Abbott (NYSE:ABT) announced that it received FDA emergency use authorization (EUA) for its IgM antibody serology test for COVID-19.
The AdviseDx SARS-CoV-2 IgM lab-based serology test runs on the Architect and Alinity platforms to detect antibodies in response to the virus, indicating a recent or prior infection.
Abbott Park, Ill.-based Abbott’s latest test is the company’s seventh to receive EUA, according to a news release. It has offered molecular tests, a rapid antigen test and an IgG antibody test up to this point.
Similar to the IgG test developed by Abbott, the IgM test has demonstrated high reliability, including 99.56% specificity and 95% sensitivity for patients tested 15 days after symptom onset.
“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,” Abbott president & CEO Robert Ford said in the release. “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.”
