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FDA Authorizes First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

The new Covid-19 tests approved by the FDA comes from Australia

Ellume Home Corona Virus Test

The FDA has given the green light for an at home Corona Virus test. Now people can buy a do it yourself Covid-19 test over the counter (without a doctor’s prescription) in pharmacies. The new test is produced by Australian manufacturer Ellume.

The Ellume test includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth connected analyzer for use with an app on the user’s smartphone. A user can follow step-by-step video instructions to perform the test including a self-collected mid-turbinate swab. The sample is analyzed and results are automatically transmitted to the user’s smartphone via Bluetooth in 15 minutes or less.

Through a secure cloud connection, Ellume’s COVID-19 home test can provide real-time reporting of test results to health authorities, employers and educators, for efficient COVID-19 mapping. Ellume says that clinical trials have shown that it works 96% of the time.

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Advances in the detection of Covid-19 have been giving people hope that things might soon get back to normal. In Israel they are already offering inexpensive tests at the airport for all travels returning from abroad so that they will not need to go into quarantine. The fastest test can get results within four hours.

Affordable quick testing will allow all airlines to test travelers before boarding planes and all nations to test arriving passengers. schools and businesses will be able to use them too. Now imagine a quick test than can be reused. Instead of checking temperatures at the entrances to stores, shopping malls and government facilities with that little electric thermometer they will have a similar tool to test for Covid-19.

Think about that for a moment. As the Corona Virus vaccine are only now being shipped out it will take time for even just most people to get vaccinated. And then there are no guarantees that there will be a permanent immunity to Covid-19 in those vaccinated and it may not work in a percentage of people. Also, even the immune could be carriers.

Ellume exclaims that its self-test will help reduce the spread of COVID-19 through rapid self-detection, providing users with real-time results at home, enabling self-isolation and patient education on escalation of medical care. The test is suitable for ages 2+ years for symptomatic and asymptomatic use.

“As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” said Ellume founder and CEO, Dr. Sean Parsons. “Ellume’s COVID-19 Home Test delivers this important first line of defense – it can be widely available without the need for a prescription, enabling the U.S. to respond to the pandemic in its most urgent stage.”

“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 M. Hahn, M.D.

“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.”



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