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

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 logIU/mL, while between the VERIS HCV Assay and the RealTime HCV Assay average bias was 0.21 logIU/mL. Bias, however, was not consistent across the measuring range. Analysis at the lower end of quantification levels 50, 100, and 1000IU/mL showed a predicted bias for VERIS HCV Assay versus COBAS Ampliprep/COBAS Taqman HCV Test between -0.42 and -0.22 logIU/mL and for VERIS HCV Assay versus RealTime HCV Assay between 0.00 and 0.13 logIU/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.