FDA Approves First At-Home Coronavirus Test Collection Kit

The FDA gave emergency use authorization to LabCorp's COVID-19 RT-PCR Test

click to enlarge The testing kit - Photo: https://www.pixel.labcorp.com/
Photo: https://www.pixel.labcorp.com/
The testing kit

The U.S. Food and Drug Administration has issued (or reissued, really) emergency use authorization for the first at-home COVID-19 test kit. 

LabCorp's COVID-19 RT-PCR Test lets patients collect samples at home via Pixel by LabCorp COVID-19 home collection kit and then submit them for testing. According to the FDA, the kit includes "a specific Q-tip-style cotton swab for patients to use to collect their sample;" due to cross-reactivity and sterilization concerns, other cotton swabs cannot be used. The kit also includes saline.

Patients have to stick the cotton swab up their nose, collect a nasal sample and then return the sample by mail in an insulated package to LabCorp for testing. LabCorp says they hope to make the home test collection kits available in most states via a doctor's order in the coming weeks, but the kits will be available initially to first responders and health care workers who have been exposed to COVID-19.

“LabCorp continues to develop new ways to help patients and healthcare providers fight the COVID-19 crisis through our leading testing capabilities and deep scientific and research expertise,” said Adam Schechter, president and CEO of LabCorp. “Our at-home collection kits are designed to make it easier and safer to test healthcare workers and first responders during this important time.”

Kits will be available at pixel.labcorp.com/covid-19 for $119.

“Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options,” said FDA Commissioner Stephen M. Hahn, M.D., in a release. “The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers.

"Specifically, 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. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”

The FDA reminds the public that this emergency authorization is only for the LabCorp COVID-19 RT-PCR Test for at-home collection of nasal swab specimens using the Pixel by LabCorp COVID-19 home collection kit. Not at-home nasal swab collection kits or other testing kits in general.