New COVID-19 antibody blood test granted emergency authorization from FDA

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CHICAGO (NewsNation Now) — The U.S. Food and Drug Administration (FDA) issued an emergency use approval for Abbott’s latest lab-based COVID-19 IgM antibody test, the company announced Monday.

Abbott said in a news release that the new IgM antibody test is the company’s seventh COVID-19 related test to receive emergency use authorization from the FDA.

Abbott first developed an IgG blood test for COVID-19 antibodies. What’s different about the newly authorized test from its widely-used predecessor is that an IgM antibody is helpful in determining a recent infection, as these particular antibodies become undetectable in the weeks to months following the initial infection. In contrast, the IgG antibodies persist in the patient’s body for longer after recovery from the virus.

“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,” the release from Abbott noted.

According to the company, the IgM test demonstrates “high reliability” in both Abbott’s research and lab studies, with “99.56% specificity and 95.00% sensitivity for patients tested 15 days after symptom onset.”

Previous Abbott tests that received FDA emergency use authorization include molecular tests, a rapid antigen test and the IgG antibody test.

Read more from Abbott on the test.

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