Evaluation of multi-assay algorithms for identifying individuals with recent HIV infection: HPTN 071 (PopART)

Wendy Grant-McAuley, Ethan Klock, Oliver Laeyendecker, Estelle Piwowar-Manning, Ethan Wilson, William Clarke, Autumn Breaud, Ayana Moore, Helen Ayles, Barry Kosloff, Kwame Shanaube, Peter Bock, Nomtha Mandla, Anneen van Deventer, Sarah Fidler, Deborah Donnell, Richard Hayes, Susan H Eshleman and for the HPTN 071 (PopART) Study Team

PLOS ONE, 2021, vol. 16, issue 12, 1-14

Abstract: Background: 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. Methods: Samples were obtained from 220 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. Results: 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. Conclusions: The four MAAs evaluated varied in sensitivity and specificity for identifying persons infected

Date: 2021
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0258644

DOI: 10.1371/journal.pone.0258644

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