FDA Issues Emergency Authorization for Coronavirus At-Home Sample Collection Kit

A lab technician handles a test tube with a live sample from a person tested for the novel coronavirus.
A lab technician handles a test tube with a live sample from a person tested for the novel coronavirus.
Photo: Andrew Milligan (Pool/AFP via Getty Images)

The Food and Drug Administration (FDA) on Saturday announced that it had issued an emergency use authorization for an at-home coronavirus sample collection kit. The kit allows consumers to self-collect a nasal sample and then send it off to be tested for the novel coronavirus, which causes the disease covid-19.

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According to the FDA, the kit, made by Everlywell, can be used by individuals at home who have been screened using an online covid-19 questionnaire that is reviewed by a healthcare provider. If the provider determines that a test is appropriate, the company will send the individual a kit. The individual will then use the kit to collect a nasal sample and send it off to specific laboratories for testing.

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Christina Song, an Everlywell spokeswoman, told the New York Times that customers’ questionnaires will be reviewed by healthcare providers affiliated with PWNHealth, the company’s telemedicine partner.

“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,” Song said.

Everlywell will provide patients with the results of their tests through its independent physician network and online portal. The spokeswoman said that the at-home kits will be available later this month and will cost $135.

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Per the Times, some public health researchers have warned that at-home nasal swab samples can be less accurate than those collected by healthcare providers. The latter samples involve inserting a long nasal swab through the person’s nose to the back of their throat.

Dr. Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health, said in a statement that the authorization of the Everlywell coronavirus at-home testing kit increases patient access to tests and also protects others from potential exposure. The FDA has authorized the Everlywell kit for use with two coronavirus diagnostic tests.

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In addition, two labs, Fulgent Therapeutics and Assurance Scientific Laboratories, are allowed to test samples collected with the kits.

This is the third at-home coronavirus sample collection kit that the FDA has authorized in recent weeks. It has also authorized a test from LabCorp, which uses nasal samples collected with a kit at home, as well as a test from the Rutgers Clinical Genomics Laboratory. Contrary to the Everlywell and LabCorp at-home kits, the Rutgers kit uses saliva samples collected at home.

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Despite assurances from President Donald Trump that the U.S. has “the greatest testing in the world,” increasing coronavirus testing capacity in the U.S. has been a challenge since the beginning of the pandemic.

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At the beginning of May, the Harvard Global Health Institute said that the country needed to be doing 900,000 tests per day in order to relax social distancing measures. According to data from the COVID Tracking Project, in May the U.S. did roughly 309,000 tests per day on average. In other words, we’re far from that.

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DISCUSSION

mnemophylax
mnemophylax

Yeah uh considering just HOW FAR that swab has to be shoved back in there to get a proper nasopharyngeal sample, I’m pretty sure that your average person is not going to be able to do it properly.