FDA Approves Emergency Use COVID-19 Home Test
The Food and Drug Administration has authorized a COVID-19 home test for emergency use, and the company that makes it says it should be affordable and available sometime next month.
WIVB-TV reports the Ellume test kit can be used at home, is relatively easy to use but does require an accompanying app, so the user has to have a smartphone.
Ellume, the company that produced the test is based in Australia, and CEO Sean Parsons says the app includes a video and step-by-step instructions.
“It is really simple. We have proven that people can do it correctly, even when they are feeling sick with coronavirus, and it is through the app that we walk people through the testing process.”
The test kit uses a nasal swab that can be adjusted for adults or children as young as two years old.
Parsons says test results can be available in as little as 15 to 20 minutes and test accuracy is rated at a minimum of 96%.
“The point of this testing is, while we are looking to vaccinate the community, is to enable as few a people to get coronavirus and as few a people to die as we possibly can to minimize the impact of coronavirus on our communities.”
America’s top immunologist, Dr. Anthony Fauci said the Ellume home test will have a huge impact on keeping Americans safe.
“That this was a long time coming. I am glad it is here and I think if used properly, it could go a long way to getting people to appreciate whether they are infected or not and prevent them from exposing themselves to other people.”
Production of the tes is underway, according to officials and their first shipments should be on store shelves stateside by the second week in January.
The test is said to be priced at about $30, or a third of the price of other home tests.