Abbott Receives FDA Emergency Use Authorization for its COVID-19 IGM Antibody Blood Test

Originally published on Abbott.com

– Data demonstrates highly reliable test results with 99.56% specificity and 95.00% sensitivity for patients tested 15 days after symptom onset

– Availability of the new IgM blood test on the ARCHITECT® and Alinity™ platforms is part of Abbott’s effort to offer tests across the disease progression of COVID-19

– Abbott’s IgM test will give a more complete picture of where patients are in their recovery

Abbott (NYSE: ABT) announced today that the U.S. 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 important 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 start of 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 key role in understanding if someone has recovered from the virus, as well as contact tracing and epidemiological studies.1

The IgM antibody, in comparison, is most useful for determining a recent infection as these antibodies become undetectable weeks to months following infection.2 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.

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% 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.

Latest News

San Francisco's Golden Gate Bridge

San Francisco Declares War on Racism; People 55 and Older Face Historic Levels of Unemployment; and More.

San Francisco begins a citywide war on racism and discrimination. Known as the birthplace of the “Summer of Love” and the counterculture movement of the 1960s, San Francisco has long stood as a bastion of individuality and inclusion. And now the city is continuing that fight with the launch of…

portrait of Abraham Lincoln

Was Abraham Lincoln a Racist?

Former Vice President Joe Biden’s mention of Abraham Lincoln’s name during the third presidential debate on Thursday, Oct. 22, was one of the most memorable exchanges in the final presidential debate of 2020. It also caused Lincoln to become a trending topic over much of social media in the hours…

AOC celebrates a victory in Among Us during her Twitch stream

AOC Livestreamed ‘Among Us’ on Twitch to Encourage Everyone (but Particularly Young People) to Vote

New York congresswoman Alexandria Ocasio-Cortez (AOC) is stepping up Democratic efforts to make sure young voters are prepared when heading to the polls on Election Day, especially in light of COVID-19. On Oct. 21, 2020, AOC livestreamed on Twitch to engage with the younger demographic that frequents the video game-centric…

Black Lives Matter face mask for preventing spread of COVID-19

BLM T-shirts and Trump Masks Cause Uproar at Early Polling Locations; New Credit Cards Allow Trans Individuals to Use Preferred Name; and More

BLM T-shirts and Trump masks cause uproar at early polling locations. Voters’ choice of clothing when heading to the polls in Florida and Tennessee has begun making headlines across the country. The Washington Post reported that Miami police officer Daniel Ubeda has come under fire for wearing a Trump-endorsing face…

Close-up image of COVID-19 virus

Black and Latinx Individuals Increasingly Worried About Impact of COVID-19 on Career; Potential Spike in New Disabilities Due to Pandemic; and More

More than 50% of Blacks and Latinx individuals significantly worried about finances and career prospects due to pandemic. COVID-19 continues to be top of mind for most of the country, especially as cases appear to be worsening in our current third wave of the illness. But a new survey of…

Rep. Jahana Hayes (D-Conn.)

Rep. Jahana Hayes Attacked in Racist Campaign Town Hall; 1 in 4 Americans Unemployed According to New Data from Axios; and More

Racist trolls interrupt Zoom town hall hosted by Jahana Hayes, Connecticut’s first Black congresswoman. “I am not OK,” wrote Rep. Jahana Hayes (D-Conn.) in a moving post describing a violent attack that took place at one of her recent campaign events. Ten minutes into the Zoom town hall for one…

reproductive, benefits, workplace

The Importance of Reproductive Benefits in the Workplace

With President Trump’s nomination of Amy Coney Barrett to take the late Justice Ruth Bader Ginsburg’s seat, the issue of reproductive rights has again become a hot button topic. While Ginsburg repeatedly voted against restrictions on birth control and abortion access, the historically conservative Barrett is expected to tip the…

domestic, violence, awareness

October: Domestic Violence Awareness Month Resources

National Domestic Violence Awareness Month takes place in October to raise awareness about this critical social and public health issue. One out of every four women and one out of every 10 men will experience sexual violence, physical violence and/or stalking by an intimate partner in their lifetime according to…