title: Evaluation of the COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) HCV Test, v2.0 and comparison to assays used in routine clinical practice in an international multicenter clinical trial: The ExPECT study.
abstract: BACKGROUND
  The COBAS(®) AmpliPrep(®)/COBAS(®) TaqMan(®) HCV Test, v2.0 (CAP/CTM2) is used for HCV RNA viral load monitoring.
  
  
  OBJECTIVE
  The performance of the CAP/CTM2 was compared to other widely used tests, including a manual version of the assay (the COBAS(®) TaqMan(®) HCV Test, v2.0 for use with the High Pure System, HPS/CTM2) predominantly used during phase III clinical trials for the new direct acting antiviral therapies.
  
  
  METHODS
  Low HCV RNA level comparisons were performed across tests (Abbott Realtime HCV Test, ART; COBAS(®) AmpliPrep(®)/COBAS(®) TaqMan(®) HCV Test, v1.0, CAP/CTM1; CAP/CTM2; and HPS/CTM2) using dilutions of the 2nd HCV WHO International Standard. Additionally, the clinical performance of the CAP/CTM2 was evaluated with 421 leftover HCV RNA-positive routine clinical samples.
  
  
  RESULTS
  All quantifiable WHO dilutions were within ±0.3log10IU/mL of the expected results across tests and the analytical sensitivity resulted in a limit of detection of 12IU/mL (95% confidence interval, 10, 15). When clinical samples were tested the results for 87% (367 of 421) of all sample comparisons were within ±0.5log10IU/mL. When low viral load results (25-3500IU/mL) were compared, values obtained by the ART assay were significantly lower (p<0.0001) than those obtained with the CAP/CTM2.
  
  
  CONCLUSIONS
  The new CAP/CTM2 showed good accuracy with comparable sensitivity to comparator assays. The new kit is well-suited for use in the routine diagnostic laboratory, especially for accurate monitoring of patients receiving triple therapy or interferone-free regimens.
authors.affiliation: Molecular Diagnostics Laboratory, IHMEM, Medical University of Graz, Graz, Austria. Electronic address: harald.kessler@medunigraz.at.
authors.forename: Harald H
authors.initials: HH
authors.lastname: Kessler
authors.affiliation: Roche Molecular Systems, Inc., Pleasanton, CA, USA.
authors.forename: Bryan R
authors.initials: BR
authors.lastname: Cobb
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
authors.forename: Heiner
authors.initials: H
authors.lastname: Wedemeyer
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Maasoumy
authors.affiliation: Covance Laboratories, Geneva, Switzerland.
authors.forename: Veronique
authors.initials: V
authors.lastname: Michel-Treil
authors.affiliation: Università degli Studi di Pisa, Pisa, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Ceccherini-Nelli
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
authors.forename: Birgit
authors.initials: B
authors.lastname: Bremer
authors.affiliation: Molecular Diagnostics Laboratory, IHMEM, Medical University of Graz, Graz, Austria.
authors.forename: Margit
authors.initials: M
authors.lastname: Hübner
authors.affiliation: Covance Laboratories, Geneva, Switzerland.
authors.forename: Anna
authors.initials: A
authors.lastname: Helander
authors.affiliation: Laboratoire ALPHABIO, Hôpital Europeen, Marseille, France.
authors.forename: Hacene
authors.initials: H
authors.lastname: Khiri
authors.affiliation: Roche Molecular Systems, Inc., Pleasanton, CA, USA.
authors.forename: Gabrielle
authors.initials: G
authors.lastname: Heilek
authors.affiliation: Roche Molecular Systems, Inc., Pleasanton, CA, USA.
authors.forename: Christian O
authors.initials: CO
authors.lastname: Simon
authors.affiliation: Roche Molecular Systems, Inc., Pleasanton, CA, USA.
authors.forename: Kevin
authors.initials: K
authors.lastname: Luk
authors.affiliation: Roche Molecular Systems, Inc., Pleasanton, CA, USA.
authors.forename: Shagufta
authors.initials: S
authors.lastname: Aslam
authors.affiliation: Laboratoire ALPHABIO, Hôpital Europeen, Marseille, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Halfon
mesh_terms: D002986:Clinical Trials as Topic; D016903:Drug Monitoring / Q000379:methods*; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D019698:Hepatitis C, Chronic / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D012367:RNA, Viral / Q000235:genetics / Q000302:isolation & purification*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D019562:Viral Load / Q000379:methods*
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic
keywords: CAP/CTM HCV Test, v2.0; Hepatitis C virus RNA; Performance