Our Work - Saliva Direct Inc.

How SalivaDirect™ is helping communities

SDI is recognized internationally for developing accessible, adaptable, cost-effective testing solutions that can efficiently scale in response to evolving public health needs. We have also built a reputation of increasing access to testing through community programs. This includes deploying a mobile lab-in-a-van to neighborhoods in Connecticut, offering testing in rural Oregon via vending machines, and supporting community-driven capacity building in Malawi.

Throughout all of our on-the-ground initiatives, we work to establish community-focused programs, ensuring that patient perspectives and stakeholder input inform each stage of the diagnostic testing process, outreach strategy, and overall program design.

Looking to set up a testing program?

Check out the map below to view labs authorized to offer SalivaDirect testing. Contact the local lab directly regarding testing opportunities in your area.

Don’t see a local lab in your area? Contact the SDI team here.

Are you a lab interested in joining our network? Complete our brief inquiry form.

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

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

Rather than purchasing reagents and instruments from a single supplier, our flexible model allows laboratories to select from a number of reagents and PCR suppliers, which have been validated for use with SalivaDirect. This makes it possible for laboratories to begin offering the SalivaDirect test with instruments already in-house.

The SalivaDirect protocol can be run at a fraction of the cost of traditional PCR test, which allows our labs to stretch resources further and scale up community based testing programs.

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.

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.

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

Click here to see this poster presented at IDWeek 2024, summarizing the Connecticut pilot.

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 of testing.

In response to this, SalivaDirect, Inc. and the Wyllie Laboratory at the Yale School of Public Health (YSPH) 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, Influenza A, and Influenza B. 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 qualifies as “preliminary analysis.”

This project is ongoing and the Malawi Liverpool Wellcome Trust Clinical Research Programme continues to use SalivaDirect+, enhancing Malawi’s surveillance testing capacity for common respiratory viruses.

If your lab would benefit from a capacity-building partnership with SalivaDirect, Inc., please contact us.

Vending Machines

SalivaDirect, Inc. piloted the use of vending machines to distribute diagnostic test kits in partnership with Santiam Hospital SCoPE Lab (SCoPE) and SimpliChek, increasing access to COVID-19 PCR testing in rural 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 registered to receive a test kit, followed self-collection instructions and deposited the kit into the vending machine’s collection bin. Once the test kit was returned, SCoPE lab was notified and retrieved samples for testing.

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

Interested in learning more? Please contact us.

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.