FDA Authorizes Antigen Test As First Over-The-Counter Fully At-Home Diagnostic Test For COVID-19

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for coronavirus disease 2019 (COVID-19). The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual two years of age or older.

The Ellume COVID-19 Home Test uses a mid-turbinate nasal swab (sample is . . .