FDA posts template on COVID-19 tests performed outside healthcare settings

July 30, 2020

The U.S. Food and Drug Administration (FDA) released a template to help commercial developers apply for emergency use authorization (EUA) for COVID-19 tests that can be performed entirely at home or in other non-healthcare settings, such as schools.

“The FDA continues to help facilitate innovation in test development, thereby enhancing Americans’ access to COVID-19 tests,” FDA Commissioner Stephen M. Hahn, MD, said in a press release. “The recommendations provided are intended to help get tests to market that are simple enough to use at home, similar to a pregnancy test."

The template includes recommendations for validating molecular and antigen diagnostic assays, such as when a sample is to be collected and analyzed, and results are to be returned without the need to send a sample to a lab for analysis. It also gives recommendations for validation of tests that are intended to be made available without a prescription.

In addition, the template outlines recommended performance for non-prescription tests intended for use in non-laboratory settings. Specifically, the agency recommends that tests have a positive percent agreement (PPA) of equal to or greater than 90 percent for asymptomatic and symptomatic people and a negative percent agreement (NPA) equal to or greater than 99 percent.

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