European Multicenter Study on Analytical Performance of DxN Veris System HCV Assay.
The analytical performance of the Veris HCV Assay for use on the new and fully automated Beckman Coulter DxN Veris Molecular Diagnostics System (DxN Veris System) was evaluated at 10 European virology laboratories. Precision, analytical sensitivity, specificity, and performance with negative samples, linearity, and performance with hepatitis C virus (HCV) genotypes were evaluated. Precision for all sites showed a standard deviation (SD) of 0.22 log10IU/ml or lower for each level tested. Analytical sensitivity determined by probit analysis was between 6.2 and 9.0 IU/ml. Specificity on 94 unique patient samples was 100%, and performance with 1,089 negative samples demonstrated 100% not-detected results. Linearity using patient samples was shown from 1.34 to 6.94 log10IU/ml. The assay demonstrated linearity upon dilution with all HCV genotypes. The Veris HCV Assay demonstrated an analytical performance comparable to that of currently marketed HCV assays when tested across multiple European sites.
Laboratory Dr. Knechten, Medical Center for HIV and Hepatitis, Aachen, Germany.
Patrick
P
Braun
Microbiology Department, Hospital Universitario 12 de Octubre and Insituto de Investigation, Hospital 12 de Octubre (i+12), Madrid, Spain.
Rafael
R
Delgado
Clinical Chemistry and Microbiology laboratories, Niguarda Ca' Granda Hospital, Milan, Italy.
Monica
M
Drago
Clinical Chemistry and Microbiology laboratories, Niguarda Ca' Granda Hospital, Milan, Italy.
Diana
D
Fanti
Virology Department, Hôpital Pellegrin, Centre Hospitalier Universitaire Bordeaux, Bordeaux, France.
Hervé
H
Fleury
Clinical Microbiology, Virology and Bioemergence Diagnosis, L. Sacco University Hospital, Milan, Italy.
Maria Rita
MR
Gismondo
Virology Department, Labor Berlin, Charité Vivantes GmbH, Berlin, Germany.
Jörg
J
Hofmann
Department of Virology, Federative Institute of Biology, Centre Hospitalier Universitaire Toulouse, Toulouse, France.
Jacques
J
Izopet
Virology Department, Labor Berlin, Charité Vivantes GmbH, Berlin, Germany.
Sebastian
S
Kühn
Clinical Microbiology, Virology and Bioemergence Diagnosis, L. Sacco University Hospital, Milan, Italy.
Alessandra
A
Lombardi
Department of Clinical Microbiology, Hospital Clinic, School of Medicine, University of Barcelona, Centre for International Health Research Barcelona (CRESIB), Barcelona, Spain.
Maria Angeles
MA
Marcos
Department of Virology, Federative Institute of Biology, Centre Hospitalier Universitaire Toulouse, Toulouse, France.
Karine
K
Sauné
Viapath Analytics, Infection Sciences, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom.
Siobhan
S
O'Shea
Microbiology Department, Hospital Universitario 12 de Octubre and Insituto de Investigation, Hospital 12 de Octubre (i+12), Madrid, Spain.
Alfredo
A
Pérez-Rivilla
Viapath Analytics, Infection Sciences, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom.
John
J
Ramble
Virology Department, Hôpital Pellegrin, Centre Hospitalier Universitaire Bordeaux, Bordeaux, France.
Pascale
P
Trimoulet
Department of Clinical Microbiology, Hospital Clinic, School of Medicine, University of Barcelona, Centre for International Health Research Barcelona (CRESIB), Barcelona, Spain.
Jordi
0000-0002-8025-3926
J
Vila
Laboratory Medicine Building, Northern General Hospital, Sheffield, United Kingdom.
Duncan
D
Whittaker
Beckman Coulter, Immunotech, Marseille, France.
Alain
A
Artus
Beckman Coulter, Immunotech, Marseille, France dwrhodes@beckman.com.
Daniel W
DW
Rhodes
D057205:Automation, Laboratory / Q000379:methods*; D005060:Europe; D016174:Hepacivirus / Q000302:isolation & purification*; D019698:Hepatitis C, Chronic / Q000821:virology*; D006801:Humans; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity; D019562:Viral Load / Q000379:methods*
HCV; analytical performance; automated; quantitation