured detection item and the next item to be detected of the multiplex type reaction tank; in some embodiments, when the currently measured item of the multiplex-type reaction cell is the second specific protein detection item and the next item to be detected is the first specific protein detection item, the controller controls the cleaning component to perform the post-detection cleaning mode according to the second cleaning parameter and the item-switching cleaning mode according to the third cleaning parameter to clean the multiplex-type reaction cell after the currently measured item of the multiplex-type reaction cell and before the next item to be detected is measured; or, when the currently determined item to be detected of the multiplex-type reaction cell is the second-type specific protein detection item and the next item to be detected is the first-type specific protein detection item, the controller controls the cleaning component not to execute the post-detection cleaning mode but to execute the post-item-switching cleaning mode according to the third cleaning parameter to clean the multiplex-type reaction cell after the currently determined item to be detected and before the next item to be detected is determined.
For example, also taking the case that the viscosity of the protein micelle of the first specific protein is greater than the viscosity of the protein micelle of the second specific protein as an example, when the currently measured item of the multiplex-type reaction chamber is the second specific protein detection item and the next item to be detected is the first specific protein detection item, the controller 60 controls the cleaning component 50 to perform the item-switching cleaning mode to clean the multiplex-type reaction chamber. In some embodiments, the controller 60 may control the cleaning component 50 to perform the item-switched cleaning mode to additionally clean the multiplex-type reaction cell, that is, when the currently measured item is the second type specific protein detection item and the next item to be detected is the first type specific protein detection item, the controller 60 controls the cleaning component 50 to perform two times of cleaning before the first type specific protein detection item is measured after the second type specific protein detection item is measured, one time is the post-detection cleaning mode and one time is the item-switched cleaning mode, and the sequence of the two times of cleaning may be adjusted.
For another example, in other embodiments, the controller 60 controls the cleaning assembly 50 to execute the item-switching cleaning mode to replace the post-detection cleaning mode, so as to clean the multiplex-type reaction chamber, that is, when the currently measured item is the second specific protein detection item and the next item to be detected is the first specific protein detection item, the cleaning assembly 50 would originally execute the post-detection cleaning mode before the second specific protein detection item is measured and the first specific protein detection item is measured, but the controller 60 controls the cleaning assembly 50 to execute the item-switching cleaning mode to replace the original post-detection cleaning mode. In some embodiments, the cleaning power of the cleaning mode after the switching of the items is stronger than the cleaning power of the first cleaning parameter in the cleaning mode after the detection.
In some embodiments, the cleaning assembly 50 further has a pre-test cleaning mode having a fourth cleaning parameter with a cleaning power stronger than the cleaning power of the second cleaning parameter; in some embodiments, the cleaning force of the fourth cleaning parameter is stronger than the cleaning force of the first cleaning parameter; in some embodiments, the cleaning force of the fourth cleaning parameter is stronger than the cleaning force of the third cleaning parameter. The pre-detection cleaning mode is related to the blank voltage. For example, blank voltage at a predetermined time point (signal detection voltage value when the cell body is filled with a specific liquid, typically using a diluent) can be collected during the measurement; specifically, for example, the blank voltage value may be read before each measurement of the detection item; of course, the blank voltage value may be read by using the multiplex type reaction cell for a predetermined time, or the blank voltage value may be read by measuring a predetermined number of detection items in the multiplex type reaction cell. When the blank voltage is in a non-preset range, the pollution degree of the pool body reaches a certain level, the continuous use may have certain influence on the measured value, and at the moment, the cleaning mode before detection can be carried out on the multiplexing type reaction pool.
