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FDA Approves At-Home COVID Test

Tracy Davenport Tracy Davenport
8th January 2021
FDA Approves At-Home COVID Test
The test can take place completely at home (Getty Images).

The Claim

The FDA has approved an at-home COVID-19 test.

Emerging story

Social media users are reporting the U.S. Food and Drug Administration (FDA) has approved an at home COVID-19 test. 

Misbar’s Analysis

Misbar discovered that on December 15, 2020, the FDA authorized an antigen test as the first over-the-counter fully at-home diagnostic test for COVID-19. “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. 

According to NPR.org, the FDA had previously authorized other tests that let people collect a sample themselves at home. But those tests still required people to send the sample to a lab and wait for the results. Another recently authorized test doesn't have to be sent off to a lab, but it requires a prescription to get it.

The approved 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 according to EllumeHealth.com. Using the dedicated app, the user follows step-by-step video instructions to perform the test including a self-collected nasal swab. The sample is analyzed, and results are automatically transmitted to the user’s smartphone via Bluetooth® in 15 minutes or less. Results can also be shared with healthcare professionals. The tests are estimated to be 96 percent accurate and will soon be available in local drug stores. 

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