title: Analytical performance of the VERIS MDx system HCV assay for detecting and quantifying HCV RNA.
abstract: The diagnosis of HCV relies on the detection of viral RNA.
  
  
  
  To 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.
  
  
  
  The 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 0logIU/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 (6.4-0.6logIU/ml). We compared the VERIS MDx HCV and CAPCTM HCV assays by testing 209 samples.
  
  
  
  The limit of detection was 6.1IU/ml [CI 95%: 5.0-8.3] and the precision, given by the standard deviation, was ≤0.11logIU/ml. Specificity was 100%. The linearity ranged from 1.5 to 6.4logIU/ml. Passing-Bablok regression analysis gave: VERIS logIU/ml=-0.33+[1.04× CAPCTM] logIU/ml, with biases for the 25th, 50th, 75th percentiles of 0.18, -0.10 and -0.06logIU/ml. The two assays were well correlated (ρ=0.92, p<0.001) and Bland-Altman analysis gave biases of 0.12, logIU/ml for genotype 1, -0.19 for genotype 2, -0.26 for genotype 3, and -0.77 for genotype 4.
  
  
  
  The VERIS MDx HCV assay performed well. But, we observed an under-quantification of the genotype 4 samples.
authors.affiliation: INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse F-31300, France; CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, Institut fédératif de biologie de Purpan, F-31300, France. Electronic address: saune.k@chu-toulouse.fr.
authors.forename: Karine
authors.initials: K
authors.lastname: Sauné
authors.affiliation: INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse F-31300, France; CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, Institut fédératif de biologie de Purpan, F-31300, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Abravanel
authors.affiliation: CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, Institut fédératif de biologie de Purpan, F-31300, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Haslé
authors.affiliation: CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, Institut fédératif de biologie de Purpan, F-31300, France.
authors.forename: Jérôme
authors.initials: J
authors.lastname: Boineau
authors.affiliation: CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, Institut fédératif de biologie de Purpan, F-31300, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Mengelle
authors.affiliation: INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse F-31300, France; CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, Institut fédératif de biologie de Purpan, F-31300, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Izopet
mesh_terms: D001782:Blood Donors; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics* / Q000302:isolation & purification*; D006526:Hepatitis C / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D007159:Immunologic Tests; D057230:Limit of Detection; D010949:Plasma / Q000737:chemistry; D016133:Polymerase Chain Reaction / Q000295:instrumentation / Q000379:methods; D012367:RNA, Viral / Q000097:blood* / Q000235:genetics / Q000302:isolation & purification; D011933:Reagent Kits, Diagnostic; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D019562:Viral Load / Q000379:methods; D014944:World Health Organization
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic
keywords: COBAS Ampliprep COBAS Taqman; HCV RNA quantification; Hepatitis C virus; VERIS MDx system HCV assay