Ellume COVID-19 Home Test U.S. Voluntary Recall. Click here.
The test is suitable for ages 2 years and above for over-the-counter home use. Clinically proven for use for people with and without symptoms, with accurate test results in 15 minutes.
Now available for sale in the U.S. at www.ellumecovidtest.com
*Other home antigen test require a 2nd test 2-3 days after the first
The test includes a nasal swab with protect child adapter, a dropper, processing fluid, and a Bluetooth® connected analyzer for use with an app on your phone.
The app will guide you through the test including an integrated information video and step-by-step instructions. The sample is analyzed and the result is displayed on your phone after 15 minutes. Results are saved within the app and can be shared via email.
The Ellume COVID-19 Home Test complies with CDC reporting requirements and automatically reports the required data to health authorities through our secure encrypted, HIPAA compliant, cloud connection.
*Other home antigen tests require a 2nd test 2 – 3 days after the first.
**No other over-the-counter COVID-19 home antigen test has been clinically tested and authorized for use without symptoms in a single test.
Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. COVID-19 is a respiratory illness primarily spread from person to person. COVID-19 symptoms can range from mild (or no symptoms) to severe illness. While multiple vaccines for COVID-19 are now authorized, rapid diagnosis remains pivotal to minimizing transmission.
The Ellume COVID-19 Home Test has not been FDA cleared or approved; but has been authorized by the FDA under an emergency use authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
