CN106501510A - Quick diagnosis test batch calibration system and method - Google Patents
Quick diagnosis test batch calibration system and method Download PDFInfo
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- CN106501510A CN106501510A CN201611065486.2A CN201611065486A CN106501510A CN 106501510 A CN106501510 A CN 106501510A CN 201611065486 A CN201611065486 A CN 201611065486A CN 106501510 A CN106501510 A CN 106501510A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
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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
- G01N35/00594—Quality control, including calibration or testing of components of the analyser
- G01N35/00693—Calibration
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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
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- G—PHYSICS
- G08—SIGNALLING
- G08C—TRANSMISSION SYSTEMS FOR MEASURED VALUES, CONTROL OR SIMILAR SIGNALS
- G08C17/00—Arrangements for transmitting signals characterised by the use of a wireless electrical link
- G08C17/02—Arrangements for transmitting signals characterised by the use of a wireless electrical link using a radio link
Abstract
The present invention provides a kind of quick diagnosis test batch calibration system and method.The quick diagnosis test batch calibration system of the present invention includes：Test strips batch information acquisition module, batch calibration information acquisition module, test data collection module and test data calibration module.Using the present invention quick diagnosis test with batch calibration system can actual user using when the prod of different batches is calibrated, to improve test result accuracy.
Description
Technical field
The present invention relates to area of medical diagnostics, more particularly to a kind of quick diagnosis test batch calibration system and side
Method.
Background technology
Quick diagnosis detect that meaning takes from other that can be beyond patient bed side, nursing dept., ward or clinical laboratory immediately
Place is carried out, and which is mainly characterized by, and simple to operate, easy to use, result is quick, device miniaturization, detects also referred to as by bed.So
Test mode why favored by people, its main cause is that it adapts to the efficiently allegro work of current social development
Mode, meets people's requirement in time, and patient can be made to obtain diagnoses and treatment as early as possible.
Quick diagnosis technology is an important development direction of clinical examination.Quick diagnosis product most of concentration is answered at present
In following classification：Infectious disease class；The steroids of reaction reproduction level；Drugs class；Applications of Cardiac Markers class；Autoantibody class；Excellent
Raw good child-rearing class；There are other such as：Fecal occult blood (FOB), c reactive protein, microdose urine protein etc..
Quick diagnosis test reagent strip belongs to a kind of conventional quick diagnostic tool, and such as very early pregnancy with ovulation tests test paper is
The maximum project of proportion is detected in the market for household person.
At present due to the reasons such as technology, raw material and processing technology, the in vitro test paper produced by quick diagnosis industry
Certain difference between batch is certainly existed between bar batch.The presence of difference between batch, causes the product of different batches for same sample
There is deviation in testing result, and its size directly affects the precision of measurement result, just because of this, for larger quick of difference between batch
Diagnosis test paper can only carry out qualitative detection, and be difficult to more accurately quantitative determination.
And in order to control the adverse effect that difference between batch brings, most of producer can be devoted to reducing difference between batch, reduce between criticizing
Difference needs to take the methods such as strict technological standards, raw material screening, sampling Detection of dispatching from the factory, although adopting for these measures can be with
Reduce differences between batches as far as possible, but on the one hand cannot tackle the problem at its root, on the other hand undoubtedly also give and research and develop and raw
Product is put forward higher requirement, and increased substantial amounts of material resources and human cost.
Content of the invention
The present invention be directed at present external quick diagnosis industry test paper production difference between batch and needs to pass through than larger
A kind of present situation of the less difference between batch of method various complicated and that expend huge cost, proposition a kind of new and effective batch
Between difference calibration system and method.
By way of difference between batch offset data of the present invention by offer product batches information and between the batch and standard items
To calibrate to the detection data of terminal client, when being tested using the test strips of different batches every time, to test knot
Fruit compensates, and reduces the result judgement deviation that differences between batches are caused, so as to reduce research and development requirement of the factory to difference between batch
With remain to while production requirement improve product test accuracy.
Further, system or method of the invention can also be further with mobile Internet cloud service and wireless telecommunications
Technology, realize by product export batch between calibration error offset data transfer so that client can be tested using mobile phone A PP and
Show result, improve the directly perceived and interactive of product.
Present invention firstly provides a kind of diagnostic test batch calibration system, including：
Test strips batch information acquisition module 100, for obtaining test strips batch information；
Batch calibration information acquisition module 200, for obtaining or storing batch calibration information MSample；
Test data collection module 300, for collecting actual test value MSurvey；
Test data calibration module 400, obtains for actual test data are carried out calibration calculating according to batch calibration information
Obtain calibration value MJudge.
Through above-mentioned module, it is already possible to reach the calibration of reagent strip test data.
