BD (Becton, Dickinson and Company), Franklin Lakes, NJ, announced its rapid, point-of-care, covid-19 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 an improvement in turnaround time for covid-19 diagnostics, because it provides real-time results and enables decision-making while the patient is still on site. 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,” says 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 healthcare providers and patients alike to help protect against additional waves of covid-19.”
The test, which has been available in the United States since July through an emergency use authorization by the 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.
For more information, visit BD.
Featured image: BD has announced CE mark of a portable, rapid point-of-care antigen test to detect covid-19 in 15 minutes, with commercial availability in Europe by the end of October.