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 compare the detection results of HIV antibody screening and Western blotting (WB) to evaluate the detection performance of two HIV antibody screening reagents. Methods The specimens sent to confirmatory laboratory from 2012 to 2016 were determined by four generations of enzyme-linked immunosorbent assay (ELISA) and Abbott-Selenium standard (referred to as selenium standard) Sexual specimens for WB confirmation experiments. Results The total number of samples was 3 557, with 2 947 positives (82.9%) and negative 610 (17.1%) positives, 2 838 positive selenium (79.8%) and 719 negative (20.2% 565 copies and 2 992 confirmations were confirmed, 2 710 (90.6%) were positive, 131 (4.4%) were negative and 151 (5.0%) were uncertain. The positive rates of two kinds of HIV screening reagents were higher than selenium (x ~ 2 = 10.994, P <0.05), the difference was statistically significant. Excluding uncertain samples, the positive rate of the three methods showed no significant difference (x ~ 2 = 10.031, P> 0.05). The positive coincidence rates of enzyme and selenium were 99.74% and 99.96%, respectively. The coincidence rates of enzyme and selenium were 84.5% and 95.0%, respectively. The S / CO value of the positive group (13.5) was significantly higher than that of the negative group (2.95) (P = 0.0002), and the difference was statistically significant.Using the ROC curve of the receiver operating characteristic curve The specific threshold is 8. Conclusion The two kinds of pre-screening reagents have good performance in detection, and the detection results of the two are consistent and the positive coincidence rate with the confirmatory test is also increased for the high-concentration samples. However, for the low-concentration or special samples, Test positive coincidence rate is relatively low, is still the detection of the difficulties and priorities.At the same time recommended for four generations of Bole positive, negative confirmation specimens should be followed up.