The Yale School of Public Health on Saturday received emergency regulatory authorization for a new covid-19 diagnostic test that detects the novel coronavirus using saliva samples instead of samples from nasopharyngeal swabs. Next, it wants to find out if the test can be used to detect cases in asymptomatic individuals, and it has a surprising partner: the NBA. The association’s key contribution? Lots of spit.
Called SalivaDirect, the test consists of a new low-cost, flexible protocol that can be used by many labs, even if they do not have the same equipment. Since SalivaDirect is a protocol, it is not a kit that you can buy. Per the Food and Drug Administration, designated laboratories could follow the methodology to obtain the required components and perform the test in their lab according to Yale’s instructions for use. Yale will offer the protocol to labs for free.
The FDA granted Yale an emergency use authorization for SalivaDirect this weekend. SalivaDirect is the fifth covid-19 test that uses saliva as a sample that the agency has authorized.
According to Yale, SalivaDirect is unique in three ways. First of all, as mentioned above, the test uses saliva samples to detect the virus, not samples from nasopharyngeal swabs. The swabs are the intimidating looking sticks you see being jammed up peoples’ noses. Yale states that getting these swabs can be uncomfortable, a factor that discourages people from getting tested frequently, and puts those performing the test at risk of getting sick. In comparison, SalivaDirect doesn’t require any special type of swab or collection device, and can be collected in any sterile container.
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Another key difference is the nucleic acid extraction step: It doesn’t have one. Yale affirms that nucleic acid extraction is time-consuming and expensive, and that the practice has been subject to worldwide shortages of supplies. Labs, scientists and public health officials have agonized over the availability of reagents, the chemicals needed to carry out coronavirus tests, at multiple times during the pandemic.
Thirdly, Yale maintains that its method is flexible given that it aims to work with as many different variations of equipment and reagents as possible. This will allow “labs to work with what they have and to prevent shortages.”
Nathan Grubaugh, a Yale School of Public Health assistant professor who was part of the team that spearheaded the development of SalivaDirect, said that researchers simplified the test so that it only costs a couple of dollars for reagents. He said the researchers expects labs will only charge $10 per sample.
“Wide-spread testing is critical for our control efforts,” Grubaugh said in a statement released by Yale. “If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine.”
After all that science, you may be thinking, where does the NBA come in? According to the Wall Street Journal, Yale needed validation studies in order to receive regulatory authorization to offer their protocol more widely, specifically for asymptomatic testing. Researchers aim to determine whether SalivaDirect can accurately detect asymptomatic cases, or cases with people who do not show symptoms of covid-19. Validation studies meant researchers needed spit, and the NBA, along with the National Basketball Players Association, just happened to offer the scientists some from players and staff.
NBA officials contacted Yale in May after reading news coverage of the team’s work on saliva testing for covid-19 and offered to collaborate. The NBA’s players are tested for covid-19 often and in many ways, per the Journal. Over the last two months, teams in their home markets and in the Walt Disney World bubble, where the NBA has restarted its season, have provided nose, mouth and saliva samples for testing.
The saliva samples are sent to Yale, while the nose and mouth samples are sent to Quest Diagnostics and BioReference Laboratories. The Yale research effort on asymptomatic testing is called Surveillance with Improved Screening and Health, or SWISH. The Journal reports that the results of the saliva tests are compared to the results of nasal and oral tests from the same players and team staffers, although no results are identifiable by name.
SWISH is ongoing and is currently testing samples from NBA staffers at Walt Disney World.
Discovering whether SalivaDirect can be used to detect asymptomatic cases may take longer than expected, however. As the Journal notes, there have been no positive covid-19 cases reported in the NBA bubble.