Safe, accurate and rapid self-test
This highly accurate home test is available for non-prescription use in the US, enabling individuals 2+ years with and without symptoms to test for COVID-19 infection in 15 minutes.
The sample is collected by the patient, then analyzed and results are automatically transmitted to the patient’s smartphone via Bluetooth®.
Patients can share their result from the test app with healthcare professionals, to enable remote diagnosis and optimal care.
The Ellume Home COVID-19 Home Test has multiple applications at the point of care. Enabling no-contact testing, the test helps to keep healthcare professionals and patients safe.
Features and Benefits
In U.S. — 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.