CN106483274A - The calibration of external diagnosis reagent internet and correction quality control system and its implementation - Google Patents
The calibration of external diagnosis reagent internet and correction quality control system and its implementation Download PDFInfo
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- CN106483274A CN106483274A CN201610863398.0A CN201610863398A CN106483274A CN 106483274 A CN106483274 A CN 106483274A CN 201610863398 A CN201610863398 A CN 201610863398A CN 106483274 A CN106483274 A CN 106483274A
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- 239000003153 chemical reaction reagent Substances 0.000 title claims abstract description 41
- 238000003745 diagnosis Methods 0.000 title claims abstract description 29
- 238000003908 quality control method Methods 0.000 title claims abstract description 26
- 238000012937 correction Methods 0.000 title claims description 9
- 238000012360 testing method Methods 0.000 claims abstract description 61
- 238000011156 evaluation Methods 0.000 claims abstract description 7
- 238000000034 method Methods 0.000 claims description 6
- 238000011088 calibration curve Methods 0.000 claims description 5
- 238000004891 communication Methods 0.000 claims description 3
- 238000012123 point-of-care testing Methods 0.000 abstract description 2
- 230000000694 effects Effects 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 241000208340 Araliaceae Species 0.000 description 1
- 235000005035 Panax pseudoginseng ssp. pseudoginseng Nutrition 0.000 description 1
- 235000003140 Panax quinquefolius Nutrition 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 235000008434 ginseng Nutrition 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000009329 sexual behaviour Effects 0.000 description 1
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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
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Abstract
The invention discloses a kind of external diagnosis reagent internet is calibrated and revises quality control system and its implementation, its system includes real-time test analyzer, is built-in with the mobile terminal server of on-line module；The real-time test analyzer is connected with the mobile terminal, and the mobile terminal is connected with the server by internet through its internal on-line module；The present invention is periodically evaluated and tested according to external diagnosis reagent characteristic, carrys out calibration standard curve according to evaluation result, it is ensured that the accuracy of the parameter of external diagnosis reagent；The parameter of different test conditions can be uploaded onto the server after the completion of evaluation and test；Client or technical support personnel pass through mobile terminal, according to demand voluntarily download or automatic synchronization external diagnosis reagent parameter, external diagnosis reagent in server is sent to POCT analyzer internal storage region, reagent curve can achieve calibration, can be prevented effectively from the test result caused because of factors such as the performance of external diagnosis reagent or environment temperatures inaccurate.
Description
Technical field
The present invention relates to a kind of external diagnosis reagent internet calibration and correction quality control system and its implementation, which belongs to
The Quality Control field of medical device product.
Background technology
The internal and international at present Quality Control for medical device product lacks effective control means, and main reason is client
Voluntarily cannot calibrate, customized when calibration curve dispatches from the factory, but in the reagent term of validity, reagent over time main performance
Index changes, and performance can decline, so as to cause reagent parameter and reagent mismatch problem；
At this stage, traditional calibration steps is voluntarily periodically re-scaled by client；Or in vitro when reagent dispatches from the factory, meeting
The memory carrier of supporting storing reagent parameter, such as IC-card, radio-frequency card, magnetic stripe card etc. are provided, but client voluntarily cannot calibrate, only
Can feed back after pinpointing the problems producer or producer unification calibration curve is adjusted after redirect new memory carrier, not only give
Using very big inconvenience is brought, it is ageing that delay is detected immediately, can also largely effect on the accuracy of measure.
Content of the invention
The technical problem to be solved is a kind of the external of the offer accurate and energy real-time update of easy to use, test
The calibration of diagnostic reagent internet and correction quality control system and its implementation.
For solving the above problems, the technical solution used in the present invention is：
A kind of external diagnosis reagent internet calibration and correction quality control system, its key technology are：Which includes that real-time test divides
Analyzer, it is built-in with the mobile terminal server of on-line module；The real-time test analyzer is connected with the mobile terminal,
The mobile terminal is connected with the server by internet through its internal on-line module.
Further, the mobile terminal includes mobile phone or panel computer.
Further, it is wired connection or wireless connection between the real-time test analyzer and the mobile terminal.
Further, it is wireless connection between the real-time test analyzer and the mobile terminal, the wireless connection
Mode include bluetooth, Wi-Fi or GPRS signal communication.
The implementation method of quality control system is calibrated and is revised using external diagnosis reagent internet, is comprised the steps：
Step 1, regular parameter after evaluation and test is input into the server are updated；
Step 2, client pass through the mobile terminal, test condition needed for selecting, accordingly from the server under autonomous selection
The corresponding parameter updated in load or automatically download step 1；
Step 3, utilize the mobile terminal, by step 2 download renewal after required test condition corresponding parameter transmit
To the memory block of the real-time test analyzer, the real-time test analyzer is by according to the right of the required test condition after renewal
Parameter is answered to be modified real-time test diagnostic reagent test data, real time calibration test result, complete to external diagnosis reagent
Quality control.
