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

The Food and Drug Administration on Tuesday opened an avenue for companies to receive emergency use authorizations to make rapid COVID-19 tests available for point-of-care and at-home. File Photo by John Angelillo/UPI

March 17 (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.


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