Point of care rapid recency testing for HIV-1 may be a cost-effective tool to identify recently infected individuals for incidence estimation, and focused HIV prevention through intensified contact tracing. We validated the Asante™ HIV-1 rapid recency^® assay for use in Uganda. Archived specimens (serum/plasma), collected from longitudinally observed HIV-1 recently and long-term infected participants, were tested with the Asante HIV-1 rapid recency assay per manufacturer's instructions. Previously identified antiretroviral therapy (ART)-naive samples with known seroconversions within 6 months of follow-up were tested in independent laboratories: the Rakai Health Sciences Program (RHSP) and the Uganda Virus Research Institute HIV Reference Laboratory (UVRI-HRL). In addition, samples from participants who seroconverted within 6–18 months and samples from individuals with chronic HIV-1 infection of at least 18 months duration were classified into three categories: ART naive, ART exposed with suppressed viral loads, and ART exposed with detectable viremia. Of the 85 samples seroconverting in ≤6 months, 27 and 42 samples were identified as “recent” by the Asante HIV-1 rapid recency test at the RHSP laboratory and UVRI-HRL, corresponding to sensitivities of 32% and 49%, respectively. There was 72% agreement between the laboratories (Cohen's kappa = 0.481, 95% CI = 0.317–0.646, p < .0001). Specificity was 100% (200/200) among chronically infected ART-naive samples. The Asante HIV-1 rapid recency assay had low sensitivity for detection of recent HIV-1 infections in Uganda, with substantial interlaboratory variability due to differential interpretation of the test strip bands. Specificity was excellent. Assessment of assay performance in other settings is needed to guide decisions on test utility.

中文翻译：

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短通讯：验证用于检测乌干达近期 HIV-1 感染的 Asante HIV-1 快速新近度检测

针对 HIV-1 的护理点快速新近度检测可能是一种具有成本效益的工具，可以识别最近感染的个体以进行发病率估计，并通过加强接触者追踪来重点预防 HIV。我们验证了 Asante™ HIV-1 rapid recency ^®在乌干达使用的化验。从最近纵向观察的 HIV-1 和长期感染的参与者中收集的存档标本（血清/血浆）按照制造商的说明使用 Asante HIV-1 快速新近度测定进行了测试。先前确定的未接受过抗逆转录病毒治疗 (ART) 且在随访 6 个月内发生已知血清转化的样本在独立实验室进行了测试：Rakai 健康科学计划 (RHSP) 和乌干达病毒研究所 HIV 参考实验室 (UVRI-HRL)。此外，来自在 6-18 个月内发生血清转化的参与者的样本和来自至少持续 18 个月的慢性 HIV-1 感染者的样本被分为三类：未接受过 ART、暴露于抑制病毒载量的 ART 和暴露于可检测到的 ART病毒血症。在 ≤ 6 个月内发生血清转化的 85 个样本中，RHSP 实验室的 Asante HIV-1 快速新近度检测和 UVRI-HRL 分别将 27 个和 42 个样本鉴定为“最近”，对应的灵敏度分别为 32% 和 49%。实验室之间的一致性为 72%（Cohen 的 kappa = 0.481，95% CI = 0.317–0.646，p  <.0001）。慢性感染的 ART 幼稚样本的特异性为 100% (200/200)。Asante HIV-1 快速新近度测定法对乌干达近期 HIV-1 感染的检测灵敏度较低，由于对试纸条带的不同解释，实验室间存在很大差异。特异性非常好。需要评估其他设置中的测定性能，以指导有关测试效用的决策。