Division of Global HIV and TB, US Centers for Disease Control and Prevention, Atlanta, GA, United States of America.
Division of Global HIV and TB, US Centers for Disease Control and Prevention, Lilongwe, Malawi.
PLoS One. 2022 Feb 11;17(2):e0262071. doi: 10.1371/journal.pone.0262071. eCollection 2022.
Tests for recent HIV infection (TRI) distinguish recent from long-term HIV infections using markers of antibody maturation. The limiting antigen avidity enzyme immunoassay (LAg EIA) is widely used with HIV viral load (VL) in a recent infection testing algorithm (RITA) to improve classification of recent infection status, estimate population-level HIV incidence, and monitor trends in HIV transmission. A novel rapid test for recent HIV infection (RTRI), Asanté™, can determine HIV serostatus and HIV recency within minutes on a lateral flow device through visual assessment of test strip or reader device. We conducted a field-based laboratory evaluation of the RTRI among pregnant adolescent girls and young women (AGYW) attending antenatal clinics (ANC) in Malawi.We enrolled pregnant AGYW aged <25 years testing HIV-positive for the first time at their first ANC visit from 121 ANCs in four high-HIV burden districts. Consenting participants provided blood for recency testing using LAg EIA and RTRI, which were tested in central laboratories. Specimens with LAg EIA normalized optical density values ≤2.0 were classified as probable recent infections. RTRI results were based on: (1) visual assessment: presence of a long-term line (LT) indicating non-recent infection and absence of the line indicating recent infection; or (2) a reader; specimens with LT line intensity units <3.0 were classified as probable recent infections. VL was measured for specimens classified as a probable recent infections by either assay; those with HIV-1 RNA ≥1,000 copies/mL were classified as confirmed recent infections. We evaluated the performance of the RTRI by calculating correlation between RTRI and LAg EIA results, and percent agreement and kappa between RTRI and LAg EIA RITA results.Between November 2017 to June 2018, 380 specimens were available for RTRI evaluation; 376 (98.9%) were confirmed HIV-positive on RTRI. Spearman's rho between RTRI and LAg EIA was 0.72 indicating strong correlation. Percent agreement and kappa between RTRI- and LAg EIA-based RITAs were >90% and >0.65 respectively indicating substantial agreement between the RITAs.This was the first field evaluation of an RTRI in sub-Saharan Africa, which demonstrated good performance of the assay and feasibility of integrating RTRI into routine HIV testing services for real-time surveillance of recent HIV infection.
检测近期 HIV 感染（TRI）使用抗体成熟标志物区分近期和长期 HIV 感染。广泛使用有限抗原亲和力酶免疫测定法（LAg EIA）与 HIV 病毒载量（VL）联合用于近期感染检测算法（RITA），以改善近期感染状态的分类，估计人群 HIV 发病率，并监测 HIV 传播趋势。一种新的近期 HIV 感染快速检测（RTRI），Asanté™，可以通过侧流设备上的目视评估测试条或读取器设备，在几分钟内确定 HIV 血清状态和 HIV 近期感染情况。我们在马拉维的产前诊所（ANC）中对接受产前检查的青春期少女和年轻妇女（AGYW）进行了现场实验室评估。我们招募了首次在第一次 ANC 就诊时首次检测 HIV 阳性且年龄<25 岁的妊娠 AGYW，来自四个高 HIV 负担地区的 121 个 ANC。同意的参与者提供血液进行近期检测，使用 LAg EIA 和 RTRI 进行检测，在中央实验室进行检测。LAg EIA 归一化光密度值≤2.0 的标本被归类为可能的近期感染。RTRI 结果基于：（1）目视评估：存在长期线（LT）表示非近期感染，不存在线表示近期感染；或（2）读取器；LT 线强度单位<3.0 的标本被归类为可能的近期感染。两种检测均将标本归类为可能的近期感染，均进行病毒载量（VL）测量；那些 HIV-1 RNA≥1,000 拷贝/mL 的标本被归类为确认的近期感染。我们通过计算 RTRI 与 LAg EIA 结果之间的相关性，以及 RTRI 与 LAg EIA RITA 结果之间的百分比一致性和 Kappa 值，评估了 RTRI 的性能。2017 年 11 月至 2018 年 6 月期间，有 380 份标本可用于 RTRI 评估；376 份（98.9%）在 RTRI 上确认为 HIV 阳性。RTRI 与 LAg EIA 之间的 Spearman's rho 为 0.72，表明相关性很强。RTRI-和 LAg EIA 基于 RITA 的百分比一致性和 Kappa 值分别>90%和>0.65，表明 RITA 之间存在实质性一致性。这是在撒哈拉以南非洲首次进行的 RTRI 现场评估，该评估表明该检测具有良好的性能，并且可以将 RTRI 整合到常规 HIV 检测服务中，以实时监测近期 HIV 感染。
