Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.
PLoS One. 2021 Dec 17;16(12):e0258644. doi: 10.1371/journal.pone.0258644. eCollection 2021.
Assays and multi-assay algorithms (MAAs) have been developed for population-level cross-sectional HIV incidence estimation. These algorithms use a combination of serologic and/or non-serologic biomarkers to assess the duration of infection. We evaluated the performance of four MAAs for individual-level recency assessments.
Samples were obtained from 220 seroconverters (infected <1 year) and 4,396 non-seroconverters (infected >1 year) enrolled in an HIV prevention trial (HPTN 071 [PopART]); 28.6% of the seroconverters and 73.4% of the non-seroconverters had HIV viral loads ≤400 copies/mL. Samples were tested with two laboratory-based assays (LAg-Avidity, JHU BioRad-Avidity) and a point-of-care assay (rapid LAg). The four MAAs included different combinations of these assays and HIV viral load. Seroconverters on antiretroviral treatment (ART) were identified using a qualitative multi-drug assay.
The MAAs identified between 54 and 100 (25% to 46%) of the seroconverters as recently-infected. The false recent rate of the MAAs for infections >2 years duration ranged from 0.2%-1.3%. The MAAs classified different overlapping groups of individuals as recent vs. non-recent. Only 32 (15%) of the 220 seroconverters were classified as recent by all four MAAs. Viral suppression impacted the performance of the two LAg-based assays. LAg-Avidity assay values were also lower for seroconverters who were virally suppressed on ART compared to those with natural viral suppression.
The four MAAs evaluated varied in sensitivity and specificity for identifying persons infected <1 year as recently infected and classified different groups of seroconverters as recently infected. Sensitivity was low for all four MAAs. These performance issues should be considered if these methods are used for individual-level recency assessments.
已经开发了用于人群横断面 HIV 发病率估计的检测和多检测算法（MAAs）。这些算法使用血清学和/或非血清学生物标志物的组合来评估感染持续时间。我们评估了四种 MAA 用于个体水平近期评估的性能。
从参加 HIV 预防试验（HPTN 071[PopART]）的 220 名血清转换者（感染<1 年）和 4396 名非血清转换者（感染>1 年）中获得样本；28.6%的血清转换者和 73.4%的非血清转换者的 HIV 病毒载量≤400 拷贝/ml。样本用两种实验室检测（LAg 亲和力，JHU BioRad 亲和力）和一种即时检测（快速 LAg）进行检测。四种 MAA 包括这些检测和 HIV 病毒载量的不同组合。使用定性多药物检测来确定正在接受抗逆转录病毒治疗（ART）的血清转换者。
MAA 确定了 54 到 100 名（25%到 46%）血清转换者为近期感染。MAA 对感染时间超过 2 年的假近期率为 0.2%-1.3%。MAA 将不同重叠的个体分类为近期和非近期。只有 32 名（15%）220 名血清转换者被所有四种 MAA 均归类为近期感染。病毒抑制影响了两种基于 LAg 的检测的性能。与自然病毒抑制的血清转换者相比，接受 ART 病毒抑制的血清转换者的 LAg 亲和力检测值也较低。
评估的四种 MAA 在识别感染<1 年的人作为近期感染方面的敏感性和特异性各不相同，并将不同组的血清转换者分类为近期感染。所有四种 MAA 的敏感性都较低。如果这些方法用于个体水平的近期评估，应考虑这些性能问题。
