A European multicentre study on the comparison of HCV viral loads between VERIS HCV assay and COBAS® TaqMan® HCV Test and RealTime HCV Assay

- Extraction/amplification for HCV RNA quantitation are integrated in one instrument.
- Method comparison of HCV viral load results demonstrated low average bias.
- Patient results over time showed similar profiles and trending between methods.
- Care should be taken when changing systems as variability exists in assay results.

BackgroundBeckman Coulter has developed the VERIS HCV Assay for use on the new fully automated DxN VERIS Molecular Diagnostic SystemÂ¥ for HCV viral load monitoring.ObjectivesEvaluate the clinical performance of the new quantitative VERIS HCV Assay.Study designComparison was performed on 279 plasma specimens from HCV infected patients tested with the VERIS HCV Assay and COBAS® Ampliprep/COBAS® Taqman® HCV Test and 369 specimens tested with the VERIS HCV Assay and RealTime HCV Assay. Patient monitoring sample results from four time points were also compared.ResultsThe average bias between the VERIS HCV Assay and the COBAS® Ampliprep/COBAS® Taqman® HCV Test was 0.04 log10 IU/mL, while between the VERIS HCV Assay and the RealTime HCV Assay average bias was 0.21 log10 IU/mL. Bias, however, was not consistent across the measuring range. Analysis at the lower end of quantification levels 50, 100, and 1000 IU/mL showed a predicted bias for VERIS HCV Assay versus COBAS® Ampliprep/COBAS® Taqman® HCV Test between −0.42 and −0.22 log10 IU/mL and for VERIS HCV Assay versus RealTime HCV Assay between 0.00 and 0.13 log10 IU/mL. Patient monitoring of HCV viral load over time demonstrated similar levels between VERIS HCV Assay results and COBAS® Ampliprep/COBAS® Taqman® HCV Test (52 samples from 13 patients) and RealTime HCV Assay (112 samples from 28 patients).ConclusionsVERIS HCV Assay for use on the DxN VERIS Molecular Diagnostic System represents a reliable new tool for easy sample to result HCV RNA viral load monitoring.