BD Launches Portable, Rapid POC Antigen Test to Detect SARS-CoV-2 in 15 Minutes

BD (Becton, Dickinson and Company Franklin Lakes, NJ, USA) has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for its rapid, point-of-care, SARS-CoV-2 diagnostic test for use with the company’s BD Veritor Plus System.

The new immunoassay test joins a portfolio of three molecular solutions for COVID-19 testing that have been registered for use with the BD MAX Molecular System, including two with EUAs and two with CE mark. The BD Veritor Plus System for Rapid Detection of SARS-CoV-2 Assay is deemed to be a CLIA-waived immunoassay designed to be used in health care settings to provide an aid to rapid diagnosis of COVID-19 in symptomatic individuals. The new assay delivers results in 15 minutes on an easy-to-use, highly portable instrument, thereby improving access to COVID-19 diagnostics as it enables real-time results and decision-making while the patient is still onsite. BD clinical studies performed at more than 20 sites across the US demonstrated that the test is capable of achieving 84% sensitivity and 100% specificity, which is in line with the performance from similar immunoassay tests for Flu A/B, RSV and Strep A on the BD Veritor Plus System.

The BD Veritor System, which is slightly larger than a cell phone, is currently in use at more than 25,000 hospitals, clinician offices, urgent care centers and retail pharmacies in all 50 US states. Its one-button functionality, workflow flexibility, and ease-of-use make it an ideal solution for settings without laboratory personnel. It also offers customers real-time reporting capabilities through the BD Synapsys informatics solution providing them with the ability to easily report data for disease monitoring and surveillance purposes.

BD is leveraging its global manufacturing network and scale and expects to increase capacity to be able to produce two million tests per week by the end of September. The company already expects to produce up to 10 million tests from July through September. So far this year, the company has provided health care providers globally with approximately 48 million swabs for flu and COVID-19 testing, more than 2.85 million COVID-19 rapid molecular diagnostic tests on the BD MAX System, and millions of products used in the treatment of COVID-19 patients, including infusion pumps, infusion sets and catheters.

"This will be a game-changer for frontline health care workers and their patients to be able to access a quick diagnostic test for COVID-19, offering results in real-time at convenient locations like retail pharmacies, urgent care centers and doctors' offices," said Dave Hickey, president of Integrated Diagnostic Solutions for BD. "Such tests will also help communities be more informed and better prepared to help prevent new spikes and additional waves of COVID-19 by enabling public health workers to quickly identify infectious individuals and trace their contacts. The highly portable, easy-to-use, point-of-care format of this test, large quantity of test kits available and existing, expansive footprint of BD Veritor Plus instruments will help bring widespread access to COVID-19 testing in the United States and around the world as additional country-specific regulatory requirements are met."