Marcus Maximilian Mücke, Benjamin Maasoumy, Julia Dietz, Victoria Therese Mücke, Christian O. Simon, Jesse Canchola, Markus Cornberg, Ed G. Marins, Michael P. Manns, Stefan Zeuzem, Heiner Wedemeyer, Christoph Sarrazin, Johannes Vermehren
- Background: The COBAS AmpliPrep/COBAS TaqMan assay HCV (CAP/CTM) is widely used in clinical routine for HCV testing. Recently, the new cobas HCV test was established for high throughput testing with minimal operator intervention. As different assays may yield different quantitative/qualitative results that possibly impact treatment decisions, the aim of this study was to externally evaluate the cobas HCV test performance in comparison to CAP/CTM in a clinically relevant setting.
Methods: Serum samples were obtained from 270 patients who received direct acting antiviral therapy with different treatment regimens at two study sites (Hannover and Frankfurt) in 2016. Overall, 1545 samples (baseline, on-treatment and follow-up) were tested in parallel by both assays.
Results: The mean difference between cobas HCV and CAP/CTM for the quantification of HCV RNA was 0.008 log10 IU/ml HCV RNA (95% limits of agreement: -0.02–0.036) showing excellent agreement of both assays. With respect to clinical cut offs (HCV RNA detectable vs. target not detected and HCV RNA above the lower limit of quantification (LLOQ) vs. <LLOQ), discordant results were obtained in 9.5% and 4.6%, respectively; the greatest differences were observed during early stages of antiviral therapy (week 1, week 2 and week 4), but none were statistically significant. Overall percent agreement for SVR between cobas HCV and CAP/CTM at the 15 IU/ml cutoff was 99.2% (95%CI 92.7%-100%).
Conclusion: The performance of the new cobas HCV test was comparable to CAP/CTM in a clinical setting representing a large patient population with HCV GT 1 and 3 treated with DAAs.
MetadatenAuthor: | Marcus Maximilian MückeORCiDGND, Benjamin MaasoumyORCiDGND, Julia DietzORCiDGND, Victoria Therese MückeORCiDGND, Christian O. Simon, Jesse Canchola, Markus CornbergORCiDGND, Ed G. Marins, Michael P. MannsORCiDGND, Stefan ZeuzemORCiDGND, Heiner WedemeyerORCiDGND, Christoph SarrazinGND, Johannes VermehrenGND |
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URN: | urn:nbn:de:hebis:30:3-516983 |
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DOI: | https://doi.org/10.1371/journal.pone.0224751 |
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ISSN: | 1932-6203 |
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Pubmed Id: | https://pubmed.ncbi.nlm.nih.gov/31738773 |
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Parent Title (English): | PLoS one |
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Publisher: | PLoS |
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Place of publication: | Lawrence, Kan. |
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Contributor(s): | Chen-Hua Liu |
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Document Type: | Article |
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Language: | English |
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Year of Completion: | 2019 |
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Date of first Publication: | 2019/11/18 |
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Publishing Institution: | Universitätsbibliothek Johann Christian Senckenberg |
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Release Date: | 2019/11/20 |
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Tag: | Antiviral therapy; Chronic hepatitis; Cirrhosis; Hepatitis C virus; Medical education; Protease inhibitor therapy; Specimen preparation and treatment; Viral load |
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Volume: | 14 |
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Issue: | (11): e0224751 |
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Page Number: | 10 |
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First Page: | 1 |
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Last Page: | 10 |
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Note: | Copyright: © 2019 Mücke et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
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HeBIS-PPN: | 456404392 |
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Institutes: | Medizin / Medizin |
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Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Sammlungen: | Universitätspublikationen |
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Open-Access-Publikationsfonds: | Medizin |
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Licence (German): | Creative Commons - Namensnennung 4.0 |
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