Researchers at the Yale School of Public Health have partnered with the National Basketball Association (NBA) and National Basketball Players Association (NBPA) to study the efficacy of a saliva-based method that quickly determines if someone is infected with the novel coronavirus.
A research team led by Yale’s Nathan Grubaugh and Anne Wyllie will begin testing select players, coaches, and staff from the NBA teams that have opted into the study, using a testing method they developed, known as SalivaDirect.
The results of the study are expected by the end of July and will be shared publicly.
SalivaDirect was developed this spring as an alternative to the nasopharyngeal (NP) swabbing method for SARS-CoV-2 testing. NP swabs are one of the most widely used sampling methods for the detection of respiratory pathogens such as COVID-19. But the method is invasive, involving inserting a swab deep into the nostril and into the region of the pharynx at the back of the throat. The swab is rotated to collect secretions, held in place for several seconds and removed. The sample is then sent to a certified lab for analysis.
By contrast, SalivaDirect is non-invasive and requires only a small saliva sample. The simplified method reduces testing times by over an hour. More importantly, the saliva method costs less, requires minimal training, and exposes health care workers to less or no risk, Grubaugh said. Preliminary results suggest SalivaDirect is highly sensitive, and the researchers’ goal is to optimize the method to be accurate at least 90% of the time.
The goal is to have the SalivaDirect method approved by the FDA and ready for use with the general public as soon as mid-July. Grubaugh and Wyllie are not seeking to commercialize the method. Rather, they are validating it for use with a wide range of commonly available reagents and equipment. As COVID-19 continues to impact communities around the world, the simplified method could help bring testing to those most in need, say the scientists.
" In talking to our partners at the NBA, we heard that in addition to finding less-invasive testing solutions for players and staff, there is a strong desire on their part to give back to the public and especially help low-income communities, so it became immediately clear that our interests were aligned," said Grubaugh, an assistant professor at the Yale School of Public Health.
Because the NBA regularly tests players and on-court staff, who necessarily work in close contact without face coverings, the group of staff and players provides a unique opportunity for a comparison study to analyze the new test’s accuracy and sensitivity, which will enable the submission to the FDA for SalivaDirect, said the researchers.
" The NBA is pleased to partner with the Yale School of Public Health to support this important study," said John DiFiori, NBA director of sports medicine. "We’re hopeful that our contributions to this work will help to advance the research in the interest of broadly accessible and minimally invasive testing."
" Our players are excited to be a part of this study," said Joe Rogowski, chief medical officer for the NBPA. "Not only does it offer the potential for players to have an alternative method of testing within the NBA campus in Orlando, but more importantly it allows them to leverage their regular testing to make a larger contribution to public health in the fight against this virus."
This new method stems from an earlier study conducted by the researchers at the Yale School of Public Health, testing saliva and NP samples from 44 inpatients and 98 health care workers at Yale New Haven Hospital shortly after the virus arrived in the state. They found that saliva samples taken from just inside the mouth provided greater detection sensitivity and consistency throughout the course of an infection than the broadly recommended nasopharyngeal approach. The study also concluded that there was less variability in results with the self-sample collection of saliva.
" Saliva samples are a viable alternative to nasopharyngeal swabs and could allow for at-home, self-administered sample collection for accurate large-scale SARS-CoV-2 testing," said Wyllie, an associate research scientist at the Yale School of Public Health.
In the initial study, by testing saliva, the team detected the presence of SARS-CoV-2 in two asymptomatic health care workers who had previously tested negative for the virus in a nasopharyngeal swab test. Saliva testing holds promise for identifying mild SARS-CoV-2 infections that are not detected with other methods, Wyllie said.
Grubaugh and Wyllie will be joined on the NBA study by Dr. Albert Ko , department chair and professor of epidemiology (microbial diseases) and of medicine (infectious diseases), and Dr. Harlan Krumholz , the Harold H. Hines, Jr. Professor of Medicine (cardiology) and professor in the Institute for Social and Policy Studies and the departments of investigative medicine and public health (health policy).