FDA issues emergency use authorization for Yale's saliva coronavirus test
The Food and Drug Administration issued an emergency use authorization to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test on Saturday.
Why it matters: The test uses a new method of rapidly processing saliva samples when testing for the virus and "is yet another testing innovation game changer that will reduce the demand for scarce testing resources,” said Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett Giroir.
How it works: The test, deemed less expensive and less invasive than traditional methods, does not require specific swabs or collection devices to gather samples. Instead, a patient's saliva can be collected in any sterile container, which could cut down on the use of medical supplies the FDA says are in shortage.
- Samples are also collected under the observation of a health care professional, meaning the method could also lower the risk posed to workers who handle samples.
What they're saying: "Because this test does not rely on any proprietary equipment from Yale and can use a variety of commercially available testing components, it can be assembled and used in high-complexity labs throughout the country," the FDA said.
The big picture: This is the fifth test the FDA has allowed that uses saliva as a sample for testing.
- SalivaDirect is being further validated as a test for asymptomatic people through a program that tests players and staff from the NBA, YaleNews writes.