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FDA allows emergency use for test to detect COVID-19, flu, RSV


BD says results could be available within two hours.

Government regulators have approved a test to detect COVID-19, influenza A and B, and respiratory syncytial virus (RSV) in patients.

The U.S. Food and Drug Administration has given emergency use authorization for a new molecular diagnostic combination test made by BD (Becton, Dickinson and Company). The test will help combat illness in the current and future respiratory virus seasons, according to BD, which announced the approval on Feb. 8.

"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," BD Vice President of Molecular Diagnostics Nikos Pavlidis said in a news release. "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 test, for use on the BD MAX Molecular Diagnostic System, uses a single nasal swab or a single nasopharyngeal swab sample to identify nucleic acid and distinguish if a patient has COVID-19, the flu, RSV, or some combination. Results can be available in as little as two hours, the company said.

The speed of results can eliminate the need for multiple tests or physician visits, according to the company, and clinicians quickly can start an appropriate treatment plan. Testing for multiple also increases testing capacity during the busy season for flu and RSV.

BD said its BD MAX System already is used in thousands of hospitals and laboratories around the globe and each unit can analyze hundreds of samples in 24 hours.

BD noted it developed the test with funding from the U.S. Department of Health and Human Services, with its Office of the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority.

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