SILVER SPRING, MD (WBAP/KLIF News) – Americans can now take a fully at-home COVID-19 diagnostic test.
The U.S. Food and Drug Administration approved the over-the-counter Ellume COVID-19 Home Test Tuesday.
The nasal swab test detects fragments of proteins of the SARS-CoV-2 virus on anyone aged two and older. Users don’t need a prescription to buy it and will get the results in about 20 minutes.
FDA Commissioner Dr. Stephen M. Hahn said the authorization of the test is a milestone in the battle against the COVID-19 pandemic.
“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 the results in as little is 20 minutes,” he said. “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 test comes on the heels of last week’s announcement of the first non-prescription test system, which is processed by LabCorp.
Since the start of the pandemic, the FDA has authorized more than 225 diagnostic COVID-19 tests, including more than 25 tests that allow for home collection of samples which are sent to a lab for testing.
Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health said when it comes to battling a virus like COVID-19 innovation is key.
“The FDA strongly supports innovation in test development and we have worked tirelessly with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them,” he said.
The FDA said some users may get a false negative or a false positive result. The agency encourages anyone with a positive result should self-isolate and seek medical care from their health care provider.
Individuals who test negative and experience COVID-like symptoms should also follow up with their health care provider because negative results don’t preclude an individual from getting infected.
The company said it wants to produce about three million tests next year.
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