Therefore, in some embodiments, the controller 60 obtains a blank voltage of the multiplexing-type reaction cell, and when the blank voltage is in a non-preset range, controls the cleaning assembly 50 to execute a pre-detection cleaning mode according to the fourth cleaning parameter to clean the multiplexing-type reaction cell, so that the blank voltage is in the preset range; the blank voltage is: when the multiplex type reaction cell contains the specific liquid, the controller 70 induces the transmitted or scattered light and converts the induced or scattered light into a voltage by controlling the irradiation of the specific liquid in the multiplex type reaction cell; the preset range of the blank voltage acquired by adopting the scattering principle is larger than a set voltage, and the preset range of the blank voltage acquired by adopting the transmission principle is smaller than the set voltage. In some embodiments, the particular liquid is a cleaning agent or a diluent.
In some embodiments, the wash assembly 50 can use a hemolysis agent, such as LN hemolysis agent, when performing the pre-test wash mode.
The above are some descriptions of multiplex type reaction cell cleaning.
The cleaning of the first-type reaction cell and the second-type reaction cell will be described below.
In some embodiments, the cleaning assembly 50 has at least a post-detection cleaning mode having at least a first cleaning parameter and a second cleaning parameter, wherein the cleaning power of the first cleaning parameter is different from the cleaning power of the second cleaning parameter, for example, the cleaning power of the first cleaning parameter is stronger than the cleaning power of the second cleaning parameter. In some embodiments, the first and second cleaning parameters include at least different cleaning durations, different types of cleaning agents, and/or different concentrations of cleaning agents.
Each time after the detection items (for example, the first specific protein detection items) of the first type reaction cells are detected, the controller 60 controls the cleaning assembly 50 to perform a post-detection cleaning mode according to the first cleaning parameters to clean the first type reaction cells; similarly, each time the measurement items (for example, the second specific protein measurement items) of the second type reaction wells are determined, the controller 60 controls the cleaning component 50 to perform a post-measurement cleaning mode according to the second cleaning parameters to clean the second type reaction wells.
For example, the viscosity of the protein micelles of the first specific protein type is greater than the viscosity of the protein micelles of the second specific protein type, then the cleaning power of the first cleaning parameter is stronger than the cleaning power of the second cleaning parameter. Specifically, the cleaning duration of the first cleaning parameter is longer than that of the second cleaning parameter; and/or the cleaning intensity of the cleaning agent type of the first cleaning parameter is greater than the cleaning intensity of the cleaning agent type of the second cleaning parameter; and/or the concentration of the cleaning agent of the first cleaning parameter is greater than the concentration of the cleaning agent of the second cleaning parameter.
In some embodiments, both the purging agent in the first cleaning parameter and the purging agent in the second cleaning parameter may be LH hemolytic agents. In some embodiments, the wash agent in the first wash parameter is an LN hemolytic agent and the wash agent in the second wash parameter is an LH hemolytic agent.
In some embodiments, the cleaning assembly 50 further has a pre-test cleaning mode having a fourth cleaning parameter with a cleaning power stronger than the cleaning power of the second cleaning parameter; in some embodiments, the cleaning force of the fourth cleaning parameter is stronger than the cleaning force of the first cleaning parameter. The pre-detection cleaning mode is related to the blank voltage. For example, blank voltage at a predetermined time point (signal detection voltage value when the cell body is filled with a specific liquid, typically using a diluent) can be collected during the measurement; specifically, for example, the blank voltage value may be read before each measurement of the detection item; of course, the blank voltage value may be read after the reaction cell is used for a predetermined period of time, or the blank voltage value may be read after the reaction cell measures a predetermined number of detection items. When the blank voltage is in a non-preset range, the pollution degree of the cell body reaches a certain level, the continuous use may have a certain influence on the measured value, and at the moment, the cleaning mode before detection can be performed on the multiplex reaction cell.
