Quantitative Adenovirus Test

ADV

For accurate monitoring of adenovirus and reducing the risk of severe disease in transplant patients

Raising the standard for viral monitoring and management

The quantitative adenovirus test (UC-DGN-ADVTM) accurately detects and monitors viral load of human Adenovirus (hADV) in immunocompromised and transplant patients. This real-time PCR test is designed to use in conjunction 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, Herpes Simplex virus, Varicella Zoster virus, and human Adenovirus on the consolidated cobas® 6800/8800 Systems with an automated and simplified workflow.

Features and benefits of the Quantitative Adenovirus Test

  • Standardisation – Results traceable to the WHO International standard for adenovirus (NIBSC code: 16/324) and reporting in IU/mL, for improved result harmonisation in testing results across hospital institutions

  • Automation: Specifically designed and optimised for use on the cobas® 6800/8800 Systems, enabling menu testing consolidation and sample to result automation

  • Simplicity & efficiency: Minimises variability and complexity in testing, offering an alternative to lab-developed tests (LDTs), reducing workload and alleviating risk of error for laboratories

Adenovirus

Adenoviruses are important causes of infections and complications in both stem cell transplant and solid organ transplant  patients and has been associated with a range of clinical syndromes.1 Adenovirus infections can spread through a cough or a sneeze, direct conjunctival inoculation, faecal-oral spread, or exposure to infected tissue or blood.2 After primary infection, the virus can remain latent for long periods of time. In immunocompromised and transplant individuals, especially in children, the latent virus can be reactivated and can be responsible for disseminated disease and graft loss, leading to high morbidity and mortality.3 Early intervention is required for making informed clinical decisions.

Intended use

This test is intended for use as an aid in the diagnosis of human ADV infections and for monitoring ADV DNA levels such as in transplanted and immunocompromised patients. The results from UC-DGN-ADV™ must be interpreted within the context of all relevant clinical and laboratory findings.

Registration status

CE-IVD

References

 

  1. Florescu et al. Adenovirus in solid organ transplant recipients: Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. The J of Clinical and Translational Research. 2019. https://doi.org/10.1111/ctr.13527

  2. Kanakry JA, et al. The clinical significance of EBV DNA in the plasma and peripheral blood mononuclear cells of patients with or without EBV diseases. Blood. 2016; Apr 21;127(16):2007-17

  3. Lion T. Adenovirus infections in immunocompetent and immunocompromised patients. Clin Microbiol Rev. 2014;27(3):441–462. doi:10.1128/CMR.00116-13

Specifications

  • Conserved assay target

    Hexon region

  • Sample type

    EDTA plasma

  • Minimum amount of sample required

    350 µL

  • Sample processing volume

    200 µL

  • Analytical sensitivity

    39.5 IU/mL

  • Linear range

    1E+02 IU/mL to 1E+08 IU/mL

  • Specificity

    100%

  • Species groups detected

    ADV (A to G)

  • Overall precision

    SD 0.06-0.16 log10

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