Study on the Analytical Performance of the DxN VERIS System HCV Assay

This article presents data from a multicenter evaluation of the VERIS HCV assay that runs on the DxN VERIS Molecular Diagnostics System.* The study by Braun et al. was published online at the Journal of Clinical Microbiology in February 2017, and is to be published in print in the journal’s April issue. Data includes an assessment of system performance related to precision, analytical sensitivity, analytical measurement range and clinical specificity. The study featured a large number of tests performed by ten (10) participating evaluation sites based in the United Kingdom, Germany, Italy, Spain and France.

Study results demonstrated overall precision with a standard deviation (SD) of 0.22 log IU/mL or lower for each level tested. This was despite the challenges involved with the evaluation of a high number of sites. The analytical sensitivity observed among the sites was between 6.2 and 9.0 IU/mL. A broad linear range and detection of all HCV genotypes were also demonstrated.

The data is robust owing to the large numbers of tests performed. The analytical results demonstrate that the VERIS HCV assay meets the recommendations of current clinical guidelines for patient management in terms of performance and precision. The consistency of the VERIS HCV assay’s analytical performance is, in part, ascribed to the fully automated capabilities of the DxN VERIS System.

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