BD Receives CE Mark for Portable, Rapid Point-of-Care COVID-19 Antigen Test That Detects SARS-CoV-2 in 15 Minutes

Becton, Dickinson and Company’s (BD Franklin Lakes, NJ, USA) rapid, point-of-care, 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. The European Centre for Disease Prevention and Control (ECDC) recently released guidance that all patients with acute respiratory symptoms should be tested for both SARS-CoV-2 and influenza A+B in parallel during flu season1. The BD Veritor Plus System can test for both infections on the same platform.

The test, which has been available in the US since July through an Emergency Use Authorization by the US Food and Drug Administration (FDA), uses the BD Veritor Plus System, which is already in use across Europe to test for conditions such as Group A Strep, influenza A+B and Respiratory Syncytial Virus (RSV). The BD Veritor Plus System, which is slightly larger than a mobile phone, offers an easy-to-use workflow that makes it an ideal solution for point-of-care settings. It also offers customers traceability and reporting capabilities through the optional BD Synapsys informatics solution. BD is leveraging its global manufacturing network and scale to produce eight million SARS-CoV-2 antigen tests per month by October and expects to produce 12 million tests 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," 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."

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