Abbott Receives EUA for COVID-19 IgM Antibody Blood Test

Abbott announced the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company's AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test 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.

The new IgM antibody test is Abbott's latest test to support in the fight against COVID-19. 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.

"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."

Similar to Abbott's IgG blood test, the IgM test has demonstrated high reliability in both Abbott's research and external virology laboratory studies. Abbott's data demonstrated 99.56% specificity and 95.00% sensitivity for patients tested 15 days after symptom onset.

The IgM test is now available on Abbott's ARCHITECT and Alinity platforms.