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LG Chem Gets FDA Emergency Use Authorization for SARS-CoV-2 Antibody Test

NEW YORK — The US Food and Drug Administration this week granted Emergency Use Authorization for LG Chem's AdvanSure SARS-CoV-2 IgG(RBD) ELISA COVID-19 antibody test.

The ELISA test is designed for the qualitative detection of immunoglobulin G to SARS-CoV-2 in human serum and plasma to help identify individuals with an adaptive immune response to the virus.

The assay may only be used by labs CLIA-certified to perform high-complexity tests and should only be used with samples from individuals who are 15 days or more past symptom onset, the FDA said.

Late last month, South Korea-based LG Chem received EUA from the FDA for another of its SARS-CoV-2 antibody tests.