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20th January 2020  Editorial by: Paul Carton

Roche Receives CE Mark for Adenovirus Assay on Transplant Recipients


Transplant recipients are vulnerable to adenovirus infection due to their compromised immune system, and this infection can cause serious health problems to the patient. The new CE marked Adenovirus Test from Roche can be used to determine whether patients are at risk of developing severe illness from an adenovirus infection. It is a real-time PCR assay that provides quantitative accuracy for detection and quantification of human adenovirus. 

The test runs with Roche Cobas Omni Utility Channel reagent on the cobas® 6800/8800 and is Roche's fourth virology test for critical transplant testing alongside Cytomegalovirus, Epstein-Barr virus and BK. The assay calibrators are traceable to the World Health Organization (WHO) international standard for adenovirus and reports in International Units Per Millilitre (IU/mL). The test minimises variability and complexity in testing, offering an alternative to lab-developed tests (LDTs), and reduces workload and alleviates risk for laboratories.

The systems provide up to 96 results in about three hours and a total of 864 results for the cobas 6800 System and 1,824 results for the cobas 8800 System from an eight-hour shift. Both make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas 6800 System) and four hours (cobas 8800 System) of work-away time with minimal user interaction.


    

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Date Published: 20th January 2020

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