“With saliva being quick and easy to collect, we realized it could be a game-changer in COVID-19 diagnostics,” said Wyllie. With testing urgently needed, the Yale team was determined to decrease both testing times and costs, to make testing widely accessible.
“Wide-spread testing is critical for our control efforts. We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about $10 per sample. If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine,” said Grubaugh.
One of the team’s goals was to eliminate the expensive saliva collection tubes that other companies use to preserve the virus for detection. In a separate study led by Wyllie and the team at the Yale School of Public Health, and recently published on medRxiv, they found that SARS-CoV-2 is stable in saliva for prolonged periods at warm temperatures, and that preservatives or specialized tubes are not necessary for collection of saliva.
The Jackson Laboratory for Genomic Medicine in Farmington, Connecticut, will partner with Yale to explore how to implement the test for a broader audience. The laboratory already analyzes patient samples for an RNA signature unique to that of SARS-CoV-2, the virus that causes COVID-19.
“We must continue to invent and implement new ways to conduct SARS-CoV-2 testing faster, more economically and with greater accessibility, while maintaining acceptable test accuracy,” said Charles Lee, the laboratory’s director. “This method is an important next step toward this goal.”
Grubaugh and Wyllie said that they are not seeking to commercialize the method. Rather, they want the simplified testing method to help those most in need. Testing for SARS-CoV-2 has been a major stumbling block in the fight against the pandemic, with long delays and shortages of testing. Some experts have said that up to 4 million tests are needed per day; SalivaDirect provides one pathway toward that goal, the researchers said.
“Using SalivaDirect, our lab can double our testing capacity,” said Professor Chen Liu, chair of Yale Pathology, who oversaw the clinical validation of the study.
“Dr. Liu and Yale Pathology Laboratory were instrumental in our application. We look forward to continuing to partner with them,” said Grubaugh.
Liu will start offering SalivaDirect as a testing option in their CLIA-certified clinical laboratory in the coming days.
The related research was funded by the NBA, National Basketball Players Association, and a Fast Grant from the Emergent Ventures at the Mercatus Center, George Mason University.