Part II in our COVID-19 series, Swabs and Spit. We take an inside look into how Berkeley scientists have set the bar for COVID-19 testing as the campus community heads back to work.

Since mid-March, schools and workplaces have shut their doors to help mitigate the spread of COVID-19. As states progress through individual reopening plans, more and more people are returning to work and school. Here at Berkeley, as students, faculty, and staff return to resume on-campus research, we also face an increased risk of outbreaks. How do we ensure the health and safety of employees and students who are returning to work in the middle of a global pandemic?

IGI FAST: A Free Asymptomatic Saliva Test for Campus

One main concern that we face across the globe comes from the increasing reports of asymptomatic and pre-symptomatic spread of the virus. Members of the IGI testing team sprang into action once again when realizing that they may be able to mitigate spread by solving another unmet need on campus—asymptomatic testing. Through a newly developed study on campus, the IGI “FAST” (Frequent ASymptomatic Testing) study, researchers hoped to investigate the efficacy of asymptomatic testing on campus as a preventative measure to minimize the spread of COVID-19. The IGI FAST study has been led by IGI founder and recently minted Nobel Laureate, Jennifer Doudna, with clinical support from Assistant Vice Chancellor, Guy Nicolette, of University Health Services. Graduate Student Alex Ehrenberg, of the Integrative Biology Department, has been working alongside the principal investigators as study coordinator.

In this study, asymptomatic employees, students, and staff have been provided with free COVID-19 testing. And what’s even better is that this test doesn’t involve the large medical q-tip going up your nose! The concept is simple: the IGI FAST study uses easy-to-collect saliva samples from participants who visit an on-campus kiosk every two weeks. The samples are then taken back to the IGI testing facility where, using the same PCR-based test performed on the swab based tests, they are tested for viral SARS-COV-2 genes. This effort was largely driven by student and postdoc volunteers, highlighting the group effort to provide surveillance testing to our campus community. To date, the study has enrolled over 4,800 participants and will have completed over 11,000 tests by the end of the study, scheduled to wrap up on October, 29th. Don’t worry, though! You can still get free asymptomatic testing through the eTang portal if you are a student, faculty, or staff member on campus!

The Hurdles of a Human Study

The effort to bring free widespread asymptomatic testing to campus hasn’t been an easy one. To get approved for a study involving human participants, Alex first wrote a protocol that would be reviewed by the Institutional Review Board (IRB), an FDA-approved committee that exists to ensure the welfare and rights of human subjects. While still in the planning stages and waiting for the protocol to be approved, a collective effort from volunteers of students, staff, and postdocs commenced troubleshooting on-site logistics. At the forefront of these efforts was an incoming freshman, Andy Cate, with an impressive background in software development. He immediately recognized the need for a platform to enroll participants and handle scheduling in a way that could be integrated into the existing databases that the IGI uses for clinical testing. Andy rapidly developed a prototype of the web app and was able to be on-site while test runs of the kiosk were being conducted, which was integral to making these trials a success. “Everyone on our team is extremely talented and hardworking,” says Andy, “and it has been a great experience working with them. I know that our work will have a big impact on the campus, and that’s what’s important to me.”

In addition to the challenge of on-site logistics, the pop up COVID testing facility, on campus at the IGI, was also actively involved with research and development of the saliva test. While collecting saliva in a tube and performing a PCR based test sounds simple to molecular biologists, the task is actually not simple at all! “On one hand, we want people to have access to advances as soon as possible due to the urgency of the pandemic”, said Neuroscience Graduate Student Holly Gildea, who is involved with the research and development of the test. “On the other hand, we have to be incredibly confident in what we’re reporting, which requires an extra level of scrutiny.” Holly, along with other volunteers, has been working diligently to troubleshoot the protocols for saliva testing. They set a goal to maintain test sensitivity and detection despite the wide range of saliva properties, like viscosity, that can vary from person to person.

