The test is suitable for ages 2+ years and will be available for non-prescription home use in the U.S*. It enables individuals, with and without symptoms, to test for COVID-19 infection in 15 minutes, anywhere.
The self-test offers a substantial benefit to COVID-19 hotspots, by enabling early detection so users can self-isolate and seek medical care to limit the spread of COVID-19.
*In U.S. – For use under Emergency Use Authorization (EUA) only.
The test includes a sterile Nasal Swab, a Dropper, Processing Fluid, and a Bluetooth® connected Analyzer for use with an App on the user’s smartphone.
Utilizing the dedicated App, the user follows step-by-step instructions to perform the test including a self-collected mid-turbinate swab. The sample is analyzed and results are automatically transmitted to the user’s smartphone via Bluetooth®. Results can be shared with healthcare professionals to enable optimal therapy.
Through a secure cloud connection, the Ellume COVID-19 Home Test provides real time reporting of test results and critical data to health authorities, employers and educators, for efficient COVID-19 mapping.
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 Cosmetics Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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 approved, rapid diagnosis remains pivotal to minimising transmission.
