Abbott Gets FDA EUA for COVID-19 IgG Antibody Test
Abbott has been given the FDA’s Emergency Use Authorization (EUA) for its AdviseDx SARS-CoV-2 IgG II diagnostic.
The serology test is now cleared for qualitative and semi-quantitative detection of IgG antibodies to the virus in human serum and plasma, according to the FDA’s authorization.
The device is meant to be used as an aid in identifying patients who have an adaptive immune response to the coronavirus in order to detect recent or prior infection. The EUA limits the test to certified laboratories. The company previously received emergency authorization for its COVID-19 IgM antibody serology test in October 2020.