On Monday, the Food and Drug Administration (FDA) approved emergency use authorization for Abbott Laboratories’ new coronavirus antibody test, the company announced.
According to the company’s press release, they plan to ship nearly 30 million antibody tests globally by the end of May “across its ARCHITECT and Alinity i platforms,” and will have the capacity to ship 60 million tests in June. The antibody tests will help indicate whether a person has been infected with the novel coronavirus in the past and has recovered or was asymptomatic.
“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,” said Robert B. Ford, president and chief executive officer for Abbott Laboratories. “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.”
Abbott’s test is the thirteenth antibody test to receive emergency use authorization from the FDA.
According to Abbott’s press release, the new antibody tests will provide more efficient results, and can exclude false-positive results 99.6 percent of the time and exclude false-negative results 100 percent of the time.
“This antibody test will be used on our Alinity i system, which is our next-generation instrument. Abbott is focused on providing hospitals and labs with as many broad and reliable testing options as possible during this pandemic,” a spokesperson from Abbott wrote in an email to Newsweek.
This emergency use approval marks the fourth time Abbott has received one from the FDA. Abbott has already launched three coronavirus tests in the U.S., including one that provides results in nearly five minutes.
“Abbott also expects to submit this week for CE Mark to the IVD Directive (98/79/EC) in the European Union for the Alinity i SARS-CoV-2 IgG test,” the company wrote in their press release.
Throughout the coronavirus pandemic, antibody tests have continued to be requested by many as they will help provide more information on how the virus has spread through different communities.
“High-quality antibody tests or serologic tests can help us understand a person and population’s exposure to Covid-19,” FDA Commissioner Stephen Hahn recently told reporters at a press briefing.
The novel coronavirus, which causes the respiratory disease COVID-19, originated in Wuhan, China but has continued to spread across the world, infecting over 4.1 million people, according to a tracker provided by Johns Hopkins University. The U.S. has remained the virus’s epicenter, with over 1.3 million confirmed cases as well as at least 79,606 deaths.
