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Regulatory Focus™ > News Articles > 2020 > 5 > Standalone at-home COVID-19 nasal swab kit receives EUA

Standalone at-home COVID-19 nasal swab kit receives EUA

Posted 18 May 2020 | By Kari Oakes 

Standalone at-home COVID-19 nasal swab kit receives EUA

A nasal swab kit that allows individuals to collect their own samples for COVID-19 diagnostic testing has been granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA).
The prescription-only kit may be used by individuals after a healthcare provider reviews their responses to an online screening questionnaire. FDA issued the EUA to Everlywell, Inc. for use with two different diagnostic tests to detect SARS-CoV-2, the virus that causes COVID-19. Those tests, to be performed at specific laboratories, were previously authorized under separate EUAs.
 “The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a FDA press release announcing the EUA for the at-home kit. “Today’s action is also another great example of public-private partnerships in which data from a privately funded study was used by industry to support an EUA request, saving precious time as we continue our fight against this pandemic.”
Components of the Everlywell COVID-19 Test Home Collection Kit include nasal swabs and a saline-filled vial for transport. Currently, just two laboratories – Fulgent Therapeutics and Assurance Scientific Laboratories – are authorized to collect and test the specimens, which they receive from patients via overnight express shipment. Everlywell has an independent physician network to communicate results to patients; an online portal for results is also available.
In the press statement, the FDA noted that data from studies conducted by the Bill and Melinda Gates Foundation and UnitedHealth Group demonstrated stability of the novel coronavirus when nasal swabs in saline are shipped. “The data from these studies are freely available to support other EUA requests, alleviating each test developer of the burden of recreating the same study,” according to the press statement.
Though other Clinical Laboratory Improvement Amendments-certified laboratories may apply for EUAs to conduct tests using the at-home nasal swab kit, FDA emphasized that “It is important to note that this is not a general authorization for at-home collection of patient samples using other collection kits, swabs, media, or tests, or for tests fully conducted at home.”

Tags: coronavirus, fda

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