Coronavirus: FDA issues emergency use authorization for new saliva test

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the SalivaDirect COVID-19 diagnostic test.

According to a news release, the new test was developed by the Yale School of Public Health and uses a new method of processing saliva samples to diagnose 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,” Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett P. Giroir, MD, says in the release. “Our current national expansion of COVID-19 testing is only possible because of FDA’s technical expertise and reduction of regulatory barriers, coupled with the private sector’s ability to innovate and their high motivation to answer complex challenges posed by this pandemic.”

The new test does not require a special type of swab or collection device, as the saliva sample can be collected in any sterile container. SalivaDirect also does not require a separate nucleic acid extraction step, which is good because extraction kits used for this step have been prone to shortages throughout the pandemic. The test has been validated and authorized for use with different combinations of commonly used reagents and instruments, according to the release.

“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,” FDA Commissioner Stephen M. Hahn, MD, says in the release. “Today’s authorization is another example of the FDA working with test developers to bring the most innovative technology to market in an effort to ensure access to testing for all people in America. The FDA encourages test developers to work with the agency to create innovative, effective products to help address the COVID-19 pandemic and to increase capacity and efficiency in testing.”

The release says that Yale intends to provide the new test protocol to interested laboratories as an “open source” protocol allowing them to follow the protocol and obtain their own components to perform the tests. It does not use any proprietary equipment from Yale and can use commercially available testing components so that it may be assembled and used in high-complexity labs throughout the country as long as they comply with the EUA.