Diagnostic microbiology and infectious disease · 2024
Performance evaluation of the Access anti-HBc Total assay on the DxI 9000 Access Immunoassay Analyzer.
СтатьяМногоцентровое исследованиеОценочное исследованиеНазвание и аннотация: Перевод в очереди
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Dzamitika Simplice, Boulaire Françoise Le, Coignard Catherine, Vincent Claire, Plantier Jean-Christophe, Lemée Véronique, Gréaume Sandrine, Voisin Isabelle, Brochot Etienne, Herpe Yves-Edouard, Demirdjian Gaiane, Karagueuzian Magali, Afful Derrick, Bayoud Rima, Hey Juliane
Аннотация
This study evaluated the diagnostic and analytical performances of the Access anti-HBc Total assay on the DxI 9000 Access Immunoassay System (Beckman Coulter Inc.). The multicenter study involved both prospective and retrospective sample collection from non-selected blood donors, hospitalized patients, or presumed anti-HBc Total positive individuals. Fresh/previously-frozen samples were tested with the Access and comparator assays to determine concordance; discrepant samples were tested with a second CE-marked assay. Among the 5983 non-selected fresh blood donor samples deemed anti-HBc Total negative, clinical specificity of the Access assay was 99.58% (95%CI: 99.38-99.72%). Clinical specificity was 99.27% (97.37-99.80%) among 273 anti-HBc Total negative hospitalized patient samples. Clinical sensitivity on 450 anti-HBc Total positive samples was 99.78% (98.75-99.96%). Evaluation in seroconversion panels revealed an average 1.4-day earlier detection versus a comparator assay. The Access assay demonstrated excellent clinical and analytical performances comparable to existing CE-marked anti-HBc Total assays. NCT04904835.