{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T05:02:25Z","timestamp":1789448545969,"version":"build-2803163510"},"reference-count":32,"publisher":"MDPI AG","issue":"18","license":[{"start":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T00:00:00Z","timestamp":1789171200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100022110","name":"bioM\u00e9rieux","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100022110","id-type":"DOI","asserted-by":"crossref"}]},{"id":[{"id":"https:\/\/ror.org\/04emprs51","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Background\/Objectives: Early detection of HIV infection is critical for timely clinical management and prevention of transmission. Fourth-generation antigen\/antibody assays improve early diagnosis by detecting p24 antigen prior to seroconversion. This study evaluated the analytical and clinical performance of the VIDAS\u00ae HIV DUO AG\/AB assay. Methods: A multicenter evaluation was conducted using WHO HIV-1 p24 standards, 50 HIV-1\/HIV-2 culture supernatants representing diverse genotypes, 40 seroconversion panels, 634 HIV-positive clinical specimens, 6063 HIV-negative samples from four populations, and 272 potentially cross-reactive samples. Precision was assessed according to CLSI EP05-A3 guidelines. Performance was evaluated against VIDAS\u00ae HIV DUO Ultra and contextualized with results reported for other fourth-generation assays. Results: VIDAS\u00ae HIV DUO AG\/AB showed a lower p24 antigen limit of detection (0.3 IU\/mL) than VIDAS\u00ae HIV DUO Ultra (0.5\u20130.6 IU\/mL) and higher relative p24 reactivity across multiple genotypes. It enabled earlier detection in more than 30% of seroconversion panels, corresponding to a cumulative gain of 60 days versus VIDAS\u00ae HIV DUO Ultra. Based on historical datasets, gains of up to 29 days were observed relative to reported performances of the ARCHITECT HIV Ag\/Ab Combo and MAGLUMI HIV Ab\/Ag Combi assays. All 634 HIV-positive clinical samples were detected, demonstrating broad genotype inclusivity within the diversity of HIV strains represented in this study. Specificity reached 99.95% (95% CI: 99.90\u201399.99%), with no cross-reactivity observed. Precision coefficients of variation were below 3.5%. Conclusions: The VIDAS\u00ae HIV DUO AG\/AB assay demonstrated high analytical sensitivity, early detection in seroconversion panels, broad genotype coverage, and excellent (&gt;99.5%) specificity, supporting its use as a fourth-generation option for HIV screening in various clinical and epidemiological settings.<\/jats:p>","DOI":"10.3390\/diagnostics16182954","type":"journal-article","created":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T09:34:01Z","timestamp":1789378441000},"page":"2954","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Analytical and Clinical Performance of VIDAS\u00ae HIV DUO AG\/AB Assay for Enhanced Early HIV Diagnosis"],"prefix":"10.3390","volume":"16","author":[{"given":"V\u00e9ronique","family":"Lem\u00e9e","sequence":"first","affiliation":[{"name":"Univ Rouen Normandie, Universit\u00e9 de Caen Normandie, INSERM, Normandie Univ, DYNAMICURE UMR 1311, CHU Rouen, Department of Virology, F-76000 Rouen, France"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"resources","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"},{"role":"investigation","vocabulary":"credit"}]},{"given":"Mathilde","family":"Lac\u00f4te","sequence":"additional","affiliation":[{"name":"bioM\u00e9rieux, 69280 Marcy l\u2019Etoile, France"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"conceptualization","vocabulary":"credit"},{"role":"methodology","vocabulary":"credit"},{"role":"data-curation","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"},{"role":"supervision","vocabulary":"credit"}]},{"given":"Peggy","family":"Nomade","sequence":"additional","affiliation":[{"name":"bioM\u00e9rieux, 69280 Marcy l\u2019Etoile, 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France"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"data-curation","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"},{"role":"investigation","vocabulary":"credit"},{"role":"resources","vocabulary":"credit"}]},{"given":"Isabelle","family":"Voisin","sequence":"additional","affiliation":[{"name":"Etablissement Fran\u00e7ais du Sang (EFS) Hauts de France\u2014Normandie (HFNO), 76000 Rouen, France"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"investigation","vocabulary":"credit"},{"role":"resources","vocabulary":"credit"},{"role":"data-curation","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"given":"Laurence","family":"Bridon","sequence":"additional","affiliation":[{"name":"bioM\u00e9rieux, 69280 Marcy l\u2019Etoile, 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Normandie Univ, DYNAMICURE UMR 1311, CHU Rouen, Department of Virology, F-76000 Rouen, France"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"resources","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"given":"Vinca","family":"Icard","sequence":"additional","affiliation":[{"name":"Croix Rousse Hospital, Hospices Civils de Lyon (HCL), Laboratory of Virology, 69004 Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"investigation","vocabulary":"credit"},{"role":"resources","vocabulary":"credit"},{"role":"data-curation","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"}]}],"member":"1968","published-online":{"date-parts":[[2026,9,12]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"86","DOI":"10.1186\/s12981-025-00776-y","article-title":"Global and regional molecular epidemiology of HIV-1 among men who have sex with men: A systematic review and 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