As it is further preferred that the diagnostic test batch calibration system also includes：
Threshold value storage module 500, for storing threshold T hrdMark；
Determination module 600, is connected with test data calibration module 400 and threshold value storage module 500, for according to calibration
Data MJudgeAnd threshold value judges that detection sample belongs to positive findings or negative findings；
Result of determination output module 700, is connected with determination module 600, for exporting result of determination.
Through above-mentioned improvement, the batch calibration system of the present invention can reach the batch calibration of test result and testing result
Interpretation.
Also, it is preferred that, the diagnostic test batch calibration system of the present invention also includes：
Communication module 800, with test strips batch information acquisition module 100, batch calibration information acquisition module 200, test
One or more modules in data collection module 300, test data calibration module 400 and result of determination output module 700
It is connected, for transmitting test strips batch information, batch calibration information MSample, actual test value MSurvey, calibration value MJudge, in result of determination
One or more.
Specifically, the communication module 800 selectively includes following one or more units：
Test strips batch information transmission unit 810, for transmitting test strips batch information；
Batch calibration information MSampleTransmission unit 820, for transmitting batch calibration information MSample；
Actual test value MSurveyTransmission unit 830, for transmitting actual test value MSurvey；
Calibration value MJudgeTransmission unit 840, for transmitting calibration value MJudge；
Result of determination transmission unit 860, for transmitting result of determination.
Presence based on communication module 800 so that the diagnostic test of the present invention with each module of batch calibration system except
Outside being integrated on same device, in can also splitting to different devices.
It is further preferred that the diagnostic test batch calibration system of the present invention also includes：
Cloud server communication module 1100, is communicated with cloud server 1000, and with batch calibration information acquisition module
200 are connected, for obtaining batch calibration information M from cloud serverSampleIt is transferred to batch calibration information acquisition module 200.
Above-mentioned design can be updated the data based on internet cloud data transfer.
It is also preferred that the diagnostic test batch calibration system of the present invention also includes：
Memory module 900, for storing result of determination.
The invention also discloses a kind of diagnostic test batch calibration steps, comprises the following steps：
Step S101, obtains test strips batch information；
Step S102, obtains or storage batch calibration information MSample；
Step S103, collects actual test value MSurvey；
Actual test data are carried out calibration according to batch calibration information and calculate acquisition calibration value M by step S104Judge.
It is further preferred that the diagnostic test batch calibration steps of the present invention also includes：
Step S105, obtains threshold T hrdMark；
Step S106, according to calibration data MJudgeAnd threshold T hrdMarkJudge that detection sample belongs to positive findings or feminine gender
As a result；
Step S107, exports result of determination.
Above-mentioned improvement is based on, the present invention can reach the batch calibration and the interpretation of testing result of test result.
It is further preferred that the diagnostic test batch calibration steps of the present invention also includes：
Step S108, selectively transmits following one or more information：Test strips batch information, batch calibration information
MSample, actual test value MSurvey, calibration value MJudge, result of determination.
Step S108 can reach the batch calibration of test result and sentencing for testing result by the data interaction of multiple devices
Read.
Improved, the diagnostic test batch calibration steps of the present invention also includes：
Step S110, is communicated with cloud server 1000, transfers batch calibration information M from cloud serverSample.
It is further preferred that the diagnostic test batch calibration steps of the present invention also includes：Step S109, storage judge knot
Really.To facilitate checking and transferring for detection history.
The diagnostic test of the present invention batch calibration steps and system are particularly well-suited to fast diagnosis reagent bar is carried out criticizing
Secondary calibration, so that, in the case of without the need for high cost control difference between batch, eliminate the impact that difference between batch brings so that quick diagnosis are surveyed
Examination reagent strip also can achieve half-quantitative detection.
The fast diagnosis reagent bar can be the reagent strip based on immunochromatography technique, such as colloid gold reagent bar, latex
Particulate reagent strip etc..Diagnostic categories can also apply to the various classifications of immunochromatography technique, including but not limited to：HCG is (early
Pregnant) detect with LH (ovulation level)；Infectious disease class antigen or the detection of antibody；Drugs class is detected；Applications of Cardiac Markers is detected；Itself
Antibody class is detected；The detection of Infection of Toxoplasma Gondii, rubella, herpes simplex virus I/II, cytomegalovirus IgM etc..
Invention applies wireless communication technique, Internet technology, mobile terminal APP technology, prod batch is calibrated
Information transfer give client test interpretation pen, actual user using when the prod of different batches is calibrated, to improve survey
Test result accuracy.
Description of the drawings
Fig. 1 is shown as the diagnostic test of first embodiment of the invention batch calibration system.
Fig. 2 is shown as the diagnostic test of second embodiment of the invention batch calibration system.
