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NBA-Funded Saliva Test For COVID-19 Cleared For Immediate Use
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Sophia Chang
Published Aug 15, 2020
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By
Sophia Chang
Published Aug 15, 2020
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Yale University researchers developing a cheap, scalable saliva test for detecting COVID-19 found a specific group of deep-pocketed and willing guinea pigs: the NBA.
The Food and Drug Administration on Saturday issued an emergency use authorization for the SalivaDirect COVID-19 diagnostic test developed by the Yale School of Public Health.
The SalivaDirect test offers several advantages in that saliva can be collected in any sterile container, so no special swabs or equipment are needed. Results can take as little as three hours, depending on how quickly the labs can obtain samples. The SalivaDirect tests also do not require a separate nucleic acid extraction step, streamlining the process and avoiding the need for special kits that have been in short supply, the FDA said.
The testing methodology for SalivaDirect also can work with a range of widely available reagents and instruments, so that most labs are already able to work with the tests. Yale is also open-sourcing the testing protocol so that labs can obtain the required components and perform the test in their lab themselves, the FDA said.
There are five saliva tests with FDA emergency authorization use, which allows "unapproved medical products or unapproved uses of approved medical products to be used" during public health emergencies, according to the agency. “But SalivaDirect’s materials cost less than $5 per sample and can produce up to 90 results in fewer than three hours in a laboratory, which means it can scale without stressing a complicated supply chain,” according to the Wall Street Journal. The cost for consumers will likely be closer to $15 or $20, ESPN 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 in a release.
"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," a press release from Yale University said.
The SalivaDirect test’s fast-track to existence comes in part from funding from the NBA and the players’ union -- over $500,000 combined, ESPN reported.
Minnesota Timberwolves’ vice president for Basketball Performance and Technology Robby Sikka, who is himself an anesthesiologist by training, had come across the work done at Yale by Nathan Grubaugh, an assistant professor of epidemiology and his team: Anne Wyllie, an associate research scientist in epidemiology and Chantal Vogels, a postdoctoral fellow.
Like all professional sports, the NBA has been hurt financially by the cancelation of its basketball season. With the league constantly testing its players while in its bubble in Orlando, the Yale researchers had a self-contained sample of test subjects who were willing to pour money into their work.
"I was hesitant," Grubaugh told ESPN. "We do research. We arenot developers of diagnostics. But this was an opportunity. They were willing to fund it. This is a crazy time for everyone anyway. I studied mosquitoes before this."
A group of NBA players and staff took the SalivaDirect test as the league prepared to return to play and the results were compared to nasal swab tests from the same group. “The results almost universally matched, according to published research that has not yet been peer-reviewed,” ESPN said.
Andy Slavitt, the acting administrator of the Centers for Medicare and Medicaid Services under President Barack Obama, promoted the Yale saliva study among former FDA commissioners in hopes of fast-tracking it for emergency use approval, ESPN reported.
"My interest was to help get a low-cost scalable test that can be a game-changer across the country," Slavitt told ESPN. "We didn't get leadership from where we needed it, but it's great to see the NBA emerge."
Yale and the NBA have committed not to make any profit off of the release of SalivaDirect.
“My goal is not to test athletes," Grubaugh told ESPN. "That's not my target population. My target population is everybody. There were concerns about partnering with the NBA when all these other people need testing. But the simple answer ended up being the NBA was going to do all this testing anyway, so why not partner with them and try to create something for everyone?"
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COVID-19
yale university
saliva
nba
Sophia Chang
Sophia Chang is a former WNYC and Gothamist reporter.
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Gothamist is funded by sponsors and member donations
Gothamist is funded by sponsors and member donations
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