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

CN108562754AInactive Publication Date: 2018-09-21河北睿达模生物科技有限公司
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Publication Date
2018-09-21
Estimated Expiration
Not applicable · inactive patent
Patent Text Reader

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.
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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...

Examples

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]