Fig. 3 is shown as the diagnostic test of third embodiment of the invention batch calibration system.
Fig. 4 is shown as the diagnostic test of fourth embodiment of the invention batch calibration system.
Fig. 5 is the flow chart of the diagnostic test batch calibration steps according to first embodiment of the invention
Fig. 6 is the flow chart of the diagnostic test batch calibration steps according to second embodiment of the invention
Fig. 7 is the flow chart of the diagnostic test batch calibration steps according to third embodiment of the invention
Fig. 8 is the flow chart of the diagnostic test batch calibration steps according to fourth embodiment of the invention
Fig. 9 is shown as the method for operating of the diagnostic test with one concrete case of batch calibration system of fourth embodiment of the invention
Flow chart.Wherein, Fig. 9 a are mobile terminal operating process, and Fig. 9 b are test pen operating process.
In figure, dotted line represents optional annexation or optional step, and dotted line frame represents selectable unit.
Specific embodiment
Embodiments of the present invention are described below by way of specific instantiation, those skilled in the art can be by this specification
Disclosed content understands other advantages and effect of the present invention easily.The present invention can also pass through in addition different concrete realities
The mode of applying is carried out or applies, and the every details in this specification can also be based on different viewpoints and application, without departing from
Various modifications and changes are carried out under the spirit of the present invention.
Refer to Fig. 1 to Fig. 9.It should be noted that the diagram provided in the present embodiment only illustrates this in a schematic way
The basic conception of invention, so when only showing the component relevant with the present invention and layout in schema rather than implementing according to reality
Component count, shape and size are drawn, and the quantity of each component which is actual when implementing can be a kind of random change, and its component cloth
Office's kenel is likely to increasingly complex.
Fig. 1 is the diagnostic test batch calibration system according to first embodiment of the invention, including：
Test strips batch information acquisition module 100, for obtaining test strips batch information；
Batch calibration information acquisition module 200, for obtaining or storing batch calibration information MSample；
Test data collection module 300, for collecting actual test value MSurvey；
Test data calibration module 400, is connected with batch calibration information acquisition module and test data collection module, is used for
Actual test data are carried out calibration according to batch calibration information and calculates acquisition calibration value MJudge.
The test strips batch information after reading device is read from reagent strip can be stored to or be transferred to test paper
Bar batch information acquisition module.Batch information can be contained in arbitrarily naked eyes or the recognizable information of reading equipment, for example, one-dimensional
Bar code, Quick Response Code, word, numeral, color lump combination, combination of shapes etc..
Batch calibration information acquisition module 200 can be connected with test strips batch information acquisition module 100, according to test strips batch
The test strips batch information that secondary data obtaining module 100 is provided, is provided to test data calibration module 400 and is believed with test strips batch
The batch calibration information M of breath couplingSample.
The batch calibration information can be pre-stored in batch calibration information acquisition module, or is obtained from outside through communication module
?.The batch calibration information being stored in batch calibration information acquisition module is renewable.
The actual test data can be stored after being tested to reagent strip by test cell to or be transferred to test number
According to collection module.
The test data calibration module calculates calibration value using following equation：
MJudge=MSurvey+(MMark-MSample) (1)
Wherein MJudgeFor calibration value, MSurveyFor actual test value, MMarkFor the standard testing value of standard items, MSampleFor the batch sampling
Test average of the sample to standard items.
Calculate through above-mentioned calibration, each measured value equal corresponding standard value calibrated, so as to effectively prevent due to producing
The adverse effect that product official written reply difference is brought for testing result.
Those skilled in the art understand, and the calculating process of value calibrated as explained above can utilize calculating of the prior art
Machine, integrated circuit modules, PLD, other hardware or existing software module are realizing.
More stable production raw material and electronic devices and components are can select, a collection of standard testing strips bar and test cell is produced
(electronics decipherer), the test value obtained after being tested to standard items (master sample of concentration known) using this batch of standard reagent bar
Average is M as standard testing valueMark.
Before dispatching from the factory, after the sampling samples of the batch reagent strip are detected to standard items obtain test value average as
MSample.
Through the diagnostic test of first embodiment batch calibration system, it is already possible to reach the school of reagent strip test data
Accurate.The batch calibration system can be integrated on test terminal in the lump with batch information reading device, test cell.
Fig. 2 is the diagnostic test batch calibration system according to second embodiment of the invention, including：
Test strips batch information acquisition module 100, for obtaining test strips batch information；
Batch calibration information acquisition module 200, for obtaining or storing batch calibration information MSample；
Test data collection module 300, for collecting actual test value MSurvey；
Test data calibration module 400, obtains for actual test data are carried out calibration calculating according to batch calibration information
Obtain calibration value MJudge.
