We had developed similar tests for other infectious diseases. PARSONS: Ellume has been developing point-of-care (POC) tests for healthcare professionals and at-home tests for consumers for more than a decade. How did the partnership between Ellume and RADx Tech lead to such rapid progress? Ninety-five percent were confident about using the test kits at home, and more than 99% read their results correctly. Studies showed that 96% of users find home tests easy to use. Remember that people may be sick and not at their best when they run the test. We designed the test kits to be easy to use, with little chance for human error. Users may share results with their doctor, employer, public health department, or school.
Results appear on the user’s smartphone in 15 minutes. PARSONS: The Ellume test is the first FDA-authorized COVID-19 test that does not need a prescription and can be done completely at home. How does the Ellume COVID-19 home test work? What do users think about the test? Fifteen minutes later, the result appears on the phone. The user squeezes a few drops into a port on the analyzer and places it near their smartphone. After swabbing their nose, the user inserts the swab into a dispenser containing a special fluid.
The user begins by downloading an app on their smartphone to guide them step-by-step through the test procedure. Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the leader of the RADx Tech and ATP programs, spoke with us about the RADx initiative, COVID-19 tests, and the project that led to the EUA for the Ellume home test.Īs of May 2021, Ellume home test kits are available for sale without a prescription at many U.S. Sean Parsons, MBBs, BSc, CEO and founder of Ellume, and Bruce J.
The company achieved this by partnering with RADx Tech/ATP.
The test is made by Ellume, an Australian company specializing in digital diagnostic tests, many of which don’t require professional laboratory services. In December 2020, the FDA issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home rapid, antigen test for COVID-19. ATP then helps expand, improve, and speed up production to make many tests available in a short time. The RADx Advanced Technology Platforms (ATP) program first identifies existing test systems or ones that are in advanced stages of development. Institutions and industries supported under the RADx Tech program developed tests that can be done in homes, drugstores, and mobile clinics. The RADx initiative includes different programs to support innovation in testing and increase availability of COVID-19 tests. Now, thanks in large part to the NIH Rapid Acceleration of Diagnostics (RADx SM) initiative, you can take a COVID-19 test at home, with results on your smartphone in as little as 15 minutes. Still, long lines and finding time to get tested are a barrier for many. labs were running 1.8 million tests per day. Food and Drug Administration (FDA) had authorized nearly 300 tests, and U.S. When SARS-CoV-2, the virus that causes COVID-19 infections, first emerged, there was no test to detect it.