HIV抗原抗体联合检测试剂在高危人群筛查中的应用  

Use of combined HIV antigen/antibody screening assay among HIV high-risk population

作　　者：郑晓虹[1] 张玮[1] 陈安琪[1] 薛以乐[1] 盖晶[1] 宁镇[1] 

机构地区：[1]上海市疾病预防控制中心艾滋病性病防治科,上海200336

出　　处：《诊断学理论与实践》2008年第2期168-171,共4页Journal of Diagnostics Concepts & Practice

基　　金：上海市卫生局科技发展基金项目(054022)

摘　　要：目的:应用第四代人类免疫缺陷病毒(HIV)抗原抗体联合检测试剂,对静脉吸毒及性乱人群、同性恋人群和临床可疑HIV感染患者进行HIV筛查,以了解第四代试剂的检测灵敏度和特异度。方法:分别用第三代和第四代HIV抗原抗体检测试剂,对静脉吸毒及性乱、同性恋、可疑HIV感染人群的样本进行检测,阳性反应样本用免疫印迹法(Westernblot,WB)进行确认;第三代试剂检测为阴性而第四代试剂呈阳性反应的标本,除进行WB确认试验外,再加作P24抗原检测和HIV-1RNA检测。结果:第三代和第四代试剂检测HIV感染的灵敏度均为100%,特异度则分别为97.99%和96.36%。但在早期感染样本中,第四代试剂的阳性反应较第三代试剂强;在检测静脉吸毒及性乱人群样本中,第四代试剂的特异度为99.37%,假阳性率为0.62%(95%可信区间为0.3%～1.2%);在检测同性恋人群样本中,第三代试剂和第四代试剂的特异度分别为99.03%和98.45%。在可疑HIV感染患者样本中,第三代和第四代试剂筛查呈阳性反应经WB确认的阳性符合率分别为92.86%和89.00%。结论:相对于第三代HIV检测试剂,第四代HIV抗原抗体联合检测试剂诊断HIV感染的灵敏度与之相同,而特异度则稍低。Objective Using fourth-generation combined HIV antigen/antibody assay for the screening of HIV in IDU （injection drug user）, MSM （men who have sex with men） and sexually promiscuous people for assessing the sensitivity and specificity of this fourth-generation HIV assay. Methods Blood specimens from IDU, MSM and sexually promiscuous people were tested using both the third-generation HIV assay and fourth-generation combined HIV antigen/antibody assay. Positive specimens were confirmed by Western blot assay. Specimens positive for fourth-generation assay but negative for third-generation assay were additionally re-tested by HIV P24 antigen test and HIV-1 RNA test. Results The sensitivity rates of third- and fourth- generation HIV assays were both 100%; the specificity rates were 97.99% and 96.36%, respectively. However, in specimens of early HIV infection, the degree of reaction positivity in fourth-generation assay was stronger than that in third-generation assay. The specificity rate of fourth-generation HIV assay was 99.37% and false positive rate was 0.62% （95% CI ： 0.3%-1.2%） in IDU and sexually promiscuous people. The specificity rates of the third- and fourth-generation HIV assay reagents were 99.03% and 98.45% respectively in MSM. The confirmed rates of the positive third- and fourth- generation HIV assay were 92.86% and 89.00%, respectively. Conclusions The sensitivity of fourth- generation HIV assay was slightly higher （without statistical significance） but specificity slightly lower than thirdgeneration HIV assay.

关 键 词：人类免疫缺陷病毒 第四代HIV试剂 筛查 HIV高危人群 

分 类 号：R512.91[医药卫生—内科学]