Abbott gets emergency FDA approval for antibody test that detects recent COVID-19 infections

CHICAGO — Abbott’s latest antibody test — meant to show whether a person has recently had COVID-19 — has gained emergency use authorization from the U.S. Food and Drug Administration.



a sign on the side of the street: Abbott's latest antibody test - meant to show whether a person has recently had COVID-19 - has gained emergency use authorization from the U.S. Food and Drug Administration.


© Stacey Wescott/Chicago Tribune/TNS
Abbott’s latest antibody test – meant to show whether a person has recently had COVID-19 – has gained emergency use authorization from the U.S. Food and Drug Administration.

The blood test detects a type of antibody, called IgM, that’s present after a person has been recently infected with COVID-19, Abbott said in a news release.

It’s the second antibody test made by Illinois-based Abbott to gain emergency use authorization, in which the FDA allows the use of unapproved medical products to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met.

Abbott’s first test looks for a different type of antibody called IgG that’s longer-lasting in the body after infection. That test can help show whether someone has recovered from the virus and can help with contact tracing, according to the company.

The new test is more useful when it comes to finding recent infections, which can be helpful for doctors trying to determine where a patient is in his recovery and if treatment or isolation is appropriate, Abbott said.

IgM often becomes undetectable weeks to months after a person becomes infected, whereas IgG may be detectable for months of years, according to the Centers for Disease Control and Prevention.

The new test is 99% accurate when it comes to negative results and 95% accurate for positive results 15 days after a patient experiences symptoms, Abbott said.

It’s the seventh COVID-19-related test made by Abbott to gain emergency use authorization.

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