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FDA authorizes first “standalone at-home sample collection kit” for coronavirus

WASHINGTON, May 16: The US Food and Drug Administration (FDA) announced Saturday that it has authorized an “at-home sample collection kit that can then be sent to specified laboratories for COVID-19 diagnostic testing.”


The FDA said in a statement that the kit is “authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider.”


It added “this allows an individual to self-collect a nasal sample at home using Everlywell’s authorized kit.”


The FDA has also authorized “two Covid-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the Everlywell Covid-19 Test Home Collection Kit.”


“These tests have been authorized under separate, individual EUAs (emergency use authorization). Additional tests may be authorized for use with the Everlywell at-home collection kit in the future, provided data are submitted in an EUA request that demonstrate the accuracy of each test when used with the Everlywell at-home collection kit,” the statement noted.(KUNA)

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