FDA Gives the Go-Ahead For First Saliva Test That Detects Coronavirus


Researchers at Rutgers University have been given the go-ahead by the Food and Drug Administration for the first saliva test that can help diagnose COVID-19, a new approach that could expand testing options for Americans and reduce the risk of infection for healthcare workers.

The test, which will initially be available at hospitals and clinics associated with the school, was authorized by the FDA under emergency powers granted to the agency amid the coronavirus pandemic.

Instead of needing to take a nasal swab of a patient's nose or throat, the patient is given a small plastic tube, which they spit into several times. The patients hand the plastic tube sample back to the healthcare worker for processing.

“The impact of this approval is significant,” said Andrew Brooks, chief operating officer and director of technology development at RUCDR, who also is a professor in the School of Arts and Sciences Department of Genetics at Rutgers University–New Brunswick. “It means we no longer have to put health care professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections. We can preserve precious personal protective equipment for use in patient care instead of testing. We can significantly increase the number of people tested each and every day as self-collection of saliva is more quick and scalable than swab collections. All of this combined will have a tremendous impact on testing in New Jersey and across the United States.”

The test's accuracy was measured by taking both saliva and swab samples from 60 patients. The samples from the nasal swab and saliva sample matched 100%, which paved the way for the test's approval.

The FDA says the saliva test should only be used "in a health care setting under the supervision of a trained healthcare provider."

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