【摘要】 按新的方案建立了用于乙型肝炎诊断试剂的国家质控标准。包括用WHO国际标准品标化建立的我国HBsAg、抗-HBs定量标准品,对试剂的特异性、灵敏度、精密性、线性进行质量控制检定的系列参比品,及经过实验制订的检定标准。经近年来的实际应用,对国产试剂质量的提高起到了推动作用。更多还原

【Abstract】 National quality control reference panels for hepatitis B diagnostic reagents have been established according to a new design,including national HBsAg and anti-HBs standards standardized by WHO international standards; reference panels for specificity, sensitivity, precision and linearity test;and national requirements set up by experiments. These panels have been used in nationwide evaluation of hepatitis B kits and in examination tests for license release. They therefore serve effectively to improve the quality of domestic kits.更多还原