三种类型HIV抗体检测技术的方法学评价  

Comparison of three kinds of HIV antibody diagnostic assays in finding HIV infection

作　　者：沈蕊[1] 裴丽健[1] 岳志远[1] 陈兵[1] 邢文革[1] 

机构地区：[1]中国疾病预防控制中心性病艾滋病预防控制中心,北京102206

出　　处：《中国艾滋病性病》2016年第5期324-327,344,共5页Chinese Journal of Aids & STD

基　　金：全球基金艾滋病项目~~

摘　　要：目的对不同原理的艾滋病病毒（HIV）抗体诊断方法进行评价,了解现有HIV抗体诊断试剂的敏感性、特异性等性能。方法应用6种血清盘[即基础血清盘、干扰样本血清盘、线性稀释系列血清盘、精密度血清盘、美国病理学家协会（CAP）能力验证血清盘以及商业阳转血清盘]对三种类型HIV抗体检测方法[HIV快速检测方法、HIV酶联免疫吸附试验（ELISA）、蛋白印迹试验（WB）]的诊断试剂的敏感性、特异性、分析灵敏度、分析特异性及精密度等指标进行评价。结果 1）A（国产抗体）、B（国产抗体）、C（国产抗原抗体）、D（进口抗原抗体）、E（国产胶体金法）、F（进口胶体硒法）6种试剂应用基础血清盘评估,敏感性均为100%（40/40）,特异性均〉97.5%（39/40）。2）A-D ELISA检测试剂板内精密度值介于4.40%~24.98%之间。3）用商业阳转血清盘评价,A-F试剂阳性率分别为18.2%、16.7%、33.3%、37.9%、19.7%、18.2%,并且差异有统计学意义（P〈0.05）;各试剂检测结果相比核酸检测的延长天数介于7~10.8天,D（进口抗原抗体）最短,WB试剂最长;重组免疫印迹试验（RIBA）与WB试剂检测结果进行配对差异有统计学意义（χ^2检验,P〈0.05）。结论参与评价的ELISA诊断试剂与快速诊断试剂均有较高的敏感性和特异性,抗原抗体检测试剂敏感性相对较高,适合作为抗体筛查试剂。4种ELISA试剂板内精密度差别较大。作为抗体确证试剂,RIBA与WB相比敏感性较高,不确定率低,从而发现早期感染的检验效能较高,减少了由于不确定带来的随访率。Objective To evaluate the quality of three kinds of human Immunodeficiency virus（HIV）antibody assay diagnostic kits in detecting HIV infection.Methods Four HIV ELISA test kits,two HIV rapid test kits and two HIV West Blot test kits were evaluated by six serum panels including master panel,seroconversion panels,cross-reacting panels,linear dilution series panels,precision quality product panels,and College of American Pathologists proficiency testing panels.Results 1）Sensitivity and specificity of all the six reagents were 100%and 97.5%respectively;2）The intraplate precision value of ELISA assays was between 4.40%-24.98%;3）Based on seroconversion panel,positive rate of A-F assays were 18.2%,16.7%,33.3%,37.9%,19.7%,18.2%,and the difference was statistically significant（P〈0.05）.Compared with nucleic acid test,the antibody diagnostic assays were 7to 10.8days longer for positive results,D assay was the shortest one,and West Blot kits was the longest.There was a statistically significant difference between recombinant immunoblot assay（RIBA）and West Blot kits（P〈0.05）.Conclusion The sensitivity and specificity of the kits are both high.The antigen/antibody combination immunoassay sensitivity was relatively high,better for antibody screening.Compared with West Blot,RIBA was better to detect the early HIV infection.

关 键 词：艾滋病病毒 抗体诊断试剂 抗原抗体诊断试剂 重组免疫印迹试剂 快速诊断试剂 阳转血清盘 

分 类 号：R512.91[医药卫生—内科学]