Health Canada has approved Roche's fully automated test, designed to assess a patient's viral load of cytomegalovirus (CMV).
The COBAS AmpliPrep / COBAS TaqMan CMV assay is the first approved test, which is standardized to the WHO International Standard, for use in quantifying CMV DNA in human plasma specimens.
The clinical information produced from the test will enable clinicians to help manage patients who have been diagnosed with CMV disease, specifically patients whose immune system has been suppressed for solid organ transplantation.
Roche Diagnostics Canada Ian Parfrement president and general manager said the company believes that the first CMV test will improve patient care for solid organ transplant recipients.
"We are proud to offer a Health Canada approved test that is standardized and automated CMV viral load testing that improves laboratory’s workflow," Parfrement added.
In addition to CMV, the COBAS AmpliPrep/COBAS TaqMan System is used in conjunction with other molecular diagnostics assays targeting Hepatitis B, Hepatitis C, and Human Immunodeficiency viruses.
Roche’s AmpErase enzyme is also included in each test to prevent carryover contamination by destroying any amplicon previously generated.