BD said the BD MAX Respiratory Viral Panel (RVP), a new molecular diagnostic combination test for SARS-CoV-2, Influenza A + B and Respiratory Syncytial Virus (RSV), has been CE marked to the IVD directive 98/79/EC.
The test uses a single nasal swab or a single nasopharyngeal swab sample to determine if a patient has COVID-19 or the flu or RSV. It helps eliminate the need for multiple tests or doctor visits and can help clinicians to implement the right treatment plan quickly. The co-testing approach also helps to increase testing capacity during the busy flu season and speeds the time to diagnosis.
The BD MAX System, a molecular diagnostic platform, is in use at thousands of laboratories worldwide, and each unit is capable of analyzing hundreds of samples over a 24-hour period. The BD MAX RVP assay is an RT- PCR assay that detects and differentiates the mRNA of SARS-CoV-2, flu A, flu B and RSV in approximately two hours, with the automated workflow of the BD MAX System.
BD MAX RVP is currently available in countries that recognize the CE mark. BD plans to submit for Emergency Use Authorization from the U.S. Food and Drug Administration in the coming weeks.