On Tuesday, the U.S. Food and Drug Administration authorized the first Coronavirus test allowing people to buy the test without a prescription. The $30 test will be available locally and allow immediate results at home to determine whether users are negative or positive, according to the Australian company that makes it, Ellume.
People can collect samples at home (thus avoiding long lines at testing sites), send the sample to a lab, and then wait for test results, reports NPR.
The new test is the first that people will be able to buy without a prescription at a local store and do entirely at home on their own. It takes about five minutes to collect the sample and produces results within 15 minutes.
A study shows the test is 96% accurate, according to the FDA and the company.
From FDA Commissioner Stephen Hahn:
Today’s authorization is a major milestone in diagnostic testing for COVID-19.
Included in the test kit is a special swab that enables a user to collect a sample from just inside his nose. It can be used on adults and children as young as 2 years old, and includes a special adapter that shortens the length when swabbing youngsters.
According to Sean Parsons, the company’s CEO, this is the first test designed as a true at-home test that allows test-takers to obtain results.
This could be used for people to test themselves, for example, before going to a sporting event or a concert or going to a church to decrease the chance that they spread it other people.
In the FDA’s announcement, Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, notes:
The fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.