NEW YORK – The US Food and Drug Administration on Wednesday granted Emergency Use Authorization to Mount Sinai Laboratory for a COVID-19 antibody test.
The assay, called COVID-19 ELISA IgG Antibody Test, detects human IgG antibodies in serum and plasma from individuals suspected of prior infection with SARS-CoV-2 by their healthcare provider.
The authorization letter states that IgG antibodies to the virus generally become detectable 10 to 14 days after infection, and that a positive test result indicates an immune response to acute or previous infection. However, the test should not be used for the diagnosis of acute infection.
The EUA is limited to MSL, Center for Clinical Laboratories, which is a division of the Department of Pathology, Molecular, and Cell-Based Medicine at the Icahn School of Medicine at Mount Sinai.
The assay is the fourth serology test to be authorized for emergency use by the FDA, following test kits from Chembio Diagnostics and Ortho Clinical Diagnostics on Tuesday and from Cellex on April 1.