Dubai, United Arab Emirates - The US Food and Drug Administration (FDA) granted an emergency permit, Tuesday, for the first test for "Covid-19" that can be performed entirely at home. The test developed by the Australian company Ellume is sold without a prescription and provides results that can be read at home.
Other home tests require a prescription, or require people to send test samples to a lab to get the results.
But the home test developed by the Australian company "Ellume" for coronavirus is sold without a prescription, and it provides results that can be read at home.
"Today's statement is a milestone in diagnostic tests for COVID-19," said Food and Drug Administration Commissioner Dr. Stephen Hahn in a written statement.
"By allowing a test that can be used without a prescription, the FDA is allowing it to be sold in places like drug stores, where a patient can buy it, wipe his nose, take the test, and see its results in less than 20 minutes," Han added.
The Food and Drug Administration said the test uses a analyzer linked to a software application on smartphones to help users take the test and interpret the results.
The Food and Drug Administration said that the Ellume test is an antigen test that "correctly identified 96% of positive samples, and 100% of negative samples in symptomatic individuals."
And in people without symptoms, the FDA said that the test correctly identified 91% of positive samples, and 96% of negative samples.
CNN's chief medical correspondent, Dr Sanjay Gupta, said that testing Americans is an important issue. "I think it would be a big thing if they could produce enough of these tests to be obtained in most, if not all, of America's homes," he said.
Gupta added that getting tested on a regular basis and having quick results can help people determine if they should stay home and when they can go out.
Because the test is not perfect, people who get a negative result must be mindful that they may be infected, and they must act accordingly, wear a mask, and distance themselves from others.
Ellume expects to produce more than 3 million tests in January.
When it applied for permission for emergency use, the company said the test would cost $ 30.