FDA warns public against using two unsafe COVID-19 antigen, antibody tests

The Food and Drug Administration is warning health care providers and the public not to use two COVID-19 antigen and antibody tests, due to high risk of false results. The FDA has not authorized or approved the two tests — Lepu Medical Technology’s SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) — in the U.S., but the agency is aware that these tests were distributed to some pharmacies to be sold for at-home testing and sold directly to consumers. Health care providers should consider re-testing with a different SARS-CoV-2 antibody test any patients who were suspected to have had recent or prior COVID-19 infection and were tested with either of the two tests in question.