COVID-19 Antibody Blood Test Receives FDA EUA

Abbott’s IgM test offer high specificity and sensitivity 15 days after onset of symptoms.

Abbott announced this morning that their AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test received an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).

"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," Robert Ford, president and chief executive officer, 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."

The IgM antibody test is most useful for determining a recent infection as these antibodies become undetectable weeks to months following infection. Having this more complete picture of where a patient is in their recovery can help healthcare providers determine if treatment, isolation or follow-up visits are needed.

Abbott first developed an IgG blood test, which often is the antibody that is longer-lasting in the body after infection. This test continues to play a role in understanding if someone has recovered from the virus, contact tracing, and epidemiological studies.

The IgM test has demonstrated 99.56% specificity and 95.00% sensitivity for patients tested 15 days after symptom onset.

This test is going to be used on the company’s Architect and Alinity platforms. The company has been active in COVID-19 testing and has been granted EUAs for 7 tests which have included molecular tests, a rapid antigen test and an IgG antibody test.