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FDA Approves Yale's 'SalivaDirect' COVID-19 Test To Increase Testing Capacity

FDA Approves Yale's 'SalivaDirect' COVID-19 Test To Increase Testing Capacity

The U.S. Food and Drug Administration (FDA) on Saturday authorized the emergency use of a saliva-based COVID-19 test, which could increase the testing capacity.

What To Know: The test is called the SalivaDirect COVID-19 diagnostic test, developed by Yale School of Public Health. The new method uses saliva specimens when testing for COVID-19 infection.

“The SalivaDirect test for rapid detection of SARS-CoV-2 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 P. Giroir, M.D., in a press release issued by the FDA.

Why It's Important: The testing method of the saliva test is said to be quite simpler than its swab counterpart. The saliva test is quite cheaper and could be run by most diagnostic labs as it doesn’t require the kits used for a swab test.

The new test developed by the researchers at the Yale School of Public Health allows the collection of saliva in any sterile container. The method was first used on asymptomatic individuals from the National Basketball Association. Yale claims the test to be simpler, less invasive than the traditional method known as Nasopharyngeal (NP) testing or swab test.

What's Next: “This is a huge step forward to make testing more accessible,” said Chantal Vogels, a Yale postdoctoral fellow, who led the laboratory development and validation along with Doug Brackney, an adjunct assistant clinical professor, in a press release issued by Yale University.

The method is immediately available for diagnostic laboratories across the country. Laboratories all over the country can opt for the test as it can potentially reduce costs, speed turnaround times and increase testing frequency. The Yale researchers from the School of Public Health have estimated it should cost about $10 to run each test.


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