The Yale School of Public Health on Saturday received authorization for emergency regulation for a new diagnostic test of covid-19 that detects the new 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 most important contribution of the association? A lot of spray.
Named SalivaDirect, the test consists of a new inexpensive, 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 you can buy. Per de Food and Drug Administration, designated laboratories were able to 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 approved Yale authorization for emergency use for SalivaDirect this weekend. SalivaDirect is the fifth test of covid-19 using saliva as a sample that the agency has authorized.
According to Yale, SalivaDirect is unique in three ways. First, as mentioned above, the test uses detectors to detect the virus, not samples from nasopharyngeal swabs. The swabs are the intimidating look sticks you see sitting in people’s noses. Yale states that getting these swabs can be uncomfortable, a factor that discourages people from getting tested often, and puts those who perform the test at risk of becoming ill. In comparison, SalivaDirect does not require any special type of swab as a collection device, and can be collected in any sterile container.
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Another important difference is the step by step process of nucleic acid: It has none. Yale confirms that extraction of nucleic acid is time consuming and expensive, and that the practice is in short supply worldwide. Labs, scientists en public health officials have agonized over the availability of reagents, the chemicals needed to perform coronavirus tests, at multiple times during the pandemic.
Third, Yale maintains that its method is flexible, given that it aims to work with as many variations of equipment and reagents as possible. This allows “labs to work with what they have and 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 researchers simplified the test so it only cost a few dollars for reagents. He said the researchers expect labs to pay only $ 10 per sample.
“Wide-spread testing is critical to our control efforts,” Grubaugh said in a statement released by Yale. “If cheap alternatives like SalivaDirect can be implemented nationwide, we can finally get a grip on this pandemic, even for a vaccine.”
After all that science, you might be thinking, where does the NBA come in? According to the Wall Street Journal, Yale needed validation studies to obtain regulatory authorization to offer its protocol more broadly, specifically for asymptomatic testing. Researchers aim to determine whether SalivaDirect can detect asymptomatic cases accurately, or cases with people who do not show symptoms of covid-19. Validation studies meant that researchers needed spit, and the NBA, along with the National Basketball Players Association, just happened to give the scientists something to offer players and staff.
NBA officials contacted Yale in May after reading news coverage from the work of the team to detective testing for covid-19 and offered to work with. NBA players are often tested on covid-19 and in many ways, per the Journal. In the last two months, teams have been in their home markets and in the Walt Disney World bubble, where the NBA is restarting 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, as SWISH. The Journal reports that the results of the saliva tests are comparable to the results of nasal and oral tests of the same players and teammates, although no results can be identified by name.
SWISH is ongoing and is currently testing samples from NBA staff at Walt Disney World.
Discovering whether SalivaDirect can be used to detect asymptomatic cases may take longer than expected. As the Journal notes, no positive covid-19 cases have been reported in the NBA bubble.
[The Wall Street Journal]
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