[Preparation of the national reference panel for hepatitis B surface antigen].
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-HBc 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 each 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.
Wu
Xing
X
Department of Cell Biology, National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China.
Zhou
Cheng
C
Gu
Wen-Jie
WJ
Li
He-Min
HM
Qi
Zi-Bai
ZB
D002681:China; D006509:Hepatitis B / Q000821:virology*; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods* / Q000592:standards*; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012015:Reference Standards
D006514:Hepatitis B Surface Antigens; D011933:Reagent Kits, Diagnostic