title: Multicenter clinical evaluation of the new 3rd generation assay for detection of antibodies against hepatitis C virus on the VIDAS(®) system.
abstract: BACKGROUND
  Detection of antibodies (anti-HCV) against hepatitis C virus (HCV) is indispensable for screening and diagnosis of viral hepatitis and for the viral safety of blood, tissue or organ donations. It gains additional importance by the new HCV drugs which improve the therapeutic possibilities dramatically.
  
  
  OBJECTIVE
  To evaluate the performance of a newly developed immune assay for anti-HCV based on the well-established VIDAS platform.
  
  
  METHODS
  The assay was evaluated with samples from anti-HCV negative blood donors and from patients with or without HCV markers in six centres in France, Spain and Egypt. The status of the samples was determined by using CE-marked immune assays (Architect, AxSym, Prism, Vitros), two immunoblots (RIBA, Inno-Lia) and/or HCV RNA results.
  
  
  RESULTS
  Specificity was 99.67% in 10,320 French blood donors without anti-HCV, 99.5% in 200 anti-HCV negative hospitalized European patients and 99.0% in 198 negative patients from Egypt. Sensitivity was 99.7% in 1054 patients pretested positive by other assays; 345 patients with known genotype had genotype 1-6; 61 patients were co-infected with HIV. VIDAS was reactive in 78% of 91 patients with uncertain or very weak anti-HCV. It became on average positive at day 37 with seroconversion panels.
  
  
  CONCLUSIONS
  This multicentric, international study with >12,000 samples show that the new VIDAS anti-HCV assay is very suitable for screening and confirmation of HCV infection. Sensitivity, specificity and recognition of seroconversion compare favorably with well-established CE-marked tests and help to clarify discrepant results obtained with other assays.
authors.affiliation: bioMérieux, R&D Immunoassays, Marcy l'Etoile, France. Electronic address: beatrice.seigneres@biomerieux.com.
authors.forename: B
authors.initials: B
authors.lastname: Seignères
authors.affiliation: EFS Nord de France, Lille, France.
authors.forename: F
authors.initials: F
authors.lastname: Descamps
authors.affiliation: EFS Rhône-Alpes, Metz-Tessy, France.
authors.forename: R
authors.initials: R
authors.lastname: Croise
authors.affiliation: EFS Rhône-Alpes, Metz-Tessy, France.
authors.forename: V
authors.initials: V
authors.lastname: Barlet
authors.affiliation: National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology, Henri Mondor Hospital, Université Paris-Est, INSERM U955, Créteil, France.
authors.forename: M
authors.initials: M
authors.lastname: Bouvier-Alias
authors.affiliation: National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology, Henri Mondor Hospital, Université Paris-Est, INSERM U955, Créteil, France.
authors.forename: S
authors.initials: S
authors.lastname: Chevaliez
authors.affiliation: National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology, Henri Mondor Hospital, Université Paris-Est, INSERM U955, Créteil, France.
authors.forename: J M
authors.initials: JM
authors.lastname: Pawlotsky
authors.affiliation: Clinical Pathology Department, Ain Shams Faculty of Medecine, Cairo, Egypt.
authors.forename: W
authors.initials: W
authors.lastname: Abdelhady
authors.affiliation: Clinical Pathology Department, Ain Shams Faculty of Medecine, Cairo, Egypt.
authors.forename: M
authors.initials: M
authors.lastname: Rafik
authors.affiliation: National Centre of Microbiology, Department of Virology, Majadahonda, Spain.
authors.forename: A M
authors.initials: AM
authors.lastname: Avellon
authors.affiliation: National Centre of Microbiology, Department of Virology, Majadahonda, Spain.
authors.forename: J M
authors.initials: JM
authors.lastname: Echevarria
authors.affiliation: bioMérieux, R&D Immunoassays, Marcy l'Etoile, France.
authors.forename: M
authors.initials: M
authors.lastname: Hausmann
authors.affiliation: bioMérieux, R&D Immunoassays, Marcy l'Etoile, France.
authors.forename: J-M
authors.initials: JM
authors.lastname: Dugua
mesh_terms: D000818:Animals; D004534:Egypt; D005602:France; D016174:Hepacivirus / Q000276:immunology*; D006526:Hepatitis C / Q000175:diagnosis*; D018937:Hepatitis C Antibodies / Q000097:blood*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods*; D013030:Spain
chemical_list: D018937:Hepatitis C Antibodies
keywords: Anti-HCV; Enzyme linked fluorescent assay