Therefore, in some embodiments, the controller 60 obtains a blank voltage of the first-type reaction cell, and when the blank voltage is within a non-preset range, the cleaning component 50 is controlled to execute a pre-detection cleaning mode according to the fourth cleaning parameter to clean the first-type reaction cell, so that the blank voltage is within the preset range; the blank voltage is: when the first type reaction cell is filled with the specific liquid, the controller 70 induces the transmitted or scattered light and converts the induced or scattered light into a voltage by controlling the irradiation of the specific liquid in the first type reaction cell; the preset range of the blank voltage acquired by adopting the scattering principle is larger than a set voltage, and the preset range of the blank voltage acquired by adopting the transmission principle is smaller than the set voltage. In some embodiments, the particular liquid is a cleaning agent or a diluent. Similarly, the controller 60 obtains a blank voltage of the second-type reaction cell, and when the blank voltage is in a non-preset range, controls the cleaning assembly 50 to execute a pre-detection cleaning mode to clean the second-type reaction cell, so that the blank voltage is in the preset range; the blank voltage is: when the second type reaction cell contains the specific liquid, the controller 70 induces the transmitted or scattered light and converts the induced or scattered light into a voltage by controlling the irradiation of the specific liquid in the second type reaction cell; the preset range of the blank voltage acquired by adopting the scattering principle is larger than a set voltage, and the preset range of the blank voltage acquired by adopting the transmission principle is smaller than the set voltage.
In some embodiments, the wash assembly 50 can use a hemolysis agent, such as LN hemolysis agent, when performing the pre-test wash mode.
The above are some descriptions of the cleaning of the first-type reaction cell and the second-type reaction cell.
In the process of cleaning the reaction cell, if the liquid path pipe connected to the reaction is also required to be cleaned, the liquid path pipe may be cleaned by sucking and discharging the cleaning agent remaining in the reaction cell one or more times during the process of cleaning the reaction cell.
The invention also discloses a sample detection method, which is applied to a sample analysis device, wherein the sample analysis device can be the sample analysis device in any embodiment. In one embodiment, the sample analysis device involved in the sample detection method can be used to determine a variety of specific proteins, such as CPR and SAA. Referring to fig. 6, the sample testing method in some embodiments includes the following steps:
step 100: and controlling the detection of any one specific protein in the plurality of specific proteins in the reaction pool.
In some embodiments, the plurality of specific proteins comprises at least two of C-reactive protein, serum amyloid, procalcitonin, interleukin-6, human chorionic gonadotropin, growth hormone, luteinizing hormone, alpha-fetoprotein, and carcinoembryonic antigen.
Step 110: and acquiring the type of the specific protein currently detected in the reaction pool.
Step 120: and after the determination is finished, cleaning the reaction tank according to the type of the specific protein. In some embodiments, referring to fig. 7, step 120 includes the following steps:
step 121: acquiring cleaning parameters corresponding to the type of the specific protein detected currently; wherein at least two specific proteins in the plurality of specific proteins correspond to different cleaning parameters, and different cleaning parameters correspond to different cleaning forces;
step 123: and cleaning the reaction tank according to the acquired cleaning parameters.
In some embodiments, the cleaning parameters include duration of cleaning, type of cleaning agent, and/or concentration of cleaning agent. For example, when the specific protein is CPR, then a first wash parameter is obtained, and when the specific protein is SAA, then a second wash parameter is obtained. The cleaning force of the first cleaning parameter is stronger than the cleaning force of the second cleaning parameter. Specifically, the cleaning duration of the first cleaning parameter is longer than that of the second cleaning parameter; and/or the cleaning intensity of the cleaning agent type of the first cleaning parameter is greater than the cleaning intensity of the cleaning agent type of the second cleaning parameter; and/or the concentration of the cleaning agent of the first cleaning parameter is greater than that of the second cleaning parameter.
Referring to fig. 8, in some embodiments, the sample detection method further includes the following steps:
step 200: before the measurement is started, acquiring a specific protein type which is currently detected in a reaction tank and a specific protein type to be detected next;
step 210: acquiring cleaning parameters corresponding to the next specific protein type to be detected; .
