NEW JERSEY - The U.S. Food and Drug Administration gave approval Friday to a home saliva-collection test for COVID-19 diagnosing.
The Rutgers Clinical Genomics Laboratory in Piscataway developed the test using the Spectrum Solutions saliva collection device. A person spits into a tube, seals it and returns it to Rutgers for testing. As many as 10,000 samples a day can be processed in 24-48 hours, according to the FDA.
The test approved through the amended emergency use authorization for Rutgers’ RUCDR Infinite Biologics allows the expansion of the saliva tests into the home with a prescription only.
"Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19," " said FDA Commissioner Stephen M. Hahn, M.D.. "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. 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, but the test developed by Rutgers is 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.
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The new saliva tests are in use at Robert Wood Johnson University Hospital in New Brunswick and University Hospital in Newark. Middlesex County has been using the saliva tests in parternship with Rutgers at one of its testing sites, reported NJ.com.