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FDA Grants Emergency Use Authorization for LG Chem COVID-19 Antibody Test

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for an ELISA-based SARS-CoV-2 antibody test developed by South Korea's LG Chem.

The AdvanSure SARS-CoV-2 IgG(S1) is designed for the qualitative detection of immunoglobulin G to SARS-CoV-2 in human and plasma samples to help identify individuals with an adaptive immune response to the virus.

Use of the test is limited to labs CLIA-certified to perform high-complexity tests, according to the FDA. It should only be used with samples from individuals who are 15 days or more past symptom onset.