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FDA issues emergency use authorization for COVID-19 antigen diagnostic test

People's Daily Online

(Xinhua) 08:42, July 07, 2020

WASHINGTON, July 6 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Monday issued an emergency use authorization (EUA) for a COVID-19 antigen diagnostic test, the Becton Dickinson Veritor System 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.

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.

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

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, Hahn said.

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

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