The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Pixel by Laboratory Corporation of America (LabCorp) COVID-19 Test Home Collection Kit for use by any individuals aged 18 years and older without a prescription. Previously, the kit was only available if recommended by a healthcare provider based on results of a COVID-19 questionnaire.

The LabCorp COVID-19 Test Home Collection Kit is the first COVID-19 direct-to-consumer (non-prescription) test system, which includes a specific Q-tip-style cotton swab and saline for patients to collect a nasal sample. Once collected, the sample can be mailed to a LabCorp lab for testing. The nasal samples will be analyzed using LabCorp’s COVID-19 RT-PCR Test for the detection of nucleic acid from SARS-CoV-2, the virus that causes COVID-19. 

Positive or invalid test results are delivered to the individual by phone call from a healthcare provider; negative test results are delivered via email or online portal. The home collection kit can be purchased online or in a store without a prescription.

Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health said, “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.”

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1.    Coronavirus (COVID-19) update: FDA authorizes first direct-to-consumer COVID-19 test system. [press release]. Silver Springs, MD: US Food and Drug Administration (FDA); December 9, 2020. 

2.    LabCorp receives FDA authorization to make at-home COVID-19 collection kits available through retail. [press release]. Burlington, NC: LabCorp; December 9, 2020.