Preparation of the national reference panel for hepatitis B surface antigen
10.3760/cma.j.issn.1003-9279.2008.04.024
- VernacularTitle:乙型肝炎病毒表面抗原国家定量标准品的研制
- Author:
Xing WU
1
;
Cheng ZHOU
;
Wen-Jie GU
;
He-Min LI
;
Zi-Bai QI
Author Information
1. 中国药品生物制品检定所
- Keywords:
Hppatitis B;
Hepatitis B surface antigens;
Reference panel;
Reference Standards
- From:
Chinese Journal of Experimental and Clinical Virology
2008;22(4):311-313
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish the national quantity standard of hepatitis B surface antigen according to the world health organization's standard material and prepare, the national liner reference panel for hepatitis B surface antigen. Methods Sera from hepatitis B patients and health blood donors in different areas were collected and detected by domastic HBsAg kits, anti-HBs kits, HBeAg kits, anti-Hbe kits, anti-Hbe kits and anti-HCV,and then confirmed by the kits produced by Abbott, which was approved by WHO. One serum with high concentration of HBsAg was calibrated with the standard sample of WHO. And then it was diluted by 1.5 fold as the liner HBsAg reference panel. Results The HBsAg concentration of one serum was 1226 IU/ml calibrated by 21 independent standardization measurements with 7 kinds of kits. The coefficient of variation of cash calibration were less then 15%. A panel contained 8 serial dilutions was established as the national liner HBsAg reference panel. The permitted range of every dilution was stipulated and the stability of the panel was detected by accelerated test. Conclusions The national quantity standard of hepatitis B surface antigen was established and the national quantitative reference panel for HBsAg which contains eight liner serum was developed.
