The standalone collection kit can be used with certain authorized tests.
The U.S. Food and Drug Administration (FDA) has authorized an at-home sample collection kit that can be used to test for COVID-19 through specified laboratories.
According to a news release, the agency issued an emergency use authorization (EUA) to Everlywell Inc., for the kit which is authorized to be used by patients at home who have been screened for COVID-19 using an online questionnaire reviewed by a healthcare provider. The FDA also authorized two diagnostic tests, performed at specific laboratories, which can use the samples.
Additional tests that can use the Everlywell samples may receive authorization later, the release says.
“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,” Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, says in the release. “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.”
The EUA permits testing of samples collected from the inside of the patient’s nose using the kit. Once the sample is collected, the patient will ship the sample overnight to a CLIA-certified laboratory, specifically Fulgent Therapeutics or Assurance Scientific Laboratories, which are running one of the in vitro diagnostic molecular tests authorized under a different EUA. The results will be returned to the patient through Everlywell’s independent physician network and their online portal, the release says.
The Everlywell home-collection kit’s EUA request used data from studies supported by The Bill and Melinda Gates Foundation and UnitedHealth Group to demonstrate stability of specimens during shipment. The kit and associated tests are only available by prescription, the release says.
Previously, the FDA approved an EUA for the Laboratory Corporation of America COVID-19 RT-PCR Test which allows patients to collect their own nasal samples at home.