Multicenter evaluation of a fully automated third-generation anti-HCV antibody screening test with excellent sensitivity and specificity.
Early detection of hepatitis C virus (HCV) is an important step in preventing progression to cirrhosis and hepatocellular carcinoma. Serologic assays for anti-hepatitis C (anti-HCV) antibody are valuable first-line tests in the screening and diagnosis of HCV infection. The aim of this multicenter study was to compare the Elecsys(®) Anti-HCV assay with alternative CE-marked Anti-HCV antibody assays against a range of samples that included 1,138 blood donors, 3,553 unselected routine daily specimens, and 46 pre-selected seroconversion panels. Specificity of the Elecsys Anti-HCV assay was 99.5% with blood donor samples and 99.4% with routine clinical specimens. These were similar to those obtained with the Prism(®) Anti-HCV, Architect(®) Anti-HCV assay, ADVIA(®) Centaur Anti-HCV assay and Vitros(®) Eci aHCV assays. Seroconversion sensitivity for the Elecsys Anti-HCV assay was similar to that of the Architect Anti-HCV, AxSYM HCV version 3.0, ADVIA Centaur Anti-HCV, and Vitros Eci aHCV assays. In fact, seroconversion testing on 46 commercially available panels showed that the difference in first detecting a positive blood sample was less than one day between assays (not statistically significant). The Elecsys Anti-HCV assay as well as the Architect, Prism, and Vitros Anti-HCV immunoassays revealed a seroconversion sensitivity of 100%, whereas the ADVIA Centaur HCV immunoassay showed a sensitivity of only 97.5% (39/40). Overall, the performance of the Elecsys Anti-HCV assay was similar to the performances of the comparator CE-marked Anti-HCV antibody assays.
Alborino
F
F
Ospedale di Dolo, Servizio di Medicina di Laboratorio, Dolo, Italy.
Burighel
A
A
Tiller
F-W
FW
van Helden
J
J
Gabriel
C
C
Raineri
A
A
Catapano
R
R
Stekel
H
H
D001331:Automation; D016174:Hepacivirus / Q000276:immunology*; D006526:Hepatitis C / Q000175:diagnosis* / Q000276:immunology / Q000821:virology; D018937:Hepatitis C Antibodies / Q000097:blood*; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
D018937:Hepatitis C Antibodies; D011933:Reagent Kits, Diagnostic