A European Multicentre Study on the Analytical Performance of the DxN VERIS System HCV Assay.
The analytical performance of the VERIS HCV Assay for use on the new, fully automated Beckman Coulter DxN VERIS Molecular Diagnostics System (DxN VERIS System)¥ was evaluated at 10 European virology laboratories. Precision, analytical sensitivity, specificity and performance with negative samples, linearity, and performance with HCV genotypes were evaluated. Precision for all sites showed an SD of 0.22 log10 IU/mL or lower for each level tested. Analytical sensitivity determined by probit analysis was between 6.2 - 9.0 IU/mL. Specificity on 94 unique patient samples was 100% and performance with 1089 negative samples demonstrated 100% not detected results. Linearity using patient samples was shown from 1.34 - 6.94 log10 IU/mL. The assay demonstrated linearity upon dilution with all HCVgenotypes. The VERIS HCV Assay demonstrated comparable analytical performance to currently marketed HCV assays when tested across multiple European sites.
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J Clin Microbiol. 2017 Feb 1. pii: JCM.02163-16. doi: 10.1128/JCM.02163-16. [Epub ahead of print]