五种国产酶免疫测定法乙型肝炎病毒表面抗原检测试剂的评价

Evaluations of 5 Kinds of China-made Enzyme Immunoassay Kits for Hepatitis B Virus Surface Antigen Detection

目的为全国人群乙型病毒性肝炎(乙肝)血清流行病学调查,筛选适宜的乙肝病毒表面抗原(Hepatitis B Virus Surface Antigen,HBsAg)检测试剂。方法选择符合国家质量标准,且在全国销量最大的五种(A、B、C、D、E)酶免疫测定法HBsAg检测试剂,平行检测由63份阳性和90份阴性品组成的参比系统各5次,将每个检测的s/n值做log(s/n+1)转换,计算并比较各试剂的可靠性指标组内相关系数(Intraclass Correlation Coefficient,ICC)、变异系数(Coefficient of Variability,CV)和真实性指标受试者工作特征(Receiver Operating Characteristic,ROC)曲线下面积(Area Under Curve,AUC)、部分(partial)ROC AUC(pAUC)、固定特异度下灵敏度[Sensitivity at a Fixed Specificity,Se(FPR=e)]等。结果五种试剂ICC、CV从优到劣的排位顺序均为E、C、D、B、A,且差异有统计学意义(Bootstrap法,P<0.05);五种试剂的AUC均在0.965～0.987,pAUC最大的试剂E、B明显高于最小的试剂A、D(Bootstrap法,P<0.05);Se(FPR=e)最高的试剂E明显高于试剂C(Bootstrap法,P<0.05)。结论五种试剂均有较强的诊断能力,其中试剂E为最佳。

Objective To Screen best EIA kit that fits best for using in serological detection of HBsAg in the national investigation of hepatitis B virus infection. Methods Top 5 kinds of kits on the best seller list of Chinamade HBsAg EIA detection reagents were selected and each was detected the HBsAg panel （63 positive and 90 negative） 5 times. The s/n ratio of each test was recorded and transformed by log（s/n＋1）. Reliability indices ICC and CV, and validity indices AUC, pAUC and Se（FPR-e） were calculated and compared between each of the kits. Results The indices of ICC and CV of the 5 kits arranged in the same order of E,C, D, B and A, from the best to the worst, and the differences between them were significantly important （Bootstrap method, P〈0.05）; The AUCs ranged from 0.965 to 0.987, and for kits E and B which had the biggest pAUCs, differs significantly from kits A and D （Bootstrap method, P〈0.05）. Kit E had the highest Se（FPR-e） which was significantly bigger than kit B （Bootstrap method, P〈0.05）. Conclusion The 5 kinds of kits are all excellent and kit E is the best.