FDA Grants Emergency COVID-19 Authorization to Yale's Open Source Method of Saliva Testing

The US Food and Drug Administration (FDA) has now issued an emergency use authorization (EUA) to Yale School of Public Health for the SalivaDirect rapid test, which uses a new method of processing saliva samples when testing for SARS-CoV-2.

Assistant Secretary for Health Admiral Brett P. Giroir, MD, called the development a “testing innovation game changer” that will reduce the scarcity of diagnostic resources amid the coronavirus disease 2019 (COVID-19) pandemic.

“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,” Giroir added.

SalivaDirect is unique in that it does not require a particular type of swab or collection device; any sterile container is suitable for saliva collection with the test.

The diagnostic also does not require a separate nucleic acid extraction step. Extraction kits used for this step have been prone to shortages in the past, so being able to test for SARS-CoV-2 without nucleic acid extraction enhances the capacity for increased testing.

The methodology has been authorized for use with several common combinations of reagents and instrumentation, so the test can be used in a variety of lab setups across the country.

Yale is providing the test using an “open source” system where designated laboratories can follow a protocol to obtain necessary components and perform the test in their lab according to Yale’s instructions. The test does not rely on proprietary equipment from Yale.

FDA noted that the method is collected by patients, meaning it could lower risk to health care workers during supervised sample collection.

“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, MD.

“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.”