Threshold value storage module 500, for storing threshold T hrdMark；
Determination module 600, is connected with test data calibration module 400 and threshold value storage module 500, for according to calibration
Data MJudgeAnd threshold value judges that detection sample belongs to positive findings or negative findings；
Result of determination output module 700, is connected with determination module 600, for exporting result of determination.
Threshold T hrdMarkAs positive threshold value, can be according to the difference of Testing index, according to anticipating with statistics
After the clinical samples of justice and normal person's pattern detection, statistics determines, the determination of threshold value belongs to routine techniques.
Determination module 600 judges calibration data M using following equationJudgeBelong to positive findings or negative findings：
If 1) MJudge≥ThrdMarkAs a result it is positive (2)
If 2) MJudge＜ ThrdMarkAs a result it is negative (3)
Those skilled in the art understand, and several decision processes calibrated as explained above can utilize calculating of the prior art
Machine, integrated circuit modules, PLD, other hardware or existing software module are realizing.
Result of determination may be output to the display unit on test terminal, also may be output to outside and carries display unit
Device such as mobile terminal etc..
The batch calibration system of second embodiment can be integrated in test eventually in the lump with batch information reading device, test cell
On end, the test terminal selectively includes display unit, and the batch calibration system can reach the batch school of test result
The interpretation of accurate and testing result.
Fig. 3 is the diagnostic test batch calibration system according to third embodiment of the invention, including：
Test strips batch information acquisition module 100, for obtaining test strips batch information；
Batch calibration information acquisition module 200, for obtaining or storing batch calibration information MSample；
Test data collection module 300, for collecting actual test value MSurvey；
Test data calibration module 400, obtains for actual test data are carried out calibration calculating according to batch calibration information
Obtain calibration value MJudge.
Threshold value storage module 500, for storing threshold T hrdMark；
Determination module 600, is connected with test data calibration module 400 and threshold value storage module 500, for according to calibration
Data MJudgeAnd threshold value judges that detection sample belongs to positive findings or negative findings；
Result of determination output module 700, is connected with determination module 600, for exporting result of determination.
Communication module 800, selectively includes following one or more units：
Test strips batch information transmission unit 810, can be with test strips batch information acquisition module 100, batch calibration information
Acquisition module 200 and/or test data calibration module 400 are connected, for transmitting test strips batch information；
Batch calibration information MSampleTransmission unit 820, with batch calibration information acquisition module 200 and test data calibration module
400 are connected, for transmitting batch calibration information MSample；
Actual test value MSurveyTransmission unit 830, with 400 phase of test data collection module 300 and test data calibration module
Even, for transmitting actual test value MSurvey；
Calibration value MJudgeTransmission unit 840, is connected with test data calibration module 400 and determination module 600, for transmitting
Calibration value MJudge；
Result of determination transmission unit 860, is connected with result of determination output module 700, for transmitting result of determination.
The communication module each unit can selectively transmission data by the way of wire communication or wireless telecommunications,
The wireless telecommunications be able to can be adopted for the wireless communication modes such as wifi wireless telecommunications, blue tooth wireless communication, the wire communication
Ability can be passed through with the communication interface for arranging coupling through suitable data line transfer, wire communication technology and wireless communication technique
The prior art that field technique personnel skillfully grasp is realized.
Based on the presence of communication module 800, each mould of the diagnostic test of third embodiment of the invention with batch calibration system
Block in addition to it can be integrated on same device, in can also splitting to different devices.
Test strips batch information acquisition module 100 can be placed in test terminal with batch information reading device one, or
Person, test strips batch information acquisition module 100 are also placed in the equipment that other possess reading device, such as mobile terminal.
Batch calibration information acquisition module 200 can be placed in test terminal, or, test strips batch information acquisition module
100 are also placed in the equipment that other possess reading device, such as mobile terminal.
Test data collection module 300 typically should be placed in test terminal.
Test data calibration module 400 is placed in also being placed in other-end equipment such as mobile terminal in test terminal
In.Test data calibration module is received with test strips batch information acquisition module, batch calibration information acquisition module and test data
Collection module can be joined directly together and also can be indirectly connected to by communication module.When detection data calibration module 400 is believed with test strips batch
Breath acquisition module 100, batch calibration information acquisition module 200 and test data collection module 300 be not in same equipment
When, detection data calibration module 400 can utilize coupling on equipment to set up test strips batch information transmission unit 810, batch
Calibration information MSampleTransmission unit 820, actual test value MSurveyTransmission unit 830, obtains test strips batch information, batch calibration letter
Breath MSampleWith actual test value MSurvey, so as to calculate acquisition calibration value.
