Abbott has launched a COVID-19 IgG antibody test with plans to ship 1 million tests this week and 4 million tests in total for April. The lab-based serology blood test can detect the antibody, IgG, which identifies if a person has had the novel coronavirus.
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 US laboratories and can run up to 100-200 tests per hour, according to the company.
This is the third COVID-19-related diagnostic offered by the company, after its two molecular tests using the m2000 laboratory system and ID Now point-of-care device. While molecular testing detects whether someone has the virus, antibody tests determine if someone was previously infected.
According to the company, antibody testing is an important next step to tell if someone has been previously infected. It will provide more understanding of the virus, including how long antibodies stay in the body and if they provide immunity. This type of knowledge could help support the development of treatments and vaccines.
“We continue to contribute in a significant and meaningful way by providing new solutions across our diagnostics testing platforms,” said Robert B. 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.”
Abbott is making the test available as part of the 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 US customers, and will ship a total of 4 million tests for April. The company is ramping up to 20 million tests in the US 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.