FDA Coronavirus (COVID-19) Update: August 20th, 2020

Silver Spring, MD – The U.S. Food and Drug Administration (FDA) today announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:

The FDA issued the third Emergency Use Authorization (EUA) for a COVID-19 Coronavirus 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 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 Coronavirus 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.

About the U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.