胶体金法检测尿液HIV-1抗体的应用评价

Evaluation of colloidal gold method for detection of HIV-1 antibody in the urine

【目的】在新疆维吾尔自治区(简称“新疆”)艾滋病防治示范区进行人类免疫缺陷病毒(HIV)抗体尿液检测的验证和推广,评估试剂的灵敏度、特异度和志愿者的检测感受,以作为是否适合地区大规模使用的依据。【方法】在新疆某地采用分层整群抽样选取调查对象进行问卷调查及采样。运用多因素logistic回归分析对问卷结果进行统计描述,探寻HIV-1尿检试剂使用意愿的影响因素。以血液酶联免疫吸附试验(ELISA)抗体检测结果为参照,计算总人群和不同人群尿液HIV-1抗体检测的特异度、灵敏度、Kappa值等指标。【结果】共招募2 504名参加尿液自检试剂应用研究的志愿者。总人群尿液HIV-1抗体检测灵敏度为94.73%(54/57),特异度为100%(2447/2 447),阳性预测值为100%(54/54),阴性预测值为99.88%(2 447/2 450)。不同人群比较各人群特异度均为100%。孕妇、性工作者人群、吸毒人员灵敏度均为100%,男男性行为者(MSM)人群灵敏度为50%(1/2),Kappa值为0.796。自愿咨询者灵敏度为80%(8/10),Kappa值为0.878。满意度调查中73.1%人群较于血液快速试剂检测更能接受尿液快速试剂检测,93.8%人群愿意推荐给他人尿液快速试剂检测,超过70%的人群均满意认可尿液快速检测试剂。多因素logistic回归分析表明年龄、文化程度、职业、婚姻状况、医疗费用支付方式和收入水平是是否接受自费购买尿液快检试剂进行自我检测的影响因素(均P<0.05)。【结论】尿液HIV-1抗体检测方法具有较好的可信度和群众满意度,可以考虑在新疆地区大规模使用。

[Objective]To verify and promote the HIV antibody urine test in a demonstration zone for HIV prevention and control in Xinjiang,and to assess the sensitivity and specificity of the test and the willingness of the volunteers,providing a basis for evaluating and determining whether it was suitable for large-scale use in the region.[Methods]Stratified cluster sampling was used to select the respondents in a place in Xinjiang for questionnaire survey and sample collecting.Questionnaire results were statistically described,and multivariate logistic regression analysis was used to explore the influencing factors of willingness to use HIV-1 urine test.The results of blood ELISA antibody detection method were used as a reference to calculate the specificity,sensitivity and Kappa value of urinary HIV-1 antibody in the total population and different populations.[Results]A total of 2504 volunteers were recruited for the urine self-testing.The sensitivity of HIV-1 antibody urine test in the total population was 94.73%(54/57),the specificity was 100%(2447),the positive predictive value was 100%(54/54),and the negative predictive value was 99.88%(2447/2450).The specificity of each population group was 100%when comparing different populations.The test sensitivity was 100%in pregnant women,prostitutes and drug users,50%(1/2)in MSM subjects,with a Kappa value of 0.796.The test sensitivity was 80%(8/10)in the volunteers,with a Kappa value of 0.878.In the satisfaction survey,73.1%population was more likely to receive urinary rapid test than the blood fast test,93.8%of the population was willing to recommend the rapid urinary detection to other people.More than 70%of the population was satisfied with the rapid urinary detection.The multivariate logistic regression analysis showed that age,degree of education,occupation,marital status,payment method of medical expenses,and income level were the influence factors of the purchase of urine fast reagent for the self-testing(P<0.05).[Conclusion]Urinary HIV-1 antibody detection method has good reliability and public satisfaction.It is suitable for large-scale use in Xinjiang.