On Feb. 12, 2021, BD (Becton, Dickinson) announced that the U.S. Food and Drug Administration (FDA) had 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 test also had been CE marked to the IVD Directive (98/79/EC).

The new EUA included 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. This ability to detect these new variants also applies to the standalone SARS-CoV-2 test for the BD MAX™ System.