Abbott has announced the launch of its third COVID-19 test, a lab-based serology blood test for the detection of the antibody, IgG, that identifies if a person has had the novel coronavirus (COVID-19).
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.
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 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."
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.
Abbott is making the test available as part of the US Food and Drug Administration (FDA) notification without an Emergency Use Authorisation (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.
