CN102636627B - Inter-batch quality control method for external diagnostic reagent - Google Patents
Inter-batch quality control method for external diagnostic reagent Download PDFInfo
- Publication number
- CN102636627B CN102636627B CN201210071913.3A CN201210071913A CN102636627B CN 102636627 B CN102636627 B CN 102636627B CN 201210071913 A CN201210071913 A CN 201210071913A CN 102636627 B CN102636627 B CN 102636627B
- Authority
- CN
- China
- Prior art keywords
- diagnosis reagent
- external diagnosis
- storage medium
- bar code
- quality control
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Landscapes
- Automatic Analysis And Handling Materials Therefor (AREA)
Abstract
The invention provides an inter-batch quality control method for external diagnostic reagents. The inter-batch quality control method comprises the following steps of printing bar codes including information about external diagnostic reagent kinds and production batch numbers on boxes containing solid or semisolid materials, such as external liquid diagnostic reagents or test paper strips and sheets, and comparing the information carried by the external diagnostic reagents with immediately updated dates of manufacture, batch numbers, correction factors, calculation formulas and formula key coefficients in a storage medium to be corrected. The storage medium comprises a built-in memory disc, a USB flash disk, a mobile hard disk drive or a self-control storage medium. According to the inter-batch quality control method for the external diagnostic reagents provided by the invention, a system can find out relevant information of correction factors and the like to accomplish the marking in the detection process without resetting marks when products of different batches appear, thus the cumbersome work of remarking due to the exchange of the product batch numbers is avoided.
Description
Technical field
The present invention relates to field of medicaments, be specifically related to a kind of external diagnosis reagent batch between quality control method
.
Background technology
The Quality Control of clinical in vitro diagnosis in vitro product is the important aspect of in clinical examination operation.In Quality Control can be divided into batch and batch between two kinds.For most of product, control batch between Quality Control comparatively criticize interior Quality Control difficulty strengthen.The a large amount of human and material resources of input and financial resources are needed to complete.Therefore, part in-vitro diagnosis product also can be taked strict to control batch interpolation, and less difference between batch as far as possible, and to batch between the product method of introducing alignment mechanism make up the deficiency of product.
The product of different batches, certainly exists different.But can be reduced by the introducing of certain bearing calibration or eliminate this species diversity.Such as, for routine biochemistry reaction kit, be generally zymetology reaction, meet first order reaction rate equation, as long as therefore determine that slope in its reactional equation and intercept can determine this kit running parameter.The product of same batch can use same parameter, and the product of different batches only needs to change the demarcation that these two parameters can complete reagent.
Summary of the invention
The invention provides a kind of external diagnosis reagent batch between quality control method, introduce carry this external diagnosis reagent kind, these information of product batch number bar code as alignment mechanism, Quality Control between the carrying out of external diagnosis reagent batch.
Object of the present invention is achieved through the following technical solutions:
A kind of external diagnosis reagent batch between quality control method, the bar code carrying this external diagnosis reagent kind, these information of product batch number printed by the outer box of this kind of solid-state or semisolid external diagnosis reagent of loading liquid external diagnosis reagent or test strips, test-paper, when system detects, the date of manufacture of immediate updating in information self-contained for external diagnosis reagent and storage medium, lot number, correction factor, computing formula and these control informations of formula critical item coefficient are carried out contrast and corrects.
Preferably, described storage medium is the built-in memory disc of system, USB flash disk, portable hard drive, floppy disk or self-control storage medium.
Compared with prior art, the advantage of technical scheme of the present invention is:
By external diagnosis reagent provided by the invention batch between quality control method, in testing process, when there is the product of different batches, do not need again to calibrate, system can according to information entrained in test strips, corresponding with the file upgraded by storage medium, finds out the relevant informations such as correction factor, completing demarcation, eliminating the tedious work again calibrated because changing batch number.
Embodiment
External diagnosis reagent of the present invention batch between quality control method, be applicable to liquid external diagnosis reagent or test strips, this kind of solid-state or semisolid external diagnosis reagent of test-paper.The outer box loading external diagnosis reagent is printed the bar code carrying this external diagnosis reagent kind, these information of product batch number, when system detects, the date of manufacture of immediate updating in information self-contained for external diagnosis reagent and storage medium, lot number, correction factor, computing formula and these control informations of formula critical item coefficient are carried out contrast and corrects.
