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



Evaluate the clinical performance of the new quantitative VERIS HCV Assay.



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.



The average bias between the VERIS HCV Assay and the COBAS®Ampliprep/COBAS®Taqman®HCV Test was 0.04 log10IU/mL, while between the VERIS HCV Assay and the RealTime HCV Assay average bias was 0.21 log10IU/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 log10IU/mL and for VERIS HCV Assay versus RealTime HCV Assay between 0.00 and 0.13 log10IU/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).



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.
Laboratory Dr. Knechten, Medical Center for HIV and Hepatits, Aachen, Germany.
Patrick
P
Braun
Clinical Chemistry and Microbiology Laboratories, Niguarda Ca' Granda Hospital, Milan, Italy.
Monica
M
Drago
Clinical Chemistry and Microbiology Laboratories, Niguarda Ca' Granda Hospital, Milan, Italy.
Diana
D
Fanti
Virology Department, Hôpital Pellegrin, CHU Bordeaux, France.
Hervé
H
Fleury
Virology Department, Labor Berlin - Charité Vivantes GmbH, Berlin, Germany.
Jörg
J
Hofmann
Department of Virology, Federative Institute of Biology, CHU Toulouse, France.
Jacques
J
Izopet
Virology Department, Labor Berlin - Charité Vivantes GmbH, Berlin, Germany.
Sebastian
S
Kühn
Clinical Microbiology, Virology and Bioemergence Diagnosis, L. Sacco University Hospital, Milan, Italy.
Alessandra
A
Lombardi
Clinical Microbiology, Virology and Bioemergence Diagnosis, L. Sacco University Hospital, Milan, Italy.
Valeria
V
Micheli
Department of Virology, Federative Institute of Biology, CHU Toulouse, France.
Karine
K
Sauné
Virology Department, Hôpital Pellegrin, CHU Bordeaux, France.
Pascale
P
Trimoulet
Laboratory Medicine Building, North Lane, Northern General Hospital, Sheffield, UK.
Duncan
D
Whittaker
Beckman Coulter, Immunotech, Marseille, France.
Alain
A
Artus
Beckman Coulter, Immunotech, Marseille, France. Electronic address: dwrhodes@beckman.com.
Daniel
D
Rhodes
D057205:Automation, Laboratory / Q000379:methods; D005060:Europe; D006526:Hepatitis C / Q000821:virology*; D006801:Humans; D010949:Plasma / Q000821:virology*; D012367:RNA, Viral / Q000097:blood; D019562:Viral Load / Q000379:methods*
D012367:RNA, Viral
COBAS(®) TaqMan(®) HCV test; HCV RNA quantification; Method comparison; RealTime HCV assay; VERIS HCV assay