乙型肝炎表面抗原酶联免疫法检测试剂的性能评价

目的对我室使用国产乙型肝炎表面抗原酶联免疫法（ELISA）检测试剂进行性能评价。方法用ELISA法使用国产试剂检测国家参考品（n=33）、临床科研血清盘（n=40）及临床标本（n=270）,判断其是否符合国家检定标准,并分析其真实性、可靠性和收益指标。结果检测国家参考品的阴性符合率为100%（20/20）,阳性符合率为100%（3/3）,三种亚型的最低检出量均为0.5ng/mL;其真实性指标：灵敏度、特异性、粗一致性和约登指数（Youden）分别为96.88%、99.45%、98.39%和0.96;可靠性指标：变异系数（CV）和Kappa值分别为5.2%和0.96;收益指标：阳性预测值与阴性预测值分别为99.20%和97.84%。结论国产试剂性能评价结果优质,适用于临床标本检测。

The quality evaluation of ELISA kit for detection of HBsAg

Objective To evaluate the home-made ELISA kit used in our laboratory for detection of HBsAg.Methods The National References（n=33）,Clinical Science Research Serum Panel（n=40） and clinical specimens（n=270） were detected by the ELISA kit.The authenticity,reliability and profit of the kit were also analyzed.Results The National References were detected by the home-made kit with results showing that the negative and positive consistency were both 100%.The minimum doses for detection of 3 subtype of HBsAg,i.e.adr,adw and ay,were all 0.5 ng/mL.The sensitivity,specificity,crude consistency and Youden Index of the home-made kit were 96.88%,99.45%,98.39% and 0.96,respectively.The reliability indices,including CV and Kappa values were 5.2% and 0.96,respectively.The profit indices,including the positive prediction values and the negative predictive values were 99.20% and 97.84%,respectively.Conclusion The home-made ELISA kit for detection of HBsAg meets the requirements of standards obtained by the National References,suggesting that the kit is highly qualified for the clinical use.