Whitehouse Centers for Disease Control and Prevention US Department of Homeland Security - Federal Emergency Management Agency

At this time, the FDA has not authorized any COVID-19 test to be completely used and processed at home. However, on April 20, 2020, the FDA authorized the first COVID-19 test for home collection of samples to be sent to a laboratory for processing and test reporting. Please note that this authorization is specific only to the home collection test that has been issued the authorized EUA (LabCorp’s COVID-19 RT-PCR Test). Any COVID-19 test intended for at-home testing, including self-collection of a sample at home, with or without the use of telemedicine, requires an authorized EUA. The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space. You can find listings of tests that have received an authorized EUA on the Emergency Use Authorizations page.

The FDA is supportive of at-home testing for COVID-19 provided there is data and science to support consumer safety and test accuracy. We are actively working with developers in this space and will continue to authorize EUAs for tests that demonstrate appropriate validation. Home collection raises several issues of importance, including whether the sample can be safely and properly collected, whether the components of the test kit are safe for use in the home environment (since some components may be toxic), proper shipment, and stability of the sample given the time lapse between collection and testing (such as, if the sample sits in a hot truck). A physician watching the collection via telemedicine may address the issue of sample collection (if the self-collection method does not raise safety concerns), but it does not address these other issues.

Last updated April 21, 2020
Source: U.S. Food & Drug Administrationlinks to external site