Our Work - Saliva Direct Inc.

How SalivaDirect™ is helping communities

Continuing to participate in routine testing is a critical step in the fight against COVID-19. Our team is committed to providing the most equitable, affordable testing options possible to our safe return to schools, workplaces, and public spaces.  

It’s important to remember that people who don’t have any symptoms can spread COVID-19. And, even those that are vaccinated can still be spread the virus. That’s why we need testing to help keep our friends, families, schools, and communities as safe as possible.

Looking to set up a testing program?

Check out the map below to view labs in your area that offer COVID-19 testing and are open to partnerships. *The labs listed below include SalivaDirect Authorized Labs as well as those that offer other COVID-19 testing options, such as nasal swabs.

Testing

The map is designed to be a tool for community organizations to identify potential laboratories to provide testing for their respective organizations.

The following labs have opted to share their information and provide details regarding where and how many tests they can provide.

Our Programs

SalivaDirect, Inc. is a public health nonprofit with a mission to respond to global health challenges through development and deployment of diagnostic testing strategies.

SDI is recognized internationally for:

Championing accessible and adaptable diagnostic testing solutions

Developing low-cost, flexible qPCR assays using saliva

Increasing access to testing through innovative community programs

Training the next generation of public health professionals

Building the workforce capacity of laboratories in low-resource settings

SalivaDirect, Inc. has disrupted the diagnostic industry with our innovative regulatory approach. Whereas other diagnostic companies create a proprietary set of reagents to be run on their proprietary PCR instruments, SalivaDirect, Inc. has taken a different approach – creating the diagnostics industry’s equivalent to a “generic” diagnostic test.

Rather than purchasing the reagents and instruments from a single supplier, our model allows for laboratories to order from different reagent suppliers which have all been validated on a wide number of common laboratory instruments and meet the U.S. Food and Drug Administration’s rigorous performance requirements. This makes it quite possible for laboratories to begin offering testing for different pathogens using PCR instruments that they already possess without sacrificing quality.

Because of this, we are able to offer our protocol-based assays at extremely low-cost – a mere $2-5 a sample (minus overhead) – enabling us to pilot and scale community-based testing programs. Click on some of these programs below to learn more about our impactful community work across the globe.

Mobile Laboratories

SalivaDirect, Inc. has piloted the use of a mobile laboratory to remove barriers and provide high-quality testing directly to communities in need.

In partnership with Yale Pathology Laboratory and with support from the NIH-RADx Underserved Populations program (RADxUP RP2 #R0604), we outfitted a cargo van to provide on-site high-complexity clinical diagnostic testing. Free SARS-CoV-2 testing (using SalivaDirect’s protocol) was offered at 123 community events across Connecticut. Tests were completed on the CLIA-licensed van, which was operated under the Yale University School of Medicine’s Department of Pathology.

Between June 2023 to July 2024, 1,428 tests were provided to community members – more than 1,000 above the pilot’s initial goal. Participants largely agreed it was easy to access the van and felt comfortable using the van for testing. In fact, 29% received their first-ever COVID-19 test at the van!

This pilot demonstrated the positive impact community-informed mobile testing could have for overcoming barriers to accessing healthcare, and its potential to serve as a framework for managing and responding to future public health needs.

Mobile community testing events at partner site WHEAT Inc (West Haven, CT). Photos feature the project team and community participants. Photo credits: Gift Amadi.

Our mobile-laboratory model is adaptable to meet different public health needs, and can be deployed by hospitals, diagnostic laboratories, or government agencies. Please contact us if you wish to explore mobile-laboratory options for your organization.

A video tour of the mobile lab-in-a-van is available here: bit.ly/SDvantour; a poster summarizing the results of the Connecticut pilot is available here.

Capacity-Building

When conducting surveillance or diagnostic testing efforts, low- and middle-income countries (LMICs) often face distinct challenges in the limited access to high-complexity laboratories as well as the significant cost for testing.

In response to this, SalivaDirect, Inc. and the Wyllie Laboratory at the Yale School of Public Health partnered with Professor Kondwani Jambo of the Malawi Liverpool Wellcome Trust Clinical Research Programme to investigate the use of SalivaDirect+ as a low-cost option for sustainable surveillance testing as well as a potential diagnostic test for use in resource-limited settings.

Together, we applied for and were awarded a grant from Balvi.io to support in-country laboratory capacity-building and community testing for SARS-CoV-2, RSV, IAV, and IBV. This effort was embedded in an existing COVID-19 community surveillance study led by Dr. Jambo, allowing us to compare the use of saliva to the use of nasopharyngeal swabs. Since December 2023, scientists at the Malawi Liverpool Wellcome Clinical Research Programme have collected 1,800+ saliva samples and successfully detected SARS-CoV-2, RSV, Influenza A, and Influenza B. Results as of September 2024 are showing substantial agreement between paired saliva and nasopharyngeal samples, demonstrating how saliva-based testing can act as a suitable low-cost alternative to nasopharyngeal swabs.

In March 2024, Dr. Orchid Allicock and Dr. Chikondi Pero from the Wyllie Laboratory hosted an in-person training for the Malawi Liverpool Wellcome Trust scientists to strengthen the laboratory’s skills in salivary diagnostics.

Please note this information be qualified as “preliminary analysis”

Our project has since wrapped, and the Malawi Liverpool Wellcome Trust Clinical Research Programme continues to use SalivaDirect+ to this day, enhancing Malawi’s surveillance testing capacity for common respiratory viruses.

If you would like SalivaDirect, Inc. to come to your laboratory, please contact us.

Vending Machines

SalivaDirect, Inc. has piloted the use of vending machines to distribute diagnostic test kits. In partnership with the Santiam Hospital SCoPE Lab (SCoPE) and SimpliChek, we worked to bring COVID-19 PCR testing to underserved populations in Oregon.

With support from the NIH-RADx Underserved Populations program (RADxUP RP2 #R0703), community members in rural Oregon were able to access on-demand PCR testing through vending machines. These kiosks were placed at five trusted community partner locations. To access testing, patients simply entered their information to receive a test kit, followed kit instructions to self-collect their saliva sample, and then dropped the completed test into a secure collection bin built into the vending machine.

Once the test kit was returned, a designated lab was notified and samples were transported to Santiam’s diagnostic laboratory. Test results were returned within 24-48 hours.

As a result of this pilot, we have submitted data to the U.S. Food and Drug Administration for Emergency Use Authorization of the vending machine distribution method.

Interested in hosting a vending machine at your organization? Please contact us at [email protected].

Toolkits

SalivaDirect, Inc. is committed to ensuring equitable access to diagnostic testing. We’ve documented our findings from different projects into toolkits for organizations to adopt and implement to fit their community needs. See our existing tool-kits below.