FDA has issue a third emergency use authorization (EUA) for a covid-19 antigen test, for the LumiraDx SARS-CoV-2 Ag Test from LumiraDX UK, London. FDA has authorized the test for use in high and moderate complexity laboratories certified Under the Clinical Laboratory Improvement Amendments (CLIA), as well as at the point-of-care (i.e., patient care settings) operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. To date, the FDA has currently authorized 218 tests under EUAs; these include 176 molecular tests, 39 antibody tests, and 3 antigen tests. For more information, visit FDA.
