THE U.S. Food and Drug Administration gave emergency authorization Tuesday for the first COVID-19 test that can be fully taken at home. Other at-home tests require a prescription or require people to send test samples to a lab to get results. But this home test developed by Australian company Ellume is sold over-the-counter and produces results that can be read at home. “Today’s authorization is a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Dr. Stephen Hahn said in a written 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 uses an analyzer that connects with a software application on a smartphone to help users perform the test and interpret results, the FDA said. The Ellume test is an antigen test that “correctly identified 96 percent of positive samples and 100 percent of negative samples in individuals with symptoms,” the FDA said. In people without symptoms, the test correctly identified 91 percent of positive samples and 96 percent of negative samples, the FDA said. Ellume expects to produce more than 3 million tests in January. When it applied for emergency use authorization, the company said it would charge $30 for the test. (SD-Agencies) | 