Our mission
To mobilize academic, government, public, and private sectors to ensure the broadest access to affordable and equitable infectious disease testing around the world.
SalivaDirect™ is a PCR test that received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA). It was designed to bypasses the RNA extraction step and use interchangeable reagents and instruments that are routinely found in clinical labs.
How is SalivaDirect™ offered?
We designed and validated SalivaDirect™ using several common and available reagents. If one reagent is out of stock or is too pricey, there are alternative reagents to use. Thus, no new manufacturing is needed. We continue to validate new reagents through bridging studies and share that information. A complete list of reagents and catalog numbers are listed in the protocol.
SalivaDirect™ can be offered by designated high complexity CLIA certified labs. We can help labs that are currently CLIA certified with the designation process, just email us at info@salivadirect.org and someone from the team will be in touch soon.
About the SalivaDirect™ test
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Saliva is commonly preferred over other specimen types, such as nasopharyngeal. With passive-drool proving to be a straight forward collection method, healthcare workers can be protected from potential exposure to sick patients through direct-to-consumer and unsupervised collection. We also found that expensive preservatives are not needed to test saliva for SARS-CoV-2, which lowers the costs of testing.
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Nucleic acid extraction is time-consuming and expensive, and there were worldwide shortages of the supplies needed to do it. For SalivaDirect™, we’ve worked out how to skip this step, making it accessible to more labs, and further reducing the costs associated with testing.
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While many labs have similar equipment, they may be from a different company, and all of these need to be authorized by the FDA. We aim to validate our method with as many different variations of equipment and reagents as possible to allow labs to work with what they have. If your equipment isn’t on our list, let us know and we will work with you.
Our story
The SalivaDirect™ team began working in March of 2020 when a team of Yale researchers established the Implementing Medical and Public Health Action Against Coronavirus (IMPACT) biorepository, which collected nasopharyngeal, oropharyngeal, rectal, urine, serum, and saliva samples from COVID-19 inpatients. While nasopharyngeal samples became the standard practice around the world due to their prior use for the detection of other upper respiratory tract pathogens, supply chains buckled under the demand for swabs, healthcare workers were put at risk of having to obtain the swabs and people felt discouraged to get tested due to the discomfort of these swabs. During this time we recognized the potential of saliva as a sample type for SARS-CoV-2 to overcome testing challenges.
The SalivaDirect™ test was developed at the Yale School of Public Health (YSPH) to enable communities and labs to establish affordable and equitable SARS-CoV-2 testing programs by leveraging their existing resources. Now existing as an independent non-profit outside of the Yale School of Public Health, we are moving forward with the development of new assays for priority diseases alongside our close collaborators throughout the past three years. We believe that only by mobilizing all interested parties around the common frameworks and principles can we collectively deliver effective and sustainable testing programs, both locally and globally.