Patrick Braun1, Rafael Delgado2, Monica Drago3, Diana Fanti3, Hervé Fleury4, Jacques Izopet5, Alessandra Lombardi6, MaAngeles Marcos7, Karine Sauné5, Siobhan O'Shea8, Alfredo Pérez-Rivilla2, John Ramble8, Pascale Trimoulet4, Jordi Vila7, Duncan Whittaker9, Alain Artus10, Daniel Rhodes11. 1. Laboratory Dr. Knechten, Medical Center for HIV and Hepatitis, Aachen, Germany. 2. Microbiology Department, Hospital Universitario 12 de Octubre and Insituto de Investigation, Hospital 12 de Octubre (i+12), Madrid, Spain. 3. Clinical Chemistry and Microbiology laboratories, Niguarda Ca' Granda Hospital, Milan, Italy. 4. Virology Department, Hôpital Pellegrin, CHU, Bordeaux, France. 5. Department of Virology, Federative Institute of Biology, CHU, Toulouse, France. 6. Clinical Microbiology, Virology and Bioemergence Diagnosis, L. Sacco University Hospital, Milan, Italy. 7. Department of Clinical Microbiology, Hospital Clinic, School of Medicine, University of Barcelona, Centre for International Health Research (CRESIB), Barcelona, Spain. 8. Viapath Analytics, Infection Sciences, Guy's and St. Thomas' NHS Foundation Trust, London, UK. 9. Laboratory Medicine Building, North Lane, Northern General Hospital, Sheffield, UK. 10. Beckman Coulter, Immunotech, Marseille, France. 11. Beckman Coulter, Immunotech, Marseille, France. Electronic address: dwrhodes@beckman.com.
Abstract
BACKGROUND: Hepatitis B viral load testing is essential to treatment and monitoring decisions in patients with chronic Hepatitis B. Beckman Coulter has developed the VERIS HBV Assay (Veris) for use on the fully automated DxN VERIS Molecular Diagnostics System.1 OBJECTIVES: To evaluate the clinical performance of the Veris HBV Assay at multiple EU laboratories STUDY DESIGN: Method comparison was performed with a total of 344 plasma specimens from HBV infected patients tested with Veris and COBAS® TaqMan® HBV Test (Cobas), 207 specimens tested with Veris and RealTime HBV Assay (RealTime), 86 specimens tested with Veris and VERSANT® HBV Assay (Versant), and 74 specimens tested with Veris and artus® HBV RG PCR kit (artus). RESULTS: Bland-Altman analysis showed average bias of -0.46 log10 IU/mL between Veris and Cobas, -0.46 log10IU/mL between Veris and RealTime, -0.36 log10IU/mL between Veris and Versant, and -0.12 log10IU/mL between Veris and artus. Bias was consistent across the assay range. Patient monitoring results using Veris demonstrated similar viral load trends over time to Cobas, RealTime, and artus. CONCLUSIONS: The VERIS HBV Assay demonstrated comparable clinical performance, with varying degrees of negative bias, compared to other currently marketed assays for HBV DNA monitoring. This negative bias should be taken into consideration if switching monitoring methods to Veris.
BACKGROUND:Hepatitis B viral load testing is essential to treatment and monitoring decisions in patients with chronic Hepatitis B. Beckman Coulter has developed the VERIS HBV Assay (Veris) for use on the fully automated DxN VERIS Molecular Diagnostics System.1 OBJECTIVES: To evaluate the clinical performance of the Veris HBV Assay at multiple EU laboratories STUDY DESIGN: Method comparison was performed with a total of 344 plasma specimens from HBV infectedpatients tested with Veris and COBAS® TaqMan® HBV Test (Cobas), 207 specimens tested with Veris and RealTime HBV Assay (RealTime), 86 specimens tested with Veris and VERSANT® HBV Assay (Versant), and 74 specimens tested with Veris and artus® HBV RG PCR kit (artus). RESULTS: Bland-Altman analysis showed average bias of -0.46 log10 IU/mL between Veris and Cobas, -0.46 log10IU/mL between Veris and RealTime, -0.36 log10IU/mL between Veris and Versant, and -0.12 log10IU/mL between Veris and artus. Bias was consistent across the assay range. Patient monitoring results using Veris demonstrated similar viral load trends over time to Cobas, RealTime, and artus. CONCLUSIONS: The VERIS HBV Assay demonstrated comparable clinical performance, with varying degrees of negative bias, compared to other currently marketed assays for HBV DNA monitoring. This negative bias should be taken into consideration if switching monitoring methods to Veris.