Innovation

FDA Approves Coronavirus Nasal Swab Test Kit For Home Use

People may soon be able to get tested for the novel coronavirus by themselves. The Food and Drug Administration (FDA) has approved a new testing kit designed to let people take a nasal sample at home and send it to a laboratory for diagnostic testing.

Texas-based company Everlywell Inc. received the emergency clearance to distribute the tool to help speed up the mass testing across the U.S. The company said the kit will not require users to leave their houses and that it would only take less than a week to get results, The Hill reported

“From the moment that you hit the order button, to the moment that you get the test results on your phone or device, that process is designed to take three to five days,” Christina Song, a spokeswoman for Everlywell, told New York Times.

To use the coronavirus testing kit, FDA said individuals must take an online questionnaire and provide the information to a health care provider. The screening aims to help determine if the test is necessary at home. 

If approved, the user will then take a nasal sample, put it in a saline solution and send it to a lab authorized to examine the kit. Everlywell established its independent physician network to look at the tests and an online portal to send the results. 

“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, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

Everlywell introduced its tool to FDA with data from studies that demonstrated stability of samples during shipping. The studies were backed by The Bill and Melinda Gates Foundation and UnitedHealth Group. 

Everlywell’s coronavirus testing kit adds to the growing list of tools the FDA authorized to help speed up the detection of COVID-19 in the U.S. and other countries. The agency approved the distribution of two other at-home tests, with one that also collects nasal swab samples and another that examines saliva. 

However, researchers noted that nasal swab tests at home have limitations. Labs may not get enough samples if the user fails to properly insert a swab through the nose into the throat. 

Coronavirus COVID-19 New York, USA - Mask People line up outside Elmhurst Hospital to get tested due to coronavirus outbreak on March 24, 2020 in Queens, New York City. New York City has about a third of the nation’s confirmed coronavirus cases, making it the center of the outbreak in the United States. (Photo by Eduardo Munoz Alvarez/Getty Images) Eduardo Munoz Alvarez/Getty Images

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