COVID-19: First Test for Patient At-Home Sample Collection

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-test-patient-home-sample-collection?utm_campaign=2020-04-21%20FDA%20Authorizes%20First%20Test%20for%20Patient%20At-Home%20Sample%20Collection&utm_medium=email&utm_source=Eloqua

FDA Authorizes First Test for Patient At-Home Sample Collection

The U.S. Food and Drug Administration (FDA) authorized the first diagnostic test with a home collection option for COVID-19. The FDA re-issued the emergency use authorization for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit. The LabCorp home self-collection kit includes a specific Q-tip-style cotton swab for patients to collect their sample. After a patient self-swabs to collect their nasal sample, they mail their sample, in an insulated package included in the kit, to a LabCorp lab for testing. LabCorp intends to make the Pixel by LabCorp COVID-19 Test home collection kits available to consumers in most states, with a doctor’s order, in the coming weeks.

Learn More Questions? If you have questions about the FDA’s authorization of this diagnostic test, contact the Division of Industry and Consumer Education.