It's being called a major milestone in testing for COVID-19. The FDA has authorized the first over the counter, fully at-home test to determine whether a person is infected.
The Ellume COVID-19 home test is for anyone two years of age or older and will be available without a prescription. The test uses a nasal swab but does not go as far back as a swab you'd get from a trained health care provider.
The test has an analyzer that connects with an app to help users conduct the test and decipher the results, which come back on your phone. The FDA says the test correctly identified 96 percent of positive samples and 100 percent of negative samples in those with symptoms.
In a statement, FDA commissioner Dr. Stephen Hahns says "by authorizing a test for over the counter use, the FDA allows it to be sold in places like drug stores where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes."
By expanding access to testing, officials hope to lower the burden on labs and supplies and give more options to Americans. The FDA says just like other antigen tests, a small percentage of positive and negative results from the test may be false. The agency advises those who test negative but have COVID-like symptoms to follow up with their healthcare provider.