FDA authorizes first at-home test collection kit for COVID-19
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The FDA authorized the first COVID-19 diagnostic test with a home collection option, reissuing an emergency use authorization that permits LabCorp to test nasal swab samples self-collected by patients at home using the company’s Pixel test kits.
The kits will “initially be made available to health care workers and first responders who may have been exposed to COVID-19 or may be symptomatic,” LabCorp said in a news release. It said it plans to make the kits available to consumers “in the coming weeks.”
According to the company’s website, a test result will cost $119. That price includes the kit, two-way overnight shipping, “physician services” and the test in LabCorp’s laboratory.
“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,” FDA Commissioner Stephen M. Hahn, MD, said in a news 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.”
Samples can be collected and tested from the patient’s nose using the testing kit’s nasal swabs and saline. Once collected, patients can mail in their sample to LabCorp in an uninsulated package.
Because of sterility and cross-reactivity risks, the FDA emphasized that cotton swabs other than those included with the test kit should not be used to collect at-home samples.
The authorization applies only to the LabCorp COVID-19 at-home collection test and is not a general authorization for at-home collection, the FDA said.
“With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” Hahn said.
Reference:
LabCorb. COVID-19 at home kits. https://www.pixel.labcorp.com/covid-19. Accessed April 21, 2020.