COVID-19 Update: FDA Issues Emergency Use Authorization for Antigen Test

The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for rapid detection of SARS-CoV-2. This is the second antigen test the FDA has authorized for the detection of SARS-CoV-2 antigens, reports Xinhua news agency.

This test is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 for high, moderate, or waived complexity testing, according to the FDA.

‘COVID-19 antigen diagnostic test is authorized for use in laboratories certified under Clinical Laboratory Improvement Amendments of 1988 for testing.’

"Expanding America's testing capabilities is the result of partnership and ingenuity between the federal government, private sector and academia," FDA Commissioner Stephen Hahn said on Monday.

Antigen tests play an important role in the overall response against COVID-19, including as a point-of-care test that can potentially scale up to test millions of Americans quickly, he added.

In May, the FDA approved EUA to American company Quidel Corp for the first COVID-19 antigen test.



Source: IANS