Performance evaluation of the Access anti-HBc Total assay on the DxI 9000 Access Immunoassay Analyzer.

Autor: Dzamitika S; Cerba Xpert, Saint-Ouen l'Aumône, France., Boulaire FL; Cerba Xpert, Saint-Ouen l'Aumône, France., Coignard C; Infectology, Specialized CoreLab Department, Eurofins Biomnis, Ivry-Sur-Seine, France., Vincent C; Biomnis Sample Library Department, Eurofins Biomnis, Ivry-Sur-Seine, France., Plantier JC; Laboratoire de Virologie, Institut de Biologie Clinique, CHU Rouen, France., Lemée V; Laboratoire de Virologie, Institut de Biologie Clinique, CHU Rouen, France., Gréaume S; PLER Laboratory, Etablissement Français du Sang Haute-de-France - Normandie, Bois Guillaume, France., Voisin I; PLER Laboratory, Etablissement Français du Sang Haute-de-France - Normandie, Bois Guillaume, France., Brochot E; Centre de Ressources Biologiques Biobanque de Picardie, CHU Amiens-Picardie, France., Herpe YE; Centre de Ressources Biologiques Biobanque de Picardie, CHU Amiens-Picardie, France., Demirdjian G; R&D Department, Beckman Coulter, Immunotech, Marseille, France., Karagueuzian M; R&D Department, Beckman Coulter, Immunotech, Marseille, France., Afful D; Clinical Affairs Department, Beckman Coulter, Chaska, MN, United States., Bayoud R; Clinical Affairs Department, Beckman Coulter, Immunotech, Marseille, France., Hey J; Clinical Affairs Department, Beckman Coulter, Immunotech, Marseille, France. Electronic address: jhey@beckman.com.
Jazyk: angličtina
Zdroj: Diagnostic microbiology and infectious disease [Diagn Microbiol Infect Dis] 2024 Sep; Vol. 110 (1), pp. 116303. Date of Electronic Publication: 2024 Apr 20.
DOI: 10.1016/j.diagmicrobio.2024.116303
Abstrakt: 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.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Rima Bayoud, Juliane Hey, Gaiane Demirdjian, Magali Karagueuzian, and Derrick Afful are Beckman Coulter employees.
(Copyright © 2024. Published by Elsevier Inc.)
Databáze: MEDLINE
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