Skip to Main Content
SalivaDirect™
Lab Login
YSPH Home

INFORMATION FOR

SalivaDirect™

Test Equitably with SalivaDirect

SalivaDirect™ meets with 190+ designated labs in 41 states to answer questions and offer individualized support. We moderate an online community to further assist labs in getting SalivaDirect™ testing up and running.

Our team is working to expand the impact of SalivaDirect™ testing, with a focus on establishing low-cost and sustainable testing in settings such as K-12 schools and with partners around the globe.

SalivaDirect™ is:

  • 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.

Important Regulatory 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.

Partners

In addition to support from Yale University, SalivaDirect partners RF Catalytic Capital, Fast—Grants and Tempus.