FDA OKs First Totally At-Home COVID-19 Diagnostic Test

Grant Boone
November 19, 2020

"We look forward to proactively working with test developers to support the availability of more at-home test options", said Jeff Shuren, director of FDA's Center for Devices and Radiological Health.

"The FDA continues to demonstrate its unprecedented speed in response to the pandemic", FDA Commissioner Dr. Stephen Hahn said.

The test kit can also be used in doctor's offices, hospitals, urgent care centers, and emergency rooms for all ages, but samples must be collected by a health care professional if the patient is under age 14.

After whisking the inside of both nostrils, the swab is placed into a fluid-filled vial.

The Food and Drug Administration issued an emergency use authorization to Lucira Health Inc.'s rapid-result All-In-One Test Kit, according to a statement from the government agency Tuesday.

People who receive a positive test result should isolate themselves and seek additional care if needed, while those who receive a negative result but still feel COVID-19 symptoms should follow up with their primary care physician, "as negative results do not preclude an individual from SARS-CoV-2 infection", according to the FDA.

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"There are now two types of COVID-19 tests that detect whether a person is infected and potentially infectious", Lucira CEO Erik Engelson said.

"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", it said. The test, which is by prescription only, delivers results in 30 minutes. Worldwide, more than 55.7 million people have been infected with SARS-CoV-2 and more than 1.3 million people have died.

News of an at-home test comes as testing sites on Long Island are seeing massive lines of people who say they don't feel well, or are concerned they've been exposed or traveled to a high risk area.There are also more spots for testing open to combat those long wait times.

The company said it expects the test to be available nationwide by early spring 2021, at a cost of $50.

There was only one time when the FDA approved one home test for infectious disease, and it was an HIV test. The single-use device was originally developed over five years for use as a flu test, before being redirected toward the COVID-19 pandemic.

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