Step 220: and when the cleaning intensity of the cleaning parameter corresponding to the currently detected specific protein type is weaker than the cleaning intensity of the cleaning parameter corresponding to the specific protein type to be detected next, controlling to additionally clean the reaction tank, or adjusting the cleaning parameter corresponding to the currently detected specific protein type to enable the cleaning intensity to be larger than or equal to the cleaning intensity of the cleaning parameter corresponding to the specific protein type to be detected next, and cleaning the reaction tank according to the adjusted cleaning parameter.
For example, when the viscosity of the currently detected protein micelle of the specific protein species is smaller than that of the next specific protein species to be detected, step 210 controls to perform additional washing on the reaction chamber or adjusts the washing parameters so as to increase the washing intensity.
The additional cleaning means that after the current detection is finished, the reaction tank is cleaned according to cleaning parameters corresponding to the currently detected specific protein type, and because the viscosity of the protein micelle of the currently detected specific protein type is smaller than that of the protein micelle of the specific protein type to be detected next, the reaction tank is additionally cleaned; it is understood that the sequence of additional washing may also be preceded by washing the reaction chamber according to the washing parameters corresponding to the specific protein species currently detected.
Adjusting the cleaning parameter corresponding to the currently detected specific protein type to make the cleaning intensity greater than or equal to the cleaning intensity of the cleaning parameter corresponding to the next specific protein type to be detected, and cleaning the reaction tank according to the adjusted cleaning parameter, which means that before the current specific protein is detected and the next specific protein is detected, the originally detected specific protein type corresponds to a cleaning parameter, but because the protein micelle viscosity of the currently detected specific protein type is smaller than the protein micelle viscosity of the next specific protein type to be detected, the cleaning parameter is adjusted, for example, the cleaning intensity of the adjusted cleaning parameter is stronger, for example, the cleaning intensity is at least not weaker than the cleaning intensity of the cleaning parameter corresponding to the next specific protein type to be detected, and then the cleaning of the reaction tank is performed according to the adjusted cleaning parameter.
In some embodiments, the sample detection method may include collecting a blank voltage (signal detection voltage value when the cell body is filled with a specific liquid, typically with a diluent) at a specified time point during the measurement process; specifically, for example, the blank voltage value may be read before each measurement of the detection item; of course, the blank voltage value may be read after the reaction cell is used for a predetermined period of time, or the blank voltage value may be read after the reaction cell measures a predetermined number of detection items. When the blank voltage is in a non-preset range, the pollution degree of the cell body reaches a certain level, the continuous use may have a certain influence on the measured value, and at the moment, the cleaning mode before detection can be performed on the multiplex reaction cell. Thus, in some embodiments, a sample detection method may comprise: and acquiring a blank voltage of the reaction tank, and when the blank voltage is in a non-preset range, cleaning the reaction tank to enable the blank voltage to be in a preset range.
The invention designs an intelligent cleaning method for specific protein, which can improve the cleaning efficiency of specific protein determination, save cleaning time and reagents and improve the cleaning efficiency on the premise of ensuring that different specific proteins can be effectively cleaned.
Reference is made herein to various exemplary embodiments. However, those skilled in the art will recognize that changes and modifications may be made to the exemplary embodiments without departing from the scope hereof. For example, the various operational steps, as well as the components used to perform the operational steps, may be implemented in differing ways depending upon the particular application or consideration of any number of cost functions associated with operation of the system (e.g., one or more steps may be deleted, modified or incorporated into other steps).
In the above embodiments, the implementation may be wholly or partially realized by software, hardware, firmware, or any combination thereof. Additionally, as will be appreciated by one skilled in the art, the principles herein may be reflected in a computer program product on a computer readable storage medium having computer readable program code pre-loaded thereon. Any tangible, non-transitory computer-readable storage medium may be used, including magnetic storage devices (hard disks, floppy disks, etc.), optical storage devices (CD-to-ROM, DVD, blu Ray disc, etc.), flash memory, and/or the like. These computer program instructions may be loaded onto a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions which execute on the computer or other programmable data processing apparatus create means for implementing the functions specified. These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including means for implementing the function specified. The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified.
