Abbott receives FDA Emergency Use Authorization for its COVID-19 IGM antibody blood test

October 12, 2020  –  Abbott (Abbott Park, IL) NYSE: ABT) received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the company’s AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test for use on the ARCHITECT and Alinity platforms.

IgM antibody testing can play an important role in understanding if someone has developed antibodies in response to the virus, indicating a recent or prior infection, Abbott said.

The new IgM antibody test is Abbott’s latest test to support in the fight against COVID-19. Since the start of the pandemic, Abbott has received EUA for seven tests, including:

  • molecular tests
  • a rapid antigen test
  • an IgG antibody test

While molecular tests detect whether someone has the virus, antibody tests determine if someone had a previous infection by detecting antibodies, such as IgM and IgG. Abbott first developed an IgG blood test, which often is the antibody that is longer-lasting in the body after infection. This test has been widely adopted and continues to play a key role in understanding if someone has recovered from the virus, as well as contact tracing and epidemiological studies, said Abbott

The IgM test is now available on Abbott’s ARCHITECT and Alinity platforms.

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