SAN FRANCISCO, Calif. (KRON) — The U.S. Food and Drug Administration on Monday gave Emergency Use Authorization for Abbott’s IgM coronavirus antibody test.
The IgM, or Immunoglobulin M, antibody test would help determine if a patient recently recovered from COVID-19. These antibodies usually become undetectable weeks to months after a person contracted the coronavirus, Abbott said.
“Antibody tests will continue to play an important role to better understand the virus, the prevalence of COVID-19 in an area and where a patient may be in their recovery,” according to the company’s president and CEO, Robert Ford.
According to Abbott, its data demonstrated 99.56% specificity and 95.00% sensitivity for patients tested 15 days after symptom onset.
The FDA has previously issued emergency use authorization to Abbott for seven other tests — including the IgG test, the antibody that is usually detectable in the body for a longer period of time.