Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Kessler, HH; Cobb, BR; Wedemeyer, H; Maasoumy, B; Michel-Treil, V; Ceccherini-Nelli, L; Bremer, B; Hübner, M; Helander, A; Khiri, H; Heilek, G; Simon, CO; Luk, K; Aslam, S; Halfon, P.
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; 67(10):67-72
Doi: 10.1016/j.jcv.2015.03.023
Web of Science
PubMed
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FullText_MUG
- Leading authors Med Uni Graz
- Kessler Harald
- Co-authors Med Uni Graz
- Hübner Margit
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- Abstract:
- The COBAS(®) AmpliPrep(®)/COBAS(®) TaqMan(®) HCV Test, v2.0 (CAP/CTM2) is used for HCV RNA viral load monitoring. 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. 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. 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. 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. Copyright © 2015 Elsevier B.V. All rights reserved.
- Find related publications in this database (using NLM MeSH Indexing)
- 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
- Find related publications in this database (Keywords)
- Hepatitis C virus RNA
- CAP/CTM HCV Test, v2.0
- Performance