HBsAg酶联免疫法诊断试剂的质量评价

Quality Evaluation of HbsAg ELISA Diagnostical Reagent

目的评价HBsAg ELISA诊断试剂盒的质量。方法应用ELISA法对HBsAg国家标准品血清盘、临床科研血清盘、临界值质控血清等进行检测,考评HBsAg诊断试剂盒质量。结果6个厂家试剂均符合国家标准品血清盘判读标准,均能检测出1IU/ml定值质控血清,但测出S/CO值却差异较大,用临床科研血清盘检测,其试剂的灵敏度、特异性、总符合率存在差异。结论不同厂家试剂质量仍存在差异,使用前应进行抽检,综合评价,选择具有灵敏度高、特异性强、精密度好的试剂,优选两种匹配较好的试剂,从而提高HBsAg检出率,减少HBsAg漏检率,有利于控制和减少乙型肝炎的输血传播。

Objective To evaluate the quality of HBsAg ELISA diagnostial reagent kits. Methods In order to evaluate the quality of HBsAg ELISA diagnostial reagent kits,it was used to detect HBsAg national standard serum, the serum for clinic studying and the quality control serum with cut-off value. Results All six different reagent kits accord with the judgement standard of national standard serum, can measure the quality control fixed value serum of 1 IU/ml, hut have great difference of S/CO ratio. In detection of serum for clinic studying, the six reagents existed differences on their sensitivity, specificity, coincidence ratio. Conclusion There were differences on the quality of different reagent kits. Before the reagent being used, the kit should be taken out to check-up its quality. We can choose the reagent kits which having high sensitivity, specificity and accuracy, and select two kinds of matching up better reagent kits, so as to improve the positive ratio of HBsAg and reduce transfusion transmit of hepatitis B virus.