The US FDA has issued an emergency use authorization (EUA) for the BD Veritor Plus SARS-CoV-2 assay, a rapid, point-of-care, antigen test manufactured by Becton Dickinson, according to an agency announcement.
According to BD, the new test delivers results in 15 minutes and enables real-time results and decision making while the patient is still onsite. It is the second antigen test authorized by the FDA to detect the novel coronavirus after Quigen’s Sofia 2 SARS antigen test was approved in mid-May. Antigen tests detect active infections but differ from PCR and antibody tests, the FDA says.
The test is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for high, moderate, or waived complexity testing, meaning it can be used in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, the FDA says.
Emergency use of this test is limited to authorized laboratories using the BD Veritor Plus Analyzer Instrument. 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, BD says.
“Expanding America’s testing capabilities is the result of partnership and ingenuity between the federal government, private sector and academia,” said FDA Commissioner Stephen M. Hahn, MD. “Today’s authorization is another achievement of that work. Antigen tests play an important role in the overall response against COVID-19, including as a point-of-care test that can potentially scale up to test millions of Americans quickly.”
According to BD, the company expects to produce up to 10 million tests from July through September and to increase capacity to produce 2 million tests per week by the end of September. BD said it intends to pursue 510(k) clearance for the BD Veritor Plus SARS-CoV-2 assay from the FDA at a later time.
“This will be a game-changer for frontline healthcare 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.”
The launch of the BD Veritor Plus System for Rapid Detection of SARS-CoV-2 Assay is the latest effort in the company’s comprehensive response to address critical health needs related to the global pandemic. 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. 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.
US customers interested in BD diagnostic solutions for COVID-19 should contact [email protected].