About Us
Our Mission
SalivaDirect, Inc. is a nonprofit dedicated to enhancing public health through accessible testing strategies in developing and deploying innovative solutions that respond to evolving global health challenges. By providing equitable testing, we aim to advocate, promote and advance diagnostic solutions.
Our Vision
SalivaDirect, Inc. will manage and support a designated lab network using protocols to provide equitable testing for communities. Our vision is to advance research and development for new assays and deploy these in pursuit of health equity.
Our History
In 2020, the SalivaDirect protocol was developed by researchers at the Yale School of Public Health (YSPH) in response to the COVID-19 pandemic. While nasal swabs became the gold-standard diagnostic sample type, supply-chains buckled under the demand for swabs and reagents, healthcare workers were put at risk having to obtain samples, and patients avoided testing due to the discomfort of the standard method.
SalivaDirect was born out of these conditions to aid communities and labs in establishing affordable and equitable SARS-CoV-2 testing programs that leverage their existing resources and improved patient experience.
Due to the flexibility and low-cost of our test, more than 200 laboratories have provided over 6.5 million tests to date across 42 states. SalivaDirect was used in testing programs across various industries to keep K-12 schools, universities, workplaces, and even the National Basketball Association (NBA) open and safe as we returned to a new sense of normalcy.
With disparities in access to testing persisting to this day, we have developed innovative programming and projects to bring testing to those left behind by the U.S. healthcare system.
In order to better support this, we have successfully spun out from Yale University in 2022 into an independent 501(c)3 organization. SalivaDirect, Inc. is a nonprofit that works to develop and deploy diagnostic testing strategies in response to global health challenges. We continue to expand our assay portfolio and deliver innovative testing solutions.
SalivaDirect has:
Delivered more than 1400 tests to over 120 high impact community events across Connecticut through our “lab-in-a-van” partnership with Yale Pathology Labs.
Piloted a vending machine model to deliver test kits throughout rural Oregon in collaboration with Santiam Hospital.
Provided tests during the humanitarian crisis in partnership with Integrated Refugee and Immigration Services (IRIS) to 100+ Afghan refugees relocating to New Haven, CT.
Trained laboratory scientists at the Malawi Liverpool Wellcome Trust to use our SalivaDirect protocol to test for respiratory viruses.
Hosted over 50 paid internships for undergraduate and graduate students, training the next generation of public health and diagnostics professionals.
Our team is currently working on SalivaDirect+, our first offering in low-cost panel testing. With the development of SalivaDirect+, the scope of our saliva-based test will expand to include SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus – all detectable from a single saliva sample. Stay tuned for updates.
Meet
the Team
Yasmine joined the SalivaDirect, Inc. team in 2021 as the Business and Strategy Manager and became Executive Director in 2023. She provides strategic leadership, oversees operations, and fosters partnerships, ensuring that SDI’s mission and goals are achieved through effective team management.
Email: [email protected]
Yasmine Ali
Executive Director
Alex joined the SalivaDirect, Inc. team in 2024 as the Director of Science. She leads the design and execution of clinical studies for FDA regulatory submissions and oversees laboratory assay development. Additionally, Alex drives innovation initiatives, fosters scientific partnerships, and secures funding to support groundbreaking research and development projects.
Email: [email protected]
Alexandra Kitz
Director of Science
Laura joined the SalivaDirect, Inc. team in 2023 as the Regulatory Compliance Manager. She and her team manage the laboratory network and the associated Quality Management System (QMS) data. Laura oversees the QMS, ensures regulatory compliance, and submits new filings to the FDA.
Email: [email protected]
Laura Burke
Regulatory Compliance Manager
Brittany joined the SalivaDirect, Inc. team in 2021. As the Director of Programs. She oversees our expanding portfolio of initiatives, which includes managing SDI’s progressive public health solutions implemented in the field. Brittany utilizes her stakeholder engagement and operations expertise to build partnerships that further SDI’s mission and enhance our impact in underserved communities.
