The US 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 the Covid-19 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% 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 FDA said.

Story Credit: CNN Health

https://edition.cnn.com/2020/12/15/health/us-coronavirus-tuesday/index.html