FDA Authorizes Emergency Use Combination Test for Lung Infections
New single molecular diagnostic test can detect and differentiate multiple respiratory infectious diseases
FRANKLIN LAKES, NJ — BD (Becton, Dickinson and Company) recently received Emergency Use Authorization from the US FDA for a new molecular diagnostic combination test for SARS-CoV-2, influenza A + B, and respiratory syncytial virus (RSV) to help combat illness in the current and future respiratory virus seasons.
The combination test uses a single nasal swab or a single nasopharyngeal swab sample to identify and distinguish if a patient has COVID-19, the flu, RSV, or some combination of the three, with results available in as little as two hours.
The test helps eliminate the need for multiple tests or clinician visits and can help clinicians implement the right treatment plan quickly. The co-testing approach also helps to increase testing capacity during the busy flu/RSV season and speed time to diagnosis.
"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," said Nikos Pavlidis, vice president of Molecular Diagnostics at BD. "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."
Development of this combination test has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Administration for Strategic Preparedness and Response; and Biomedical Advanced Research and Development Authority, under contract number 75A50121C00025.
- This press release was originally published on the BD website