Threshold value storage module 500, determination module 600, result of determination output module 700 are also placed in test terminal
It is placed in other-end equipment such as mobile terminal, generally, three is in same equipment.Determination module 600 with
Test data calibration module 400 and threshold value storage module 500 can be joined directly together, and also can be indirectly connected to through communication module.For example
When threshold value storage module 500, determination module 600 are not located in same equipment with test data calibration module 400, mould is judged
Block 600 can utilize coupling on equipment to set up calibration value MJudgeTransmission unit 840 is obtaining calibration value MJudge, so as to further obtain
Obtain and export result of determination.
During result of determination output module 700 is used for exporting result of determination to display unit or storage element.Display unit
Or storage element can be the display unit or storage element for carrying, also single using the display unit on external equipment or storage
Unit shows or stores the display screen of result of determination such as mobile terminal, storage card, internal memory etc..Show in external equipment when needing or
During storage result of determination, can mate on equipment and set up result of determination transmission unit 860.
The batch calibration system of 3rd embodiment can reach the batch school of test result by the data interaction of multiple devices
The interpretation of accurate and testing result.
Fig. 4 is the diagnostic test batch calibration system according to fourth embodiment of the invention, including：
Test strips batch information acquisition module 100, for obtaining test strips batch information；
Batch calibration information acquisition module 200, for obtaining or storing batch calibration information MSample；
Test data collection module 300, for collecting actual test value MSurvey；
Test data calibration module 400, obtains for actual test data are carried out calibration calculating according to batch calibration information
Obtain calibration value MJudge.
Threshold value storage module 500, for storing threshold T hrdMark；
Determination module 600, is connected with test data calibration module 400 and threshold value storage module 500, for according to calibration
Data MJudgeAnd threshold value judges that detection sample belongs to positive findings or negative findings；
Result of determination output module 700, is connected with determination module 600, for exporting result of determination；
Communication module 800, same to third embodiment of the invention：
Cloud server communication module 1100, is communicated with cloud server 1000, with batch calibration information acquisition module 200
It is connected, for obtaining batch calibration information M from cloud serverSampleIt is transferred to batch calibration information acquisition module 200.
Memory module 900, selectively with 860 phase of result of determination output module 700 and/or result of determination transmission unit
Even, for storing result of determination.
Before reagent strip product export batch products are carried out with batch sampling Detection, and obtains sample testing average (MSample) and
Other batch calibration informations, and these data are uploaded cloud server 1000.Cloud server 1000 is preserved and is safeguarded all
Dispatch from the factory product batch information and batch sample value and calibration information.
Cloud server communication module 1100 can be joined directly together with batch calibration information acquisition module 200, or through batch
Calibration information MSampleTransmission unit (820) is connected with batch calibration information acquisition module 200.For obtaining batch from cloud server
Calibration information MSampleIt is transferred directly to batch calibration information acquisition module (200) or through batch calibration information MSampleTransmission unit (820)
By batch calibration information MSampleIt is transferred to batch calibration information acquisition module (200).
It is for example mobile whole that cloud server communication module 1100 can also be placed in other-end equipment in test terminal
In end, preferably, the excellent remote communicating function based on mobile terminal such as mobile phone, it is recommended that by cloud server communication module 1100
It is arranged in mobile terminal.Cloud server communication module 1100 can send to cloud server and transfer batch calibration information MSample's
Request instruction, and receive the batch calibration information M of cloud server transmissionSampleInformation and other calibration informations.
Cloud server communication module 1100 can be also connected with test strips batch information acquisition module 100, can be according to examination
Paper slip batch information sends the batch calibration information M for transferring coupling from cloud serverSampleRequest instruction, receiving cloud service
The coupling batch calibration information M that device sendsSampleAfterwards, by the batch calibration information M of couplingSampleIt is transferred to batch calibration information acquisition module
200.Likewise, cloud server communication module 1100 can be joined directly together with test strips batch information acquisition module 100, Huo Zhejing
Test strips batch information transmission unit (810) are connected.
Or, cloud server communication module 1100 need not be connected with test strips batch information acquisition module 100, direct root
Send according to customer instruction and transfer or update batch calibration information MSampleRequest instruction, receiving cloud server transmission batch school
Calibration information MSampleAfterwards, by batch calibration information MSampleIt is transferred to batch calibration information acquisition module 200 and is stored in batch calibration information
In acquisition module 200, in concrete test, by batch calibration information acquisition module 200 according to the output of test strips batch information with
Coupling batch calibration information.
When cloud server communication module 1100 is located in same equipment with batch calibration information acquisition module 200, batch
Secondary calibration information acquisition module 200 directly can obtain batch calibration information from cloud server communication module 1100.When high in the clouds takes
When business device communication module 1100 is not located in same equipment with batch calibration information acquisition module 200, batch calibration information is obtained
Module 200 can pass through batch calibration information MSampleTransmission unit 820 obtains batch calibration letter from cloud server communication module 1100
Breath.
