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[目的]评价5种乙肝病毒表面抗原(HBsAg)诊断试剂盒,筛选高质量的诊断试剂,确保血样HBsAg检测结果准确无误。[方法]5种HBsAg试剂盒均采用ELISA方法,对购买的国家参考品和收集的180份临床血浆标本进行检测,分别与参考品标准和本单位经北京万泰和上海科华双试剂检测一致的结果比较。[结果]5种试剂对灵敏度和精密度参考品的检测均符合要求;检测23份参考品结果的总符合率为96.52%,阳性符合率为100.00%,阴性符合率为96.00%;检测180份临床标本,总符合率为98.56%,阳性符合率为99.00%,阴性符合率为98.67%;检测阳性临床标本的δ值为-6.55(C)~-37.61(E);检测阴性临床标本的δ值为0.92(A)~1.65(E)。[结论]5种试剂在灵敏度、特异性、符合性、准确性方面存在差异,综合评价C试剂质量最符合要求。
[Objective] To evaluate five HBsAg diagnostic kits and screen high-quality diagnostic reagents to ensure the accuracy of HBsAg in blood samples. [Methods] The five kinds of HBsAg kits were detected by ELISA. The purchased national reference samples and 180 clinical plasma samples were collected and tested respectively. The results were in good agreement with reference standards and the two reagents of Beijing Wan Tai and Shanghai Kehua Results comparison. [Results] The sensitivity and precision reference of 5 kinds of reagents were all tested to meet the requirements. The total coincidence rate of 96 samples for reference samples was 96.52%, the positive coincidence rate was 100.00% and the negative coincidence rate was 96.00% The total coincidence rate was 98.56%, the positive coincidence rate was 99.00% and the negative coincidence rate was 98.67%. The δ value of positive clinical specimens was -6.55 (C) ~ -37.61 (E) The value is 0.92 (A) to 1.65 (E). [Conclusion] The sensitivity, specificity, conformance and accuracy of the five kinds of reagents were different. The comprehensive evaluation of the quality of C reagent best met the requirements.