A European multicientre study on the comparison of HBV viral loads between VERIS HBV assay and Roche COBAS® TAQMAN® HBV test, Abbott RealTime HBV assay, Siemens VERSANT HBV assay, and Qiagen artus HBV RG kit

Abstract

Background: Hepatitis B viral load testing is essential to treatment and monitoring decisions in patients with chronic Hepatitis B. Beckman Coulter has developed the VERIS HBV Assay (Veris) for use on the fully automated DxN VERIS Molecular Diagnostics System.¹ OBJECTIVES: To evaluate the clinical performance of the Veris HBV Assay at multiple EU laboratories STUDY DESIGN: Method comparison was performed with a total of 344 plasma specimens from HBV infected patients tested with Veris and COBAS^® TaqMan^® HBV Test (Cobas), 207 specimens tested with Veris and RealTime HBV Assay (RealTime), 86 specimens tested with Veris and VERSANT^® HBV Assay (Versant), and 74 specimens tested with Veris and artus^® HBV RG PCR kit (artus).

Results: Bland-Altman analysis showed average bias of -0.46 log₁₀ IU/mL between Veris and Cobas, -0.46 log₁₀IU/mL between Veris and RealTime, -0.36 log₁₀IU/mL between Veris and Versant, and -0.12 log₁₀IU/mL between Veris and artus. Bias was consistent across the assay range. Patient monitoring results using Veris demonstrated similar viral load trends over time to Cobas, RealTime, and artus.

Conclusions: The VERIS HBV Assay demonstrated comparable clinical performance, with varying degrees of negative bias, compared to other currently marketed assays for HBV DNA monitoring. This negative bias should be taken into consideration if switching monitoring methods to Veris.

Keywords: Artus HBV RG kit; COBAS(®) TaqMan(®) HBV test; HBV DNA quantification; RealTime HBV assay; VERIS HBV assay; VERSANT HBV assay.