- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA issued emergency use authorizations (EUAs) to Siemens for its ADVIA Centaur SARS-CoV-2 IgG (COV2G) and Atellica IM SARS-CoV-2 IgG (COV2G) tests, which are the first COVID-19 serology tests that display an estimated quantity of antibodies present in the tested individual’s blood. These tests are known as “semi-quantitative” because they do not display a precise measure, but rather, they provide an estimate of the quantity of a patient’s antibodies produced against infection with the virus that causes COVID-19.
- Testing updates:
- To date, the FDA has currently authorized 198 tests under EUAs; these include 161 molecular tests, 35 antibody tests, and 2 antigen tests.
The 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.
- Lee Herring