南京市男男性行为人群基于抗体亲和力的HIV-1抗体阳转检测

Recent HIV type 1 Seroconversion Detection on MSM in Nanjing by Avidity-Based Assay

评价了由美国疾病预防控制中心研制的基于抗体亲和力的用于HIV-1阳性血清阳转检测的方法--有限抗原亲和力酶联免疫吸附法(LAg-EIA)和亲和力指数酶联免疫吸附法(AI-EIA),并将其初步应用于南京市男男性行为(MSM)人群的阳转检测.方法:101份博卡HIV阳性血清和4份标准对照血清作为评价血清.检测一致性通过不同检测时间、板内、板间以及不同批次包被板之间的比较进行评价.用LAg-EIA法对2013年、 2015年及2016年男男性行为人群确证阳性血清阳转进行检测.结果:LAg-EIA法的总体一致性在97.22%以上(95%可信区间),检测时间一致性分别为97.22%, 98.94%和97.83%;板内一致性为99.78%;板间一致性为99.89%;不同批次一致性为99.99%. AI-EIA法的一致性在90.00%以上(95%可信区间),检测时间一致性分别为90.00%, 93.37%和93.56%;板内一致性为99.30%;板间一致性为97.06%;不同批次一致性为99.62%.南京市3年男男性行为人群HIV-1阳性中有42.8%, 65.7%和40.0%的血清为新近阳性,按照我国国家CDC平均阳转156 d来看,这些感染在156d以内;有57.1%, 34.2%和60.0%的血清为长期感染, HIV-1感染超过156d.每年平均阳转时间有波动,但确证感染检测总体较迟.结论:两种方法的一致性均高于90.00%,是适合于实际应用的好方法,其中, LAg-EIA法的一致性高于AI-EIA法.用LAg-EIA法检测南京市3年数据表明该人群确证感染检测总体较迟,不利于该病的预防和控制.

In this report, two avidity-based assays were developed by American centers for disease control and prevention, for detection recent HIV type 1 seroconversion, were assessed and used to detect the sera conversion of confirmed positive sera from man sexed with man(MSM) in Nanjing. Method: 101 Boca panel HIV-1 positive sera and 4 standard control sera were used as assessing sera. Assay consistencies were carried on and compared between different operation times, within one run, run to run, different lots of coated plates. And the assay was used to detect the sera convention of the MSM in 2013,2015 and 2016 in Nanjing. Results: The consistency of limiting antigen enzyme immunoassay(LAg-EIA)was over 97.22%(95% confidence). The consistencies of time was 97.22%, 98.94%, or 97.83% respectively. The consistence was 99.78% for in-plate, 99.89% for plate to plate, and 99.99% for different batch of coating. The consistency of avidity index enzyme immunoassay(AI-EIA) was over 90.00%(95% confidence). The consistence of time was 90.00%, 93.37% or 93.56% respectively. The consistency was 99.30% in-plate, 97.06% between-plate, and 99.62% between two coating lots. The seroconversation of confirmed positive sera from MSM in 2013,2015 and 2016 in Nanjing were detected by LAg-EIA, and the recent infection was 42.8%, 65.7% or 40.0%, with the infection term within 156 days according to the data from NCDC;and the late infection was 57.1%, 34.2% or 60.0%, with the infection term longer than 156 days. Although it was different between each year, the results showed the MSM was confirmed positive very late. Conclusion: The consistency of two methods were both over 90.00%, resulted in a reliable method for practical application. Besides, LAg-EIA has a higher consistency than that of AI-EIA following present assay protocol. The LAg-EIA detection results implied a late infection confirmation in MSM and which is much harmful to prevention and control of this disease.