FDA Approves New Over-the-Counter COVID-19 Test
It’s been a good week so far in the fight against the coronavirus pandemic.
On Monday, doses of Pfizer’s vaccine began rolling out to hospitals around the nation. Lubbock’s first doses are expected to come in on Wednesday. One day later, we learned that Moderna’s COVID-19 vaccine was doing well and could be approved for use very soon.
We also learned on Tuesday about a new, first-of-its-kind test that was approved by the U.S. Food and Drug Administration. According to the FDA, the new test is authorized for those two years old and older and takes as little as 20 minutes to find out the results.
The FDA says the Ellume COVID-19 Home Test is a rapid test that detects fragments of proteins of the virus from a nasal swab sample:
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.
The FDA added that it was possible to have false positives and negatives with the test, so they asked that you follow-up with a healthcare professional, especially if you're experiencing COVID-19 symptoms.