FDA Authorizes First OTC At-Home COVID-19 Test

The US Food and Drug Administration has issued an emergency use authorization for the Ellume COVID-19 Home Test, a rapid, lateral flow antigen test that is the first over-the-counter at-home diagnostic test for COVID-19.

The test makes use of nasal swab samples and can be utilize in any individuals aged 2 years and older. This authorization follows a similar one in November for the first prescription home COVID-19 test. Overall, more than 225 diagnostic tests for COVID-19 have been authorized by the FDA since the beginning of the pandemic, 25 of which can be used at home.

“Similar to other antigen tests, a small percentage of positive and negative results from this test may be false. Therefore, for patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible,” the FDA wrote in a press release.

In an examination of the test’s accuracy, it correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms, and 91% of positive and 96% of negative samples from patients without symptoms.

—Michael Potts

Reference:

US Food and Drug Administration. Coronavirus (COVID-19) Update: FDA authorizes antigen test as first over-the-counter fully at-home diagnostic test for COVID-19. News release. December 15, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-antigen-test-first-over-counter-fully-home-diagnostic?utm_medium=email&utm_source=govdelivery