> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# EUA Granted for ‘Fully At-Home’ Covid Test
- URL: https://www.fdaweb.com/eua-granted-for-fully-at-home-covid-test/
- Published: 2020-12-15T12:00:00.000Z
- Updated: 2026-09-14T16:40:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148300

FDA has issued an emergency use authorization (EUA) for Ellume’s Covid-19 Home Test, the first over-the-counter fully at-home diagnostic test for Covid-19\. The rapid, lateral flow antigen test is designed to detect fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual two years of age or older, an [FDA release](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-antigen-test-first-over-counter-fully-home-diagnostic?ref=fdaweb.com) says.

“Similar to other antigen tests, a small percentage of positive and negative results from this test may be false,” the agency says, adding that for patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible. Individuals who test negative and experience Covid-like symptoms should follow up with their health care provider, FDA says.

The EUA was based on data showing the test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms. “In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples,” FDA says. “The Ellume Covid-19 Home Test uses an analyzer that connects with a software application on a smartphone to help users perform the test and interpret results. Results are delivered in as little as 20 minutes to individuals via their smartphone. The mobile application requires individuals to input their zip code and date of birth, with optional fields including name and e-mail address, and reports the results as appropriate to public health authorities to monitor disease prevalence.”

FDA says Ellume expects to make more than three million tests in January.