The control information of external diagnosis reagent is using USB flash disk, portable hard drive, floppy disk or self-control storage medium etc. as storage medium, be stored in system with the form of file update, or using the part as system of storage medium, information directly stores, and directly upgrades the file in USB flash disk or portable hard drive.
The information such as date of manufacture, product batch number of external diagnosis reagent is carried on bar code, when system detects, first the relevant informations such as the date of manufacture corresponding with this lot number diagnostic reagent on bar code, lot number, correction factor, computing formula, formula critical item coefficient whether are carried in certainty annuity updating file or storage medium, if will normally run containing system, if do not carried, system will be pointed out or be quit work.
Embodiment 1 fluorescent quantitation test strip
Test strips shell is printed with bar code, carries the relevant informations such as test strips kind, product batch number.The updating file corresponding with this test strips is downloaded, the relevant informations such as the correction factor containing this lot number test strips in updating file to enterprise web site.In testing process, when occurring the product of different batches, do not need again to calibrate, system can according to information entrained in test strips, corresponding with the file upgraded by USB flash disk, finds out the relevant informations such as correction factor, complete demarcation.Eliminate the tedious work again calibrated because changing batch number.
Embodiment 2 biochemical reaction kit
The information such as the correction factor of this kit are downloaded in the information enterprise website that the bar code of kit outside carries kit lot number.
Above-described embodiment, just in order to technical conceive of the present invention and feature are described, its objective is and is one of ordinary skilled in the art can be understood content of the present invention and implement according to this, can not limit the scope of the invention with this.The change of every equivalence done by the essence of content of the present invention or modification, all should be encompassed in protection scope of the present invention.
Claims (2)
1. external diagnosis reagent batch between a quality control method, it is characterized in that, comprise the following steps:
Step 1) on the outer box being loaded with liquid solid-state or semi-solid external diagnosis reagent, be provided with bar code, described bar code comprises the following information about described external diagnosis reagent: external diagnosis reagent kind, product batch number, date of manufacture, correction factor, computing formula and formula critical item coefficient;
Step 2) before the outer box of described external diagnosis reagent is detected, by these six groups of data of the external diagnosis reagent kind of this external diagnosis reagent immediate updating, product batch number, date of manufacture, correction factor, computing formula and formula critical item coefficient stored in storage medium;
Step 3) is when detecting the outer box of described external diagnosis reagent, first determine whether the bar code on outer box contains following information: external diagnosis reagent kind, product batch number, date of manufacture, correction factor, computing formula and formula critical item coefficient, if the information that described bar code carries is complete, then detect and continue down to carry out, if the information that described bar code carries lacks any one in external diagnosis reagent kind, product batch number, date of manufacture, correction factor, computing formula and formula critical item coefficient, detect and will be stopped;
Step 4) is when carrying out continuation and detecting at the outer box complete to bar code carry information, if find the product of different batches, without the need to again calibrating, according to the information that described bar code carries, with six groups of data comparisons one by one of immediate updating in storage medium, and complete calibration eventually through the correction of these six groups of data.