Further, in the step 1 test and assess content include calibration curve draft, Quality Control test, clinical sample test,
The test and appraisal of varying environment temperature and/or different sample type tests.
It is using the beneficial effect produced by technique scheme：
The present invention is periodically evaluated and tested according to external diagnosis reagent characteristic, carrys out calibration standard curve according to evaluation result, it is ensured that
The accuracy of the parameter of external diagnosis reagent；The parameter of different test conditions can be uploaded onto the server after the completion of evaluation and test；Visitor
Family or technical support personnel pass through mobile terminal, voluntarily download according to demand or automatic synchronization external diagnosis reagent parameter, will
External diagnosis reagent in server is sent to POCT analyzer internal storage region, and reagent curve can achieve calibration, Neng Gouyou
Effect avoids the test result caused because of factors such as the performance of external diagnosis reagent or environment temperatures inaccurate.
Description of the drawings
Fig. 1 is the workflow diagram of external diagnosis reagent cloud quality control system in the present invention.
Specific embodiment
For making the object, technical solutions and advantages of the present invention clearer, with reference to Fig. 1 and specific embodiment to invention
Carry out clear, complete description.
As shown in figure 1, the present embodiment is related to a kind of calibration of external diagnosis reagent internet and revises quality control system and in fact
Existing method, the wherein calibration of external diagnosis reagent internet and correction quality control system include real-time test analyzer, are built-in with online
The mobile terminal server of module；The real-time test analyzer is connected with the mobile terminal, the mobile terminal warp
Its internal on-line module is connected with the server by internet.
Further, the mobile terminal includes mobile phone or panel computer.
Further, it is wired connection or wireless connection between the real-time test analyzer and the mobile terminal.
Further, it is wireless connection between the real-time test analyzer and the mobile terminal, the wireless connection
Mode include bluetooth, Wi-Fi or GPRS signal communication.
The implementation method of quality control system is calibrated and is revised using external diagnosis reagent internet, is comprised the steps：
Step 1, regular parameter after evaluation and test is input into the server are updated；
Step 2, client pass through the mobile terminal, test condition needed for selecting, accordingly from the server under autonomous selection
The corresponding parameter updated in load or automatically download step 1；
Step 3, utilize the mobile terminal, by step 2 download renewal after required test condition corresponding parameter transmit
To the memory block of the real-time test analyzer, the real-time test analyzer is by according to the right of the required test condition after renewal
Parameter is answered to be modified real-time test diagnostic reagent test data, real time calibration test result, complete to external diagnosis reagent
Quality control.
Further, in the step 1 test and assess content include calibration curve draft, Quality Control test, clinical sample test,
The test and appraisal of varying environment temperature and/or different sample type tests.
As shown in figure 1, the present embodiment is periodically evaluated and tested by actual, drafted according to mark curve, Quality Control test, clinical sample
All many condition such as test, varying environment temperature and different sample types, parameter is uploaded onto the server, and client is further according to actual feelings
Condition is carried out for Sexual behavior mode different parameters, is selected desired parameters by APP software, is obtained the parameter from server, selectes ginseng
Number is downloaded, and sending to client each needs the instrument of undated parameter to be changed automatically.
Finally it should be noted that：Above example only in order to technical scheme to be described, rather than a limitation；Although
With reference to the foregoing embodiments the present invention is described in detail, it will be understood by those within the art that：Which still may be used
To modify to the technical scheme described in previous embodiment, or equivalent is carried out to which part technical characteristic；And
These modifications are replaced, and do not make the essence of appropriate technical solution depart from spirit and the model of embodiment of the present invention technical scheme
Enclose.
Claims (6)
1. quality control system is calibrated and revised in a kind of external diagnosis reagent internet, it is characterised in that：Which includes that real-time test is analyzed
Instrument, it is built-in with the mobile terminal server of on-line module；The real-time test analyzer is connected with the mobile terminal, institute
State mobile terminal to be connected with the server by internet through its internal on-line module.
2. quality control system is calibrated and revised in external diagnosis reagent internet according to claim 1, it is characterised in that：Described
Mobile terminal includes mobile phone or panel computer.
3., according to the arbitrary described external diagnosis reagent internet calibration of claim 1 or 2 and correction quality control system, its feature exists
In：It is wired connection or wireless connection between the real-time test analyzer and the mobile terminal.
4., according to the arbitrary described external diagnosis reagent internet calibration of claim 1 or 2 and correction quality control system, its feature exists
In：Be wireless connection between the real-time test analyzer and the mobile terminal, the mode of the wireless connection include bluetooth,
Wi-Fi or GPRS signal communication.
