NEW YORK – Roche announced on Wednesday that its Elecsys Epstein-Barr Virus panel for use with blood samples received CE marking.
The panel, which includes an Elecsys EBV IgM test, an Elecsys EBV VCA IgG test, and Elecsys EBV EBNA IgG test, detects EBV-specific antibodies at different stages of infection. Used together, the tests can help determine how far the infection has progressed in a patient, Roche said in a statement. The time to result for the tests is 18 minutes and the company said it plans to file for regulatory approval from the US Food and Drug Administration in the future.
The company's PCR-based Cobas Epstein-Barr Virus test received de novo class II clearance from the FDA in August on the Cobas 6800 and Cobas 8800 systems.
After the first infection, EBV remains in a dormant state for life, and clinical symptoms can vary according to the patient's immune status. EBV can be used to confirm glandular fever and rule out other diseases, such as infections in pregnant women that may cause congenital disorders, Roche added.
In addition, knowing the EBV status of donors and recipients of transplants can help clinicians determine risk of complications, since recipients usually have weaker immune systems.