Analytical performance of the VERIS MDx system HCV assay for detecting and quantifying HCV RNA |
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| Affiliation: | 1. INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse F-31300, France;2. CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, Institut fédératif de biologie de Purpan, F-31300, France;1. Bundeswehr Institute of Microbiology, Neuherbergstr. 11, D- 80937 München, Germany;2. Department of Internal Medicine II, Universityhospital Regensburg, Franz-Josef-Strauß-Allee 11, D- 93053 Regensburg, Germany;3. Institute of Clinical Microbiology and Hygiene, Franz-Josef-Strauß-Allee 11, D-93053 Regensburg, Germany;4. Department of Cardiothoracic Surgery, Universityhospital Regensburg, Franz-Josef-Strauß-Allee 11, D- 93053 Regensburg, Germany;1. Department of Virology, Faculty of Medicine, University of Helsinki, Helsinki, Finland;2. Department of Biodiversity and Molecular Ecology, Research and Innovation Centre, Fondazione Edmund Mach, San Michele all’Adige, TN, Italy;3. Department of Virology and Immunology, University of Helsinki and Helsinki University Hospital, HUSLAB, Helsinki, Finland;4. School of Medicine, University of Tampere, Tampere, Finland;5. Department of Internal Medicine, Tampere University Hospital, Tampere, Finland;1. Clinical Hematology Department, University Hospital of Martinique, Martinique, France;2. Virology Laboratory, University Hospital of Martinique, Martinique, France;3. Hematology Laboratory, University Hospital of Martinique, Martinique, France;4. Internal Medicine Department 3C/5D, University Hospital of Martinique, Martinique, France;5. Intensive care Department, University Hospital of Martinique, Martinique, France;1. Microbiology Service, Germans Trias i Pujol University Hospital, Germans Trias i Pujol Health Sciences Research Institute (IGTP), Badalona, Spain;2. Centro de Investigación Biomédica en Red (CIBER) en Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain;3. Liver Unit, Internal Medicine, Lab. Malalties Hepàtiques, Vall d''Hebron Institute of Research (VHIR-HUVH), Barcelona, Spain;4. Centro de Investigación Biomédica en Red (CIBER) de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain;5. Universitat Autònoma de Barcelona, Barcelona, Spain;6. Roche Diagnostics SL, Sant Cugat del Vallès, Spain;7. Centro de Investigación Biomédica en Red (CIBER) de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain;1. Alberta Provincial Laboratory for Public Health, Edmonton, Alberta, Canada;2. Alberta Provincial Laboratory for Public Health, Calgary, Alberta, Canada;3. Microbiology, Immunology and Infectious Diseases, University of Calgary, Calgary, Alberta, Canada;4. Microbiology and Immunology, University of Alberta, Edmonton, Alberta, Canada |
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| Abstract: | BackgroundThe diagnosis of HCV relies on the detection of viral RNA.ObjectiveTo evaluate the performance of the VERIS/MDx System HCV Assay, a new automated system for quantifying HCV RNA, and to compare with the COBAS® Ampliprep/COBAS® Taqman™ (CAPCTM) HCV Test version 2.0.Study designThe limit of detection was determined by Probit analysis with the 3rd International WHO HCV standard and precision by assaying in duplicate control samples with HCV RNA concentrations of 7.9; 5.0; 3.4; 1.6 and 0 log IU/ml over 20 days. Analytical specificity was assessed by assaying 180 samples from negative anti-HCV and HCV RNA blood donors and linearity with replicates of serial dilutions of a clinical plasma (6.4–0.6 log IU/ml). We compared the VERIS MDx HCV and CAPCTM HCV assays by testing 209 samples.ResultsThe limit of detection was 6.1 IU/ml [CI 95%: 5.0–8.3] and the precision, given by the standard deviation, was ≤0.11 log IU/ml. Specificity was 100%. The linearity ranged from 1.5 to 6.4 log IU/ml. Passing-Bablok regression analysis gave: VERIS log IU/ml = −0.33 + [1.04× CAPCTM] log IU/ml, with biases for the 25th, 50th, 75th percentiles of 0.18, −0.10 and −0.06 log IU/ml. The two assays were well correlated (ρ = 0.92, p < 0.001) and Bland-Altman analysis gave biases of 0.12, log IU/ml for genotype 1, −0.19 for genotype 2, −0.26 for genotype 3, and −0.77 for genotype 4.ConclusionThe VERIS MDx HCV assay performed well. But, we observed an under-quantification of the genotype 4 samples. |
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| Keywords: | Hepatitis C virus HCV RNA quantification VERIS MDx system HCV assay COBAS Ampliprep COBAS Taqman |
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