1. Utility of the new cobas HCV test for viral load monitoring during direct-acting antiviral therapy
- Author
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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, and Liu, Chen-Hua
- Subjects
RNA viruses ,Chronic Hepatitis ,Medizin ,Social Sciences ,Hepacivirus ,Chronic Liver Disease ,Sociology ,Public and Occupational Health ,Pathology and laboratory medicine ,Protease Inhibitor Therapy ,Hepatitis C virus ,Liver Diseases ,virus diseases ,Medical microbiology ,Viral Load ,Vaccination and Immunization ,Cirrhosis ,Molecular Diagnostic Techniques ,Viruses ,Medicine ,RNA, Viral ,Pathogens ,Drug Monitoring ,Research Article ,Adult ,Science ,Immunology ,Antiretroviral Therapy ,Gastroenterology and Hepatology ,Research and Analysis Methods ,Real-Time Polymerase Chain Reaction ,Microbiology ,Antiviral Agents ,Education ,Antiviral Therapy ,Virology ,Humans ,ddc:610 ,Medicine and health sciences ,Biology and life sciences ,Flaviviruses ,Organisms ,Viral pathogens ,Hepatitis C, Chronic ,Hepatitis viruses ,digestive system diseases ,Microbial pathogens ,High-Throughput Screening Assays ,Medical Education ,Specimen Preparation and Treatment ,Preventive Medicine ,Medical Humanities ,Viral Transmission and Infection - Abstract
BackgroundThe 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.MethodsSerum 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.ResultsThe 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. ConclusionThe 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.
- Published
- 2019