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.”
For more information visit labcorp.com.
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.