FDA Authorizes Another COVID-19 At-Home Sample Collection Ki
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U.S. Food and Drug Administration has authorized an at-home sample collection kit that can then be sent to specified laboratories for COVID-19 diagnostic testing. Emergency use authorization (EUA) to Everlywell, Inc. for the EverlyWell COVID-19 Test Home Collection Kit.

Permits testing of a sample collected from inside the patient’s nose using the authorized self-collection kit that contains nasal swabs to collect a sample and a tube filled with saline to transport the sample back to a specified lab. Ship the sample overnight to a specific CLIA-certified lab that is running one of the in vitro diagnostic molecular tests authorized under a separate EUA for use with the EverlyWell at-home sample collection kit. Results will be returned to the patient through Everlywell’s independent physician network and their online portal.

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. EverlyWell is currently the only authorized COVID-19 at-home sample collection kit for use with multiple authorized COVID-19 diagnostic tests.


Source: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-standalone-home-sample-collection-kit-can-be-used
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