Pixel by LabCorp Covid-19 Test home collection kit is the first Covid-19 direct-to-consumer test system that does not require any prescription
LabCorp has received the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the over-the-counter sale of the Pixel by LabCorp Covid-19 Test home collection kit.
With the FDA authorisation, Pixel by LabCorp Covid-19 Test home collection kit becomes the first Covid-19 direct-to-consumer test system available for people aged 18 years and older, without needing prescription.
The kit is intended to help users know the status of their Covid-19 infection, which could help users to determine if self-isolation (quarantine) is appropriate or discuss with a professional for health care decision, said the company.
LabCorp Diagnostics chief medical officer and president Brian Caveney said: “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.
“With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities.”
Users who purchased the Pixel by LabCorp Covid-19 collection kit requires to register their product at the Pixel by LabCorp website and follow the instructions included.
The consumers are allowed to use the test kit to self-collect their sample in home, and send the sample for processing at LabCorp, preventing the spreading of the infection.
The company will securely deliver the results to the consumer through the Pixel by LabCorp portal. Consumers who test positive with be counseled by a healthcare provider for treatment and actions.
LabCorp said that its Covid-19 PCR test has not been FDA approved, but authorised by the FDA under an EUA, only for the detection of nucleic acid from SARS-CoV-2, and not any other viruses or pathogens.
FDA Centre for Devices and Radiological Health director Jeff Shuren said: “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.
“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.”