Through the Eyes of a Participant

I can tell you, first hand, that all of the saliva kiosk staff have been hard-working and determined to accomplish their goal of increasing the availability of accurate testing. The IGI FAST study has involved an extraordinarily dedicated team of over 80 students, staff, and postdocs, which makes the process of free saliva testing so effortless and simple! To get started, participants would enroll online and, after filling out a few questions and giving informed consent, make an appointment to come to one of two saliva kiosks, located at the Genetics and Plant Biology building (GPBB) and Latimer Hall. Each participant is provided with a unique QR code for their visit. Once arrived, there are four checkpoints to navigate through. The first checkpoint verifies the participant’s appointment for that day and verbally confirms their asymptomatic status. The participant then walks up to the registration checkpoint where they scan their QR code and confirm their name. Saliva kiosk volunteers then make a new requisition in the system for a saliva test, providing the participant with a barcoded sample tube that is electronically attached to their name in the system. Proceeding to the third checkpoint, the spit station, each participant is met with a “spit coach” that gives clear instruction on how to give a saliva sample. Each saliva collection tube is equipped with a clean funnel on the top of the tube, which makes spitting into it quite easy. The participant is asked to fill the tube to a clearly labeled “fill line.” Once the participant gives an adequate saliva sample, they sanitize their tube and head to check-out. Here, they scan their tube and verify their name and date of birth. This ensures that each participant submits a tube that correctly corresponds to their identity. After this verification, they place their tube in a rack and go on with their day. All in all, this process usually takes just five to 10 minutes. At the end of the day, hundreds of these saliva samples are taken to the IGI testing facility, extracted, and tested.

A walk through of the saliva kiosk. Participants progress through four checkpoints to check-in, register and grab their sample tube, give their sample and check-out. Designed for efficiency, all of this takes place in under 10 minutes.

Volunteers Coming Together to Make a Difference

To make this process a smooth one, and to ensure the safety of our campus community, countless hours have been put in by volunteers. One of those volunteers, Alexandra Tsitsiklis, who recently graduated with a PhD in Immunity and Infectious Diseases, reflected on the incredibly difficult task that is bringing students and staff back to campus. “It is so important that we do it safely and protect our more vulnerable friends and coworkers, as well as prevent outbreaks that could spread to the community.” Alexandra believes the FAST study “will help us develop an effective way to identify and contain the inevitable cases on campus.” She continues with the hope that similar efforts will be enacted for other colleges. “Testing saliva is a fast and simple alternative to nasal swabs that doesn’t require medical professionals and lots of PPE,” she says. Alexandra has been involved with the saliva testing efforts from the very beginning. Without her, things would not have progressed so smoothly. “I was excited to help out in the initial stages of the IGI FAST study—figuring out what works best for the setup of the saliva testing site and troubleshooting the saliva collection process to ensure that we get good samples from participants. We are still constantly learning and improving the process as we go.”

As a volunteer myself, I have been warmed to discover the camaraderie and willingness to work toward the unified goal of providing free widespread testing to the campus community. With leadership from volunteers like Erica Moehle, a diagnostic site coordinator who has been integral in the saliva testing efforts, the sky's the limit. Erica has attributed the success of the saliva kiosk to the immense efforts of volunteers, both on site and at the testing facility. “It has been a huge effort to get this to happen, and it couldn't have happened without all the people who decided they wanted to make a difference.” The FAST study has benefitted from the work of countless volunteers and paid staff, many of whom are not named here for the sake of brevity.

Future Outlook: More Testing

Even with these initial successes, however, the fight against COVID-19 is not over. When asked about the challenges our campus community faces this fall as some students return, Erica cited a recent increase in cases on campus. “Over the summer, our campus has been a relatively secluded population, with positivity rates at or below 1 percent”. She commented that the recent increase in cases, confirmed by University Health Services, is an example of how the campus is a microcosm of the pandemic. “We were prepared for this, with steady increases in testing capacity over the summer, but it underscores the need for vigilance and responsible behavior.” To keep up with the increasing number of students on campus, and to streamline the campus testing efforts, most asymptomatic testing on campus will switch over from saliva to self nasal swabs and the IGI FAST study will finish at the end of October. While the saliva test has been a convenient way to increase campus participation and help keep everybody safe, it is no longer the only asymptomatic testing option on campus. Additionally, even though the saliva test has been clinically validated, traditionally swab samples still work the best with the testing pipeline set up in the IGI pop-up testing lab. Under the direction of Carolyn Sherry, IGI FAST kiosk project manager, limited saliva testing will still happen with small populations of the campus community, including campus Greek life, who will try out a new take-home saliva kit. This will allow campus to continue widespread asymptomatic testing while working hard to continuously optimize the testing platforms we have.

If you want to get tested, it is currently free for all students, faculty and staff! Check out the University Health Services website dedicated to COVID-19 for more information about how to get started.

This blog post is the second of a series of three outlining the efforts of a campus-wide initiative to increase testing capacity to keep our community safe. Keep an eye out for Part III, which will provide an updated look into how asymptomatic testing continues to evolve in the middle of this global pandemic.

Phillip Frankino is a graduate student in molecular and cell biology