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

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

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.

Publication types

  • Evaluation Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Automation, Laboratory
  • Europe
  • Genotype
  • Hepatitis B / blood*
  • Hepatitis B virus / genetics*
  • Humans
  • Limit of Detection
  • Molecular Diagnostic Techniques / methods*
  • RNA, Viral / blood
  • RNA, Viral / genetics
  • Real-Time Polymerase Chain Reaction*
  • Sensitivity and Specificity
  • Viral Load / methods*

Substances

  • RNA, Viral