Wu S, Su T, Lin J, Chen Y, Wang Y, Zhou C, Xu Q, Li H
National Institute for the Control of Pharmaceutical and Biological Products, Beijing, People's Republic of China.
Biologicals. 1993 Sep;21(3):193-6. doi: 10.1006/biol.1993.1075.
A National Quality Control Reference Panel for Hepatitis B Diagnostic Kits has been established. Markers for these standards which were prepared include National Standards for HBsAg and anti-HBs calibrated against WHO International Standards. In addition, Reference Panels for HBeAg, anti-HBe, anti-HBc, anti-HBc IgM and HBV were established and National Requirements set. These panels have been used for the nationwide evaluation of HB kits and for licensing purposes.
已建立了一个全国性的乙型肝炎诊断试剂盒质量控制参考小组。所制备的这些标准品的标志物包括参照世界卫生组织国际标准校准的乙型肝炎表面抗原（HBsAg）和乙型肝炎表面抗体（抗-HBs）国家标准品。此外，还建立了乙型肝炎e抗原（HBeAg）、乙型肝炎e抗体（抗-HBe）、乙型肝炎核心抗体（抗-HBc）、乙型肝炎核心抗体IgM（抗-HBc IgM）和乙肝病毒（HBV）参考小组，并制定了国家要求。这些参考小组已用于全国范围内乙型肝炎试剂盒的评估和许可目的。
