title: Performance evaluation of the Vitros anti-hepatitis C virus antibody assay for use in clinical laboratories.
abstract: OBJECTIVE
  We evaluated the performance of Vitros anti-HCV assay.
  
  
  METHODS
  Precision performance was assessed for 20 days. A total of 1011 sera were tested for anti-HCV with Vitros and Elecsys assays. Specimens positive for any of the two assays were retested with Architect assay. Discrepant results were evaluated with recombinant immunoblot assay (RIBA) and HCV RNA quantification.
  
  
  RESULTS
  Total imprecision of Vitros assay was 11.6% and 3.3% CV for negative and positive QC. Among the 1011 sera, 17 showed discrepant results between the three assays. Six were positive and three negative for RIBA. HCV RNA was not detected from all discrepant cases. Sensitivity and specificity were 99.5% and 99.5% for the Vitros, and 100.0% and 99.9% for the Elecsys assay.
  
  
  CONCLUSIONS
  Sensitivities and specificities of the anti-HCV assays were sufficiently high for use in clinical laboratories, but retesting of weak positive results may be necessary.
authors.affiliation: Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Yongjung
authors.initials: Y
authors.lastname: Park
authors.forename: Yoonmi
authors.initials: Y
authors.lastname: Seok
authors.forename: Jonghyeon
authors.initials: J
authors.lastname: Choi
authors.forename: Hyon-Suk
authors.initials: HS
authors.lastname: Kim
mesh_terms: D019411:Clinical Laboratory Techniques / Q000592:standards; D005260:Female; D006461:Hemolysis; D016174:Hepacivirus / Q000378:metabolism; D018937:Hepatitis C Antibodies / Q000097:blood* / Q000276:immunology; D006801:Humans; D015151:Immunoblotting / Q000379:methods; D008297:Male; D016133:Polymerase Chain Reaction; D011247:Pregnancy; D012367:RNA, Viral / Q000235:genetics / Q000378:metabolism; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D018937:Hepatitis C Antibodies; D012367:RNA, Viral