The Food and Drug Administration has granted an emergency use authorization to a test designed to detect the virus that causes Covid-19 in saliva.
The agency granted the EUA for the use of saliva in Covid-19 testing using Salt Lake City-based Spectrum Solutions’ SDNA-1000 collection device as part of a process developed by Rutgers University’s RUCDR Infinite Biologics – Rutgers Clinical Genomics Laboratory. The test also uses Thermo Fisher Scientific’s TaqPath SARS-CoV-2 detection system and nucleic acid extraction technology from Perkin Elmer. Rutgers noted in its own announcement that RUCDR developed the test in partnership with Spectrum and Accurate Diagnostic Labs, and that the test would allow for broader population screening than nose and throat swabs.
“Using saliva to test for Covid-19 overcomes many of the challenges the nation faces that are inherent to current testing methods including supply shortages and risks to exposure for healthcare professionals,” Spectrum CEO Stephen Fanning said in a statement. “Now, under a medical professional’s direction, the saliva collection can be self-administered by individuals who may be in quarantine or self-isolation, removing the need to be in close contact with medical staff.”
Several tests for Covid-19 are under development or have already received EUAs from the FDA, most of them using swab samples or antibody testing. The latter method will be especially important to determining whether people have been infected before, even if they experienced mild or no symptoms.
The approval was based on results of a study conducted at Rutgers University that compared saliva against swab samples as a means to test for SARS-CoV-2 infection, using Spectrum’s device for collection. RUCDR COO Andrew Brooks called the impact of the EUA “significant.”
“It means we no longer have to put healthcare professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections,” he said in a statement for Rutgers. “We can preserve precious personal protective equipment for use in patient care instead of testing.”
Brooks added that the test would also increase the number of people tested, given that self-collection of saliva is faster and more scalable than swab collections.
“This test can help hospital-based and private physicians to accurately assess the infection status of more patients, with RUCDR Infinite Biologics doing the analysis,” RUCDR CEO Jay Tischfield said in a statement.
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