A new laboratory-based diagnostic search for the new coronavirus developed by researchers at Yale University’s School of Public Health has been approved by the Food and Drug Administration for emergency use.
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SalivaDirect is a simple, affordable, and less invasive test method that has been found to provide similar results to the traditional nasal swab test.
“This is a huge step forward in making testing more accessible,” said Chantal Vogels, a Yale postdoctoral fellow who led the laboratory development and validation with Doug Brackney, an adjunct assistant clinical professor. “This started as an idea in our lab, shortly after we found that saliva was a promising example for detecting SARS-CoV-2, and it now has the potential to be used on a large scale to protect public health. We are pleased to make this contribution to the fight against coronavirus. ”
The development of the test was spearheaded by Yale School of Public Health assistant professor Nathan Grubaugh and associate research scientist Anne Wyllie, who sought to increase the availability of tests on saliva and reduce overall test times and costs.
“Wide-spread testing is critical to our control efforts. “We’ve simplified the test so that it only costs a few dollars for reagent, and we expect labs to only pay about $ 10 per sample,” Grubaugh said. If cheap alternatives like SalivaDirect can be implemented nationwide, we can finally get a grip on this pandemic, even for a vaccine. ”
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The Jackson Laboratory for Genomic Medicine in Farmington, Connecticut, will partner with Yale to investigate how you can perform the test for a wider audience.
“We need to continue to invent and implement new ways to perform SARS-CoV-2 tests faster, more economically and with greater accessibility, while maintaining acceptable test accuracy,” said Charles Lee, director of the laboratory. “This method is an important next step toward this goal.”
The Yale School of Public Health will also continue to work with the pathology department of Ivy League University.
“Using SalivaDirect, our laboratory can double our test capacity,” said Professor Chen Liu, chair of Yale Pathology, which oversees the clinical validation of the study.
Liu added that the department’s CLIA-certified clinical laboratory will offer SalivaDirect as a test option in the coming days.
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Similar research was funded by the National Basketball Players Association and a Fast Grant from the Emergent Ventures at George Mercon University’s Mercatus Center. SalivaDirect is also offered to NBA players and staff as part of a program to help test for asymptomatic individuals.
According to Johns Hopkins University, there are more than 5.3 million confirmed cases of coronavirus in the United States and more than 169,000 deaths associated with the pandemic.
