The U.S. Food and Drug Administration has authorized the first at-home sample collection kit for COVID-19, which can be used to send samples to specified laboratories for diagnostic testing.
The Everlywell COVID-19 Test Home Collection Kit allows a person to self-collect a nasal sample at home. It can be used by people who have been screened using on online questionnaire that is reviewed by a health care provider, the FDA said.
Additionally, the FDA authorized two COVID-19 diagnostic tests that can be used with the at-home collected samples.
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said the development provides “increased patient access to tests” and “protects others from potential exposure.”
“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,” Shuren said in a statement.
