FDA authorizes 1st over-the-counter, at-home test
The FDA has authorized the first at-home COVID-19 test that doesn't require a prescription and provides results within 20 minutes.
The Ellume COVID-19 Home Test is an antigen test that detects fragments of proteins from the SARS-CoV-2 virus on a nasal swab and then reports results to your phone.
“Today’s authorization is a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Stephen Hahn said in a statement. “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.”
The test "correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms," the FDA said. "In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples."
The company says it will deliver 20 million at-home tests, which are manufactured in Australia, to the U.S. in the first half of 2021.
ABC News’ Stephanie Ebbs contributed to this report.







