In an effort to accurately confirm the number of people infected with the coronavirus in the United States, the Food and Drug Administration (FDA) greenlit its third at-home testing kit on May 16 — with a unique ability to conduct tests that mirror ones being executed at actual facilities. The FDA gave Everlywell Inc., a Texas-based testing company, the okay to sell their nasal swabbing kit in the form of an “emergency use authorization,” or EUA, allowing people to perform nasal swabs at home.
The emergency use authorization given to the Everlywell at-home kit means that while the standards for the FDA’s approval of the product is lower than usual, due to the nature of the times we’re living in, the organization believes that the kit is trustworthy. This is also thanks in part to other “statutory criteria” met for the EUA.
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As a result of this authorization, people across the U.S. curious as to whether they have the coronavirus now have a third at-home test option to choose from. The FDA previously gave EUA to two other at-home sample collection kits: another nasal swabbing kit created by LabCorp in March and a saliva testing kit by Rutgers New Jersey Medical School’s Clinical Genomics Laboratory earlier in May. The latter is the first saliva testing option in this process.
People using Everlywell’s nasal swabbing at-home kit are guaranteed results within three to five days, spokesperson Christina Song explained to the New York Times on May 16. The process begins with an online survey to determine whether the person actually needs a test. The survey includes questions about possible exposure to anyone who has been infected and if any coronavirus-related symptoms like fever or loss of taste and smell are experienced.
If it is concluded that the person needs a test — that is determined by a medical professional reviewing the answers — Everlywell mails out the kit. The person then receives the nasal swabbing kit and saline solution, which will house the swab when the kit is mailed back to Everlywell. Results are determined shortly after and posted in the person’s online portal.
The FDA explained during Saturday’s announcement that the samples collected with Everywell’s at-home kit would be tested in diagnostic tests “performed at specific laboratories” also approved by EUA; in this case, the labs are Fulgent Therapeutics in California and Assurance Scientific Laboratories in Alabama.
“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,” explained Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, in Saturday’s press release.
Everlywell’s at-home nasal swabbing kit, available to the public at the end of May, will cost testers $109.
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