title: Evaluation of the new ARCHITECT anti-HCV screening test under routine laboratory conditions.
abstract: BACKGROUND
  An improved test version of the Abbott ARCHITECT anti-hepatitis C virus (HCV) test became available at the end of 2005.
  
  
  METHODS
  We compared the new test version with the Ortho Vitros anti-HCV test by evaluating 2034 serum samples in parallel on both systems under routine laboratory conditions. Discordant samples were tested in the Inno-LIA HCV Score assay as well as in the RIBA HCV 3.0.
  
  
  RESULTS
  Of the 2034 samples 140 (6.9%) yielded positive and 1856 (91.2%) negative results in both assays. We observed discordant results in 38 samples (1.9%). All discrepant samples showed a low S/CO ratio of 1.0-6.9 (mean 2.8) in the Ortho assay and of 1.3-3.0 (mean 1.96) in the ARCHITECT assay. As expected, most of them could not be confirmed by immunoblot testing. Comparison of the results of the two immunoblots (Inno-LIA and RIBA) revealed a great variability in test results.
  
  
  CONCLUSIONS
  This study represents the first comparative evaluation of the modified version of the Abbott ARCHITECT anti-HCV assay in comparison with the Ortho Vitros anti-HCV test. Under routine laboratory testing, we observed good overall concordance between the two assays and no evidence that one assay shows more false-reactive or negative results than the other.
authors.affiliation: Institute for Medical Virology, Frankfurt University Medical School, Paul Ehrlich-Street 40, D-60596 Frankfurt am Main, Germany. Annemarie.Berger@em.uni-frankfurt.de
authors.forename: Annemarie
authors.initials: A
authors.lastname: Berger
authors.forename: Holger
authors.initials: H
authors.lastname: Rabenau
authors.forename: Regina
authors.initials: R
authors.lastname: Allwinn
authors.forename: Hans Wilhelm
authors.initials: HW
authors.lastname: Doerr
mesh_terms: D005260:Female; D016174:Hepacivirus / Q000276:immunology*; D006526:Hepatitis C / Q000175:diagnosis* / Q000276:immunology; D018937:Hepatitis C Antibodies / Q000097:blood*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D015151:Immunoblotting; D008163:Luminescent Measurements; D008403:Mass Screening; D011237:Predictive Value of Tests; D011247:Pregnancy; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014773:Virology / Q000379:methods
chemical_list: D018937:Hepatitis C Antibodies; D011933:Reagent Kits, Diagnostic