When cloud server communication module 1100 is located in same equipment with test strips batch information acquisition module 100,
Cloud server communication module 1100 directly can obtain test strips batch information from test strips batch information acquisition module 100.When
When cloud server communication module 1100 is not located in same equipment with test strips batch information acquisition module 100, cloud service
Device communication module 1100 can be obtained from test strips batch information acquisition module 100 by test strips batch information transmission unit (810)
Take batch information.
Memory module 900 is including but not limited to non-voltile memory, random access memory or hard disk etc..Memory module
900 can also be placed in other-end equipment such as mobile terminal in test terminal, also can be at test terminal or other ends
Memory module is all provided with end equipment.For with result of determination output module 700 be located at same equipment memory module, can directly from
Result of determination output module 700 obtains result of determination.For the storage for not being located at same equipment with result of determination output module 700
Module, can be obtained from result of determination output module 700 and be stored result of determination by result of determination transmission unit 860.
The batch calibration system of fourth embodiment can be reached by the data interaction of multiple devices based on internet cloud data
Batch calibration, the interpretation of testing result and the storage of test result, is preferred embodiment.
As a specific case, the diagnostic test of fourth embodiment of the invention can be arranged with batch calibration system
In mobile terminal and test pen.The communication module 800 of coupling, wherein, test strips batch are set on mobile terminal and test pen
Data obtaining module 100, cloud server communication module 1100, memory module 900 are arranged in mobile terminal, and test data is received
Collection module 300, test data calibration module 400, threshold value storage module 500, determination module 600, result of determination output module
700 are arranged in test pen.During operation, as shown in figure 9, the batch using mobile scanning terminal test strips (in prod)
Calibration information is transferred from Cloud Server according to batch information after information, calibration information and batch information is transferred to through communication module
Test pen.By test pen collecting test value, and according to threshold value and the calibration information from mobile terminal and batch information meter
Calibration value is calculated, further according to calibration value result of determination, and result of determination is transferred to mobile terminal storage through communication module or is shown.
Fig. 5 is the flow chart of the diagnostic test batch calibration steps according to first embodiment of the invention, including following step
Suddenly：
Step S101, obtains test strips batch information；
Step S102, obtains or storage batch calibration information MSample；
Step S103, collects actual test value MSurvey；
Actual test data are carried out calibration according to batch calibration information and calculate acquisition calibration value M by step S104Judge.
The test strips batch information can be read from reagent strip by reading device and be obtained.
The batch calibration information can be obtained from memory cell or through data transfer from outside according to test strips batch information
Obtain.
The actual test data can be obtained after being tested to reagent strip by test cell.
In step S104, following equation can be adopted to calculate calibration value：
MJudge=MSurvey+(MMark-MSample) (1)
Wherein MJudgeFor calibration value, MSurveyFor actual test value, MMarkFor the standard testing value of standard items, MSampleFor the batch sampling
Test average of the sample to standard items.
Through the diagnostic test of first embodiment batch calibration steps, it is already possible to reach reagent strip test number at low cost
According to calibration.
Fig. 6 is the flow chart of the diagnostic test batch calibration steps according to second embodiment of the invention, including following step
Suddenly：
Step S101, obtains test strips batch information；
Step S102, obtains or storage batch calibration information MSample；
Step S103, collects actual test value MSurvey；
Actual test data are carried out calibration according to batch calibration information and calculate acquisition calibration value M by step S104Judge.
Step S105, obtains threshold T hrdMark；
Step S106, according to calibration data MJudgeAnd threshold T hrdMarkJudge that detection sample belongs to positive findings or feminine gender
As a result；
Step S107, exports result of determination.
Wherein, step S106 judges calibration data M using following equationJudgeBelong to positive findings or negative findings：
If 1) MJudge≥ThrdMarkAs a result it is positive (2)
If 2) MJudge＜ ThrdMarkAs a result it is negative (3)
Result of determination may be output to the display unit on test terminal, also may be output to outside and carries display unit
Device such as mobile terminal etc..
Second embodiment of the invention can reach the batch calibration and the interpretation of testing result of test result.
Fig. 7 is the flow chart of the diagnostic test batch calibration steps according to third embodiment of the invention, including following step
Suddenly：
Step S101, obtains test strips batch information；
Step S102, obtains or storage batch calibration information MSample；
Step S103, collects actual test value MSurvey；
Actual test data are carried out calibration according to batch calibration information and calculate acquisition calibration value M by step S104Judge.
Step S105, obtains threshold T hrdMark；
Step S106, according to calibration data MJudgeAnd threshold T hrdMarkJudge that detection sample belongs to positive findings or feminine gender
As a result；
Step S107, exports result of determination.
