FDA approves first at-home coronavirus test kit that provides results within 30 minutes

Jessica Schladebeck, New York Daily News
·1 min read

The U.S. Food and Drug Administration has approved the first coronavirus test kit developed to be performed entirely at home and also yield results in just a half hour.

The agency announced Tuesday night it has granted emergency use authorization to the Lucira COVID-19 All-in-One Test Kit for patients 14 and older. It requires test-takers to swab themselves and then swirl it in a vial full of laboratory solution.

From there, users will have to wait about 30 minutes for their diagnosis to appear on the test’s light-up unit display.

The single-use test, which requires a prescription for use, will also be made available at hospitals and doctor’s offices.

The FDA so far has approved more than 300 tests for coronavirus — the majority of them requiring a nasal swab — but the Lucira kit is the first that can be performed and processed without being sent away for testing.

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19. A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.

“Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them.”


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