Aug. 16 (UPI) — The U.S. Food and Drug Administration issued an emergency use authorization Saturday to the Yale School of Public Health for an open source, saliva-based COVID-19 test that uses commercially available equipment.
According to the FDA, the test uses a new method of processing saliva samples. It also doesn’t require any type of special collection swab, and samples can be placed in any sterile container.
This is the fifth COVID-19 test the FDA authorized using saliva samples. The agency’s release said saliva-based tests have had variable performance, but the data submitted by Yale meets federal criteria for emergency authorization for COVID-19 testing.
In addition to eliminating the need for nasal swabs, which have been in short supply, saliva-based tests are more comfortable to administer — and can be collected by the person being tested in a supervised environment, reducing the possible risk to healthcare professionals.
The test also does not require a separate nucleic acid extraction step — which matters because the extraction kits used for that step have been subject to recent shortages.
“Being able to perform a test without these kits enhances the capacity for increased testing, while reducing the strain on available resources. Additionally, the SalivaDirect methodology has been validated and authorized for use with different combinations of commonly used reagents and instruments, meaning the test could be used broadly in most high-complexity labs,” the FDA’s press release said.
“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 M. Hahn, M.D. “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.”
Yale plans to provide the Saliva Direct protocol to interested laboratories as an “open source” protocol, the FDA said.
That means participating labs don’t need to pay for proprietary equipment or instructions to perform COVID-19 testing, and can instead use commercially available equipment using instructions from Yale.
