title: Efficiency of the ortho VITROS assay for detection of hepatitis C virus-specific antibodies increased by elimination of supplemental testing of samples with very low sample-to-cutoff ratios.
abstract: The clinical significance of specimens with low sample-to-cutoff (S/Co) ratios in the Ortho VITROS chemiluminescence assay (CIA) for detection of antibodies to hepatitis C virus (HCV) was evaluated. In one study of 482 CIA-reactive samples, none of the 83 samples with S/Co ratios of < 5 was HCV RNA positive. In a subsequent study, 332 samples with S/Co ratios of between 1 and 20 were tested with the recombinant immunoblot assay (RIBA). None of the 163 samples with S/Co ratios of < 5 was RIBA positive, 83% were RIBA negative, and 28 samples (18%) were RIBA indeterminate. HCV RNA and/or clinical evidence of hepatitis was not found in the 27 indeterminate cases examined. These results show that over 99% of samples with very low S/Co ratios (< or = 5) have no evidence of HCV infection. Therefore, we suggest that the HCV antibody testing algorithm for the VITROS assay might be modified to eliminate supplemental testing of samples with very low S/Co ratios.
authors.affiliation: Molecular Diagnostic Laboratory, VA Connecticut Healthcare System, 950 Campbell Avenue, West Haven, CT 06516, USA.
authors.forename: Margret
authors.initials: M
authors.lastname: Oethinger
authors.forename: Donald R
authors.initials: DR
authors.lastname: Mayo
authors.forename: JoAnne
authors.initials: J
authors.lastname: Falcone
authors.forename: Pankaj K
authors.initials: PK
authors.lastname: Barua
authors.forename: Brigitte P
authors.initials: BP
authors.lastname: Griffith
mesh_terms: D016174:Hepacivirus / Q000235:genetics / Q000276:immunology* / Q000302:isolation & purification; D006526:Hepatitis C / Q000175:diagnosis / Q000276:immunology; D018937:Hepatitis C Antibodies / Q000097:blood*; D006801:Humans; D008163:Luminescent Measurements; D012367:RNA, Viral / Q000302:isolation & purification; D015203:Reproducibility of Results
chemical_list: D018937:Hepatitis C Antibodies; D012367:RNA, Viral