五种国产酶免疫测定法抗乙型肝炎病毒表面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 Surface Antigen Detection

作　　者：王锋[1] 马景臣[2] 张文英[1] 余陶[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392-395,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表面抗原抗体(Antibody to Hepatitis B Virus Surface Antigen,Anti-HBs)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-HBs检测试剂,平行检测由44份阳性和108份阴性品组成的参比系统各5次,将每个检测的s/n值(样品速率值与Index标准品平均速率值之比)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 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等。结果五种试剂ICC、CV从优到劣的排序均为D、E、B、C、A,除CV项目试剂E与B外,其他试剂间差异有统计学意义(Bootstrap法,P<0.05);五种试剂的AUC均在0.980～0.993,pAUC从大到小的排序为C、E、D、B、A,除试剂A明显低外,其余并无明显差别;而特异度为0.97时,试剂E的灵敏度明显高于B、C、D,更高于试剂A。结论综合考虑可靠性和真实性指标,以及试剂的用途,认为试剂D为最佳。Objective To Screen an EIA kit that fits best for using in serological detection of anti-HBs in the national investigation of hepatitis B virus infection. Methods Top 5 kinds of kits on the best seller list of China-made anti-HBs EIA detection kits were selected and each was detected the anti-HBs panel（44 positive and 108 negative） 5 times. The s/n ratio of each test was recorded and transformed by log（s/n＋1）. ICC and CV, the reliability indices and AUC, pAUC and Se（FPR=e）, the validity indices were calculated and compared between each kit. Results The indices of ICC and CV of the 5 kinds of kits arranged in the same order of D, E, B, C and A, from the best to the worst and the differences between them were significantly important （Bootstrap method, P〈0.05）, except for between E and B in the index of CV; the AUCs ranged from 0.980 to 0.993 and pAUCs did not differ with each other, except with kit A, the lowest one. Kit E had the highest sensitivity which was higher than kits B, C and D when the specificity was fixed at 0.97, and the later kits were higher than kit A（Bootstrap method, P〈0.05）. Conclusion All the 5 kits are excellent and have synthetically considered the reliability and validity indicators and its function, kit D is the best.

关 键 词：诊断试验 抗乙型肝炎病毒表面抗原抗体 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]