While the principles herein have been illustrated in various embodiments, many modifications of structure, arrangement, proportions, elements, materials, and components and otherwise, used in the practice of the disclosure, which are particularly adapted to specific environments and operative requirements, may be employed without departing from the principles and scope of the present disclosure. The above modifications and other changes or modifications are intended to be included within the scope of this document.
The foregoing detailed description has been described with reference to various embodiments. However, one skilled in the art will recognize that various modifications and changes may be made without departing from the scope of the present disclosure. Accordingly, the disclosure is to be considered in an illustrative and not a restrictive sense, and all such modifications are intended to be included within the scope thereof. Also, advantages, other advantages, and solutions to problems have been described above with regard to various embodiments. However, the benefits, advantages, solutions to problems, and any element(s) that may cause any element(s) to occur or become more pronounced are not to be construed as a critical, required, or essential feature or element of any or all the claims. As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, system, article, or apparatus. Furthermore, the term "coupled," and any other variation thereof, as used herein, refers to a physical connection, an electrical connection, a magnetic connection, an optical connection, a communicative connection, a functional connection, and/or any other connection.
It will be appreciated by those skilled in the art that many changes could be made to the details of the above-described embodiments without departing from the underlying principles of the invention. Accordingly, the scope of the invention should be determined only by the claims.

Claims (17)

1. A sample analyzer is characterized by comprising a sampling part, a reagent supply part, a reaction part, a detection part, a cleaning assembly and a controller;
the sampling part is used for acquiring a sample so as to convey the sample to the reaction part;
the reagent supply part is used for storing a reagent and supplying the reagent to the reaction part;
the reaction part at least comprises a multiplexing type reaction tank; the multiplex reaction tank can be at least used for preparing a first specific protein sample and a second specific protein sample; the first-type specific protein sample is prepared by the multiplex-type reaction cell by receiving the sample delivered by the sampling section and the first-type reagent supplied by the reagent supply section, and is used for measurement of a first-type specific protein detection item; the second type specific protein sample is prepared by the multiplex-type reaction cell by receiving the sample transferred by the sampling section and the second type reagent supplied by the reagent supply section, and is used for measurement of the second type specific protein detection item;
the detection part comprises a specific protein detection part which can be used for detecting the first specific protein sample and the second specific protein sample so as to obtain the detection result of the first specific protein and the detection result of the second specific protein;
the cleaning component is at least used for cleaning the multiplex reaction tank; the cleaning assembly at least has a post-detection cleaning mode, and the post-detection cleaning mode at least has a first cleaning parameter and a second cleaning parameter, wherein the cleaning force of the first cleaning parameter is stronger than that of the second cleaning parameter;
after the detection items of the multiplex-type reaction tank are determined, the controller controls the cleaning assembly to execute the cleaning mode after detection so as to clean the multiplex-type reaction tank; wherein:
the controller acquires detection items of the multiplex reaction tank; when the detection items of the multiplex reaction tank are the first-class specific protein detection items, after the detection items are determined, the controller controls the cleaning component to execute the post-detection cleaning mode according to the first cleaning parameters so as to clean the multiplex reaction tank; when the detection items of the multiplex-type reaction tank are the second type specific protein detection items, after the detection items are determined, the controller controls the cleaning component to execute the post-detection cleaning mode according to the second cleaning parameters so as to clean the multiplex-type reaction tank.
2. The sample analysis device of claim 1, wherein the wash component further has a post-item-switch wash mode having a third wash parameter with a wash strength that is stronger than a wash strength of the second wash parameter;
the controller judges whether to control the cleaning component to execute the cleaning mode after the item switching so as to clean the multiplex type reaction tank according to the currently measured detection item and the next item to be detected of the multiplex type reaction tank;
when the currently determined detection item of the multiplex-type reaction tank is the second-type specific protein detection item and the next item to be detected is the first-type specific protein detection item, the controller controls the cleaning component to execute the post-detection cleaning mode according to the second cleaning parameter and execute the item switching cleaning mode according to the third cleaning parameter to clean the multiplex-type reaction tank after the currently determined detection item and before the next item to be detected is determined; or,
when the currently measured detection item of the multiplex-type reaction tank is the second-type specific protein detection item and the next item to be detected is the first-type specific protein detection item, the controller controls the cleaning component not to execute the post-detection cleaning mode but to execute the item-switching cleaning mode according to the third cleaning parameter to clean the multiplex-type reaction tank after the currently measured detection item and before the next item to be detected is measured.
