The FDA has authorized a new at-home sample collection kit for COVID-19. It's the only one that's allowed to be used with multiple diagnostic tests at multiple labs.
On Saturday, the agency cleared Everlywell, Inc.'s nasal swab testing kit for emergency use. People who think they might have the coronavirus are required to take an online screening test first. A health care provider would then review the completed questionnaire and prescribe an at-home kit if needed. The person would ship their sample overnight to one of two authorized labs. Finally, they would get their results through Everlywell's independent physician network and online portal.
Director of the FDA’s Center for Devices and Radiological Health, Jeffrey Shuren, M.D., J.D., said, "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."
According to The New York Times, Everlywell says the overall process should only take three to five days. The company says the $135 test kit will be available later this month.
