A European multicenter study on the analytical performance of the VERIS HBV assay.

Autor: Braun P; Laboratory Dr. Knechten, Medical Center for HIV and Hepatitis, Aachen, Germany., Delgado R; Microbiology Department, Hospital Universitario 12 de Octubre and Insituto de Investigation, Hospital 12 de Octubre (i + 12), Madrid, Spain., Drago M; Clinical Chemistry and Microbiology laboratories, Niguarda Ca' Granda Hospital, Milan, Italy., Fanti D; Clinical Chemistry and Microbiology laboratories, Niguarda Ca' Granda Hospital, Milan, Italy., Fleury H; Virology Department, Hôpital Pellegrin, CHU, Bordeaux, France., Izopet J; Department of Virology, Federative Institute of Biology, CHU, Toulouse, France., Lombardi A; Clinical Microbiology, Virology and Bioemergence Diagnosis, L. Sacco University Hospital, Milan, Italy., Mancon A; Clinical Microbiology, Virology and Bioemergence Diagnosis, L. Sacco University Hospital, Milan, Italy., Marcos MA; Department of Clinical Microbiology, Hospital Clinic, School of Medicine, University of Barcelona, Centre for International Health Research (CRESIB), Barcelona, Spain., Sauné K; Department of Virology, Federative Institute of Biology, CHU, Toulouse, France., O Shea S; Viapath Analytics, Infection Sciences, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom., Pérez-Rivilla A; Microbiology Department, Hospital Universitario 12 de Octubre and Insituto de Investigation, Hospital 12 de Octubre (i + 12), Madrid, Spain., Ramble J; Viapath Analytics, Infection Sciences, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom., Trimoulet P; Virology Department, Hôpital Pellegrin, CHU, Bordeaux, France., Vila J; Department of Clinical Microbiology, Hospital Clinic, School of Medicine, University of Barcelona, Centre for International Health Research (CRESIB), Barcelona, Spain., Whittaker D; Laboratory Medicine Building, North Lane, Northern General Hospital, Sheffield, United Kingdom., Artus A; Beckman Coulter, Immunotech, Marseille, France., Rhodes D; Beckman Coulter, Immunotech, Marseille, France. Electronic address: dwrhodes@beckman.com.
Jazyk: angličtina
Zdroj: Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology [J Clin Virol] 2018 Feb - Mar; Vol. 99-100, pp. 50-56. Date of Electronic Publication: 2017 Dec 19.
DOI: 10.1016/j.jcv.2017.12.009
Abstrakt: Background: Hepatitis B viral load monitoring is an essential part of managing patients with chronic Hepatits B infection. Beckman Coulter has developed the VERIS HBV Assay for use on the fully automated Beckman Coulter DxN VERIS Molecular Diagnostics System. 1 OBJECTIVES: To evaluate the analytical performance of the VERIS HBV Assay at multiple European virology laboratories.
Study Design: Precision, analytical sensitivity, negative sample performance, linearity and performance with major HBV genotypes/subtypes for the VERIS HBV Assay was evaluated.
Results: Precision showed an SD of 0.15 log 10 IU/mL or less for each level tested. Analytical sensitivity determined by probit analysis was between 6.8-8.0 IU/mL. Clinical specificity on 90 unique patient samples was 100.0%. Performance with 754 negative samples demonstrated 100.0% not detected results, and a carryover study showed no cross contamination. Linearity using clinical samples was shown from 1.23-8.23 log 10 IU/mL and the assay detected and showed linearity with major HBV genotypes/subtypes.
Conclusions: The VERIS HBV Assay demonstrated comparable analytical performance to other currently marketed assays for HBV DNA monitoring.
(Copyright © 2017 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE