The FDA revoked the emergency use authorization (EUA) of the Chembio Diagnostic System, Inc.'s, DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test. Antibody tests, a type of serological test, can help provide information on a person's and population's exposure to COVID-19.
The FDA took a meaningful step forward in getting more tests to more Americans more quickly and making that process even easier for developers. This was achieved by posting template updates regarding the validation of molecular diagnostic tests for developers that intend their assay to be used for pooling patient samples or for screening asymptomatic individuals not suspected of having COVID-19.
To date, the FDA has authorized 140 tests under EUAs, which include 118 molecular tests, 21 antibody tests, and 1 antigen test.
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.