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Utility of the new cobas HCV test for viral load monitoring during direct-acting antiviral therapy

Mücke, Marcus M ; Maasoumy, Benjamin ; Dietz, Julia ; Mücke, Victoria T ; Simon, Christian O ; Canchola, Jesse A ; Cornberg, Marcus ; Marins, Ed G ; Manns, Michael P ; Zeuzem, Stefan ; Wedemeyer, Heiner ; Sarrazin, Christoph ; Vermehren, Johannes Liu, Chen-Hua

PloS one, 2019-11, Vol.14 (11), p.e0224751-e0224751 [Periódico revisado por pares]

United States: Public Library of Science

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Utility of the new cobas HCV test for viral load monitoring during direct-acting antiviral therapy
Autor: Mücke, Marcus M ; Maasoumy, Benjamin ; Dietz, Julia ; Mücke, Victoria T ; Simon, Christian O ; Canchola, Jesse A ; Cornberg, Marcus ; Marins, Ed G ; Manns, Michael P ; Zeuzem, Stefan ; Wedemeyer, Heiner ; Sarrazin, Christoph ; Vermehren, Johannes
Liu, Chen-Hua
Assuntos: Adult ; Analysis ; Antiviral agents ; Antiviral Agents - administration & dosage ; Antiviral drugs ; Assaying ; Biological products industry ; Biology and life sciences ; Clinical medicine ; Clinical trials ; Daclatasvir ; Dasabuvir ; Drug dosages ; Drug Monitoring - instrumentation ; Endocrinology ; Gastroenterology ; Hepacivirus - genetics ; Hepacivirus - isolation & purification ; Hepatitis ; Hepatitis C virus ; Hepatitis C, Chronic - blood ; Hepatitis C, Chronic - drug therapy ; Hepatitis C, Chronic - virology ; Hepatology ; High-Throughput Screening Assays - instrumentation ; Hospitals ; Humans ; Infections ; Interferon ; Internal medicine ; Liver ; Medical schools ; Medical tests ; Medicine ; Medicine and health sciences ; Molecular Diagnostic Techniques - instrumentation ; Mortality ; Patients ; Quality of life ; Real-Time Polymerase Chain Reaction - instrumentation ; Research and Analysis Methods ; Ribonucleic acid ; RNA ; RNA, Viral - genetics ; RNA, Viral - isolation & purification ; Sampling methods ; Social Sciences ; Sofosbuvir ; Statistical analysis ; Statistical methods ; Substance abuse treatment ; Target detection ; Therapy ; Viral Load - drug effects ; Virology
É parte de: PloS one, 2019-11, Vol.14 (11), p.e0224751-e0224751
Notas: ObjectType-Article-1
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Competing Interests: Roche Diagnostics funded this study, provided the cobas HCV RNA kits, and Christian O. Simon, Jesse A. Canchola and Ed G Marins are employees of Roche Diagnostics. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials.
Descrição: 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. 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. 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.
Editor: United States: Public Library of Science
Idioma: Inglês

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Utility of the new cobas HCV test for viral load monitoring during direct-acting antiviral therapy

Mücke, Marcus M ; Maasoumy, Benjamin ; Dietz, Julia ; Mücke, Victoria T ; Simon, Christian O ; Canchola, Jesse A ; Cornberg, Marcus ; Marins, Ed G ; Manns, Michael P ; Zeuzem, Stefan ; Wedemeyer, Heiner ; Sarrazin, Christoph ; Vermehren, Johannes Liu, Chen-Hua

United States: Public Library of Science

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