Hepatitis B e antigen single quality control product and preparation process thereof

A technology of hepatitis B and quality control products, applied in the field of medical inspection quality control, can solve the problems of quality control obstacles in the immune room, few types of quality control products, unstable supply, etc., and achieve low production costs, easy access, and sufficient sources Effect

Inactive Publication Date: 2018-09-21
河北睿达模生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In clinical immunoassays, third-party medical laboratory quality control products are an important means to ensure the quality of inspection as indoor quality control, but there is still a gap compared with indoor quality control of biochemistry, blood cells, and urine, mainly reflected in the variety of quality control products Less, expensive, and unstable supply, etc., have become obstacles to the normal development of quality control in the immune room

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1 Hepatitis B e antigen single quality control product

[0027] (1) Hepatitis B e recombinant antigen diluent: dilute hepatitis B e recombinant antigen 2000 times

[0028] (2) Quality control product stabilizer:

[0029] Bovine serum albumin 30g / L

[0030] Fructose 20 g / L

[0031] Dipotassium hydrogen phosphate 20mmol / L

[0032] Calf serum 25 g / L

[0033] Sodium Thimerosal 5 g / L

[0034] Antigen stabilizer PPCD 10 g / L

[0035] Surfactant SDS 15 g / L.

Embodiment 2

[0036] Example 2 Stability

[0037] The quality control product was frozen at -20°C and tested continuously for 24 months. The long-term frozen storage stability is good, and the results are shown in the table below.

[0038]

0 days

6 months

12 months

18 months

24 months

Test result (COI)

15. 37

15. 46

15. 28

15.79

15.43。

[0039] The quality control product was refrigerated at 2-8°C and tested continuously for 60 days. The long-term refrigerated stability was good, and the results are shown in the table below.

[0040]

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PUM

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Abstract

The invention relates to the field of quality control of medical examination, in particular to the preparation of a single quality control substance of a hepatitis B e antigen. The hepatitis B virus eantigen is diluted to a required value by using a specific stabilizer to prepare the quality control product. The preparation process is simple, the production cost is low, added substances and contents are controllable, the product belongs to a liquid type, redissolution is not required, and the composition is stable. Through a biological traceability link program and reference method assignmentof the program, the product can be used as a third-party medical laboratory quality control product during the validity period to meet the needs of clinical infectious disease testing.

Description

technical field [0001] The invention relates to the field of medical inspection quality control, in particular to the preparation of a single quality control substance for hepatitis B e antigen. Background technique [0002] Hepatitis B virus (HBV) is a pathogen that causes hepatitis B in humans. HBV is a major cause of chronic hepatitis, liver cirrhosis, and liver cancer, and it is widely prevalent throughout the world. Hepatitis B virus e antigen (HBeAg) is a major structural protein of the hepatitis B virus core, and is the core part of the hepatitis B virus, so it is generally believed that HBeAg positive is a sign of infectivity. During the incubation period and even the entire course of the disease, HBeAg can be detected. HBeAg is the third item in the five inspections of hepatitis B. It is not a component of the virus, but a by-product during the synthesis of HBcAg. HBeAg is an indicator of virus replication. Positive HBeAg indicates that the virus in the body is r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/96G01N33/569
CPCG01N33/56983G01N33/96G01N2333/02
Inventor 刘伟兰沈志远李伟皓李君华
Owner 河北睿达模生物科技有限公司
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