Email: [email protected]
Brittany Choate
Director of Programs
Russell joined the SalivaDirect, Inc. team in 2021 as an Intern while enrolled at the Yale School of Public Health. After earning their Master of Public Health (MPH) degree, Russell transitioned to a full-time position as a Senior Business Development Associate in 2023. Their responsibilities include supporting fundraising efforts, managing grants, contributing to strategic planning, and serves as a liaison to SDI’s Board of Directors.
Email: [email protected]
Russell Thomas
Senior Business Development Associate
Victoria joined the SalivaDirect, Inc. team in 2024 as the Marketing Manager. She specializes in go-to-market strategy and digital media. Her responsibilities include implementing our marketing strategies to enhance SDI’s programs and increase brand visibility. Additionally, she oversees all advertising communications, handles media inquiries, and manages event information.
Email: [email protected]
Victoria Hurley
Marketing Manager
Tasha joined the SalivaDirect, Inc. team in 2022 as a Fractional CHRO. She oversees all aspects of human resources, including talent management, operations, and employee benefits. She is responsible for developing all of SDI’s HR policies and strategies, as well as leading the company’s learning and development initiatives.
Email: [email protected]
Tasha Kitty
CHRO Consultant/ Human Resources
Jazmin joined the SalivaDirect, Inc. team in 2024 as an Executive Assistant. She is responsible for managing various administrative needs, ensuring seamless coordination of schedules, and supporting key executives. Jazmin plays a critical role in streamlining communication and maintaining organizational efficiency.
Email: [email protected]
Jazmin Steir
Executive Assistant/ Admin
Meet the SDI Board
Anne Wyllie
Avi Robbins
Shyam Saladi
Mostafa Analoui
Prem Premsrirut
Robby Sikka
Lolahon Kadiri
Testimonials
What People Are Saying
What is the SalivaDirect Test?
SalivaDirect was developed at the Yale School of Public Health to test persons suspected of having COVID-19 for the virus, SARS-CoV-2. It is ideal for large-scale testing and offers a number of advantages over traditional testing methods. SalivaDirect received emergency use authorization (EUA) from the U.S. Food and Drug Administration on Aug. 15, 2020.
Can I buy a SalivaDirect kit through your website to test myself or my family?
SalivaDirect, Inc. does not provide testing or testing kits. Please visit our lab directory for assistance in locating and scheduling SalivaDirect testing in your area.
Where can I get tested?
We have a network of laboratories authorized to administer the SalivaDirect test. Please visit our lab directory to find a participating lab near you.
Can schools get their students tested with SalivaDirect? How about other organizations?
While we are working to develop testing partnerships that may be of use to you or your organization, we also suggest reaching out to local CLIA certified laboratories to encourage them to work with you to implement SalivaDirect testing to help provide you with testing options. High-complexity CLIA labs can apply for designation.
How much does a SalivaDirect test cost?
The exact price a lab may charge for a single SalivaDirect depends on a number of factors including costs for their facilities, their staff, their instrumentation and logistics required for test collection and result delivery. Our mission with SalivaDirect however, was to drive down testing costs and help make testing more accessible around the country. For this, the method we developed greatly reduces the cost of reagents (the substances used in chemical analysis) required to test your sample. With this method, we have reduced testing costs to $1.29-$4.30 for the reagents per test (however the cost of the test is higher due to the other expenses a laboratory may have as indicated above). This cost is expected to further drop with large-volume purchases and the use of robotics for high-volume automated testing. SalivaDirect also does not require expensive tubes containing special preservatives to collect your saliva sample, which further reduces costs.
How else is SalivaDirect different from other testing methods?
In addition to being less expensive, SalivaDirect offers a number of other advantages. They include:
It is non-invasive. SalivaDirect requires only a small sample of saliva as opposed to the standard nasopharyngeal (NP) swab. The NP method requires what is essentially a long Q-tip that is inserted deep into the nostril and then rotated.
It is quick and safe. Because SalivaDirect only requires a small saliva sample, the time requirement for an individual is minimal, even less than a minute. People basically have to spit into a small container. The procedure is safer in that there is less risk of exposure to health care workers collecting the samples.
It is accurate. Results show that SalivaDirect is highly sensitive and is accurate 94% of the time, comparable to results for NP-based tests.
