FDA authorizes first over-the-counter fully at-home COVID-19 diagnostic test

Virus Outbreak Home Test
Posted at 11:28 AM, Dec 15, 2020

WASHINGTON, D.C. — A home test for COVID-19 will soon be on U.S. store shelves.

The U.S. Food and Drug Administration (FDA) on Tuesday issued an emergency use authorization for the first kit that consumers can buy without a prescription to test themselves entirely at home.

Regulators granted use for a similar home test last month, but it requires a doctor’s prescription.

The new test kit from Australian company Ellume allows users to swab themselves and get the results at home in about 20 minutes.

The test detects fragments of proteins of the coronavirus from a nasal swab sample from anyone 2 years old and up. It connect to a digital app to help users interpret the results.

Similar to other antigen tests, the FDA says a small percentage of positive and negative results from this test may be false. Therefore, for patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible.

Individuals with positive results should self-isolate and seek additional care from their health care provider. Those who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from coronavirus infection.

The company says it will have 3 million tests available next month.

“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. Today is a promising step forward and we are eager to continue advancing additional innovation in COVID-19 testing that the science supports,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health.