SalivaDirect was issued an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) on August 15, 2020. It is the first EUA issued by the FDA for a protocol. Thus, there is not a SalivaDirect kit to buy, only a protocol that we can provide for free to conduct cheap saliva testing.

If you have questions, please email us at salivadirect@gmail.com.

SalivaDirect: FDA EUA202097 Authorization Letter

SalivaDirect: External lab authorization request form


What is SalivaDirect?

Regularly testing large numbers of people will play a huge role in monitoring transmission of SARS-CoV-2. Quickly detecting and isolating active cases – people who can transmit the virus, whether symptomatic or asymptomatic – is the cornerstone for limiting disease spread. In addition, accurate data on the number of active cases is necessary to inform policy makers (at local, state, and federal levels) as well as individuals what the short-term risk of spread is and how safe it is to do things like return to workplaces, attend school, and see friends and family.

COVID-19_SalivaDirect (2)

Overview of the SalivaDirect workflow. Created with biorender.com.

Ramping up testing for effective SARS-CoV-2 surveillance has faced several barriers. One of those is the reliance on nasopharyngeal swabs, or “NP swabs.” Getting these swabs can be uncomfortable, which discourages people from getting tested frequently. NP swabs also have to be collected by someone who is trained to do so, adding a logistical barrier and putting those performing the test at risk of getting sick. Because SARS-CoV-2 rapidly spread worldwide, it has put immense strain on the supply chains that provide materials for tests, including swabs and test reagents. SalivaDirect is our answer to these problems.

SalivaDirect is a new method for testing people suspected of SARS-CoV-2 infection. While it still relies on a similar molecular process as earlier tests (called RT-qPCR), we made it simpler to drive down costs and place less stress on the supply chains.

SalivaDirect is unique in 3 ways:

  1. We test from Saliva, not NP swabs. This means that 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.
  2. It doesn’t require extracting the nucleic acid from samples before testing. 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.
  3. Our test is 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.

SalivaDirect Pre-print

SalivaDirect Protocol


What isn’t SalivaDirect

  • SalivaDirect is a protocol, not a kit – so we do not have products to distribute. Rather, for authorized labs, we can provide a protocol for doing inexpensive saliva-based RT-qPCR testing.
  • SalivaDirect is not a point-of-care or at-home rapid test. It 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.
  • 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.

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 table below). 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.

Screen Shot 2020-08-11 at 12.28.25 PM

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.

How to become an authorized lab to use SalivaDirect?

If you represent a high complexity CLIA certified lab within the United States and would like to become authorized, please follow the steps below. We are currently working with Yale and FDA legal teams to draft the conditions of the authorization and to formalize regulatory oversight of the process. As this is the first time that the FDA has issued an EUA like this, please understand that it will take us several days to get the required legal documents approved. Then, we will prioritize authorizing labs planning on testing schools first.

If you meet the requirements, here is what you would need to do:

  1. Fill out this submission form. This will help us understand if you meet the criteria for participation, and to determine what we’d need to do to help you get set up.
  2. If you represent a for-profit organization, we may issue a license. The license will be free, but we will want to negotiate how much you charge for the tests. We made this to be inexpensive, and we need those savings to be transferred to your customers.
  3. If we agree to you becoming a designated lab, we will send you a Letter of Authorization, the Fact Sheet, and the Instructions For Use.
  4. You will follow the Intended Use in the instructions, and order only the designated products for testing (you’ll have options).
  5. You will be required to report to us any false positive or false negative findings. If significant problems arise, we will make the required protocol changes.
  6. We will notify you of any protocol changes (such as newly validated reagents or platforms) in the updated Instructions For Use.
  7. We may schedule weekly Zoom meetings for you and other groups to provide feedback. This will be to help keep our calendars free and to allow you to interact with other users.
  8. If you have questions, please email us at salivadirect@gmail.com (not our personal emails).

What’s next?

Even though we have an EUA for SalivaDirect, we’re not satisfied; 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. There are three further areas that we’re developing to make SalivaDirect even better, the results of which 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. Once these are validated, we will post those results here.
  • 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.
  • Rapid detection. We are working on approaches to replace the PCR step with either LAMP or RPA. PCR will still have a role, but a simple rapid test has the ability to be point-of-care. 
  • 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. We are working to see how SalivaDirect compares to swabs tested via conventional methods for detecting these cases, in partnership with the National Basketball Association and National Basketball Players Association. See below.

SWISH

To determine if SalivaDirect can accurately detect asymptomatic cases, our team at the Yale School of Public Health are partnering with the National Basketball Association and National Basketball Players Association, as they look to continue playing while ensuring the health of players and staff. The partnership, the Surveillance with Improved Screening and Health (SWISH) Study involves side-by-side testing of samples collected from players and staff using a standard nasal/oral test for SARS-CoV-2 and SalivaDirect. We’ll compare the outcomes of each test, and post the results at the study conclusion (likely late August).


SalivaDirect research partnerships

If you are interested in using SalivaDirect for other research studies, such as the evaluation of our data, refinement of testing cadences, and operational considerations for testing children, please reach out to Robby Sikka (robbysikka@gmail.com) for further discussions with the COVID Sports and Society Workgroup