BD (Becton, Dickinson and Company) has announced its rapid, point-of-care (POC), SARS-CoV-2 antigen test for use on the BD Veritor™ Plus System has been CE marked to the IVD Directive (98/79/EC).

The new test delivers results in 15 minutes on an easy-to-use, portable instrument, which is a critical improvement in turnaround time for COVID-19 diagnostics, because it provides real-time results and enables decision-making while the patient is still onsite.

The company expects commercial availability of this new assay at the end of October for countries in Europe that recognize the CE mark.

“Availability of the SARS-CoV-2 assay on the BD Veritor™ Plus System in Europe builds on our molecular test on the BD MAX™ System that has been available since March,” said Roland Goette, president of BD EMEA Region. “The addition of a truly portable, point-of-care test that can deliver results while the patient waits will be welcomed by health care providers and patients alike to help protect against additional waves of COVID-19.”

BD is leveraging its global manufacturing network and scale to produce 8 million SARS-CoV-2 antigen tests per month by October and expects to produce 12 million tests per month by March 2021.