Multicenter performance evaluation of the Elecsys HCV Duo immunoassay
- Background: The diagnostic accuracy of the Elecsys® HCV Duo antigen-antibody combination immunoassay (Roche Diagnostics GmbH) was evaluated for the detection of hepatitis C virus (HCV) infection, versus commercially available comparators. Methods: This multicenter study (August 2020–March 2021) assessed the specificity of the Elecsys HCV Duo immunoassay and comparator assays in blood donor and routine clinical laboratory samples; sensitivity was determined in confirmed HCV-positive samples and seroconversion panels. The Elecsys HCV Duo immunoassay was compared with the Monolisa HCV Ag-Ab ULTRA V2, Murex HCV Ag/Ab Combination and ARCHITECT HCV Ag assays, as well as nucleic acid testing (NAT). The antibody (anti-HCV) module of the Elecsys HCV Duo immunoassay was compared with the Elecsys Anti-HCV II, Alinity s Anti-HCV, ARCHITECT Anti-HCV and RIBA HCV 3.0 SIA assays. Results: The specificity of the Elecsys HCV Duo immunoassay was 99.94% (95% confidence interval [CI], 99.89–99.97) and 99.92% (95% CI, 99.71–99.99) in blood donor (n = 20,634) and routine clinical laboratory samples (n = 2531), respectively. The specificity of the Elecsys HCV Duo immunoassay was similar or better than comparator assays. The sensitivity of the Elecsys HCV Duo immunoassay in confirmed HCV-positive samples (n = 257) was 99.6%. In seroconversion panels, the Elecsys HCV Duo immunoassay detected infections earlier (2.2–21.9 days) than all but one of the comparator assays and detected HCV 1.8 days later than NAT. Conclusions: The Elecsys HCV Duo immunoassay shows high diagnostic accuracy, reduces the diagnostic window, and could be used when NAT is not possible.
Verfasserangaben: | Mario MajchrzakGND, Korbinian Bronner, Syria LapercheORCiD, Elena RiesterGND, Ed Bakker, Ralf Bollhagen, Markus KlinkichtGND, Marion VermeulenORCiD, Michael SchmidtORCiD |
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URN: | urn:nbn:de:hebis:30:3-786018 |
DOI: | https://doi.org/10.1016/j.jcv.2022.105293 |
ISSN: | 1386-6532 |
Pubmed-Id: | https://pubmed.ncbi.nlm.nih.gov/36126395 |
Titel des übergeordneten Werkes (Englisch): | Journal of clinical virology |
Verlag: | Elsevier |
Verlagsort: | Amsterdam |
Dokumentart: | Wissenschaftlicher Artikel |
Sprache: | Englisch |
Datum der Veröffentlichung (online): | 17.09.2022 |
Datum der Erstveröffentlichung: | 05.09.2022 |
Veröffentlichende Institution: | Universitätsbibliothek Johann Christian Senckenberg |
Datum der Freischaltung: | 09.02.2024 |
Freies Schlagwort / Tag: | Diagnostic tests; Hepatitis C; Hepatitis C antibodies; Hepatitis C antigens; Immunoassay |
Jahrgang: | 156 |
Ausgabe / Heft: | 105293 |
Aufsatznummer: | 105293 |
Seitenzahl: | 8 |
Institute: | Medizin |
DDC-Klassifikation: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
Sammlungen: | Universitätspublikationen |
Lizenz (Deutsch): | Creative Commons - CC BY - Namensnennung 4.0 International |