Abbott's New Coronavirus Antibody Test Detects Recent Exposures

GREEN OAKS, IL — The U.S. Food and Drug Administration issued an emergency use authorization to a new type of COVID-19 antibody test blood test developed by Abbott Labs that can indicate if someone was recently exposed to the coronavirus.

Abbott's new, lab-based antibody test called AdviseDx SARS-CoV-2 Immunoglobin M is the seventh coronavirus test developed by the medical device maker to receive emergency FDA authorization since the start of the pandemic.

They include both antibody tests, which detect whether someone's immune system has been exposed to the virus, and molecular tests, which look for the presence of an active infection.

So far, the company has received authorizations for four types of molecular tests, an antibody test that detects the longer-lasting Immunoglobin G, or IgG, antibody and an antigen test that delivers rapid, but less accurate results.

The new test measures levels of Immunoglobin M, or IgM, antibodies, which become undetectable in the weeks and months after infection. According the company, testing for IgM antibodies can help doctors determine if isolation, treatment or other follow-ups are needed.


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The recently authorized test has a 99.56 percent specificity rate and a 95 percent sensitivity rate for patients tested 15 days after the onset of symptoms, according to company officials, meaning it has a 0.44 percent chance of a false positive and a 5 percent chance of a false negative.

"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," Robert Ford, president and chief executive officer of Abbott, said in a statement. "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."

This article originally appeared on the Lake Forest-Lake Bluff Patch