The new test is faster and simpler than nasal and oral swab tests and enables screening on a massive scale.
Researchers at Washington University School of Medicine in St. Louis have developed a new saliva test to detect the SARS-CoV-2 virus. Results from the COVID-19 diagnostic test are available in a few hours. The test is sensitive to detecting even tiny levels of the virus in a saliva sample and does not require special swabs and reagents that have been in short supply.
Developed in collaboration with the biotechnology company Fluidigm, the test could help simplify and expand the availability of COVID-19 diagnostic testing across broad populations. Such testing does not rely on the extraction of viral RNA to detect the virus—a time-consuming and expensive process—and could be scaled up easily, in part because people can collect their own samples, relieving healthcare workers of the task of sample collection.
On Aug. 25, Fluidigm received emergency use authorization (EUA) from the Food and Drug Administration as the manufacturer of the test. This authorization allows the university to perform the test. Washington University filed a separate EUA application with the FDA that is still pending.
The test will be conducted at the McDonnell Genome Institute in the Genome Technology Access Center on the Washington University Medical Campus. The McDonnell Genome Institute is certified to conduct diagnostic testing on human samples under national regulatory standards known as Clinical Laboratory Improvement Amendments (CLIA).