血液/口腔黏膜渗出液/尿液HIV抗体快速检测试剂的性能评价

Performance evaluation of HIV antibodies rapid diagnostic tests on blood, oral mucosal transudate and urine

目的构建血液、口腔黏膜渗出液(OMT)、尿液HIV抗体快速评价盘,评价3种血液,2种OMT和1种尿液HIV抗体快速检测试剂的性能。方法用血液、OMT、尿液国家参考品,实验室评价盘(包括实验室基础盘、实验室干扰盘、实验室稀释系列盘、实验室精密度盘),商业阳转血清盘,对6种(3种血液,2种OMT和1种尿液)HIV抗体快速检测试剂进行评价,肉眼判读结果,并用金标免疫层析试纸读数仪测定相应的GOD值。结果1)6种试剂的阴性参考品符合率均为20/20,HIV-1阳性参考品符合率均为18/18,3种血液和2种OMT试剂的HIV-2阳性参考品符合率均为2/2。2)3种血液试剂的阳性样本符合率和阴性样本符合率均为40/40,2种OMT试剂的阳性样本符合率均为40/40,阴性样本符合率分别为40/40和38/40。尿液试剂的阳性样本符合率和阴性样本符合率为30/30。3)3种血液试剂的分析灵敏度均为2/3,2种OMT试剂的分析灵敏度分别为3/5和0/5,尿液试剂的分析灵敏度为3/5。4)3种血液试剂的分析特异性均为45/45,2家OMT试剂的分析特异性分别为45/45和36/45,尿液试剂的分析特异性为45/45。5)GOD结果显示6家试剂的批内精密度在7.8%~44.0%之间。结论6家试剂的阴性参考品符合率,阳性参考品符合率,阳性样本符合率、阴性样本符合率均较好。1家OMT试剂的分析灵敏度和分析特异性较差,6种试剂的批内精密度存在差异。

Objective To construct the evaluation panels of HIV blood,OMT and urine RDTs,and evaluate performances of 3 HIV blood RDTs,2 HIV OMT RDTs and a HIV urine RDTs.Methods 3 HIV blood RDTs,2 HIV OMT RDTs and a HIV urine RDTs were evaluated by blood,OMT and urine national reference panel,the lab basic panel,the lab analytical specificity panel,the lab dilution panel,the lab precision panel and HIV-1 seroconversion panel.The results were visually read and detected by the reader to get GOD value.Results 1)For the 6 HIV RDTs,consistency of the negative reference was all 20/20,and that of HIV-1 positive reference was all 18/18.For the 3 HIV blood RDTs and 2 HIV OMT RDTs,consistency of HIV-2 positive reference was all 2/2.2)For the 3 HIV blood RDTs,consistency of positive sample and that of negative sample were all 40/40.For the 2 HIV OMT RDTs,consistency of positive sample was all 40/40,and that of negative sample was 40/40 and 38/40.For the HIV urine RDTs,consistency of positive sample and that of negative sample were all 30/30.3)The analytical sensitivity of the 3 HIV blood RDTs was all 2/3,of the 2 HIV OMT RDTs was 3/5 and 0/5,and of the HIV urine RDTs was 3/5.4)The analytical specificity of the 3 HIV blood RDTs was all 45/45,of the 2 HIV OMT RDTs was 45/45 and 36/45,and of the HIV urine RDTs was 45/45.5)The within-lot precision ranged from 7.8%to 44%of the 6 HIV RDTs.Conclusion The 6 HIV RDTs have high consistency of negative reference,positive reference,positive sample and negative sample.The HIV OMT RDTs have lower analytical sensitivity and specificity.The 6 HIV RDTs have different within-lot precision.