LabCorp at-home COVID-19 test kit gets FDA emergency authorization
BURLINGTON, N.C. (WTVD) -- North Carolina-based LabCorp has received emergency use authorization from the Food and Drug Administration for a COVID-19 At-Home Test Kit.
The kit allows for patients to take a nasal swab sample for testing.
Patients can get the kit if it's recommended by a healthcare provider after completing a COVID-19 questionnaire. The test hasn't been FDA cleared or approved but LabCorp received an Emergency Use Authorization (EUA) from the FDA to issue the kits. The EUA permits nasal swab specimens to be collected at home using LabCorp's "Pixel" kit.
The kit includes a specific Q-tip-style cotton swab for patients to use to collect their sample.
Because other cotton swabs may not be sterile, the FDA said other cotton swabs or Q-tips should not be used with the test.
Initially, the test will be available for healthcare workers and first responders who have symptoms or have been exposed to COVID-19.
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Those who want to purchase a kit will have to fill out a survey online to confirm they are eligible.
It will become available to others in the coming weeks.
"For tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor's office, hospital or other testing site," said FDA Commissioner Stephen M. Hahn, M.D. said. "With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home."
How does the test work?
If you are eligible for testing, you can buy the test online and complete the checkout process. All Pixel by LabCorp testing requires a physician order.
Pixel by LabCorp has contracted with PWNHealth LLC and its affiliated professional entities (collectively, PWNHealth) to provide physician services.
LabCorp will send you an email when your kit has shipped and when it has been delivered. The patient must follow the enclosed instructions to register the kit and collect the sample. The patient will then use the included FedEx overnight shipping envelope to return the sample to the LabCorp laboratory. You will receive an email when your results are ready and can be accessed through your Pixel by LabCorp account.
LabCorp says the virus may not be detected if the sample is not collected as directed.
