Validation of the Asante™ HIV-1 Rapid Recency® Assay for detection of recent HIV-1 infections in Uganda.

Abstract

OBJECTIVE\nPoint 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.\n\n\nMETHODS\nArchived 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 ART-naïve 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). Additionally, 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 naïve, ART exposed with suppressed viral loads and ART exposed with detectable viremia.\n\n\nRESULTS\nOf the 85 samples seroconverting in ≤ 6 months, 27 and 42 were identified as recent by the Asante™ HIV-1 rapid recency® test at RHSP lab 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 to 0.646, p < 0.0001). Specificity was 100% (200/200) among chronically infected ART naïve samples.\n\n\nCONCLUSION\nThe Asante™ HIV-1 rapid recency® assay had low sensitivity for detection of recent HIV-1 infections in Uganda, with substantial inter-laboratory 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.