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NEW YORK – The US Food and Drug Administration on Monday said it has updated its template for the development of rapid antigen-based SARS-CoV-2 tests.

The template, which is intended to guide test developers, includes current recommendations from the FDA concerning data and information that should be submitted to the agency to support Emergency Use Authorization applications for tests to detect a SARS-CoV-2 antigen. Included in the update are recommendations related to studies that support claims for screening asymptomatic individuals and multiplex antigen tests, FDA said.

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