April 21, 2020

FDA Authorizes First COVID-19 Test for Home Collection

FDA COVID-19 EUA

On April 20, 2020, the US FDA authorized the first COVID-19 test for home collection of specimens. Importantly, the Emergency Use Authorization (EUA) is specifically for the home specimen collection method for the LabCorp COVID-19 RT-PCR Test. The specimen must still be sent to a laboratory for processing and test reporting.

FDA has advised that any COVID-19 test intended for use at-home, including the use of a self-collection device or method, requires an authorized EUA. This guidance applies to any testing conducted via telehealth/telemedicine.

COVID-19 tests that have been an authorized by FDA, including EUA’s for home collection, can be found on the FDA Emergency Use Authorizations page.

For additional information on COVID-19 testing and FDA EUA, please visit the FDA FAQ on Diagnostic Testing page.

FDA FAQs on Diagnostic Testing

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