Abbott公司HAVAb2.0和HAV-IgG试剂的评价  

Comparisons for kits HAVAb2.0 and HAV-IgG

作　　者：周文亭[1] 王锋[1] 黄昌红[2] 赵守军 张勇[1] 毕胜利[1] 曹经瑗[1] 

机构地区：[1]中国疾病预防控制中心病毒病预防控制所卫生部医学病毒和病毒病重点制中心,北京102206 [2]河南省开封市疾病预防控制中心,开封475000 [3]Department of Radiology, University of California, San Francisco 94143,USA

出　　处：《中华实验和临床病毒学杂志》2017年第2期169-171,共3页Chinese Journal of Experimental and Clinical Virology

基　　金：国家高技术研究发展计划（863计划）（2011AA02A114）

摘　　要：目的 比较Abbott公司的两种抗甲型肝炎（甲肝）病毒（HAV）抗体检测试剂的性能,为甲肝抗体检测试剂的选择提供参考.方法 用两种试剂将倍比稀释的标准品平行检测4遍后,用logistic回归拟合标准曲线,并计算两试剂的组内相关系数（Interclass correlation coefficient, ICC）.选取120份甲肝抗体水平在不同浓度的参比血清用两种方法平行检测,计算灵敏度和特异度、及受试者工作特征（Receive operation characteristic, ROC）曲线下面积（Area under curve, AUC）. 结果 HAV-IgG拟合标准曲线的R2值和ICC为0.9977和0.999,略高于HAVAb2.0试剂的0.9893和0.995（P〉0.05）.以HAV-IgG作为金标准,计算HAVAb2.0的灵敏度和特异度分别为93.15%和100%,AUC为0.994. 结论 试剂HAV-IgG与HAVAb2.0差异很小,均为良好的甲肝抗体检测试剂.Objective Two kits for detecting anti-HAV antibody produced by Abbott Laboratories are evaluated for their performance in order to use in the anti-HAV antibodies detections.Methods Serially diluted standard reference serum were detected 4 times with HAVAb2.0 kit and HAV-IgG kit , then fit standard curves and calculated Interclass correlation coefficient （ICC）.120 serum that have different levels of anti-HAV antibodies were chosen to be detected by two kits and calculated sensitivity and specificity, receive operation characteristic （ROC） curve and area under curve （AUC） while the results of HAV-IgG were used as golden standard.Results R2 and ICC for HAV-IgG were 0.9977 and 0.999, respectively, higher than 0.9893 and 0.995（P〉0.05） for HAVAb2.0.Sensitivity and specificity for HAVAb2.0 were 93.15% and 100% and AUC was 0.994 when kit HAV-IgG was chosen as golden standard.Conclusion There is little difference in performance between HAV-IgG and HAVAb2.0, both of them can be used in anti-HAV antibodies detection.

关 键 词：抗甲型肝炎病毒抗体 诊断试剂 稳定性 真实性 

分 类 号：R392-33[医药卫生—免疫学]