Abbott COVID test receives FDA approval

ABBOTT PARK - Abbott said Monday that the U.S. Food and Drug Administration issued emergency use authorization for the company's new coronavirus antibody test. The new lab-based serology test is Abbott's latest effort to support the fight against COVID-19, the company said.

Abbott's AdviseDx coronavirus IgM (Immunoglobulin M) test is for use on the ARCHITECT and Alinity platforms. IgM antibody testing can play an important role in understanding if someone has developed antibodies in response to the virus, indicating a recent or prior infection.

Since the start of the pandemic, Abbott has received emergency use authorization for seven tests, including molecular tests, a rapid antigen test and an IgG antibody test, it said.

"Abbott has developed tests to detect the virus at each stage of infection so doctors and their patients are equipped with knowledge of how they are responding to the virus and progressing through recovery," said Robert B. Ford, president and chief executive officer, Abbott. "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."