May 8, 2020

FDA Authorizes First COVID-19 Test for Home Collection Using Saliva

FDA COVID-19 EUA


  • On May 7, 2020, the US FDA authorized the first COVID-19 test for home collection using saliva. Importantly, the Emergency Use Authorization (EUA) is specifically  for the Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay when used with the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. A healthcare provider must determine the test to be appropriate and the specimen must still be sent to a laboratory for processing and test reporting.

 

  • The FDA EUA for Rutgers Clinical Genomics Laboratory’s test permits testing of a saliva sample collected from the patient using a self-collection kit. Once a patient collects a saliva sample, it is returned to the Rutgers Clinical Genomics Laboratory in a sealed package for testing.

 

  • 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.