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

• Published in: Diagnostic microbiology and infectious disease Vol. 110; no. 1; p. 116303
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.09.2024; Elsevier
• Subjects: Adult; Blood Donors; Dxl 9000; Female; HBc; HBc Total; Hepatitis B - diagnosis; Hepatitis B Antibodies - blood; Hepatitis B Core Antigens - blood; Hepatitis B Core Antigens - immunology; Hepatitis B infection; Human health and pathology; Humans; Immunoassay; Immunoassay - methods; Immunoassay - standards; Life Sciences; Male; Microbiology and Parasitology; Middle Aged; Prospective Studies; Retrospective Studies; Sensitivity and Specificity; Virology; HBc; Immunoassay; HBc Total; Dxl 9000; Hepatitis B infection; hepatitis B infection
• ISSN: 0732-8893; 1879-0070; 1879-0070
• DOI: 10.1016/j.diagmicrobio.2024.116303

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.