The limit of detection as determined by blinded standards sent out by the FDA to all labs with an EUA shows that the sensitivity of SalivaDirect is comparable to many other great PCR tests out there – including those with RNA extraction.
My lab is also working on COVID-19 testing. Can we use the SalivaDirect test?
Potentially yes. If your lab is a high-complexity CLIA certified laboratory and located within the United States it can request designation to implement SalivaDirect under our EUA by filling out an application form here.
Will SalivaDirect be further improved in the coming weeks and months?
SalivaDirect, Inc. is currently in the process of adding additional laboratories to our network to expand accessibility. Additionally, we are launching new clinical trials to detect new targets. Subscribe to our newsletter for the latest updates!
Is an at-home saliva collection kit available?
SalivaDirect, Inc. does not have any at-home saliva collection kits at this time.
How can we become a distributor of SalivaDirect?
SalivaDirect is a protocol performed by CLIA labs in the SalivaDirect network. If you are a CLIA-certified laboratory, visit our Clinical Labs page.
I am an employer and wish to test my employees. How can I use SalivaDirect?
Contact us to locate a network laboratory in your area. You can also refer a CLIA laboratory near you by sharing the link to our Clinical Labs page and work with them to become authorized to use SalivaDirect.
Where can I find the SalivaDirect protocol?
The protocol is publicly available. Please note that in order to offer the SalivaDirect test to your consumers, your laboratory is required to be designated by SalivaDirect Inc and receive the complete Instructions For Use (IFU).
How can my lab get designated to use SalivaDirect?
The designation process is available here.
How does saliva compare to other sample types (nasopharyngeal swab, nasal swab etc.) in terms of sensitivity and specificity for SARS-CoV2?
Results from our validation work when developing SalivaDirect are available here. While data from our submission to the FDA is also available, we have a more extensive overview of how SalivaDirect performs as compared to other sample types in our SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity preprint. In addition, the limit of detection as determined by blinded standards sent out by the FDA to all labs with an EUA shows that the sensitivity of SalivaDirect is comparable to many other great PCR tests out there – including those with RNA extraction.
Can you provide me with a list of equipment that we can perform SalivaDirect testing on?
Here is the current list of validated equipment that can be used for SalivaDirect. Only validated equipment can be used. However, this list is updated as more equipment is bridged on to the EUA. If you don’t see your equipment listed and would like to get your equipment bridged, contact us to discuss this at [email protected].
Can other fluorophores/PCR kits/proteinase K be used instead of what is listed on the EUA?
SalivaDirect can only be run with the validated reagents and equipment listed on our EUA. However, we validated multiple reagents and platforms in an effort to circumvent any supply chain issues, as well as to help keep prices for listed reagents down through competition between suppliers. If you have a preferred reagent or supplier that you would recommend for inclusion on our EUA, please contact us to discuss bridging this onto our EUA at [email protected].
What if we don’t have one of the PCR platforms listed on the EUA? Do we have to buy all new PCRs?
Our mission with SalivaDirect was to help labs easily implement saliva testing. By including a variety of PCR instruments onto our EUA we hoped that most labs would be able to utilize existing platforms and help avoid the expense of purchasing additional equipment which could put pressure on the supply chain and mean an extra expense. If your PCR instrument is not currently listed, before purchasing additional equipment, please contact us to see if we can work together to bridge your existing platform onto our EUA.
Do we need to submit CLIA verification data (such as 5 positive and 5 negative saliva samples) for each different kit manufacturer we intend to use?
No, we have done all that validation for you. Your CLIA verification data is just to demonstrate that you have successfully implemented SalivaDirect in your lab and allows us to assist you with troubleshooting if we identify any issues with your data.
Can frozen specimens that are thawed be used for validation?
Yes.
Does a second RT-qPCR (if needed) work from a frozen sample?
Yes, we have had success with retesting either frozen saliva samples or the prepared lysate after a couple of freeze/thaw cycles.
Can the PCR systems listed on the EUA also be used for the heat inactivation step?
Yes.
We currently have a class II type A2 biosafety cabinet; is this sufficient for processing samples for this protocol?
