在普遍开展抗逆转录病毒治疗的环境中，评估用于横断面 HIV 发病率估计的多分析算法。
Evaluation of multi-assay algorithms for cross-sectional HIV incidence estimation in settings with universal antiretroviral treatment.
机构信息
Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Baltimore, MD, USA.
出版信息
BMC Infect Dis. 2022 Nov 11;22(1):838. doi: 10.1186/s12879-022-07850-0.
BACKGROUND
Multi-assay algorithms (MAAs) are used to estimate population-level HIV incidence and identify individuals with recent infection. Many MAAs use low viral load (VL) as a biomarker for long-term infection. This could impact incidence estimates in settings with high rates of early HIV treatment initiation. We evaluated the performance of two MAAs that do not include VL.
METHODS
Samples were collected from 219 seroconverters (infected < 1 year) and 4376 non-seroconverters (infected > 1 year) in the HPTN 071 (PopART) trial; 28.8% of seroconverter samples and 73.2% of non-seroconverter samples had VLs ≤ 400 copies/mL. Samples were tested with the Limiting Antigen Avidity assay (LAg) and JHU BioRad-Avidity assays. Antibody reactivity to two HIV peptides was measured using the MSD U-PLEX assay. Two MAAs were evaluated that do not include VL: a MAA that includes the LAg-Avidity assay and BioRad-Avidity assay (LAg + BR) and a MAA that includes the LAg-Avidity assay and two peptide biomarkers (LAg + PepPair). Performance of these MAAs was compared to a widely used MAA that includes LAg and VL (LAg + VL).
RESULTS
The incidence estimate for LAg + VL (1.29%, 95% CI: 0.97-1.62) was close to the observed longitudinal incidence (1.34% 95% CI: 1.17-1.53). The incidence estimates for the other two MAAs were higher (LAg + BR: 2.56%, 95% CI 2.01-3.11; LAg + PepPair: 2.84%, 95% CI: 1.36-4.32). LAg + BR and LAg + PepPair also misclassified more individuals infected > 2 years as recently infected than LAg + VL (1.2% [42/3483 and 1.5% [51/3483], respectively, vs. 0.2% [6/3483]). LAg + BR classified more seroconverters as recently infected than LAg + VL or LAg + PepPair (80 vs. 58 and 50, respectively) and identified ~ 25% of virally suppressed seroconverters as recently infected.
CONCLUSIONS
The LAg + VL MAA produced a cross-sectional incidence estimate that was closer to the longitudinal estimate than two MAAs that did not include VL. The LAg + BR MAA classified the greatest number of individual seroconverters as recently infected but had a higher false recent rate.
背景
多指标算法（MAAs）用于估计人群 HIV 发病率并识别近期感染的个体。许多 MAA 将低病毒载量（VL）用作长期感染的生物标志物。这可能会影响早期 HIV 治疗启动率较高的环境中的发病率估计。我们评估了两种不包含 VL 的 MAA 的性能。
方法
从 HPTN 071（PopART）试验中的 219 名血清转换者（感染<1 年）和 4376 名非血清转换者（感染>1 年）中采集样本；28.8%的血清转换者样本和 73.2%的非血清转换者样本的 VLs≤400 拷贝/ml。使用 Limiting Antigen Avidity 测定法（LAg）和 JHU BioRad-Avidity 测定法对样本进行检测。使用 MSD U-PLEX 测定法测量两种 HIV 肽的抗体反应性。评估了两种不包含 VL 的 MAA：一种包含 LAg-Avidity 测定法和 BioRad-Avidity 测定法（LAg+BR）的 MAA，以及一种包含 LAg-Avidity 测定法和两种肽生物标志物（LAg+PepPair）的 MAA。将这些 MAA 的性能与一种广泛使用的包含 LAg 和 VL 的 MAA（LAg+VL）进行了比较。
结果
LAg+VL（1.29%，95%CI：0.97-1.62）的发病率估计值接近纵向发病率（1.34%，95%CI：1.17-1.53）。另外两种 MAA 的发病率估计值更高（LAg+BR：2.56%，95%CI 2.01-3.11；LAg+PepPair：2.84%，95%CI：1.36-4.32）。LAg+BR 和 LAg+PepPair 还将更多感染超过 2 年的个体错误地归类为近期感染，而非 LAg+VL（分别为 1.2%[42/3483]和 1.5%[51/3483]，而 0.2%[6/3483]）。LAg+BR 将比 LAg+VL 或 LAg+PepPair 更多的血清转换者归类为近期感染（80 比 58 和 50），并确定了大约 25%的病毒抑制血清转换者为近期感染。
结论
LAg+VL MAA 产生的横断面发病率估计值比不包含 VL 的两种 MAA 更接近纵向估计值。LAg+BR MAA 将最多的个体血清转换者归类为近期感染，但假近期率更高。
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