FDA issues EUA to Yale School of Public Health for testing COVID-19 via saliva samples

WASHINGTON, Aug. 15 (Xinhua) -- The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) on Saturday to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection.

SalivaDirect does not require any special type of swab or collection device, according to the FDA. A saliva sample can be collected in any sterile container.

This test is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past, said the FDA in a release.

Being able to perform a test without these kits enhances the capacity for increased testing, while reducing the strain on available resources, said the release.

"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 Giroir.

"Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents," said FDA Commissioner Stephen Hahn.

This is the fifth test that the FDA has authorized that uses saliva as a sample for testing.

(ASIA PACIFIC DAILY)