This antibody test adds to Abbott's existing COVID-19 tests that are already being used, including its m2000 molecular laboratory system and its ID NOW molecular point-of-care device.
"We continue to contribute in a significant and meaningful way by providing new solutions across our diagnostics testing platforms," said Robert Ford, president and chief executive officer, Abbott. "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."
While molecular testing detects whether someone has the virus, antibody tests determine if someone was previously infected.
Abbott's SARS-CoV-2 IgG test identifies the IgG antibody, which is a protein that the body produces in the late stages of infection and may remain for up to months and possibly years after a person has recovered. Abbott's IgG antibody test will initially be available on its ARCHITECT i1000SR and i2000SR laboratory instruments. More than 2,000 of these instruments are in use in U.S. laboratories. These instruments can run up to 100-200 tests per hour.
Abbott is making the test available as part of the U.S. Food and Drug Administration (FDA) notification without an Emergency Use Authorization (EUA) pathway outlined in Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. Additionally, Abbott plans to file an EUA submission with the FDA and plans to CE Mark to the IVD Directive (98/79/EC) in the European Union.
Abbott is significantly scaling up its manufacturing for antibody testing and is expecting to immediately ship close to 1 million tests this week to U.S. customers, and will ship a total of 4 million tests in total for April. The company is ramping up to 20 million tests in the U.S. in June and beyond as it expands the tests to run on its new Alinity i system. Abbott also will be expanding its laboratory antibody testing to the detection of the antibody, IgM, in the near future.