FDA provides path for authorization of at-home COVID-19 tests

March 16 (UPI) — The Food and Drug Administration on Tuesday introduced a path for manufacturers to receive emergency authorization for take-home COVID-19 tests.

The agency issued a supplemental template that would allow point-of-care or at-home tests to be authorized for over-the-counter use without validating how they perform on people without systems.


“We believe this effort will pave the way for further expanding the availability of tests authorized for screening asymptomatic individuals, help bolster existing and new testing programs and increase consumer access to testing,” FDA medical device director Jeffrey Shuren said in a statement.

The template will allow developers to seek emergency use authorization for kits that will allow businesses to conduct COVID-19 screening through serial testing, which involves testing the same individual multiple times over several days.

The Centers for Diseases Control and Prevention recommends serial testing at least once per week, as the process can provide a greater chance of detecting infection in an asymptomatic person than a single rapid test.

Under the program, companies can receive authorization to make their tests available for home or point-of-care use if they are effective at identifying the virus in people with symptoms and mitigating false results through repeated testing.

In a fact sheet released alongside the announcement, the agency also urged the importance of businesses implementing other measures such as mask-wearing and social distancing to prevent virus spread as well as quarantining and contact tracing in the event of a positive test.

A year in pandemic: How COVID-19 changed the world

January 31, 2020

National Institutes of Health official Dr. Anthony Fauci (C) speaks about the coronavirus during a press briefing at the White House in Washington, D.C. Health and Human Services Secretary Alexander Azar (L) announced that the United States is declaring the virus a public health emergency and issued a federal quarantine order of 14 days for 195 Americans. Photo by Leigh Vogel/UPI | License Photo

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