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J Clin Virol. 2018 Feb - Mar;99-100:50-56. doi: 10.1016/j.jcv.2017.12.009. Epub 2017 Dec 19.

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

Author information

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, CHU, Bordeaux, France.
5
Department of Virology, Federative Institute of Biology, CHU, Toulouse, France.
6
Clinical Microbiology, Virology and Bioemergence Diagnosis, L. Sacco University Hospital, Milan, Italy.
7
Department of Clinical Microbiology, Hospital Clinic, School of Medicine, University of Barcelona, Centre for International Health Research (CRESIB), Barcelona, Spain.
8
Viapath Analytics, Infection Sciences, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom.
9
Laboratory Medicine Building, North Lane, Northern General Hospital, Sheffield, United Kingdom.
10
Beckman Coulter, Immunotech, Marseille, France.
11
Beckman Coulter, Immunotech, Marseille, France. Electronic address: dwrhodes@beckman.com.

Abstract

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 log10 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 log10 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.

KEYWORDS:

Analytical performance; HBV DNA quantification; VERIS HBV assay

PMID:
29328964
DOI:
10.1016/j.jcv.2017.12.009
[Indexed for MEDLINE]

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