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left-of-center2012

(34,195 posts)
Tue Dec 15, 2020, 05:19 PM Dec 2020

Over-the-counter home test for COVID-19 gets US green light

The first home test for COVID-19 that doesn’t require a prescription will soon be on U.S. store shelves. U.S. regulators Tuesday authorized the rapid coronavirus test, which can be done entirely at home. The announcement by the Food and Drug Administration represents another important step in efforts to expand testing options.

Regulators granted emergency use for a similar home test last month, but that one needs a doctor’s prescription. The agency’s action Tuesday allows sales in places like drugstores “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, in a statement.

Initial supplies of the over-the-counter test will be limited. Australian manufacturer Ellume said it expects to produce 3 million tests next month before ramping up production over the first half of 2021.

A company spokesperson said the test will be priced around $30 and be available at pharmacies and for purchase online. The test connects digitally to a smart phone app that displays the results and then helps interpret the results. Users can also connect with a health professional via the app.

https://apnews.com/article/over-the-counter-home-coronavirus-test-ac070f4d42d9d7eacc486c9bed4ccaa0

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crimycarny

(1,351 posts)
3. Here is the accuracy
Tue Dec 15, 2020, 05:38 PM
Dec 2020

“The Ellume COVID-19 Home Test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms. In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples. “

I can’t help but think this is another case of those with $$ or connections getting this test the earliest due to limited supply. People will rush out to purchase as many as they can—hoard—just like toilet paper.

Zoonart

(11,869 posts)
4. I heard it being said ( Laurie Garret?)that this test should cost no more than fifty cents per test.
Tue Dec 15, 2020, 05:39 PM
Dec 2020

Countries in Europe are planning to have them in vending machines on the streets.

https://www.wired.com/story/covid-19-testing-is-expensive-it-doesnt-have-to-be
Update: 50 cents to manufacture.

dhill926

(16,346 posts)
7. I had a test a week and a half ago....
Tue Dec 15, 2020, 06:46 PM
Dec 2020

nasal swab, but no pain, very little discomfort. They said it was a new technique....

forthemiddle

(1,381 posts)
8. These results won't be added to the official numbers
Tue Dec 15, 2020, 07:14 PM
Dec 2020

So if they become popular, our numbers will go down!
GOP Governors will be thrilled!

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