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FDA authorizes first over-the-counter, fully at-home coronavirus diagnostic test

The Food and Drug Administration on Tuesday approved the first over-the-counter, fully at-home diagnostic test for COVID-19.

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The rapid antigen test, called the Ellume COVID-19 Home Test, runs a liquid sample along a surface with reactive molecules and detects protein fragments of the SARS-CoV-2 virus, which causes COVID-19 disease, from a nasal swab sample. The test is for people ages two years and older.

“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 Dr. Stephen M. Hahn. “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 Ellume COVID-19 Home Test is the first COVID-19 test that can be done completely at home without a prescription. Like other antigen tests, there is a small chance it could yield false positive and negative results.

The approved home test correctly identified 96% of positive samples and 100% of negative samples for individuals with symptoms, according to the FDA. For people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples. The test uses an analyzer that connects with a software program on a smartphone so that users can perform the test and interpret results. Test takers can get results within minutes from their smartphone.

Ellume anticipates producing more than three million tests next month.

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The authorization of the first fully at-home COVID-19 diagnostic test follows the approval of the first prescription coronavirus test for home use. The FDA has authorized more than 225 diagnostic tests for COVID-19 since the pandemic began. More than 25 of those involve at-home collection of samples that are then sent to a lab for testing.

According to health guidance, individuals with positive results should self-isolate and seek medical care. Those who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results does not mean a person does not have COVID-19.

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