LG Chem’s COVID-19 Antibody Test Gains Emergency Authorization
The FDA has granted an Emergency Use Authorization to South Korea-based LG Chem’s AdvanSure SARS-CoV-2 IgG enzyme-linked immunosorbent assay for COVID-19.
The test, which looks for immunoglobulin G antibodies to the SARS-CoV-2 virus in human serum and plasma, is intended as an aid in identifying people with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. It is not authorized for use in diagnosing or excluding acute SARS-CoV-2 infections.
Samples should only be taken for this test from individuals who are 15 days or more post symptom onset, the FDA said.
Emergency use of the test is limited to authorized laboratories.