COVID-19 Home Test
Our over the counter, self-performed rapid test detecting SARS-CoV-2 antigen with results in 15 minutes. It is suitable for ages 2+ years for asymptomatic screening and symptomatic testing.
Utilizing the dedicated app, users follow 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.
Not available in Australia.
Influenza Home Test
We have developed a single use flu test that can detect influenza from the comfort of the user’s own home. The test connects to the user’s smartphone through the test’s designated app. Test results are displayed on the user’s phone within 12 minutes of completing the test.
To make this product available to as many people as possible, we have partnered with GlaxoSmithKline (GSK), a global leader in consumer healthcare. Further announcements coming soon.
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.