{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T03:30:14Z","timestamp":1789097414122,"version":"build-2803163510"},"reference-count":53,"publisher":"Public Library of Science (PLoS)","issue":"2","license":[{"start":{"date-parts":[[2024,2,23]],"date-time":"2024-02-23T00:00:00Z","timestamp":1708646400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004441","name":"Swedish International Development Cooperation Agency","doi-asserted-by":"crossref","award":["2015"],"award-info":[{"award-number":["2015"]}],"id":[{"id":"10.13039\/100004441","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>Mozambique is a high-prevalence country for HIV and early detection of new HIV infections is crucial for control of the epidemic. We aimed to evaluate the accuracy of the 4<jats:sup>th<\/jats:sup>-generation rapid diagnostic test (RDT) Alere<jats:sup>TM<\/jats:sup> HIV Combo in detecting acute and seroconverted HIV-infection, among sexually-active women attending three clinical health centers in Maputo, Mozambique.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>Women aged 14\u201355 years (n = 920) seeking care at the Mavalane Health Area, Maputo (February 2018-January 2019) were included, and blood specimens sampled. Sociodemographic and sexual behavior data were collected. Point-of-care HIV testing was performed using Alere Determine<jats:sup>TM<\/jats:sup> HIV-1\/2 and Uni-Gold<jats:sup>TM<\/jats:sup> HIV-1\/2. All samples were also tested using Enzygnost\u00ae HIV Integral 4 and Innotest\u00ae HIV Antigen mAb in laboratory. The 4<jats:sup>th<\/jats:sup>-generation RDT Alere<jats:sup>TM<\/jats:sup> HIV Combo was evaluated on serum samples in the laboratory. Finally, Innotest\u00ae HIV Antigen mAb, Enzygnost\u00ae HIV Integral 4 (Ag\/Ab), and HIV RNA quantification acted as gold standard assays in the evaluation of Alere<jats:sup>TM<\/jats:sup> HIV Combo test for HIV antigen detection (in clinical samples and in three HIV-1 seroconversion panels).<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>The antibody component of the 4th generation Alere<jats:sup>TM<\/jats:sup> HIV Combo RDT demonstrated a sensitivity and specificity of 100% examining clinical samples. However, the test did not detect HIV p24 antigen in any clinical samples, while Innotest\u00ae HIV Antigen mAb, verified by Enzygnost\u00ae HIV Integral 4 (Ag\/Ab) and\/or HIV RNA quantification, detected HIV antigen in six clinical samples. Furthermore, the Alere<jats:sup>TM<\/jats:sup> HIV Combo RDT had a low sensitivity in the detection of HIV p24 antigen in seroconversion panels. The HIV prevalence among the examined women was 17.8%.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusions<\/jats:title>\n<jats:p>The 4<jats:sup>th<\/jats:sup>-generation RDT Alere<jats:sup>TM<\/jats:sup> HIV Combo showed similar sensitivity to the 3<jats:sup>rd<\/jats:sup>-generation RDTs to detect seroconverted HIV-infections. However, the sensitivity for detection of HIV p24 antigen and diagnosing acute HIV infections, before seroconversion, was low. There is an urgent need to develop and evaluate simple and affordable POC tests with high sensitivity and specificity for diagnosing individuals with acute HIV infection in resource-limited settings with high HIV prevalence.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0298912","type":"journal-article","created":{"date-parts":[[2024,2,23]],"date-time":"2024-02-23T18:36:52Z","timestamp":1708713412000},"page":"e0298912","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":5,"title":["Laboratory-based evaluation of the 4th-generation AlereTM HIV Combo rapid point-of-care test"],"prefix":"10.1371","volume":"19","author":[{"given":"Alice","family":"Manjate","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotta","family":"Nilsson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Axelsson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3455-6691","authenticated-orcid":true,"given":"Sarah","family":"Lindroth","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Desiree","family":"Sirbu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1059-217X","authenticated-orcid":true,"given":"Jahit","family":"Sacarlal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u00f6ren","family":"Andersson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-3445-6968","authenticated-orcid":true,"given":"Magnus","family":"Unemo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2024,2,23]]},"reference":[{"key":"pone.0298912.ref001","unstructured":"UNAIDS, In Danger. 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