FDA authorizes first over-the-counter, non-prescription, Home COVID-19 test

The US Food and Drug Administration has granted an emergency use authorization for a non-prescription, over-the-counter Covid-19 test kit for at-home use for the first time.

The Lab Corp Pixel COVID-19 Test Home Collection Kit allows anyone 18 and older to buy the kit and collect nasal swab samples at home, the FDA said in a news release Wednesday, December 9th. The samples are then sent to the facility for testing.

Positive or invalid results come by phone, negative results arrive by email.

This home sample collection kit can be purchased online or in a store without a prescription. 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 health care decisions after discussion with a health care professional.

“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,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “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.”

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Ms. Jenn Landers | Patient Advocate Alliance LLC
Edited by Dr. Justin Groode 

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