三种四代HIV筛查试剂检测窗口期的差异研究

Evaluation the performance of three HIV antigen-antibody combination assays in the detection of HIV in the window period

目的 比较3种不同技术原理的第四代HIV筛查试剂诊断HIV感染检测窗口期的差异.方法 采用第四代电化学发光法（ECLIA）、化学发光法（CLIA）及酶联免疫法（ELISA）3种不同技术原理的HIV抗原抗体联合检测试剂,对2009至2011年本实验室男男同性恋高危人群队列发现的急性HIV感染者26例的37份血浆样本及购买的国际HIV感染阳转血清盘22份样本进行检测,比较3种试剂检测HIV感染的窗口期长短及敏感度.3种试剂检测HIV早期感染敏感度比较使用卡方检验进行统计学分析.结果 3种试剂检测窗口期长短不同.对国际HIV感染阳转血清盘22份样本,ECLIA和CLIA试剂检测结果一致,窗口期比ELISA试剂估计缩短至少1～5d.对本室收集的急性HIV感染37份样本,ECLIA和CLIA试剂全部检出,ELISA试剂结果一致率为94.6％.3种试剂对HIV感染阳转前样本检测敏感度差异有统计学意义,ECLIA和CLIA试剂敏感度相同（93.5％）,高于ELISA试剂敏感度（71.0％）（x2=5.14,P＜0.05）.结论 3种不同技术原理四代筛查试剂对HIV早期感染检测窗口期及敏感度存在差异,ECLIA试剂和CLIA试剂间无差异,优于ELISA试剂.

Objective To evaluate the detectability of HIV antigen-antibody in the window period of acute infection by three HIV antigen-antibody assays.Methods Twenty-two samples of HIV seroconversion serum panels and thirty-seven HIV acute infected plasm samples from our laboratory collected from cohort study of men who have sex with men between 2009 and 2011,were assayed by ECLIA,CLIA and ELISA methods.All assays were evaluated for the ability to detect HIV in the window period,and the sensitivity of each assay for acute samples was analyzed.Chi square test was used for statistical analysis.Results The ability of detecting HIV in the window period of each assay was different.For HIV seroconversion serum panels,the results of ECLIA and CLIA assays were consistent,and the window period was shortened at least 1 to 5 days compared with ELISA assay.For HIV acute samples,all were HIV positive by ECLIA or CLIA assay,but for ELISA assay,94.6％ was positive.For samples before seroconversion,ECLIA and CLIA assay had the same sensitivity （93.5％）,which is superior to ELISA assay （71.0％） （x2 =5.14,P ＜0.05）.Conclusion The ability of detecting HIV in the window period was different for each assay.The results of ECLIA and CLIA assay are consistent,superior to ELISA assay.