四代酶联免疫试剂和硒标快速试剂用于HIV抗体补充试验的比较  

Comparison and analysis of WB as gold standard and two HIV antibody screening kits for HIV diagnosis

作　　者：吴可可[1] 虞成超[1] 钭慧芬[1] 吴矛矛 郑文力[1] 

机构地区：[1]温州市疾病预防控制中心,浙江温州325000

出　　处：《中国艾滋病性病》2017年第3期248-250,共3页Chinese Journal of Aids & STD

基　　金：温州市科技计划项目(Y20160503)~~

摘　　要：目的通过对比分析艾滋病病毒(HIV)抗体筛查阳性结果与蛋白印迹试验(WB)结果,评价2种HIV抗体筛查试剂的检测性能。方法对2012-2016年送到确证实验室的标本,用四代酶联免疫吸附试验(ELISA)伯乐(简称酶标)和雅培硒标(简称硒标)测定,同时对于一阴一阳或双阳性的标本进行WB确证实验。结果总标本数3 557份,酶标阳性2 947份(82.9%),阴性610份(17.1%);硒标阳性2 838份(79.8%),阴性719份(20.2%);初筛双阴性565份,2 992份进行确证实验,确证阳性2 710份(90.6%),阴性131份(4.4%),不确定151份(5.0%)。两种HIV初筛试剂酶标阳性率比硒标高(x^2=10.994,P<0.05),差异有统计学意义。排除不确定标本,三种方法阳性率的差异无统计学意义(x^2=10.031,P>0.05)。酶标、硒标阳性符合率分别为99.74%、99.96%;酶标、硒标的阴性符合率分别为84.5%、95.0%。确证阳性组S/CO值(13.5)明显高于阴性组(2.95)("2=2 841,P=0.000),差异有统计学意义。用受试者特征曲线(ROC曲线)确定伯乐试剂特定阈值为8。结论两种初筛试剂检测性能良好,对于高浓度的标本,两者的检测结果比较一致,与确证试验的阳性符合率也升高;但对于低浓度或特殊标本,与确证试验阳性符合率相对较低,仍是检测的难点和重点。同时建议对于四代伯乐初筛阳性,确证阴性的标本,应进行随访。Objective To evaluate two kits of screening HIV antibody hy comparing and analyzing the results with Western Blot （WB） test results. Methods From 2012 to 2016, ELISA kit （Bio-Rad） and a rapid kit （Abbot Determine HIV-1/2） were used for initial screening HIV antibody. All positive screening results were followed by WB test. Results Among 3557 samples of HIV antibody tests, 2947（82.9%） were positive, of which 610 were negative by ELISA kit （Bio-Rad） ; 2838（79.8%） were positive, and 719（20.2%） as negative by Abbot Determine HIV-1/2. 2710（90.6%） were confirmed as positive, and 131（4.4%） as negative and 151（5.0%） as indeterminate by Western blot assay. The Bio-Rad positive rate was higher than Abbot Determine HIV-1/2, with differences be- tween the two of anti HIV detection results significant （X^2=10. 994, P〈0.05）. Three kits had no significant differences （X^2= 10. 031, P〉0.05）. The positive accordance rate of Bio-Rad and Abbot Determine HIV-1/2 were 99.74%, and 99.96%, and the negative accordance rate were 84.5%, and 95%. The S/CO ratio from Bio-Rad in confirmed positive group（13.5） was higher than that in negative group（2.95） （X^2=2 841 ,P：0. 000）. ROC curve to determine the Bio-Rad threshold was 8. Conclusion The performance of two HIV antibody screening kits is good. As for the samples of high concentration, the results of two kits agree well, and the positive coincidence rate is rai- sing. As for samples of low concentration or special samples, the positive coincidence rate is relatively low. We rec- ommend those with Bio-Rad early screening positive, and the confirmed negative samples should be followed up.

关 键 词：艾滋病病毒 抗体 蛋白印迹试验 酶联免疫吸附试验 

分 类 号：R512.91[医药卫生—内科学] R373.9[医药卫生—临床医学]