NEWS

FDA Authorizes First Direct-to-Consumer COVID-19 Test, Improving Accessibility

At-home COVID-19 test kit

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Key Takeaways

  • The U.S. Food & Drug Administration (FDA) approved the first direct-to-consumer coronavirus testing system on December 9. 
  • The testing kit will not require a prescription and will be available to individuals 18 years and older. 
  • The FDA says the kits are intended to help individuals gain information about possible COVID-19 infection and determine if self-isolation (quarantine) is necessary and/or readily make a plan for healthcare decisions.

The U.S. Food & Drug Administration (FDA) announced on December 9 it has approved an emergency use authorization (EUA) for the first direct-to-consumer coronavirus testing system, a step the agency said is one of many measures necessary to reduce rapidly growing COVID-19 infections.

“This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a news release of LabCorp’s Pixel COVID-19 test kit. “While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing.”

What Does Direct-to-Consumer Mean? 

Put simply, direct-to-consumer means the kits will be available (to people 18 years and older) without a prescription.

"With the first over-the-counter at-home collection kit ever authorized by the FDA for COVID-19, we are empowering people to learn about their health and make confident decisions,” Brian Caveney, MD, chief medical officer and president of LabCorp Diagnostics, said in a news release. “With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities.

As a result of this authorization, Gail Trauco, RN, CEO and founder of Medical Bill 911, says the test will be in high demand. "Patients will not be required to locate a COVID testing center and wait in long lines," she tells Verywell.

Gail Trauco, RN

LabCorp has positioned themselves on the frontline to make testing simple and readily available.

— Gail Trauco, RN

How Does the Kit Work?

According to the FDA, the direct-to-consumer kit will allow people to self-collect nasal swabs at home and then send the sample for testing to LabCorp. While insurance is not required to purchase the test, LabCorp’s website said the company can bill insurance for the cost of the test. The company also emphasized that the test is not a substitute for visiting a healthcare professional.

“Positive or invalid test results are then delivered to the user by phone call from a healthcare provider,” the FDA’s website noted, adding that negative test results are delivered via email or the online portal. “It is intended to enable users to access information about their COVID-19 infection status that could aid with determining if self-isolation (quarantine) is appropriate and to assist with healthcare decisions after discussion with a healthcare professional.

In November, the FDA issued an EUA for the Lucira COVID-19 All-In-One Test Kit, the first self-test for COVID-19 that provides rapid results at home using nasal swabs. While experts expressed excitement about the test’s approval, many of them also emphasized the possibility of inaccurate results.

“The test is good for a single point in time,” Amesh A. Adalja, MD, senior scholar at the Johns Hopkins Center for Health Security, told Verywell. “But no test is perfect, and what you do afterward matters, too.”

But one thing is for sure, Trauco says: "LabCorp has positioned themselves on the frontline to make testing simple and readily available." 

What This Means for You

The authorization of this at-home, non-prescription testing kit will allow more people to get tested for COVID-19, therefore possibly reducing the spread of the virus and improving the overall health of people nationwide.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.

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  1. U.S. Food and Drug Administration. Coronavirus (COVID-19) update: FDA authorizes first direct-to-consumer COVID-19 test system. Updated December 9, 2020.