FDA grants EUA to LabCorp’s Covid-19 home collection kit

10 December 2020 (Last Updated December 10th, 2020 10:15)

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to life sciences company LabCorp’s Pixel by LabCorp COVID-19 Test Home Collection Kit.

FDA grants EUA to LabCorp’s Covid-19 home collection kit
The kit is indicated for use in people aged 18 years and above. Credit: Tsuguliev / Shutterstock.

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to life sciences company LabCorp’s Pixel by LabCorp COVID-19 Test Home Collection Kit.

The test is the first of its kind to be available over the counter without needing a prescription. It is indicated for use in people aged 18 years and above.

With the latest development, LabCorp can potentially sell the kit through its retail channels.

Using the kit, customers can self-collect the sample at their own home, containing the virus transmission. After collecting the sample, users can send it for processing at LabCorp.

LabCorp Diagnostics chief medical officer and president Dr Brian Caveney said: “With the first over-the-counter at-home collection kit ever authorised by the FDA for Covid-19, we are empowering people to learn about their health and make confident decisions.

“With this authorisation, we can help more people get tested, reduce the spread of the virus, and improve the health of our communities.”

After purchasing the Pixel by LabCorp COVID-19 collection kit, users are asked to register it at the Pixel by LabCorp website and follow the instructions provided.

The company will send the kit to collect the nasal swab sample, which needs to be shipped back to its lab. The test for SARS-CoV-2 virus will be conducted in the lab.

Users will be able to access the results through the website.

According to LabCorp, the average time to deliver results after receiving the sample is one to two days.

If the user tests positive for Covid-19, a healthcare professional will provide guidance to help with the treatment.

LabCorp’s Covid-19 PCR test has been authorised only for the detection of nucleic acid from SARS-CoV-2 and cannot be used for testing any viruses or pathogens.