FDA Issues ‘Emergency Use Authorization’ for COVID-19 Antibody Test in New York Hospital
GAME CHANGER
The Food and Drug Administration has issued an “emergency use authorization” for an antibody test that can be used in a New York hospital to identify individuals who recovered from the coronavirus and may be immune. The test, known as enzyme-linked immunosorbent assay, or ELISA, detects antibodies against the virus in “serum and plasma specimens collected from individuals suspected of prior infection with the virus that causes COVID-19,” according to the letter from the FDA to Mount Sinai Hospital, where the test is now authorized for use. ELISA could be a game changer for healthcare workers on the frontlines in the fight against the virus as doctors, paramedics, and nurses who are identified as immune would be able to help those infected without worrying about becoming infected themselves, The Daily Beast previously reported. “With this assay we can figure out who was infected and who wasn’t. That means we can determine the true infection rate and infection fatality rate,” Dr. Florian Krammer previously told The Daily Beast.