FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens

May 11, 2020 by Mandy Qualls

Filed under COVID-19 for Employers, COVID-19 for the Workforce

Last modified May 12, 2020

On Friday, May 7, the Food and Drug Administration (FDA) announced the authorization of the first COVID-19 diagnostic test with the option of using the collection of saliva samples from home.

This announcement builds on last month’s emergency use authorization 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.

According to the FDA press release, 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.

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