BD has received the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a new molecular diagnostic combination test for SARS-CoV-2, Influenza A + B and Respiratory Syncytial Virus (RSV).
BD Respiratory Viral Panel for BD MAX System is an RT- PCR assay is designed for use on the BD MAX Molecular Diagnostic System.
The test requires a single nasal swab or a single nasopharyngeal swab sample, to detect and differentiate between the Covid-19, the flu, RSV, or their combination.
Based on simplified and automated workflow of the BD MAX System, the BD Respiratory Viral Panel delivers results within two hours.
BD molecular diagnostics vice president Nikos Pavlidis said: “While fears of a ‘tripledemic’ this respiratory season have largely diminished, accurately differentiating influenza and RSV from Covid-19 and providing appropriate treatment remains a challenge for our customers.
“This diagnostic test provides the ability to identify multiple pathogens using a single sample and can quickly pinpoint the causative virus or viruses and enable clinicians to administer appropriate treatment early in the course of infection.”
The BD MAX System is already being used by several hospitals and laboratories, and a single unit can analyse hundreds of samples within 24 hours.
It allows customers to leverage research use only (RUO) assays and user-defined protocols (UDP) to quickly address emerging needs.
BD Respiratory Viral Panel for BD MAX System is an important addition to wide-ranging assays available on the BD MAX System.
The assays include for respiratory infections, sexually transmitted infections, gastrointestinal infections, and health care associated infections.
The test is said to eliminate the need for multiple tests or doctor visits and can help clinicians to quickly implement the right treatment plan.
In addition, its co-testing approach also supports the expansion of testing capacity during the busy flu/RSV season and reduces the time to diagnosis, said BD.
Furthermore, federal funds from the Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) supported the development of the combination test
