Abbott receives FDA EUA for COVID-19 antibody test

Oct. 15, 2020

Abbott announced that the U.S. Food and Drug Administration (FDA) issued an 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, according to a press release.

Abbott first developed an IgG blood test, which often is the antibody that lasts longer in the body after infection.

The IgM antibody, in comparison, 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, according to Abbott.

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 percent specificity and 95 percent sensitivity for patients tested 15 days after symptom onset, according to Abbott.

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