3. The sample analysis device of claim 2, wherein the cleaning assembly further has a pre-test cleaning mode having a fourth cleaning parameter with a cleaning force that is stronger than the cleaning force of the second cleaning parameter; preferably, the cleaning force of the fourth cleaning parameter is stronger than the cleaning force of the first cleaning parameter, and/or the cleaning force of the fourth cleaning parameter is stronger than the cleaning force of the third cleaning parameter;
before the multiplex type reaction tank detection items are measured, the controller obtains a blank voltage of the multiplex type reaction tank, and when the blank voltage is in a non-preset range, the controller controls the cleaning assembly to execute the cleaning mode before detection according to the fourth cleaning parameter so as to clean the multiplex type reaction tank, so that the blank voltage is in a preset range.
4. A sample analyzer is characterized by comprising a sampling part, a reagent supply part, a reaction part, a detection part, a cleaning assembly and a controller;
the sampling part is used for acquiring a sample so as to convey the sample to the reaction part;
the reagent supply part is used for storing a reagent and supplying the reagent to the reaction part;
the reaction part at least comprises a first type reaction tank and a second type reaction tank; the first type reaction cell is used for receiving the sample conveyed by the sampling part and the first type reagent supplied by the reagent supplying part to prepare a first type specific protein sample for determining a first type specific protein detection item; the second type reaction cell is used for receiving the sample conveyed by the sampling part and a second type reagent supplied by the reagent supplying part so as to prepare a second type specific protein sample for measuring a second type specific protein detection item;
the detection part comprises a first specific protein detection part and a second specific protein detection part; the first specific protein detection part is used for detecting the first specific protein sample to obtain a detection result of the first specific protein; the second specific protein detection part is used for detecting the second specific protein sample to obtain a detection result of the second specific protein;
the cleaning assembly is used for cleaning the first-class reaction tank and the second-class reaction tank; the cleaning assembly at least has a post-detection cleaning mode, the post-detection cleaning mode at least has a first cleaning parameter and a second cleaning parameter, wherein the cleaning force of the first cleaning parameter is stronger than that of the second cleaning parameter;
after the detection items of the first-class reaction cells are determined, the controller controls the cleaning component to execute the cleaning mode after detection according to the first cleaning parameters so as to clean the first-class reaction cells; and after the detection items of the second type reaction tank are determined, the controller controls the cleaning component to execute the cleaning mode after detection according to the second cleaning parameters so as to clean the second type reaction tank.
5. The sample analysis device of claim 4, wherein the cleaning assembly further comprises a pre-test cleaning mode having a fourth cleaning parameter with a cleaning power greater than the cleaning power of the second cleaning parameter, preferably the cleaning power of the fourth cleaning parameter is greater than the cleaning power of the first cleaning parameter;
before the detection items of the first-class reaction tank are measured, the controller acquires a blank voltage of the first-class reaction tank, and when the blank voltage is in a non-preset range, the cleaning component is controlled to execute a cleaning mode before detection according to the fourth cleaning parameter so as to clean the first-class reaction tank, so that the blank voltage is in a preset range; and/or the presence of a gas in the gas,
before the second type reaction tank detection items are measured, the controller obtains blank voltage of the second type reaction tank, and when the blank voltage is in a non-preset range, the cleaning component is controlled to execute the cleaning mode before detection according to the fourth cleaning parameter so as to clean the second type reaction tank, and the blank voltage is in a preset range.
