February 12, 2021 – BD (Becton, Dickinson and Company) (Franklin Lakes, NJ) announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a new molecular diagnostic test for both SARS-CoV-2 and Influenza A+B that can return results in two to three hours.
The new EUA includes updated information in the test’s instructions for use that addresses variants of the SARS-COV-2 virus, including variants from the U.K. and South Africa.
A computer analysis showed that 99.9% of the genetic sequences of the these variants are an identical match to at least one of the two molecular targets for the test, the company said. This ability to detect these new variants also applies to the standalone SARS-CoV-2 test for the BD MAX System.
The BD SARS-CoV-2/Flu assay is run on the BD MAX System and distinguishes between SARS-CoV-2 and Influenza A+B, providing a positive or negative result for each virus using a single specimen.
The BD SARS-CoV-2/Flu for BD MAX System kits are now available for order in the United States and Europe. The test is the latest addition to the company’s comprehensive COVID-19 diagnostics response.