Before implementing SalivaDirect, you should consult with your CLIA director, local EHS and/or local state health department to confirm the safest way to conduct SARS-CoV-2 testing and carry out the SalivaDirect protocol in your lab.
How long does it take to test samples using SalivaDirect?
This will vary between labs. While we have found that one technician can run 93 samples in around 3 hours, differences in workflow, sample volume, data reporting, and other factors, could affect how long it takes to complete this protocol in your lab.
Do we have to use 8-strip tubes for sample processing? Can we use a 96-well deep plate instead?
The use of 8-strip tubes helps to prevent cross contamination between samples which could occur if sealing and re-opening plates, or if plates are not adequately sealed when vigorously vortexing the sample. However, this doesn’t mean that you can only run 8 samples at a time. You can combine these strips and process a full PCR plate of samples at once.
Are the protocols for the 96- and 384-well format PCRs different?
While the cycling conditions are the same, the 384-well format requires a smaller reaction volume, so is indeed different to that detailed for the 96-well format.
What data do we need to share with the SalivaDirect team as part of the designation process? Does it have to be exactly 5+ and 5- saliva samples?
As part of the designation process we ask that you share your CLIA verification data with us. Your CLIA verification is to be conducted at the discretion of your CLIA laboratory director, which could be a certain number – decided by them – of positive and negative saliva samples. We ask to see your CLIA verification data as if we notice any potential issues we will be able to troubleshoot these with you.
Can SalivaDirect be used with automation to help increase sample throughput?
Currently samples have to be prepared manually, exactly as detailed in our protocol. However, if you have automation in place that you think will work for SalivaDirect, please contact us to discuss bridging experiments for the addition of your workflow to the EUA. We also recommend that you start by testing some saliva samples in an approach that is closely aligned to the steps in our protocol to test the potential for your system to handle and adequately process saliva samples. You may wish to compare some samples through both the manual SalivaDirect process and your proposed automated process to ensure concordant results. These results will also be helpful for us in assessing the potential for bridging your system onto our EUA.
Will you be including any all-in-one extraction/RT-PCR machines?
It is unlikely. Key to decreasing the cost of testing with SalivaDirect, while improving testing efficiency, was through removing RNA extraction. The all-in-one RNA extraction/PCR platforms would mean that a sample would be prepared as per the SalivaDirect protocol, then loaded onto these machines, taking additional time and cost through putting an RNA extraction step back into the method. By the time you’ve done the SalivaDirect work-up, it is at that stage ready to go straight onto PCR so using these machines will defeat the cost- and time-savings that SalivaDirect can offer.
What is the SalivaDirect Authorized Laboratory Agreement?
SalivaDirect, Inc. has created an Authorized Laboratory Agreement as a fillable pdf form that will be used to designate qualified laboratories to offer the SalivaDirect test under the EUA 202097.
The Agreement must be filled out where indicated (including relevant Exhibits) and signed by an individual authorized to sign on behalf of the laboratory. Please rename your file, add your laboratory name to the subject line and email the agreement to [email protected]. Please note that SDI will sign the Agreement only after your CLIA verification data are reviewed and approved by our team. Laboratory networks with five (5) or more CLIA-certified laboratory sites should use the Authorized Laboratory Network Agreement that has been specifically designed for laboratory networks (please email us to request the multi-site Authorized Laboratory Network Agreement form).
Why is there a confidentiality clause in the Authorized Laboratory Agreement?
The SalivaDirect Instructions for Use (the “IFU”) document is the “product” authorized by the FDA for emergency use and can be shared only with laboratories designated as authorized laboratories by SalivaDirect, Inc. Per terms of the EUA 202097 and the Authorized Laboratory Agreement, the designated laboratories must not share the IFU with anyone outside of their own laboratories or publicly post or display the IFU.
Our laboratory has multiple sites, does each site need to have a separate designation?
Laboratory networks with five (5) or more CLIA-certified laboratory sites go through a slightly different process, under which we can designate multiple sites that are controlled by the same legal entity. Multi-site laboratory networks should contact us to request the Authorized Laboratory Network Agreement.
