title: Multicenter evaluation of the Elecsys® anti-HCV II assay for the diagnosis of hepatitis C virus infection.
abstract: Routine screening of patients at risk of hepatitis C virus (HCV) infection has become a priority given recent improvements in therapeutic options and the asymptomatic nature of most chronic infections. The aim of this study was to evaluate the performance of the Elecsys® Anti-HCV II assay, a new qualitative antibody immunoassay, compared with currently available assays, and assess its suitability for routine diagnostic testing. The sensitivity of the Elecsys® Anti-HCV II, ARCHITECT® Anti-HCV, AxSYM® HCV 3.0, PRISM® HCV, Vitros® ECi Anti-HCV, Elecsys® Anti-HCV, and ADVIA Centaur® HCV assays was compared using commercially available seroconversion panels and samples from patients known to be HCV positive and infected with HCV genotypes 1-6. Specificity was investigated using samples from blood donors, unselected hospitalized patients, and patients with potential cross-reacting factors or from high-risk groups. The Elecsys® Anti-HCV II assay detected more positive bleeds than the comparator assays, was more sensitive in recognizing early HCV infection, and correctly identified all 765 samples known to be HCV positive, regardless of genotype. The overall specificity of the Elecsys(®) Anti-HCV II assay was 99.84% (n=6,850) using blood donor samples, 99.66% (n=3,922) using samples from unselected hospitalized patients, and 99.66% (n=2,397) using samples from patients with potentially cross-reacting factors or from high-risk groups. The specificity of the Elecsys® Anti-HCV II assay was superior or equal to the comparator assays. In conclusion, the Elecsys® Anti-HCV II assay is a sensitive and specific assay suitable for routine use in the reliable detection of anti-HCV antibodies.
authors.affiliation: Liver Unit, Vall d'Hebron University Hospital, Barcelona, Spain. jiesteban@vhebron.net
authors.forename: Juan I
authors.initials: JI
authors.lastname: Esteban
authors.forename: Josef
authors.initials: J
authors.lastname: van Helden
authors.forename: Flora
authors.initials: F
authors.lastname: Alborino
authors.forename: Philippe
authors.initials: P
authors.lastname: Bürgisser
authors.forename: Cristina
authors.initials: C
authors.lastname: Cellerai
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pantaleo
authors.forename: Adolfo
authors.initials: A
authors.lastname: Eiras
authors.forename: Maria I
authors.initials: MI
authors.lastname: Rodriguez
authors.forename: Valeria
authors.initials: V
authors.lastname: Ghisetti
authors.forename: Michael
authors.initials: M
authors.lastname: Gleich
authors.forename: Roland
authors.initials: R
authors.lastname: Imdahl
authors.forename: Claudia
authors.initials: C
authors.lastname: Kaiser
authors.forename: Petra
authors.initials: P
authors.lastname: Möller
authors.forename: Olaf
authors.initials: O
authors.lastname: Wetlitzky
authors.forename: Manuel
authors.initials: M
authors.lastname: Segovia
authors.forename: Harald
authors.initials: H
authors.lastname: Schennach
authors.forename: Annelies
authors.initials: A
authors.lastname: Mühlbacher
mesh_terms: D019411:Clinical Laboratory Techniques / Q000379:methods*; D005260:Female; D016174:Hepacivirus / Q000276:immunology*; D006526:Hepatitis C / Q000175:diagnosis*; D018937:Hepatitis C Antibodies / Q000097:blood*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D008297:Male; D011247:Pregnancy; D012680:Sensitivity and Specificity
chemical_list: D018937:Hepatitis C Antibodies