Antibody tests for coronavirus are an important weapon in the fight against the pandemic because they can also tell whether someone has had the virus in the past. Such information is crucial to evaluate how wide the virus has actually spread — as well as how long antibodies stay in the body and whether the antibodies provide immunity to the virus.
Abbott plans to distribute 4 million tests by the end of the month, ramping up to 20 million tests a month by June.
“We continue to contribute in a significant and meaningful way by providing new solutions across our diagnostics testing platforms,” Abbott CEO Robert B. Ford said in a news release. “I’m extremely proud of the many Abbott people who are working around the clock to get as many tests as we can to healthcare workers and patients.”
Abbott’s new SARS-CoV-2 IgG test identifies the IgG antibody. IgG is a protein that the body produces in the late stages of infection; it may remain in the body for months and possibly years after recovery. The new test will initially be available on the more than 2,000 Architect i1000SR and i2000SR laboratory instruments used in U.S. laboratories. The instruments are able to run up to 100 to 200 tests per hour.
Abbott is making the test initially available without an FDA emergency use authorization, per a pathway in the agency’s policy. The company plan to file an EUA submission, as well as seek a CE Mark in the European Union.
Other Abbott coronavirus tests already in use include its m2000 molecular laboratory system and its ID Now molecular point-of-care device.