Anne Wyllie, research scientist at YSPH, discusses the success of the SalivaDirect testing protocol

On July 28-29, researchers, industry professionals and public health leaders from around the world will gather in Chicago, Illinois for the first annual conference on saliva tests hosted by the Saliva Direct Initiative from the Yale School of Public Health. During the two-day event, attendees will discuss lessons learned about saliva-based testing during COVID-19 and explore potential new roles for technology in improving public health and future public health response. global emergency.

Developed in 2020 at the start of the COVID-19 pandemic, SalivaDirect is an open-source PCR test that is less expensive, less time-consuming, and more user-friendly than tests that require a nasal swab. Given the proven sensitivity and reliability of the protocol, the United States Food and Drug Administration granted SalivaDirect an Emergency Use Authorization (EUA) in August 2020. Since then, the Yale School of Public Health designated 184 labs nationwide to use SalivaDirect and more than 7 million tests. have been carried out to date.

Yale School of Public Health Research Scientist Anne Wylieprincipal investigator of the SalivaDirect Initiative, recently discussed the upcoming conference, the success of SalivaDirect and its potential future applications.

What motivated you to organize the next conference on saliva testing?

AW: Our clinical laboratory partners in more than 40 states and territories drive everything we do at the SalivaDirect Initiative. Their collective efforts over the past two years represent a tremendous achievement in the response to the pandemic. I am honored to call them colleagues and inspired by their dedication. It was an amazing trip. This conference will showcase the unique public health alliance in which SalivaDirect has evolved. We are especially inspired by the intention of so many lab leaders to align with SalivaDirect’s goal of increasing access to equitable testing for all communities. This conference is one of the many ways we continue to advance this mission and foster additional scientific collaboration.

What do you hope to accomplish at the conference?

AW: Our goal is to 1) recognize and share lessons learned from COVID-19 so far in the pandemic, 2) begin to formalize the SalivaDirect lab network as a pandemic-ready emergency response mechanism, and 3) cultivating interest in research that could further unlock the power of saliva as a diagnostic methodology. Additionally, we look forward to learning how to continue to best support our SalivaDirect lab partners as champions of public health in both their contributions to research and health care in their communities.

What future applications does the SalivaDirect Initiative plan to develop?

AW: COVID-19 has demonstrated the global need for laboratories to have tests that are flexible, easy to implement, and easily scalable with minimal capital investment and multiple lines of supply. To achieve the high and sustained patient compliance necessary to mitigate widespread disease transmission, ideal tests should be non-invasive, self-administered, rapid, and affordable. Saliva-based testing has offered these benefits and more during the COVID-19 pandemic.

Entering new phases of the COVID-19 pandemic, our research at SalivaDirect continues to evolve. We are monitoring emerging variants to ensure that our test continues to accurately identify positive cases. Working with the FDA to move our EUA to full regulatory clearance known as 510(k) is also a priority. We have also submitted for regulatory approval (CE mark) in the European Union.

We are currently developing new saliva-based tests for influenza A/B and respiratory syncytial virus (RSV). We will add these targets to our current test to create a three-in-one or multiplex test. This will allow labs to test a single sample for all three viruses at the same time. We also identify other diseases and conditions for which saliva-based testing could improve patient diagnosis and access to care.

What were the most important lessons you learned from developing SalivaDirect and sharing it with the world?

AW: For starters, we appreciate the immense potential of open science to produce rapid innovation to support the pandemic response. Using this strategy to launch SalivaDirect nationwide has taught us how to maximize the limited resources of a single lab for the benefit of many labs and patients. COVID-19 has shown the importance of leveraging existing national laboratory infrastructure. We designed SalivaDirect for use with low-cost PCR reagents, collection kits, and machines that most high-complexity labs have readily available. We have included materials from multiple manufacturers in the EUA, allowing for substitutions to guard against shortages or supply chain delays.

Even more, I appreciate the miracles that our small and mighty team at Yale continues to generate in fulfilling our mission. From the start, we had very limited resources, which is still the case. However, in the spirit of collaboration, so many individuals and organizations, here at Yale and around the world, have contributed pretty much to making crowdsourcing work. It’s amazing to see how much we’ve accomplished and continue to create.

The mission of the SalivaDirect Initiative emphasizes the importance of equitable access to testing. Can you explain how SalivaDirect helps make testing fairer?

AW: As public health specialists, we are committed to developing solutions that provide equitable access to care. Many communities struggled to launch large-scale testing early in the pandemic because they lacked the resources – testing was too expensive, especially for our most vulnerable communities. Unfortunately, this problem still persists today. Our mission at SalivaDirect is to reduce testing costs for laboratories so that the savings can be passed on to the communities they serve. We achieved this by running our test for free as an open source protocol. We have validated many low cost reagents and many PCR machines for use with the test and eliminated one of the most expensive and time consuming steps in the PCR test process – RNA extraction.

With SalivaDirect, labs use fewer resources (staff, time, budget) and many significantly increase the number of tests they can process in a day. Importantly, saliva samples can be collected without the need for highly trained healthcare personnel – people can simply collect their own saliva at a testing center or at home. As a result, healthcare workers can remain active in direct patient care and less personal protective equipment is needed. All this to say that SalivaDirect is a high quality, low cost PCR test option. Reducing the costs associated with molecular testing stretches laboratory resources and federal and state budgets, as well as patient costs. Together, these factors can contribute to more equitable access to testing for patients.

Did you ever imagine that the SalivaDirect protocol would be so widely used when you first conceived the idea of ​​applying it to COVID-19?

AW: Yes and no. I have been researching saliva as a type of sample for infectious disease surveillance for over a decade. At the start of the pandemic, I recognized that this could be a game-changer in public health for communities. When developing the SalivaDirect COVID-19 protocol, we specifically intended to address as many testing challenges as possible.

To make it easier for labs to perform the protocol, we have developed three different ways to perform the test. To minimize supply chain pressure and leverage existing resource availability, the test includes more than a dozen reagents and 26 PCR machines. That’s a lot of variables. And, I’m happy to report that over the past two years, SalivaDirect’s network of over 180 independent labs have performed over 7 million tests with significantly fewer reported issues compared to nasal swab testing.

I am really satisfied with the reliability of the test. The total number of tests performed is also incredible, and we are working to increase it. With decreasing government financial support for testing in general, the low cost of running SalivaDirect tests makes it even more useful for laboratories, state health departments, school systems, employers, and communities to provide molecular tests.

And even if you haven’t asked, I’ll also add – to keep our kids in school, our workforce employed, and our supply chain vibrant, COVID-19 testing continues to be a important part of managing the pandemic. Our communities must remain vigilant against SARS-CoV-2. I am confident that the SalivaDirect Initiative will continue to support these efforts by providing fair testing options.

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