Abbott launches antibody test for COVID-19.
Abbott 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.
Antibody tests to expand testing and help healthcare workers- While molecular testing detects whether someone has the virus, antibody tests determine if someone was previously infected.
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.
