Inter-batch quality control method for external diagnostic reagent

A technology of in vitro diagnosis and quality control methods, applied in the field of medicine, can solve problems such as increased difficulty, and achieve the effect of saving tedious work

Active Publication Date: 2012-08-15
SUZHOU INST OF BIOMEDICAL ENG & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For most products, controlling inter-batch quality ...

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Example 1 Fluorescence quantitative detection test strip

[0015] A barcode is printed on the outer shell of the test strip, carrying relevant information such as the type of the test strip and the production batch number. Go to the enterprise website to download the update file corresponding to the test strip, which contains the correction factor and other relevant information of the test strip of the batch number. During the detection process, when there are different batches of products, there is no need to re-calibrate. The system will find out the correction factor and other relevant information according to the information carried on the test strip and the file updated through the U disk, and complete the test. calibration. The tedious work of recalibrating due to changing the batch number of the product is saved.

Embodiment 2

[0016] Example 2 Biochemical Reaction Kit

[0017] The barcode on the outside of the kit carries the batch number information of the kit. Just download the calibration factor and other information of the kit from the company website.

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PUM

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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 [0001] The invention relates to the field of medicine, in particular to an inter-batch quality control method for in vitro diagnostic reagents. Background technique [0002] The quality control of clinical in vitro diagnostic products is an important aspect in clinical testing operations. Quality control can be divided into two types: intra-assay and inter-assay. For most products, controlling inter-batch quality control is more difficult than intra-batch quality control. Need to invest a lot of manpower, material resources and financial resources to be able to complete. Therefore, some in vitro diagnostic products can also adopt strict control of intra-assay variation, minimize inter-assay variation, and introduce a calibration mechanism for inter-assay products to make up for product insufficiency. [0003] There are bound to be some differences between different batches of products. However, this difference can be reduced or eliminated by introducing a...

Claims

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Application Information

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IPC IPC(8): G01N33/15
Inventor 尹焕才唐玉国王心醉韩坤孙海旋
Owner SUZHOU INST OF BIOMEDICAL ENG & TECH
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