FDA authorizes first at-home saliva test for COVID-19
The U.S. Food and Drug Administration announced on Friday emergency use authorization for the first diagnostic test with the option of using home-collected saliva samples for novel coronavirus (COVID-19) testing, according to a statement released by the agency.
The authorization, granted to Rutgers Clinical Genomics Laboratory for their COVID-19 molecular test, permits testing of a saliva sample collected from the patient using a designated self-collection kit. Once patients collect their saliva sample, they return it to the Rutgers Clinical Genomics Laboratory in a sealed package for testing.
The Rutgers Clinical Genomics Laboratory test is currently the only authorized COVID-19 diagnostic test that uses saliva samples to test for SARS-CoV-2, the strain of coronavirus that causes COVID-19. The test remains prescription only.
The announcement follows an authorization last month for the first diagnostic test with a home-collection option, which uses a sample collected from the patient’s nose with a nasal swab and saline.