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Article Dans Une Revue Diagnostic Microbiology and Infectious Disease Année : 2024

Performance Evaluation of the Access anti-HBc Total Assay on the DxI 9000 Access Immunoassay Analyzer

Résumé

This study evaluated the diagnostic and analytical performances of the Access anti-HBV core antigen (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.
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Dates et versions

hal-04560988 , version 1 (26-04-2024)

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Citer

Simplice Dzamitika, Françoise Le Boulaire, Catherine Coignard, Claire Vincent, Jean-Christophe Plantier, et al.. Performance Evaluation of the Access anti-HBc Total Assay on the DxI 9000 Access Immunoassay Analyzer. Diagnostic Microbiology and Infectious Disease, 2024, pp.116303. ⟨10.1016/j.diagmicrobio.2024.116303⟩. ⟨hal-04560988⟩
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