April 21, 2020

FDA Authorizes First COVID-19 Test for At-Home Sample Collection

The FDA issued an emergency use authorization (EUA) for LabCorp’s COVID-19 RT-PCR test to permit testing of samples self-collected by patients at home using a special home collection kit.

Headlines surrounding this development have confused the public into believing an at-home test for COVID-19 is now available. This is not the case. This EUA applies to the testing of a sample collected form the patient’s nose using a designated self-collection kit that contains nasal swabs and saline. Users must mail in their sample in an insulated package to a LabCorp for testing.

This product will be made available in the coming weeks in most states with a doctor’s order. Of note, due to sterility concerns and cross reactivity to inherent genetic materials in cotton swabs, only the special Q-tip style cotton swaps included with the kit should be used. Other cotton swabs should not be used with this test.

For more information, read the announcement in full.