The UC-DGN-HSV/VZVTM test is an in vitro nucleic acid amplification test for the qualitative detection of human Herpes Simplex Virus-1 (HSV-1), Herpes Simplex Virus-2 (HSV-2) and Varicella Zoster Virus (VZV) DNA in human EDTA plasma samples. The test is designed to be used with the cobas omni Utility Channel on the cobas® 6800/8800 Systems in countries accepting the CE mark.
With the addition of this test, Roche’s transplant menu now allows comprehensive testing for Cytomegalovirus, Epstein-Barr virus, BK virus, human Adenovirus and HSV and VZV on the consolidated cobas® 6800/8800 Systems with an automated and simplified workflow.
Automation: Specifically designed and optimized for use on the cobas® 6800/8800 Systems, enabling consolidation and automation for transplant testing.
Human herpes simplex virus 1 and 2, are responsible for oral and genital mucocutaneous ulcers in the general population. Reactivation of HSV is common among transplant recipients, and is the second most common cause of viral infection after transplantation. The clinical manifestations of HSV infection range from limited mucocutaneous outbreaks to disseminated infections involving visceral organs and the central nervous system.
Varicella zoster virus is responsible for chickenpox and shingles, causes symptomatic infection through reactivation or primary infection in approximately 1% to 20% of solid-organ transplant recipients and more than 40% in hematopoietic stem cell transplant recipients. Reactivation of VZV is the most common route of VZV disease in adult transplant recipients. As with HSV, the clinical manifestations of VZV disease are wide ranging, but can be severe and associated with increased mortality, especially in the early post-transplant period.
This test is intended for use as an aid in the diagnosis of human HSV and VZV infections such as in transplanted and immunocompromised patients. The results from UC-DGN-HSV/VZV™ must be interpreted within the context of all relevant clinical and laboratory findings.
CE-IVD
UC-DGN-HSV/VZVTM is a trademark of Diagenode sa. Exclusively distributed worldwide by Roche Diagnostics GmbH.
References
Shiley, Kevin & Blumberg, Emily. (2011). Herpes viruses in transplant recipients: HSV, VZV, human herpes viruses, and EBV. Hematology/oncology clinics of North America. 25. 171-91. 10.1016/j.hoc.2010.11.012.
UC-DGN-HSV/VZVTM is a trademark of Diagenode sa. Exclusively distributed worldwide by Roche Diagnostics GmbH.