乙型肝炎病毒表面抗原国家定量标准品的研制

Preparation of the national reference panel for hepatitis B surface antigen

目的研制乙型肝炎病毒表面抗原（HBsAg）国家定量标准品及定量线性参考品。方法收集各地乙型肝炎患者和健康献血员血样，用不同厂家乙型肝炎、丙型肝炎病毒血清学试剂盒筛选。6个协作单位用7种试剂以世界卫生组织（WHO）HBsAg定量标准品标定1份HBsAg国家定量标准品，稀释后得到HBsAg国家定量线性参考品。结果经7种试剂共21次协作标定，得到HBsAg国家定量标准品的浓度为1226IC／ml，各次检测结果的变异系数均小于15％。将国家定量标准品系列稀释后得到由8个不同浓度血清组成的HBsAg国家线性参考品，经检测后表明其浓度与理论浓度的差值均〈15％，通过加速试验检测该参考品的稳定性效期暂定为5年。将其作为HBsAg国家线性参考品并初步限定检测结果的允许值范围。结论标定1份HBsAg国家定量标准品并建立了由8份血清组成的HBsAg国家定量线性参考品，

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 eash 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.