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

Harald H Kessler; Bryan R Cobb; Heiner Wedemeyer; Benjamin Maasoumy; Veronique Michel-Treil; Luca Ceccherini-Nelli; Birgit Bremer; Margit Hübner; Anna Helander; Hacene Khiri; Gabrielle Heilek; Christian O Simon; Kevin Luk; Shagufta Aslam; Philippe Halfon

doi:10.1016/j.jcv.2015.03.023

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

J Clin Virol. 2015 Jun:67:67-72. doi: 10.1016/j.jcv.2015.03.023. Epub 2015 Mar 31.

Authors

Affiliations

¹ Molecular Diagnostics Laboratory, IHMEM, Medical University of Graz, Graz, Austria. Electronic address: harald.kessler@medunigraz.at.
² Roche Molecular Systems, Inc., Pleasanton, CA, USA.
³ Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
⁴ Covance Laboratories, Geneva, Switzerland.
⁵ Università degli Studi di Pisa, Pisa, Italy.
⁶ Molecular Diagnostics Laboratory, IHMEM, Medical University of Graz, Graz, Austria.
⁷ Laboratoire ALPHABIO, Hôpital Europeen, Marseille, France.

PMID: 25959162
DOI: 10.1016/j.jcv.2015.03.023

Abstract

Background: The COBAS(®) AmpliPrep(®)/COBAS(®) TaqMan(®) HCV Test, v2.0 (CAP/CTM2) is used for HCV RNA viral load monitoring.

Objectives: 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.

Study design: 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.

Keywords: CAP/CTM HCV Test, v2.0; Hepatitis C virus RNA; Performance.

Publication types

Comparative Study
Evaluation Study
Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Clinical Trials as Topic
Drug Monitoring / methods*
Hepacivirus / genetics
Hepacivirus / isolation & purification*
Hepatitis C, Chronic / diagnosis*
Hepatitis C, Chronic / virology
Humans
Molecular Diagnostic Techniques / methods*
RNA, Viral / genetics
RNA, Viral / isolation & purification*
Reagent Kits, Diagnostic
Sensitivity and Specificity
Viral Load / methods*

Substances

RNA, Viral
Reagent Kits, Diagnostic