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.
A European multicenter study on the analytical performance of the VERIS HBV assay / P. Braun, R. Delgado, M. Drago, D. Fanti, H. Fleury, J. Izopet, A. Lombardi, A. Mancon, M.A. Marcos, K. Sauné, S. O Shea, A. Pérez-Rivilla, J. Ramble, P. Trimoulet, J. Vila, D. Whittaker, A. Artus, D. Rhodes. - In: JOURNAL OF CLINICAL VIROLOGY. - ISSN 1386-6532. - 99-100:(2018), pp. 50-56. [10.1016/j.jcv.2017.12.009]
A European multicenter study on the analytical performance of the VERIS HBV assay
A. Mancon;
2018
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 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.
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