Infectious Disease

The FDA approves the primary over-the-counter COVID-19 take a look at

December 15, 2020

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The FDA has granted the first emergency approval for an over-the-counter home diagnostic test for COVID-19.

The Ellume COVID-19 home test is approved for use in people 2 years and older, regardless of whether or not they have symptoms of COVID-19.

During analysis, the test correctly identified 96% of positive samples and 100% of negative samples in people with COVID-19 symptoms, according to the FDA.

“Today’s approval marks an important milestone in diagnostic testing for COVID-19. By approving an over-the-counter test, the FDA allows it to be sold in places like drug stores, where a patient can buy it, wipe their nose, do the test, and find out the results in just 20 minutes, ”FDA commissioner Stephen M. Hahn, M.D, said in a press release.

“As we continue to approve additional tests for home use, we are helping to improve Americans’ access to testing, reduce the burden on laboratories and testing supplies, and provide Americans with more testing options that they can use conveniently and safely from home can test, “said Hahn.

The FDA first issued emergency approval for a COVID-19 at home test in November, but it required a prescription.

Since the pandemic began, more than 225 COVID-19 diagnostic tests have been approved, including 25 that allow for home samples.

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