June 30, 2022 – BD announced that 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.
“SARS-Cov-2, influenza and RSV are a triple threat, as patient symptoms and clinical presentation can be nearly identical,” said Nikos Pavlidis, vice president of Molecular Diagnostics at BD. “A combined testing panel is key to enabling clinicians to quickly and efficiently diagnose, differentiate and treat patients to help manage the spread of the infections.”
The BD MAX™ System, a molecular diagnostic platform, is already 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 easy-to-use and automated workflow of the BD MAX™ System.
The BD RVP assay for BD MAX™ System is an important addition to the extensive number of assays available on the system across respiratory, STI, gastrointestinal, women’s health and health care associated infections. The broad menu of assays in combination with the open system capabilities on a fully automated sample-to-result molecular platform make the BD MAX™ System a valued platform for infectious disease testing in thousands of labs worldwide.
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.