European Multicenter Study on Analytical Performance of DxN Veris System HCV Assay-Reference-Cited by-同舟云学术

European Multicenter Study on Analytical Performance of DxN Veris System HCV Assay

Published:2017-04 Issue:4 Volume:55 Page:1186-1192
ISSN:0095-1137
Container-title:Journal of Clinical Microbiology
language:en
Short-container-title:J Clin Microbiol

Author:

Braun Patrick¹,Delgado Rafael²,Drago Monica³,Fanti Diana³,Fleury Hervé⁴,Gismondo Maria Rita⁵,Hofmann Jörg⁶,Izopet Jacques⁷,Kühn Sebastian⁶,Lombardi Alessandra⁵,Marcos Maria Angeles⁸,Sauné Karine⁷,O'Shea Siobhan⁹,Pérez-Rivilla Alfredo²,Ramble John⁹,Trimoulet Pascale⁴,Vila Jordi⁸^ORCID,Whittaker Duncan¹⁰,Artus Alain¹¹,Rhodes Daniel W.¹¹

Affiliation:

1. Laboratory Dr. Knechten, Medical Center for HIV and Hepatitis, Aachen, Germany

2. Microbiology Department, Hospital Universitario 12 de Octubre and Insituto de Investigation, Hospital 12 de Octubre (i+12), Madrid, Spain

3. Clinical Chemistry and Microbiology laboratories, Niguarda Ca' Granda Hospital, Milan, Italy

4. Virology Department, Hôpital Pellegrin, Centre Hospitalier Universitaire Bordeaux, Bordeaux, France

5. Clinical Microbiology, Virology and Bioemergence Diagnosis, L. Sacco University Hospital, Milan, Italy

6. Virology Department, Labor Berlin, Charité Vivantes GmbH, Berlin, Germany

7. Department of Virology, Federative Institute of Biology, Centre Hospitalier Universitaire Toulouse, Toulouse, France

8. Department of Clinical Microbiology, Hospital Clinic, School of Medicine, University of Barcelona, Centre for International Health Research Barcelona (CRESIB), Barcelona, Spain

9. Viapath Analytics, Infection Sciences, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom

10. Laboratory Medicine Building, Northern General Hospital, Sheffield, United Kingdom

11. Beckman Coulter, Immunotech, Marseille, France

Abstract

ABSTRACT 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 log 10 IU/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 log 10 IU/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.

Funder

Beckman Coulter, Inc.

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Link

https://journals.asm.org/doi/pdf/10.1128/JCM.02163-16

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