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

作　　者：张勇[1] 王锋[1] 马景臣[2] 张文英[1] 余陶[1] 赵守军 毕胜利[1] 

机构地区：[1]中国疾病预防控制中心病毒病预防控制所传染病预防控制国家重点实验室,北京100052 [2]河北省疾病预防控制中心,石家庄050021 [3]Department of Radiology,University of California

出　　处：《中国疫苗和免疫》2009年第5期388-391,共4页Chinese Journal of Vaccines and Immunization

基　　金：卫生部全国乙型病毒性肝炎血清流行病学调查专项资金

摘　　要：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.

关 键 词：诊断试验 乙型肝炎病毒表面抗原 评价 受试者工作特征曲线 

分 类 号：R373.2[医药卫生—病原生物学]