{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T17:37:47Z","timestamp":1793036267931,"version":"4.5.0"},"reference-count":60,"publisher":"Public Library of Science (PLoS)","issue":"5","license":[{"start":{"date-parts":[[2022,5,3]],"date-time":"2022-05-03T00:00:00Z","timestamp":1651536000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/publicdomain\/zero\/1.0\/"}],"funder":[{"DOI":"10.13039\/100009054","name":"U.S. President\u2019s Emergency Plan for AIDS Relief","doi-asserted-by":"publisher","award":["Through CDC"],"award-info":[{"award-number":["Through CDC"]}],"id":[{"id":"10.13039\/100009054","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosglobalpublichealth.org"],"crossmark-restriction":false},"short-container-title":["PLOS Glob Public Health"],"abstract":"<jats:p>We previously described development of a rapid test for recent infection (RTRI) that can diagnose HIV infection and detect HIV-1 recent infections in a single device. This technology was transferred to a commercial partner as Asante Rapid Recency Assay (ARRA). We evaluated performance of the ARRA kits in the laboratory using a well-characterized panel of specimens. The plasma specimen panel (N = 1500) included HIV-1 (N = 570), HIV-2 (N = 10), and HIV-negatives (N = 920) representing multiple subtypes and geographic locations. Reference diagnostic data were generated using the Bio-Rad HIV-1-2-O EIA\/Western blot algorithm with further serotyping performed using the Multispot HIV-1\/2 assay. The LAg-Avidity EIA was used to generate reference data on recent and long-term infection for HIV-1 positive specimens at a normalized optical density (ODn) cutoff of 2.0 corresponding to a mean duration of about 6 months. All specimens were tested with ARRA according to the manufacturer\u2019s recommendations. Test strips were also read for line intensities using a reader and results were correlated with visual interpretation. ARRA\u2019s positive verification line (PVL) correctly classified 575 of 580 HIV-positive and 910 of 920 negative specimens resulting in a sensitivity of 99.1% (95% CI: 98.0\u201399.6) and specificity of 98.9% (95% CI: 98.1\u201399.4), respectively. The reader-based classification was similar for PVL with sensitivity of 99.3% (576\/580) and specificity of 98.8% (909\/920). ARRA\u2019s long-term line (LTL) classified 109 of 565 HIV-1 specimens as recent and 456 as long-term compared to 98 as recent and 467 as long-term (LT) by LAg-Avidity EIA (cutoff ODn = 2.0), suggesting a mean duration of recent infection (MDRI) close to 6 months. Agreement of ARRA with LAg recent cases was 81.6% (80\/98) and LT cases was 93.8% (438\/467), with an overall agreement of 91.7% (kappa = 0.72). The reader (cutoff 2.9) classified 109\/566 specimens as recent infections compared to 99 by the LAg-Avidity EIA for recency agreement of 81.8% (81\/99), LT agreement of 9% (439\/467) with overall agreement of 91.9% (kappa = 0.72). The agreement between visual interpretation and strip reader was 99.9% (95% CI: 99.6\u201399.9) for the PVL and 98.1% (95% CI: 96.6\u201398.9) for the LTL. ARRA performed well with HIV diagnostic sensitivity &gt;99% and specificity &gt;98%. Its ability to identify recent infections is comparable to the LA-Avidity EIA corresponding to an MDRI of about 6 months. This point-of-care assay has implications for real-time surveillance of new infections among newly diagnosed individuals for targeted prevention and interrupting ongoing transmission thus accelerating epidemic control.<\/jats:p>","DOI":"10.1371\/journal.pgph.0000316","type":"journal-article","created":{"date-parts":[[2022,5,3]],"date-time":"2022-05-03T17:21:54Z","timestamp":1651598514000},"page":"e0000316","update-policy":"https:\/\/doi.org\/10.1371\/journal.pgph.corrections_policy","source":"Crossref","is-referenced-by-count":26,"title":["Performance evaluation of the Asante Rapid Recency Assay for verification of HIV diagnosis and detection of recent HIV-1 infections: Implications for epidemic control"],"prefix":"10.1371","volume":"2","author":[{"given":"Ernest 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