SalivaDirect™ is unique in 3 ways:
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.
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.
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.
What SalivaDirect™ is not
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.
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. 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.
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 four 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.
Important Information about SalivaDirect™
SalivaDirect™has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.