The First Ellume at-Home COVID-19 Test Has Been Approved by the FDA
The first-ever over-the-counter COVID-19 test has been approved by the United States Food and Drug Administration for emergency use and here’s what you need to know.
This morning, the first COVID-19 test accessible without a doctor’s note has been approved by the FDA and will become available to the public. People experiencing symptoms of the virus can take the test at home and process their results independently. According to CNET, “the test comes from Ellume.”
Today, the FDA issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for #COVID19. The Ellume COVID-19 Home Test is authorized for people 2 years old and up, including those not showing symptoms. https://t.co/fdd2B7fYPE pic.twitter.com/eAHMKcZ4MV— U.S. FDA (@US_FDA) December 15, 2020
According to a statement from the FDA documented by CNET, the organization describes the test as “a non-prescription home use test intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens from mid-turbinate nasal swabs that are self-collected by an individual age 16 years or older, or are collected by an adult from an individual 2 years of age and older.” On their Instagram, the governmental organization detailed how they have been utilizing EUAs during the pandemic.
All you need to do to take this simple at-home test is download the Ellume app from the app store, swab one nostril, put the used Q-tip into fluorophene, and wait 15-20 minutes for your results. According to CNET, studies about the at-home test have yielded exciting results, including “In symptomatic individuals, the test was found to be 96% effective in identifying positive cases and 100% effective in identifying negative cases. Those numbers fall slightly with asymptomatic individuals, with the test correctly identifying 91% of positive cases and 96% of negatives.”
As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories & test supplies, & giving Americans more testing options from the comfort & safety of their own homes. https://t.co/LM5UkYWg8C pic.twitter.com/lV1Y3TTfqO— Dr. Stephen M. Hahn (@SteveFDA) December 15, 2020
The testing company estimates that they will make three million tests available for purchase by January 2021. We applaud the scientists who have made this breakthrough possible and look forward to hearing more news about the COVID-19 vaccine in the months to come.