五种国产酶免疫测定法抗乙型肝炎病毒e抗原抗体检测试剂的评价  

Evaluation of 5 Kinds of China-made Enzyme Immunoassay Kits for Antibody to Hepatitis B Virus e Antigen Detection

作　　者：王锋[1] 马景臣[2] 余陶[1] 张文英[1] 赵守军 张勇[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396-399,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,筛选适宜的抗乙肝病毒e抗原抗体(Antibody to Hepatitis B Viruse Antigen,Anti-HBe)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Anti-HBe检测试剂,平行检测由66份阳性和86份阴性品组成的参比系统各5次,将每个检测的co/s值(诊断试验截断值与样品速率值之比)做log(co/s+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 Vaviability,CV)和真实性指标曲线下面积(Area Under Curve,AUC)、部分(partial)AUC(pAUC)、固定特异度下的灵敏度[Sensitivity at a Particular False-Positive-Rate,Se(FPR=e)]等。结果五种试剂ICC、CV从优到劣的排序均为A、E、C、D、B,ICC除试剂C与E外,其他试剂间差异均有统计学意义(Bootstrap法,P<0.05);五种试剂的AUC均在0.969～0.996,pAUC从大到小的排序为C、E、D、A、B,且试剂C明显高于试剂A、B、D、E(Bootstrap法,P<0.05);Se(FPR=e)排序为C、D、E、B、A,试剂C明显高于其他四种试剂(Bootstrap法,P<0.05)。结论五种符合国家质量标准的试剂诊断性能均好,其中试剂C为最佳。Objective The aim of this study is to select a better one from five EIA kits made in China for the serological detection of anti-HBe in a national hepatitis B survey. Methods Top 5 kinds of kits on the best seller list of China-made anti-HBe EIA detection were selected and each was detected the anti-HBe panel （66 positive and 88 negative） 5 times. The co/s ratio of each test was recorded and transformed by log（co/s＋1）. ICC and CV, the reliability indices and AUC, pAUC and Se（FPR=e）, the validity indices were calculated and compared between every two kits. Results The indices of ICC and CV of the 5 kinds of kits arranged in the same order of A, E, C, D and B, from the best to the worst. For ICC, there were significantly different between every two of them （Bootstrap method, P〈0.05）, except for between kit C and E. The magnitude of AUCs were from 0.969 to 0.996; the orders ofpAUC and Se（FPR=c） indices was C, E, D, A, B, and C, D, E, B, A respectively; both the indices of kit C were significantly higher than others （Bootstrap method, P〈0.05）. Conclusion All the 5 kinds of kits are excellent and kit C is the best.

关 键 词：诊断试验 抗乙型肝炎病毒e抗原抗体 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]