Production and use methods of hepatitis B surface antigen serum indoor quality control product

A hepatitis B surface antigen, indoor quality control technology, applied in the medical field, can solve the problems of no preparation and use methods, achieve the optimization of process and product quality control methods, reliable quality of quality control products, accurate and rapid discovery of random problems Effect

Inactive Publication Date: 2016-12-07
CHANGSHA KINGMED MEDICAL DIAGNOSTICS INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Among the relevant patents that have been applied for in China, there is no existing patent on hepatitis B quality control products, that is, in the related technical field, the complete operation method and process are still blank, there is no complete and clear preparation and use method, let alone Sensitivity to random variables and spotting random issues and making continuous improvements

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] A kind of manufacture method of hepatitis B surface antigen serum indoor quality control product, comprises the steps:

[0033] 1) Raw material collection and screening:

[0034] ①Collect HBsAg-positive and negative plasma or serum, mark the hepatitis B-positive plasma or serum and hepatitis B-negative plasma or serum separately, and screen the plasma or serum without obvious hemolysis, jaundice, fat or contamination as a reserve plasma or serum;

[0035] ② Determine the four items of infection (TPPA, HbSAg, HIV, HCV-IgG) on the preparatory plasma or serum screened in step ①, and screen out the negative plasma or serum as the spare plasma or serum;

[0036] 2) Production of diluted serum:

[0037] ① Place the spare plasma or serum obtained in 1) in an environment of 55°C-60°C, keep it warm for 0.5-1h, and perform inactivation treatment;

[0038] ② Centrifuge the inactivated plasma or serum in step ①, the centrifugation speed is 3000-3500r / min, and the centrifugation ...

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Abstract

The invention discloses production and use methods of a hepatitis B surface antigen serum indoor quality control product. The production method includes the five steps of: raw material collection and screening, preparation of diluted serum, storage and monitoring of a standby quality control product, quality control, and continuous improvement; and the use method include the three steps of: storage, re-dissolving, and application. The production and use methods are complete and clear, are sensitive to random variables, and can find random problems and perform continuous improvement. The methods are low in difficult and has good operability since the most common Levery-Jennings quality control chart is employed; and the methods are very sensitive to unpredictable random problems that occur in a production process since a quality control limit of 13S is employed, so that the methods can be used for continuously improving and optimizing the production process in detail during production.

Description

technical field [0001] The invention relates to the medical field, in particular to a method for manufacturing and using an indoor quality control product of hepatitis B surface antigen serum. Background technique [0002] A quality control is a quality control substance (fixed and non-fixed) used in in vitro diagnostics, a substance, material, article or device intended for use in a testing system intended for medical use, the purpose of which is to evaluate or verify Performance characteristics such as measurement precision, measurement accuracy, and possible analytical bias of the detection system due to changes in reagents or analytical instruments. Quality control substances (fixed value and non-fixed value), which can be used for proficiency testing and quality control in the laboratory. [0003] Among the relevant patents that have been applied for in China, there is no existing patent on hepatitis B quality control products, that is, in the related technical field, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/96G01N1/28
CPCG01N33/96G01N1/28G01N2001/2893
Inventor 向玉珍刘程荣唐春燕刘文琼欧阳伟李慧源周梅华代冰
Owner CHANGSHA KINGMED MEDICAL DIAGNOSTICS INST
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