Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19


Test is authorized for individuals two years of age or older, including those not showing symptoms

The announcement today (December 15, 2020) of the first fully at-home OTC COVID-19 diagnostic test follows last month’s authorization of the first prescription COVID-19 test for home use and last week’s announcement of the first non-prescription test system, in which a lab processes the self-collected sample. The FDA has authorized more than 225 diagnostic tests for COVID-19 since the start of the pandemic, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing. The Ellume COVID-19 Home Test is the first COVID-19 test that can be used completely at home without a prescription. 

FDA.gov

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