FDA authorizes first at-home saliva diagnostic test for COVID-19
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The FDA authorized the first COVID-19 diagnostic test using home-collected saliva specimens by issuing an emergency use authorization to Rutgers Clinical Genomics Laboratory, according to an FDA press release.
The emergency use authorization (EUA) permits the testing of samples self-collected with the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device, adding to the EUA in April for a home-collected nasal swab test.
“Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site,” FDA Commissioner Stephen M. Hahn, MD, said in the release. “We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic. The FDA has authorized more than 80 COVID-19 tests and adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency,” he added.
According to the release, patients must return their self-collected saliva sample to the Rutgers Clinical Genomics Laboratory in a sealed package.
The FDA also noted that the authorization of this test is unique to the Rutgers Clinical Genomics Laboratory and is not a general authorization for saliva collection devices or other collection methods. According to the release, the test remains prescription only.