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The Ellume -19 Home Test kit is an easy-to-use rapid antigen home test that detects an active -19 infection in 15 minutes without sending to a lab. IT IS THE ONLY OTC ANTIGEN The Ellume COVID-19 Home Test is the only home test to use innovative fluorescent technology, previously only used by doctors, to detect COVID-19 infection and generate highly accurate results in 15 minutes. <br />The easy-to-use home test includes a free app that will guide you through the test including an information video and step-by-step instructions. <br />The sample is analyzed and the unambiguous result is displayed in words on your phone (no interpretation of faint test lines required). Unique sample quality control technology ensures this test will only run when there is enough sample to provide an accurate result, which minimizes the risk of false negative results and reduces the risk of people unintentionally spreading COVID-19.<br />Clinically proven for use by people with and without symptoms, this test is suitable for ages 2 years and above. The test features a user-friendly nasal swab with child adapter to ensure safety & comfort when swabbing children. <br />This test has been designed to withstand mutations to the virus and we have an ongoing testing program ensuring it covers the latest variants as they appear. The test targets a protein in the virus (the nucleocapsid protein), which remains largely unchanged in SARS-CoV-2 variants. <br />In October, we conducted a voluntary recall of some specific tests when we identified some tests had an increased chance of providing a false positive result. So that our test continues to be one of the most accurate rapid antigen tests on the market, we implemented additional controls to ensure our product meets our high-quality standards. We apologize for the frustration this caused. We have taken appropriate measures so that the product now on shelves meets our highest quality standards<br /><br /><br /><br />DISCLAIMER : This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA; This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, This product 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 -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. <br /><br />FALSE RESULTS: We're not perfect, but we're trying to be. Thanks to our test’s unique features, including our internal sample quality control system, the Ellume -19 Home test is one of the most accurate OTC home antigen tests available. Unfortunately, no test is perfect and false positive and false negative results are possible with all tests. Please refer to the Ellume FAQ found on our website to learn more about false results or to review our clinical trial data. If you have received a false result, please contact Customer Support.<br /> <br />
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