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Diagnostic tests are, well, weird.
For the coronavirus, you may have to get a swab shoved up your nose to sense an active infection. Or down your throat. Or both. Or, depending on the exact kind of test you’re taking, maybe you could just spit into a vial and call it a day.
The latter is clearly the most convenient option. And thanks to a pioneering technology from the Yale School of Public Health, it may become an increasingly common method of COVID testing as schools begin to reopen.
Yale has been granted Food and Drug Administration (FDA) emergency authorization for a type of saliva-based COVID-19 test called SalivaDirect. This decidedly non-invasive diagnostic simply requires a spit sample that can be collected in a sterile container. It’s a rapid response test, meaning that results can be delivered in just hours.
But this particular system comes with several other advantages. SalivaDirect isn’t the first saliva-based coronavirus test. In fact, it’s the fifth to win FDA authorization. What does set it apart from its predecessors is lower reliance on materials such as reagents and for extra steps in the testing process, including one called nucleic acid extraction.
Without the need for a swab or the materials involved in other kinds of tests, such a saliva-based test could help address the major supply chain bottlenecks that have inflated testing turnaround times for COVID.
“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 in a statement.
Adoption could become broad-based as the process for this test doesn’t require proprietary materials. Theoretically, the test could be conducted in most commercial labs and across a spectrum of machines.
“This test gained authorization today by FDA’s device center,” wrote former FDA commissioner Scott Gottlieb in a tweet. “Among its many compelling attributes, it doesn’t require complex steps for extracting viral RNA; so it won’t rely on reagents that’ve been in short supply and constrained the testing supply chain.”
Another twist: The test was largely validated by testing on NBA players and staff, who are currently in a bubble in Disney World in order to finish out the 2020 basketball season.
Supply chain issues aside, the SalivaDirect testing process has another practical, and human, benefit—allowing health care workers to stay separated from patients and thus reducing their potential exposure to the coronavirus.