title: Multicenter evaluation of a fully automated third-generation anti-HCV antibody screening test with excellent sensitivity and specificity.
abstract: 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.
authors.affiliation: Ospedale di Dolo, Servizio di Medicina di Laboratorio, Dolo, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Alborino
authors.forename: A
authors.initials: A
authors.lastname: Burighel
authors.forename: F-W
authors.initials: FW
authors.lastname: Tiller
authors.forename: J
authors.initials: J
authors.lastname: van Helden
authors.forename: C
authors.initials: C
authors.lastname: Gabriel
authors.forename: A
authors.initials: A
authors.lastname: Raineri
authors.forename: R
authors.initials: R
authors.lastname: Catapano
authors.forename: H
authors.initials: H
authors.lastname: Stekel
mesh_terms: 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
chemical_list: D018937:Hepatitis C Antibodies; D011933:Reagent Kits, Diagnostic