Step S108, selectively transmits following one or more information：Test strips batch information, batch calibration information
MSample, actual test value MSurvey, calibration value MJudge, result of determination.
When step S101- step S107 is completed using distinct device, can be passed between different devices using step S108
Transmission of data.The mode transmission data of optional wire communication or wireless telecommunications, the wireless telecommunications can be wifi wireless telecommunications,
The wireless communication modes such as blue tooth wireless communication, ZigBe, the wire communication can adopt the communication interface for arranging coupling through suitable
Data line transfer, such as USB etc., wire communication technology and wireless communication technique can be skillfully grasped by those skilled in the art
Prior art realize.
The data interaction of Tong Guo the multiple devices of third embodiment of the invention is reached the batch calibration of test result and is examined
Survey the interpretation of result.
Fig. 8 is the flow chart of the diagnostic test batch calibration steps according to fourth embodiment of the invention, including following step
Suddenly：
Step S101, obtains test strips batch information；
Step S102, obtains or storage batch calibration information MSample, the batch calibration information MSampleDerive from step S110；
Step S103, collects actual test value MSurvey；
Actual test data are carried out calibration according to batch calibration information and calculate acquisition calibration value M by step S104Judge.
Step S105, obtains threshold T hrdMark；
Step S106, according to calibration data MJudgeAnd threshold T hrdMarkJudge that detection sample belongs to positive findings or feminine gender
As a result；
Step S107, exports result of determination.
Step S108, selectively transmits following one or more information：Test strips batch information, batch calibration information
MSample, actual test value MSurvey, calibration value MJudge, result of determination.
Step S110, is communicated with cloud server, transfers batch calibration information M from cloud serverSample.Test strips can be based on
Batch information transfers the batch calibration information M of coupling from cloud serverSample；Or transferred batch from cloud server based on customer instruction
Secondary calibration information MSample.
Step S109, stores result of determination.
The communication of mobile terminal realization and cloud server, mobile terminal can be utilized to send to cloud server and transfer
Batch calibration information MSampleRequest instruction, and receive cloud server transmission batch calibration information MSampleInformation and other calibration letters
Breath.
Step S108 can be completed by wireless telecommunications between mobile terminal and test pen.
Fourth embodiment of the invention can reach test result based on internet cloud data by the data interaction of multiple devices
Batch calibration, the interpretation of testing result and storage, be preferred embodiment.
The principle and its effect of above-described embodiment only illustrative present invention, of the invention not for limiting.Any ripe
The personage for knowing this technology all can carry out modifications and changes to above-described embodiment under the spirit and the scope without prejudice to the present invention.Cause
This, those of ordinary skill in the art is complete with institute under technological thought without departing from disclosed spirit such as
Into all equivalent modifications or change, should by the present invention claim be covered.
Claims (19)
1. a kind of diagnostic test batch calibration system, it is characterised in that include：
Test strips batch information acquisition module (100), for obtaining test strips batch information；
Batch calibration information acquisition module (200), for obtaining or storing batch calibration information MSample；
Test data collection module (300), for collecting actual test value MSurvey；
Test data calibration module (400), calculates acquisition for actual test data are carried out calibration according to batch calibration information
Calibration value MJudge.
2. diagnostic test as claimed in claim 1 batch calibration system, it is characterised in that the test data calibration module
Calibration value is calculated using following equation：
MJudge=MSurvey+(MMark-MSample) (1)
Wherein MJudgeFor calibration value, MSurveyFor actual test value, MMarkFor the standard testing value of standard items, MSampleFor the batch sampling samples
Test average to standard items.
3. diagnostic test as claimed in claim 1 batch calibration system, it is characterised in that the test strips batch information is obtained
Delivery block (100), batch calibration information acquisition module (200), test data calibration module (400) is located at test terminal or shifting
In dynamic terminal, described test data collection module (300) are in test terminal.
4. diagnostic test as claimed in claim 1 batch calibration system, it is characterised in that batch school is used in the diagnostic test
Barebone also includes：
Threshold value storage module (500), for storing threshold T hrdMark；
Determination module (600), is connected with test data calibration module (400) and threshold value storage module (500), for according to school
Quasi- data MJudgeAnd threshold value judges that detection sample belongs to positive findings or negative findings；
Result of determination output module (700), is connected with determination module (600), for exporting result of determination.
5. diagnostic test as claimed in claim 4 batch calibration system, it is characterised in that determination module (600) adopt
Calibration data M is judged with following equationJudgeBelong to positive findings or negative findings：
If 1) MJudge≥ThrdMarkAs a result it is positive (2)
If 2) MJudge＜ ThrdMarkAs a result it is negative (3).
