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The FDA Just Approved a $30 At-Home Covid Test — Here s What You Need to Know

How does the home test work? The Ellume Covid Home Test is an antigen test, which means it identifies specific proteins that are found on the surface of the virus when someone is infected with Covid-19. How accurate is the test? With all antigen tests, positive results are highly accurate and should be treated as a presumptive positive (meaning, you should act as though you have Covid until another test can verify it). However, there is a higher chance of false negatives, because antigen levels can drop lower than what the tests can detect, according to the FDA. In other words, a negative antigen test result doesn t rule out a Covid-19 infection.

Coronavirus Australia live news: FDA approves at-home COVID testing kit developed by Ellume Health in Brisbane

Coronavirus Australia live news: FDA approves at-home COVID testing kit developed by Ellume Health in Brisbane
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First OTC, app-connected COVID-19 test authorized by FDA

Share The U.S. FDA announced today an Emergency Use Authorization for the first over-the-counter COVID-19 diagnostic test for home use. Developed by Australian digital diagnostics company Ellume Health, the single-use kit is accompanied by a Bluetooth-connected app that guides users through the testing process and automatically reports its results for disease monitoring. The test returns its results in 15 to 20 minutes. It s intended for use with self-collected nasal swab samples from individuals aged 16 years or older, or adult-collected samples from children aged two years or older. The Ellume COVID-19 Home Test kit comes with a sterile nasal swab with a child adapter, processing fluid, a dropper and a Bluetooth-connected sample analyzer. Users are instructed to download the accompanying Ellume COVID-19 Home Test App for iOS or Android, which includes a quick start guide on how to connect the app to the analyzer as well as an instructional video on how to collect a sample a

Coronavirus Ellume at-home test developed in Brisbane approved for emergency use in US

Coronavirus Ellume at-home test developed in Brisbane approved for emergency use in US Posted TueTuesday 15 updated WedWednesday 16 DecDecember 2020 at 4:34am CEO and founder Dr Sean Parsons said clinical tests found it was 96 per cent accurate. ( Share Print text only Cancel A new at-home coronavirus test, developed by a Brisbane company, has been approved for emergency use in the United States. Key points: The new at-home quick test was produced by a Brisbane company The US FDA approved it for emergency use, allowing it to be sold over the counter in pharmacies Another Queensland-based team has helped produced a COVID-19 app being used by medical professionals worldwide

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