emergency use authorization approved

FDA Authorizes First OTC Fully At-Home Diagnostic Test for COVID-19

December 16, 2020

The FDA has issued an Emergency Use Authorization (EUA) for the Ellume COVID-19 Home Test, the first over-the-counter (OTC) fully at-home diagnostic test the agency has approved for COVID-19 infections.

The antigen test detects the SARS-CoV-2 virus from a nasal swab sample and uses a smartphone and a downloadable app to provide testing instructions and deliver results in as little as 20 minutes.

The agency previously approved a prescription COVID-19 test for home use and a nonprescription test that requires a lab to process the self-collected sample.

The Ellume Home Test correctly identifies 96 percent of positive samples and 100 percent of negative samples in individuals with symptoms. In people without symptoms, it correctly identifies 91 percent of positive samples and 96 percent of negative samples. It will cost about $30 and will be available by January.

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