6. diagnostic test as claimed in claim 4 batch calibration system, it is characterised in that the threshold value storage module
(500), determination module (600) and result of determination output module (700) are arranged in test terminal or mobile terminal.
7. the batch calibration system of the diagnostic test as described in claim 1 or 4, it is characterised in that the diagnostic test with batch
Secondary calibration system also includes：
Communication module (800), with test strips batch information acquisition module (100), batch calibration information acquisition module (200), survey
One in examination data collection module (300), test data calibration module (400) and result of determination output module (700) or
Multiple modules are connected, for transmitting test strips batch information, batch calibration information MSample, actual test value MSurvey, calibration value MJudge, sentence
Determine one or more in result；
And/or
Cloud server communication module (1100), with cloud server (1000) communicate, and with batch calibration information acquisition module
(200) it is connected, for transferring batch calibration information M from cloud serverSampleIt is transferred to batch calibration information acquisition module (200).
8. diagnostic test as claimed in claim 7 batch calibration system, it is characterised in that described communication module (800) wrap
Include following one or more units：
Test strips batch information transmission unit (810), for transmitting test strips batch information；
Batch calibration information MSampleTransmission unit (820), for transmitting batch calibration information MSample；
Actual test value MSurveyTransmission unit (830), for transmitting actual test value MSurvey；
Calibration value MJudgeTransmission unit (840), for transmitting calibration value MJudge；
Result of determination transmission unit (860), for transmitting result of determination.
9. diagnostic test as claimed in claim 7 batch calibration system, it is characterised in that the cloud server communicates mould
Block (1100) is connected with test strips batch information acquisition module (100), is additionally operable to send from high in the clouds according to test strips batch information
Server transfers the batch calibration information M of couplingSampleRequest instruction.
10. diagnostic test as claimed in claim 4 batch calibration system, it is characterised in that the diagnostic test batch
Calibration system also includes：
Memory module (900), for storing result of determination.
11. diagnostic test as claimed in claim 10 batch calibration systems, it is characterised in that memory module (900)
In test terminal and/or mobile terminal.
A kind of 12. diagnostic test batch calibration steps, comprise the following steps：
Step S101, obtains test strips batch information；
Step S102, obtains or storage batch calibration information MSample；
Step S103, collects actual test value MSurvey；
Actual test data are carried out calibration according to batch calibration information and calculate acquisition calibration value M by step S104Judge.
13. diagnostic test as claimed in claim 12 batch calibration steps, it is characterised in that in step S104, adopt
Following equation calculates calibration value：
MJudge=MSurvey+(MMark-MSample) (1)
Wherein MJudgeFor calibration value, MSurveyFor actual test value, MMarkFor the standard testing value of standard items, MSampleFor the batch sampling samples
Test average to standard items.
14. diagnostic test as claimed in claim 12 batch calibration steps, it is characterised in that further comprising the steps of：
Step S105, obtains threshold T hrdMark；
Step S106, according to calibration data MJudgeAnd threshold T hrdMarkJudge that detection sample belongs to positive findings or negative knot
Really；
Step S107, exports result of determination.
15. diagnostic test as claimed in claim 14 batch calibration steps, it is characterised in that wherein, step S106 is using under
Row formula judges calibration data MJudgeBelong to positive findings or negative findings：
If 1) MJudge≥ThrdMarkAs a result it is positive (2)
If 2) MJudge＜ ThrdMarkAs a result it is negative (3).
16. diagnostic test as claimed in claim 14 batch calibration steps, it is characterised in that further comprising the steps of：
Step S109, stores result of determination.
The 17. batch calibration steps of diagnostic test as described in claim 12 or 14, it is characterised in that further comprising the steps of：
Step S108, selectively between different device transmission below one or more information：Test strips batch information, batch
Calibration information MSample, actual test value MSurvey, calibration value MJudge, result of determination.
18. diagnostic test as claimed in claim 17 batch calibration steps, it is characterised in that further comprising the steps of：
Step S110, is communicated with cloud server (1000), transfers batch calibration information M from cloud serverSample.
19. diagnostic test as claimed in claim 18 batch calibration steps, it is characterised in that step S110 is based on test paper
Bar batch information transfers the batch calibration information M of coupling from cloud serverSample；Or transferred from cloud server based on customer instruction
Batch calibration information MSample.
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| CN201611065486.2A CN106501510A (en) | 2016-11-28 | 2016-11-28 | Quick diagnosis test batch calibration system and method |
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| US6295506B1 (en) * | 1997-10-27 | 2001-09-25 | Nokia Mobile Phones Limited | Measurement apparatus |
| TW201400813A (en) * | 2012-02-17 | 2014-01-01 | Vitrum Diagnostics Inc | Informative diagnostic kit and device for immunochromatographic detection |
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