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

Abstract Background Beckman Coulter has developed the VERIS HCV Assay for use on the new fully automated DxN VERIS Molecular Diagnostic System ¥ for HCV viral load monitoring. Objectives Evaluate the clinical performance of the new quantitative VERIS HCV Assay. Study design Comparison 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. Results The average bias between the VERIS HCV Assay and the COBAS ® Ampliprep/COBAS ® Taqman ® HCV Test was 0.04 log 10  IU/mL, while between the VERIS HCV Assay and the RealTime HCV Assay average bias was 0.21 log 10  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 log 10  IU/mL and for VERIS HCV Assay versus RealTime HCV Assay between 0.00 and 0.13 log 10  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). Conclusions VERIS 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.