title: HCV RNA detection in HCV antibody-positive patients with the COBAS AmpliPrep/COBAS TaqMan HCV test, v2.0 in comparison with FDA-approved nucleic acid tests.
abstract: BACKGROUND
  Analysis of hepatitis C virus (HCV) RNA levels is critical for assessing the efficacy of antiviral therapy and the achievement of a sustained virologic response.
  
  
  OBJECTIVE
  This study evaluated the clinical performance of the COBAS AmpliPrep/COBAS TaqMan HCV quantitative test, version 2.0 (TAQMAN v2.0) with the COBAS AmpliPrep/COBAS TaqMan HCV quantitative test, version 1.0 (TAQMAN v1.0), the VERSANT HCV qualitative assay (VERSANT), and the COBAS AMPLICOR HCV test, v2.0 (AMPLICOR) qualitative test for the detection of HCV RNA in serum or EDTA plasma from patients who are or have been infected with HCV and carry HCV antibodies.
  
  
  RESULTS
  A total of 277 participants were evaluable for the percent agreement analysis of the TAQMAN v2.0 with the VERSANT and with the AMPLICOR. The overall percent agreement between the TAQMAN v2.0 and the VERSANT or the AMPLICOR was 99.3% (95% CI: 97.4%, 99.8%) or 98.9% (95% CI: 96.9%, 99.6%), respectively. The overall percent agreement between the TAQMAN v2.0 and the TAQMAN v1.0 when 267 of the original samples were assessed was 98.9% (95% CI=96.7%, 99.6%).
  
  
  CONCLUSIONS
  The TAQMAN v2.0 demonstrated high correlation with the previously approved HCV RNA quantitative and qualitative tests.
authors.affiliation: Roche Molecular Systems, Inc., 4300 Hacienda Drive, Pleasanton, CA 94588, United States.
authors.forename: Ann
authors.initials: A
authors.lastname: Butcher
authors.affiliation: Roche Molecular Systems, Inc., 4300 Hacienda Drive, Pleasanton, CA 94588, United States.
authors.forename: Shagufta
authors.initials: S
authors.lastname: Aslam
authors.affiliation: Roche Molecular Systems, Inc., 4300 Hacienda Drive, Pleasanton, CA 94588, United States.
authors.forename: Pari
authors.initials: P
authors.lastname: Hemyari
authors.affiliation: Roche Molecular Systems, Inc., 4300 Hacienda Drive, Pleasanton, CA 94588, United States.
authors.forename: Ula
authors.initials: U
authors.lastname: Cowen
authors.affiliation: Roche Molecular Systems, Inc., 4300 Hacienda Drive, Pleasanton, CA 94588, United States. Electronic address: gabrielle.heilek@roche.com.
authors.forename: Gabrielle
authors.initials: G
authors.lastname: Heilek
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000097:blood* / Q000175:diagnosis* / Q000188:drug therapy; D006801:Humans; D057230:Limit of Detection; D008297:Male; D025202:Molecular Diagnostic Techniques; D016133:Polymerase Chain Reaction / Q000379:methods; D012367:RNA, Viral / Q000097:blood*; D011933:Reagent Kits, Diagnostic; D019562:Viral Load / Q000379:methods*
chemical_list: D000998:Antiviral Agents; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic
keywords: Hepatitis C virus; Limit of detection; Nucleic acid testing; Sustained virologic response