Yale’s diagnostic test uses a new method of processing saliva samples when testing for COVID-19 infection without requiring a special swab or collection device, as the saliva can be collected in any sterile container. The test also does not require a separate nucleic acid extraction step.
According to a news release, the SalivaDirect methodology could increase the capacity for testing and reduce the strain on available resources.
Yale plans to offer the test’s protocol to interested laboratories as an open-source protocol, allowing the labs to obtain the required components and perform the test in their lab.
The FDA has already authorized four previous saliva tests, which, because they are self-collected, could potentially lower the risk for healthcare workers responsible for sample collection. Despite varying performances in previous saliva tests, the FDA determined that Yale’s test met the criteria for EUA.
“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 Dr. Brett Giroir said 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.”
“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,” added FDA Commissioner Dr. Stephen Hahn. “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.”