The test uses a single nasal swab or to differentiate if a patient has COVID-19, influenza A/B or respiratory syncytial virus (RSV).
Becton Dickinson and Company (BD) has received 510(k) clearance from the U.S. FDA for its combination BD Respiratory Viral Panel for BD MAX System, a single molecular diagnostic combination test that identifies and distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in approximately two hours.
The test, which has been available in the United States since February through an Emergency Use Authorization (EUA) from FDA, helps eliminate the need for multiple individual tests or doctor visits and can help clinicians implement the right treatment plan quickly. The co-testing approach also helps increase testing capacity during the busy flu season and speed up the time for diagnosis.
“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,” said Nikos Pavlidis, vice president and general manager for Diagnostics at BD. “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 BD MAX System, a molecular diagnostic platform, is already in use at thousands of hospitals and medium-throughput laboratories worldwide, and each unit is capable of analyzing hundreds of samples over a 24-hour period. The BD MAX RVP test is an RT-PCR assay that detects and differentiates the RNA of SARS-CoV-2, flu A, flu B and RSV in approximately two hours.
Development of this combination test has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA).