US clears first saliva test to help diagnose new virus

Rutgers University researchers have received U.S. clearance for the first saliva-based test to help diagnose COVID-19

An infectious disease expert not involved with the new test said it would help overcome some of the patient discomfort and difficulties in taking swab samples.

“You want to be in all types of situations with all types of options so that we can have as much testing as possible in whatever form is suitable,” said Dr. Amesh Adalja of Johns Hopkins University. Adalja noted that similar saliva tests have helped expand testing for HIV and other conditions.

Rutgers tested the accuracy of its method by taking both saliva and swab samples from 60 patients. The results from patients' saliva samples had a 100% match with results from the swabs.

Rutgers developed the laboratory method for the test using saliva collection kits from Spectrum Solutions, a Utah company that provides similar devices for DNA-based ancestry testing services. The Rutgers lab can currently process 10,000 patient samples per day, according to Brooks.

In its authorization letter to Rutgers, the FDA said the test should only be performed “in a health care setting under the supervision of a trained health care provider.” The FDA has not cleared any COVID-19 tests for use at home, though several companies have announced plans to make them available.

Additionally, the FDA said patients who test negative with the saliva-based kit should have their results confirmed with a second testing method.

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