Coronavirus (COVID-19) Update: Daily Roundup August 19, 2020

Coronavirus (COVID-19) Update: Daily Roundup August 19, 2020

The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic: The FDA issued the third Emergency Use Authorization (EUA) for a COVID-19 antigen test.  An antigen test is a diagnostic test that quickly detects fragments of proteins found on or within the virus by testing samples collected from the patient’s nasal cavity using swabs. The EUA was issued for LumiraDX UK Ltd.’s LumiraDx SARS-CoV-2 Ag Test, and 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. The FDA posted frequently asked questions for consumers about UV lights and lamps. Consumers may be interested in purchasing ultraviolet-C (UVC) lamps to disinfect surfaces in the home or similar spaces. The FDA is providing answers to consumers’ questions about the use of these lamps for disinfection during the COVID-19 pandemic. Testing updates: To date, the FDA has currently authorized 218 tests under EUAs; these include 176 molecular tests, 39 antibody tests, and 3 antigen tests.

Additional Resources: FAQs on Testing for SARS-CoV-2 Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)