About SalivaDirect

Saliva-based

You don’t have to stick an uncomfortable swab up your nose, which will increase testing compliance. This also protects healthcare workers from potential exposure to sick patients and works around worldwide swab shortages. We also found that expensive preservatives are not needed to test saliva, which lowers the costs.

Extraction-free

Nucleic acid extraction is time-consuming and expensive, and there have been 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.

Flexible

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 are aiming to validate our method with as many different variations of equipment and reagents as possible to allow labs to work with what they have and to prevent shortages. If your equipment isn’t on our list, let us know and we will work with you.

A kit

SalivaDirect™ is a protocol, not a kit – so we do not have products to distribute. Rather, for designated laboratories, we can provide a protocol for doing inexpensive saliva-based RT-qPCR testing.

A point-of-care or rapid test

SalivaDirect™ requires a high complexity CLIA certified lab. While we removed the difficult RNA-extraction step, the test is still considered complex, as it requires PCR.

A perfect solution for all COVID-19 testing

SalivaDirect™ is a tool that will help improve the efficiency of testing for population screening, but it won’t solve everything. We still need faster, cheaper, and portable tests. We’ll use our experience here to help bring more of those tests to reality too.

A common question that we receive is “what company is behind this assay?” The answer is – well, there isn’t one. 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 (see Reagents & Instruments table). Thus, no new manufacturing is needed. We will continue to validate new reagents through bridging studies and will share that information here. A complete list of reagents and catalog numbers are listed in the protocol.

SalivaDirect™ will be offered by authorized high complexity CLIA certified labs. At this moment we cannot help you to find or set up a lab to run SalivaDirect™, as we are focused on authorizing labs that are currently CLIA certified. Also, we are currently not able to offer testing to the public, although we are working to develop testing partnerships that may be of use to you or your organization. We will post more information on which labs are using SalivaDirect™ soon.

We are advancing the use of saliva-based testing as a readily-deployable, sensitive, patient-friendly option that increases access to affordable and equitable infectious disease testing.

SalivaDirect™ is an Emergency Use Authorized (EUA) PCR test that bypasses the RNA extraction step and uses interchangeable reagents and instruments that are routinely found in clinical labs.

Our test:

• Uses self-collected saliva, not swabs
• Has sensitivity and accuracy comparable to the CDC’s PCR test with RNA-extraction
• Reduces the risk of transmission among healthcare workers
• Cost-effective ($1-4/sample in reagents and consumables, excluding labor and overhead)
• Easily implemented in CLIA laboratories under our EUA, with minimal in-house validation and no direct interaction with the FDA. One lab technician can manually run 93 samples in 3-4 hours; this throughput can increase if pooled or automated workflows are in place.

How will SalivaDirect™ be offered?

A common question that we receive is “what company is behind this assay?” The answer is – well, there isn’t one. 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 (see Reagents & Instruments table). Thus, no new manufacturing is needed. We will continue to validate new reagents through bridging studies and will share that information here. A complete list of reagents and catalog numbers are listed in the protocol.

SalivaDirect™ will be offered by authorized high complexity CLIA certified labs. With our growing lab network we can help you to find a lab that offers SalivaDirect™. As the test developers, we are not able to offer testing to the public, but please consult our list of designated labs to find potential testing partnerships that may be of use to you or your organization.

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 its 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 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. Not only did saliva samples detect COVID-19 cases comparably to nasopharyngeal swabs, but it detected a higher viral load and also picked up asymptomatic cases.

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. We believe that only by mobilizing all interested parties around the common frameworks and principles can we collectively deliver effective and sustainable testing programs nationwide.

What’s next?

We are still doing research on how to increase the number of people that can be tested per day and reduce the supplies and equipment needed per test. We hope that this will make SalivaDirect™ an even better option for low-resource and remote settings. Ongoing developments to make SalivaDirect™ even better will also be posted here as we go along:

• Automation: We are working with several institutions to validate robotic systems to automate the sample processing and/or PCR.
• Pooling: By combining saliva from many people and testing it all at once, we can increase the number of samples that can be tested per day and reduce the amount of each reagent used per person.

Asymptomatic detection: Most available SARS-CoV-2 tests have not been validated to detect asymptomatic infections, which is the primary goal of large-scale population screening and surveillance. While the high sensitivity of SalivaDirect™ means that it has been awarded conditions for asymptomatic screening by the FDA, thanks to our partnership with the National Basketball Association, National Basketball Players Association and Mirimus Labs, we are applying for full asymptomatic labelling.

• RF Catalytic Capital
• Tempus
• Fast Grants
• Mirimus
• Flambeau
• COVID Safe Schools
• Access Medical Labs
• Grubaugh Lab
• GS Biomark
• Lighthouse Lab Services
• Lindus Health
• Veritas The Genome Company

The SalivaDirect team at the Yale School of Public Health is seeking a Postdoc to help lead multidisciplinary projects in the realm of microbiology, immunology, epidemiology, and clinical diagnostics, with a strong focus on saliva as a sample type. Our research has developed from the use of saliva to explore community rates of carriage and transmission of the bacteria, Streptococcus pneumoniae, to the use of saliva for SARS-CoV-2 detection, with our clinical diagnostic test “SalivaDirect” now in labs all around the US. An example of our range of work can be found here.

This is a “wet” lab position and a background in microbiology and/or immunology is preferred. This position is available starting any time from July 2021 and will be for a minimum of 2 years. Our work is largely team-based - whether within our group or with external collaborators. While we work hard, we strive to also enjoy life. We also understand the challenges in life so are flexible and supportive.

This work will include one or more of the following:

• Community transmission studies of upper respiratory tract pathogens
• Development, validation, and optimization of molecular diagnostic approaches for pathogen detection
• Development, validation, and optimization of antibody detection assays
• Other interesting projects as research interests develop!

Job description:

1. Design, execute and lead research projects, primarily exploring pathogen or antibody detection in saliva
2. Train Ph.D. students, MPH students, undergrads, visiting students, and/or lab assistants on microbiology techniques and data analyses
3. Participate in collaborative projects with colleagues in partner institutions, and research groups locally, nationally and internationally
4. Analyze, interpret, and report research result
5. Write papers and give scientific presentations at meetings and conferences
6. Assist with grant applications and IRB submissions

Job requirements:

• Ph.D. in microbiology, molecular biology, immunology, clinical research or related field
• BSL2 training, experience working with clinical samples or human pathogens
• Strong written and oral communication skills
• Must be highly dependable, diligent, and well-organized with good attention to detail
• Ability to work on a busy team, lead a team, and also work independently
• Commitment to equity, diversity, and inclusion in work practices
• Undertake mandatory training as required by the University and Department.

Funding: Our work is funded by various entities - NIH, industry partners, pharma, and even donations. This position will be supported for at least 2 years, with extensions depending on future funding. Applying for outside fellowships is encouraged, but not required. The starting salary is $55,000. The position will remain open until filled, and the start date is anytime between July and December 2021.