BD (Becton, Dickinson and Company) announced that the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for a rapid, point-of-care, SARS-CoV-2 diagnostic test.
The FDA said BD’s assay is the second antigen test the agency has authorized for the detection of SARS-CoV-2 antigens.
In a statement, U.S. Department of Health and Human Services (HHS) Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett P. Giroir, MD, said BD’s test “is the latest point-of-care testing advance that will significantly expand testing in distributed locations for the benefit of all Americans. This development will help identify community spread of the virus by further enabling rapid diagnosis of COVID-19." He added that the POC test will also help protect at-risk populations.
The test, which is for use with BD’s Veritor Plus System, delivers results in 15 minutes on an easy-to-use, portable instrument, according to BD. 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 U.S. states, the company added.
The solution also can be used with BD’s Synapsys informatics solution for real-time reporting of data for disease monitoring and surveillance purposes.
The FDA said it authorized the test 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.