6. The sample analysis device according to claim 1 or 4, wherein the first and second washing parameters comprise at least different washing time periods, different kinds of washing agents, and/or different concentrations of washing agents.
7. The sample analysis device of claim 1 or 4, wherein the wash duration of the first wash parameter is greater than the wash duration of the second wash parameter; and/or the cleaning intensity of the cleaning agent type of the first cleaning parameter is greater than the cleaning intensity of the cleaning agent type of the second cleaning parameter; and/or the concentration of the cleaning agent of the first cleaning parameter is greater than that of the cleaning agent of the second cleaning parameter.
8. The sample analysis device of claim 1 or 4, wherein the first specific protein comprises at least a C-reactive protein and the second specific protein comprises at least a serum amyloid protein.
9. The sample analysis device according to claim 6 or 7, wherein the wash agent comprises at least a haemolysing agent.
10. The sample analysis device of claim 1 or 4, wherein the first type of reagent and the second type of reagent comprise at least the same type of hemolytic agent.
11. The sample analysis device according to any one of claims 1 to 10, wherein the reaction portion further comprises a blood routine reaction portion, and the detection portion further comprises a blood routine detection portion;
the blood routine reaction part is used for receiving the sample conveyed by the sampling part and the third type reagent supplied by the reagent supply part so as to prepare a blood routine sample for measuring a blood routine detection item;
the blood routine detection part comprises one or more of a DIFF detection part, a RBC detection part, an HGB detection part, an NRBC detection part and a RET detection part; the DIFF detection part is used for detecting four classes of white blood cells, the HGB detection part is used for detecting hemoglobin concentration, and the RBC detection part is used for detecting red blood cell count and/or platelet count; the RET detection part is used for detecting reticulocyte count, and the NRBC detection part is used for detecting nucleated red blood cell count, white blood cell count and basophil count.
12. The sample analysis device of claim 11, wherein the third type of reagent comprises at least a hemolytic agent; the washing component uses hemolytic agent in the third type of reagent for washing.
13. A sample detection method applied to a sample analysis device capable of measuring a plurality of specific proteins, the sample detection method comprising:
controlling the detection of any one of the plurality of specific proteins in the reaction pool;
acquiring the type of the specific protein currently detected in the reaction tank;
acquiring cleaning parameters corresponding to the type of the specific protein detected currently; wherein at least two specific proteins in the plurality of specific proteins correspond to different cleaning parameters, and different cleaning parameters correspond to different cleaning forces;
and after the measurement is finished, cleaning the reaction tank according to the obtained cleaning parameters.
14. The method for testing a sample according to claim 13, wherein the washing parameters comprise washing duration, kind of a washing agent, and/or concentration of a washing agent.
15. The sample detection method as claimed in claim 13, further comprising:
acquiring a specific protein type which is detected in a reaction tank at present and a specific protein type to be detected next;
acquiring cleaning parameters corresponding to the next specific protein type to be detected;
and when the cleaning intensity of the cleaning parameter corresponding to the currently detected specific protein type is weaker than the cleaning intensity of the cleaning parameter corresponding to the specific protein type to be detected next, controlling to additionally clean the reaction tank, or adjusting the cleaning parameter corresponding to the currently detected specific protein type to enable the cleaning intensity to be larger than or equal to the cleaning intensity of the cleaning parameter corresponding to the specific protein type to be detected next, and cleaning the reaction tank according to the adjusted cleaning parameter.
16. The method according to any one of claims 13 to 15, wherein the plurality of specific proteins comprises at least two of C-reactive protein, serum amyloid, procalcitonin, interleukin-6, human chorionic gonadotropin, growth hormone, luteinizing hormone, alpha-fetoprotein, and carcinoembryonic antigen.
17. A computer-readable storage medium, characterized by comprising a program executable by a processor to implement the method of any one of claims 13 to 16.
CN202110728093.XA 2021-06-29 2021-06-29 Sample analysis device and sample detection method Pending CN115541538A (en)

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