16/05/2020
16/05/2020
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)