不同检测方法验证男男性行为者中HIV早期感染者的比较

Validation of different testing strategies for detect early HIV infection among men who have sex with men

目的本研究拟评估HIV抗体(抗原)快速检测方法结合HIV核酸检测方法检出早期感染者的能力,建立适宜外展条件下MSM高危人群的检测方法。方法采用横断面调查方法,于2022年4月至2023年10月,依托社会组织和自愿咨询检测门诊开展研究对象的招募和问卷调查。每位研究对象采集指尖血进行HIV抗体快速检测、HIV抗体抗原快速检测及基于干血斑的核酸检测,开展检测方法的灵敏度、特异度和一致性检验分析。结果827名研究对象以25~39岁年龄组居多,分别有58.79%、53.94%、46.86%的MSM正确知晓现有诊断技术检测HIV抗体的窗口期为感染后的3周、抗原为2周、核酸为1周。HIV抗体快速检测方法检出阳性样本44名,HIV抗体筛查阳性率为5.32%;HIV抗体抗原快速检测方法检出抗体阴性、抗原阳性1名,抗体阳性、抗原阴性44名,HIV抗体/抗原筛查阳性率为5.44%,其中1名为早期感染者;基于干血斑的核酸检测方法检出阳性样本49名,HIV核酸阳性率为5.93%,其中5名为HIV早期感染者。HIV早期感染者比例为0.60%。以随访观察的HIV WB试验检测结果为金标准,HIV抗体快速检测方法的灵敏度为89.58%,特异度为99.87%,一致性检验Kappa值为0.94;HIV抗体抗原检测方法的灵敏度为93.75%,特异度为100.00%,一致性检验Kappa值为0.97;基于干血斑核酸检测方法的灵敏度和特异度为100.00%,一致性检验Kappa值为1.00。结论通过HIV抗原和核酸检测发现了HIV抗体检测阴性样本人群中存在的HIV早期感染者,对于外展条件下的MSM高危人群,优先使用HIV抗体抗原检测方法进行HIV筛查试验。对于疑似早期感染者,推荐通过收集干血斑开展核酸检测。

Objective The aim of this study was to evaluate the ability of a rapid HIV antibody(antigen)diagnostic reagent combined with HIV nucleic acid detection to detect early HIV infection and establish a suitable testing strategy for high-risk groups of men having sex with men(MSM).Methods A cross-sectional survey was conducted from April 2022 to October 2023 based on data from nongovernmental organizations,voluntary consultations,and testing clinics.Fingertip blood of each study participant was collected for the rapid detection of the HIV antibody and HIV antibody antigens,as well as preparation for dry blood spots.Qualitative nucleic acid detection was performed for dry blood spots.The sensitivity,specificity,and consistency of the detection methods were analyzed.Results The majority of the 827 study participants were 25-39 years old;further,58.79%,53.94%,and 46.86%of MSM correctly understood that the window period for detection of the HIV antibody by existing diagnostic technology was three weeks after infection,two weeks for the antigen,and one week for nucleic acid,respectively.The HIV antibody diagnostic reagent detected 44 antibodypositive samples,and the screening positive rate of the HIV antibody was 5.32%.The HIV antibody antigen diagnostic reagent detected one antibody-negative and antigen-positive and 44 antibody-positive and antigen-negative.The screening positive rate of the HIV antibody/antigen was 5.44%,and one sample was early infected.The dry blood spots-nucleic acid detection reagent detected 49 positive samples,and the positive rate of HIV nucleic acid was 5.93%,five of which were HIV early infected.The proportion of patients with early HIV infection was 0.60%.Using the results of the dry blood spots-nucleic acid test as the gold standard,the sensitivity of the HIV antibody rapid diagnostic reagent was 89.58%,specificity was 99.87%,and the kappa value of consistency was 0.94.The sensitivity of the HIV antibody antigen diagnostic reagent was 93.75%,specificity was 100.00%,and the kappa value of the consistency test was 0.97.The sensitivity and specificity of dry blood spots-nucleic acid were 100.00%,and the kappa value of the consistency test was 1.00.Conclusions Early HIV infection was detected in HIV-negative samples by HIV antigen and nucleic acid detection.Priority should be given to HIV antibody antigen diagnostic reagents for HIV screening in high-risk MSM groups.For suspected early infections,nucleic acid testing through the collection of dry blood spots is recommended under outreach conditions.