2. external diagnosis reagent according to claim 1 batch between quality control method, it is characterized in that, described storage medium be the built-in memory disc of system, USB flash disk, portable hard drive, floppy disk or self-control storage medium in any one.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210071913.3A CN102636627B (en) | 2012-03-19 | 2012-03-19 | Inter-batch quality control method for external diagnostic reagent |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210071913.3A CN102636627B (en) | 2012-03-19 | 2012-03-19 | Inter-batch quality control method for external diagnostic reagent |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102636627A CN102636627A (en) | 2012-08-15 |
| CN102636627B true CN102636627B (en) | 2015-04-08 |
Family
ID=46621097
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201210071913.3A Active CN102636627B (en) | 2012-03-19 | 2012-03-19 | Inter-batch quality control method for external diagnostic reagent |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102636627B (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109142763A (en) * | 2018-08-29 | 2019-01-04 | 湖南达道生物工程有限公司 | A kind of POCT detection device having auto-scaling and its implementation |
| CN111239429A (en) * | 2018-11-29 | 2020-06-05 | 深圳迈瑞生物医疗电子股份有限公司 | In-vitro diagnostic apparatus, reagent management device and method for replacing reagent |
| 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 |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1510987A (en) * | 2002-12-17 | 2004-07-07 | 重机公司 | Electronic component mistake assembling preventing system |
| CN1556494A (en) * | 2004-01-01 | 2004-12-22 | 邹剑钢 | Commodity automatic identification antifalse system using coding method |
| CN1734450A (en) * | 2005-05-23 | 2006-02-15 | 深圳创维－Rgb电子有限公司 | Method for storing and inquiring identity information of sale merchandise |
| CN1808460A (en) * | 2005-01-20 | 2006-07-26 | 英业达股份有限公司 | Package verification system and method |
| CN101149792A (en) * | 2006-09-21 | 2008-03-26 | 国际商业机器公司 | System and method for performing inventory using a mobile inventory robot |
-
2012
- 2012-03-19 CN CN201210071913.3A patent/CN102636627B/en active Active
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1510987A (en) * | 2002-12-17 | 2004-07-07 | 重机公司 | Electronic component mistake assembling preventing system |
| CN1556494A (en) * | 2004-01-01 | 2004-12-22 | 邹剑钢 | Commodity automatic identification antifalse system using coding method |
| CN1808460A (en) * | 2005-01-20 | 2006-07-26 | 英业达股份有限公司 | Package verification system and method |
| CN1734450A (en) * | 2005-05-23 | 2006-02-15 | 深圳创维－Rgb电子有限公司 | Method for storing and inquiring identity information of sale merchandise |
| CN101149792A (en) * | 2006-09-21 | 2008-03-26 | 国际商业机器公司 | System and method for performing inventory using a mobile inventory robot |
Also Published As
| Publication number | Publication date |
|---|---|
| CN102636627A (en) | 2012-08-15 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| Kuang et al. | miRDeep-P2: accurate and fast analysis of the microRNA transcriptome in plants | |
| Shi et al. | Overview of sixteen green analytical chemistry metrics for evaluation of the greenness of analytical methods | |
| Imbeaud et al. | Towards standardization of RNA quality assessment using user-independent classifiers of microcapillary electrophoresis traces | |
| Jia et al. | The calibration of cellphone camera-based colorimetric sensor array and its application in the determination of glucose in urine | |
| CN102636627B (en) | Inter-batch quality control method for external diagnostic reagent | |
| Bunk et al. | MetaQuant: a tool for the automatic quantification of GC/MS-based metabolome data | |
| US20090204250A1 (en) | System and method for integrating rfid sensors in manufacturing system comprising single use components | |
| CN101680877B (en) | System for measuring an analyte concentration in a bodily fluid sample | |
| Yang et al. | A portable system for on-site quantification of formaldehyde in air based on G-quadruplex halves coupled with A smartphone reader | |
| WO2009142087A1 (en) | Automatic analyzer | |
| CN104063254B (en) | Online upgrading method for electric energy meter | |
| Nagelmüller et al. | Leaf Length Tracker: a novel approach to analyse leaf elongation close to the thermal limit of growth in the field | |
| Saleh et al. | Guidelines for accurate application of green and white analytical concepts: Merits vs demerits with insights of significant milestones of assessment tools applied for antiviral drugs | |
| Lee et al. | An acridine-based fluorescent sensor for monitoring ClO− in water samples and zebrafish | |
| Żurawik et al. | Revisiting mitochondrial pH with an improved algorithm for calibration of the ratiometric 5 (6)-carboxy-SNARF-1 probe reveals anticooperative reaction with H+ ions and warrants further studies of organellar pH | |
| IL298014A (en) | Method of evaluating the quality of a color reference card | |
| CN115728445B (en) | Sensor calibration method, device, equipment and computer readable storage medium | |
| Morcia et al. | A chip digital PCR assay for quantification of common wheat contamination in pasta production chain | |
| EP3734439A1 (en) | Server, printer, and program | |
| CN103575774A (en) | Electrochemical test strip reading device and method | |
| Li et al. | sRNAminer: A multifunctional toolkit for next-generation sequencing small RNA data mining in plants | |
| Pandey et al. | WGSSAT: a high-throughput computational pipeline for mining and annotation of SSR markers from whole genomes | |
| Rodrigues et al. | Resistance to oxidation of white wines assessed by voltammetric means | |
| Zheng et al. | Alternative splicing during fiber development in G. hirsutum | |
| CN104246511B (en) | Reagent preparation support equipment and method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |