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FDA approves over-the-counter at-home COVID test
The latest development in the fight against the coronavirus pandemic includes an over-the-counter at-home COVID-19 test.
ORLANDO, Fla. - The latest major development in the fight against the pandemic is an over-the-counter at-home COVID-19 test kit.
It is complete with a nasal swab, an analyzer, and Bluetooth technology, so you can receive test results through an app on your phone in just 15 minutes.
“Squeeze five drops of fluid into the sample port of the analyzer,” an informational video explains.
“I think it’s a great idea I think it’ll definitely bring a lot of possibility to people who are looking for some ways to get tested quickly,” said Lorraine Breiner, who lives in Orlando.
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The Food and Drug Administration approved the first over-the-counter coronavirus test just days before the agency is expected to authorize a second vaccine manufactured by Moderna.
The FDA
issued an emergency use authorization Tuesday for the Ellume COVID-19 Home Test, the first over-the-counter diagnostic test for COVID-19. Ellume Health, a developer of diagnostic medical tests based in Australia, says the test can be used anywhere and returns results in 15 minutes.
The test employs nasal swabs to look for fragments of coronavirus proteins. The results are then sent to the user’s smartphone. It can be used to test anyone age 2 or older.
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. Today s authorization is a major milestone in diagnostic testing for COVID-19, FDA Commissioner Stephen Hahn said in a statement announcing the authorization.
The test kit includes a special swab that enables users to collect a sample from just inside their nose. Because it can be used on adults and children as young as 2 years old, the swab comes with a special adapter that shortens the length when swabbing youngsters.
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The Food and Drug Administration has approved the first over-the-counter diagnostic test for COVID-19.
The FDA issued an emergency use authorization Tuesday for the Ellume COVID-19 Home Test. Ellume Health, a developer of diagnostic medical tests based in Australia, says the test can be used anywhere and returns results in 15 minutes.
It employs nasal swabs to test for fragments of coronavirus proteins. The results are then sent to the user’s smartphone. It can be used to test anyone age 2 or older. Today’s authorization is a major milestone in diagnostic testing for COVID-19. 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, said FDA Commissioner Stephen Hahn. As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the bu