FDA Authorizes First COVID-19 Test with At-Home Sample Collection Option

April 22, 2020

This is the first diagnostic test authorized by the FDA with a home collection option for COVID-19.

The FDA has authorized the first diagnostic test with a home collection option for coronavirus disease 2019 (COVID-19) for the Laboratory Corporation of America (LabCorp), in a press release on Wednesday.1

The FDA initially issued an emergency use authorization (EUA) on March 16 for LabCorp’s RT-PCR Test, which qualitatively detects nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in upper and lower respiratory specimens from individuals with suspected COVID-19.2

LabCorp has planned to make Pixel by LabCorp COVID-19 Test home self-collection kits available with a physician’s order in most states in the coming weeks. The molecular test allows samples to be collected from a patient’s nose through a designated self-collected kit containing nasal swabs and saline. After self-collection, the sample is mailed in an insulated package to a LabCorp lab to be tested.1

The FDA warned that due to sterility and cross-reactivity concerns, the particular Q-tip cotton swab that comes with the home self-collection kit, and no other cotton swabs, should be used to collect samples; the administration additionally warned that the authorization applies solely to the LabCorp COVID-19 RT-PCR Test, and has not authorized general at-home collection of patient samples.1

“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, MD, in a statement.1

“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,” he added. “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.”1

References:

1. Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection. News Release. FDA; April 21, 2020. Accessed April 22, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-test-patient-home-sample-collection
2. Hinton DM. FDA; April 20, 2020. Accessed April 22, 2020. https://www.fda.gov/media/136148/download