Abbott receives FDA EUR for its Covid-19 IgM antibody blood test

Availability of the new IgM blood test on the Architect and Alinity platforms

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Abbott
Abbott's Alinity Diagnostics Systems

Abbott announced that the US Food and Drug Administration (FDA) issued 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. IgM antibody testing can play an essential role in understanding if someone has developed antibodies in response to the virus, indicating a recent or prior infection.

The new IgM antibody test is Abbott’s latest test to support in the fight against Covid-19. Since the pandemic, Abbott has received emergency use authorization for seven tests, including molecular tests, a rapid antigen test, and an IgG antibody test.

“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,” said Robert B Ford, president, and chief executive officer, Abbott. “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.”

Understanding a person’s immune response with antibody tests

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 vital role in understanding if someone has recovered from the virus, as well as contact tracing and epidemiological studies.

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

Like Abbott’s IgG blood test, the IgM test has demonstrated high reliability in Abbott’s research and external virology laboratory studies. Abbott’s data demonstrated 99.56% specificity, and 95.00% sensitivity for patients tested 15 days after symptom onset.

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

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