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COVID-19: New And Updated EUA Templates Focus On Serology Tests

 
• By Elizabeth Orr

The US FDA issued a new template for serology test-makers that detect or correlate to neutralizing antibodies, and also updated an existing template to reflect concerns over viral mutations

Coronavirus 2019-nCoV Blood Sample. Corona virus outbreaking. Epidemic virus Respiratory Syndrome. China
• Source: Shutterstock

Developers of serology tests for COVID-19 got additional guidance from the US Food and Drug Administration (FDA) on 17 March, as the agency issued a new emergency use authorization (EUA) template for the diagnostics and updated an existing one.

The agency has issued a total of nine EUA templates for molecular, antigen and serology/antibody tests as a way to show sponsors what information to include when submitting new applications....

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