2nd Abbott Labs Coronavirus Antibody Test Gets Emergency Approval

NORTH CHICAGO, IL — The U.S. Food and Drug Administration has granted emergency use authorization to a second coronavirus antibody test developed by Abbott Labs, the North Chicago-based medical device company announced Monday.

Antibody testing can determine if a person has contracted the new coronavirus by measuring the immune system's response to the infection. Also known as serology testing, it allows scientists to better understand how much of the population has been infected and whose donated blood might be used to treat COVID-19 patients. It is unknown to what degree such antibodies offer immunity to future infections.

"Having more options of highly reliable tests across our platforms will help healthcare workers and health officials as they conduct broad scale testing for COVID-19," CEO Robert Ford said in a release announcing the approval.

The new antibody test is the company's fourth COVID-19 test to receive temporary approval from U.S. regulators over the past two months. The first two were aimed at detecting active infections and included a rapid test capable of producing results within 15 minutes.

"Abbott is a leader in providing antibody testing at large scale on multiple systems, which is helping meet the needs of laboratories as they look to build testing capacity," Ford said.

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Earlier:

• Rapid Coronavirus Test From Abbott Labs Receives Emergency Approval
• Abbott Labs Ships Over 1 Million Rapid Coronavirus Tests To Every State
• Coronavirus Test Made By Abbott Labs Wins Emergency FDA Approval

Last month, Abbott received emergency certification from U.S. and European regulators for an antibody test on another of its platforms. According to the company, it has begun shipping them to the U.S., U.K., Spain and India. The previous tests ran on Abbot's ARCHITECT machines, while the new ones require an Alinity i system, described by the company as its "next-generation immunoassay instrument."

Abbott officials plan to ship nearly 30 million of antibody tests by the end of the month, with a planned capacity of 60 million tests in June across both platforms, according to the announcement.

Coronavirus antibody tests looks for two key immunoglobins: IgG and IgM. Generally, a body infected with COVID-19 first produces IgM, so a positive result can indicate the virus is still fresh and remains potentially contagious. As the immune system continues to respond to the virus, it produces more of the IgG antibody.

A study to test the effectiveness of Abbott's IgG test found it had a 99.6 percent ability to avoid false positives and 100 percent ability to exclude false negatives in COVID-19 patients tested 14 days after the onset of their symptoms.

While studies have shown most people who contract COVID-19 develop antibodies, scientists have yet to determine whether they offer protection against re-infection and for how long, whether the degree of immunity may depend on the severity of the infection or whether those with potential immunity may still transmit the virus to others.