LG Chem Gets FDA’s Emergency Use Authorization for Its AdvanSure COVID-19 Test

LG Chem of South Korea has been granted Emergency Use Authorization (EUA) by the FDA for its AdvanSure SARS-CoV-2 IgG(S1) test for COVID-19 infections.

The enzyme-linked immunosorbent assay test kit, which detects antibodies to the coronavirus in human serum and plasma, can identify recent or prior infections.

The FDA said samples should only be tested from individuals who are 15 days or more after the onset of symptoms. And the test samples must be analyzed by laboratories that meet the requirements to perform high-complexity tests.