Performance evaluation of the Access anti-HBc Total assay on the DxI 9000 Access Immunoassay Analyzer.
Diagn Microbiol Infect Dis
; 110(1): 116303, 2024 Apr 20.
Article
em En
| MEDLINE
| ID: mdl-38838460
ABSTRACT
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.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article