Herpes Simplex Virus and Varicella Zoster Virus Test

HSV_VZV

Real-time PCR kit for detection of HSV-1, HSV-2 and VZV

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.

Features and benefits of the UC-DGN-HSV/VZVTM test:

  • Accuracy: Detection and differentiation of HSV-1, HSV-2 and VZV infections to support management in transplants or immunocompromised patients.
  • Automation: Specifically designed and optimized for use on the cobas® 6800/8800 Systems, enabling consolidation and automation for transplant testing.

  • Simplicity and efficiency: Minimize variability and complexity in testing by offering an alternative to Lab-developed tests (LDTs), thereby reducing workload and alleviating risk for laboratories.

Herpes simplex virus 1

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 1

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.

Intended use

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.

Registration status

CE-IVD

 

 

UC-DGN-HSV/VZVTM is a trademark of Diagenode sa. Exclusively distributed worldwide by Roche Diagnostics GmbH.

References

 

  1. 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.

Specifications

  • Pathogens detected

    HSV-1, HSV-2 and VZV

  • Conserved Assay Targets

    HSV-1: UL5 gene, HSV-2: UL30 gene, VZV: ORF-31 gene

  • Sample type

    EDTA plasma

  • Minimum amount of sample required

    350 µL

  • Sample processing volume

    200 µL

  • Analytical sensitivity

    56.5 c/mL (HSV-1),  67.7 c/mL (HSV-2), 75.1 c/mL (VZV)

  • Specificity

    100%

UC-DGN-HSV/VZVTM is a trademark of Diagenode sa. Exclusively distributed worldwide by Roche Diagnostics GmbH.