NEW YORK – The US Food and Drug Administration said on Monday that it issued Emergency Use Authorization for PerkinElmer's Euroimmun's Anti-SARS-CoV-2 ELISA test, the first serology test whose results were independently validated by the federal government.
The test qualitatively detects IgG antibodies against the coronavirus in human serum and plasma and is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, the FDA said.