TY  - JOUR
A1  - Majchrzak, Mario
A1  - Bronner, Korbinian
A1  - Laperche, Syria
A1  - Riester, Elena
A1  - Bakker, Ed
A1  - Bollhagen, Ralf
A1  - Klinkicht, Markus
A1  - Vermeulen, Marion
A1  - Schmidt, Michael
T1  - Multicenter performance evaluation of the Elecsys HCV Duo immunoassay
T2  - Journal of clinical virology
N2  - 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.
KW  - Hepatitis C
KW  - Hepatitis C antibodies
KW  - Hepatitis C antigens
KW  - Immunoassay
KW  - Diagnostic tests
Y1  - 2022
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/78601
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-786018
SN  - 1386-6532
VL  - 156
IS  - 105293
PB  - Elsevier
CY  - Amsterdam
ER  -