Becton Dickinson announced today that it received CE Mark approval in Europe for its rapid COVID-19 test.

Franklin Lakes, N.J.-based BD’s rapid, point-of-care SARS-CoV-2 antigen test for use on the BD Veritor Plus system delivers results in 15 minutes on a portable instrument to allow for on-site results and decision making, according to a news release.

BD’s test has been available in the U.S. since July after receiving FDA emergency use authorization (EUA) but now expands to Europe, where the BD Veritor Plus system is already in use for testing with Group A Strep, influenza A & B and respiratory syncytial virus (RSV).

The BD Veritor Plus, which is slightly larger than a mobile phone, includes an easy-to-use workflow for point-of-care use and offers traceability and reporting capabilities through the BD Synapsys informatics platform. Its ability to test for both SARS-CoV-2 (the virus causing COVID-19) and influenza A & B aligns with the recent European Centre for Disease Prevention & Control guidance that all patients with acute respiratory symptoms should be tested for both in parallel during flu season.

By leveraging its global manufacturing network, BD intends to produce 8 million SARS-CoV-2 antigen tests per month by October, with 12 million tests set as the total expected per month by March 2021.

“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,” BD EMEA region president Roland Goette said in the news release. “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.”