US-based medical technology company BD has received the US Food and Drug Administration (FDA) 510(k) approval for its Respiratory Viral Panel (RVP), used with BD MAX System.
The BD RVP is a single molecular diagnostic combination test that can identify and differentiate SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV).
It determines if a patient has Covid-19 or the flu or RSV, using a single nasal swab or a single nasopharyngeal swab sample, within two hours.
BD said that the RVP test will help eliminate the need for multiple individual tests or doctor visits and help clinicians implement the right treatment plan rapidly.
Also, its co-testing approach also helps increase the testing capacity during the busy flu season and speeds up the time for diagnosis.
BD Diagnostics vice president and general manager Nikos Pavlidis said: “Last year, we experienced a threat of a ‘tripledemic’ with COVID, flu and RSV circulating simultaneously, and that threat remains for the coming respiratory season.
“As patient symptoms and clinical presentation can be nearly identical, a combined testing panel is key to enabling clinicians to quickly and efficiently diagnose, differentiate and treat patients, and help manage the spread of the infections.
“The advanced robotic architecture of the BD MAX System automates manual, time-intensive processes, which has never been more important than in today’s environment of staffing shortages and laboratory scientist burnout.”
The MAX RVP test is an RT-PCR assay designed to detect and differentiate the RNA of SARS-CoV-2, flu A, flu B and RSV, using the BD MAX System.
BD MAX System is a molecular diagnostic platform with a simple and automated workflow that requires minimal human interaction.
It facilitates diagnostic testing across respiratory infections, sexually transmitted infections, gastrointestinal infections, women’s health and healthcare-associated infections.
BD has been offering the combined diagnostic test in the US, under an Emergency Use Authorization (EUA) granted by the US FDA in February this year.
The BD RVP test for BD MAX System received the CE IVD mark in May last year.
With the current 510(k) approval, the company will discontinue its RVP EUA version and replace it with the RVP that runs on the BD MAX System.
Furthermore, BD received federal funds from the US Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), for the development of the combination test.