5., using the external diagnosis reagent internet calibration described in claim 1 and the implementation method of correction quality control system, which is special
Levy and be, comprise the steps：
Step 1, regular parameter after evaluation and test is input into the server are updated；
Step 2, client pass through the mobile terminal, test condition needed for selecting, accordingly from the server under autonomous selection
The corresponding parameter updated in load or automatically download step 1；
Step 3, utilize the mobile terminal, by step 2 download renewal after required test condition corresponding parameter transmit
To the memory block of the real-time test analyzer, the real-time test analyzer is by according to the right of the required test condition after renewal
Parameter is answered to be modified real-time test diagnostic reagent test data, real time calibration test result, complete to external diagnosis reagent
Quality control.
6. external diagnosis reagent internet according to claim 5 is calibrated and revises the implementation method of quality control system, and which is special
Levy and be：In the step 1 test and assess content include calibration curve draft, Quality Control test, clinical sample test, varying environment temperature
Degree test and appraisal and/or different sample type tests.
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| CN201610863398.0A CN106483274A (en) | 2016-09-29 | 2016-09-29 | The calibration of external diagnosis reagent internet and correction quality control system and its implementation |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107622398A (en) * | 2017-08-17 | 2018-01-23 | 广东华银医药科技有限公司 | A kind of character surveillance method applied to external diagnosis reagent |
| CN108281178A (en) * | 2018-02-12 | 2018-07-13 | 深圳迎凯生物科技有限公司 | The newer method and device of in-vitro diagnosis device parameter |
| CN110346588A (en) * | 2018-04-04 | 2019-10-18 | 深圳市帝迈生物技术有限公司 | A kind of reagent consumption modification method, reagent liquid injection system and blood analyser |
| CN111323608A (en) * | 2020-02-24 | 2020-06-23 | 杭州微策生物技术有限公司 | POCT detection equipment with temperature and humidity correction function and detection method |
| CN111508596A (en) * | 2020-04-21 | 2020-08-07 | 蓝怡科技集团股份有限公司 | Reagent parameter upgrading method and device, in-vitro detection system and storage medium |
| CN112101830A (en) * | 2020-11-23 | 2020-12-18 | 广州万孚健康科技有限公司 | Preparation and calibration method and system of test strip for detecting HIV antibody and storage medium |
| EP3767426A4 (en) * | 2018-02-12 | 2021-03-31 | Shenzhen Linkray Biotech Co., Ltd | In-vitro diagnosis device parameter update method and device |
| CN114002424A (en) * | 2021-12-31 | 2022-02-01 | 深圳市帝迈生物技术有限公司 | Sample analyzer and detection method thereof |
| CN117288971A (en) * | 2023-11-24 | 2023-12-26 | 深圳市希莱恒医用电子有限公司 | Intelligent interaction control method and system for electrolyte analyzer |
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Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107622398A (en) * | 2017-08-17 | 2018-01-23 | 广东华银医药科技有限公司 | A kind of character surveillance method applied to external diagnosis reagent |
| CN108281178A (en) * | 2018-02-12 | 2018-07-13 | 深圳迎凯生物科技有限公司 | The newer method and device of in-vitro diagnosis device parameter |
| EP3767426A4 (en) * | 2018-02-12 | 2021-03-31 | Shenzhen Linkray Biotech Co., Ltd | In-vitro diagnosis device parameter update method and device |
| CN110346588A (en) * | 2018-04-04 | 2019-10-18 | 深圳市帝迈生物技术有限公司 | A kind of reagent consumption modification method, reagent liquid injection system and blood analyser |
| CN111323608A (en) * | 2020-02-24 | 2020-06-23 | 杭州微策生物技术有限公司 | POCT detection equipment with temperature and humidity correction function and detection method |
| CN111508596A (en) * | 2020-04-21 | 2020-08-07 | 蓝怡科技集团股份有限公司 | Reagent parameter upgrading method and device, in-vitro detection system and storage medium |
| CN112101830A (en) * | 2020-11-23 | 2020-12-18 | 广州万孚健康科技有限公司 | Preparation and calibration method and system of test strip for detecting HIV antibody and storage medium |
| CN112101830B (en) * | 2020-11-23 | 2021-04-23 | 广州万孚健康科技有限公司 | Preparation and calibration method and system of test strip for detecting HIV antibody and storage medium |
| CN114002424A (en) * | 2021-12-31 | 2022-02-01 | 深圳市帝迈生物技术有限公司 | Sample analyzer and detection method thereof |
| CN117288971A (en) * | 2023-11-24 | 2023-12-26 | 深圳市希莱恒医用电子有限公司 | Intelligent interaction control method and system for electrolyte analyzer |
| CN117288971B (en) * | 2023-11-24 | 2024-02-23 | 深圳市希莱恒医用电子有限公司 | Intelligent interaction control method and system for electrolyte analyzer |
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