About our test

Drive-thru COVID-19 testing in Navato, CA Spring 2020

SalivaDirect: A simpler, safer PCR test

SalivaDirect™ is a new process developed at the Yale School of Public Health to test for infection with SARS-CoV-2, the virus that causes COVID-19.

SalivaDirect uses a saliva sample, rather than an invasive nasal or throat sample, to detect the presence of the virus. While it relies on a similar molecular process as earlier tests, it simplifies the test process to drive down costs and ease stress on supply chains.

SalivaDirect has numerous advantages over similar tests:

  • It’s simpler to perform. SalivaDirect is a qRT-PCR test—the most accurate type of test available—but it uses a simplified process, which creates efficiencies by using materials and equipment that are easier to source than other PCR tests.
  • Sample collection is safer. Unlike nasopharyngeal (NP) tests, which require an invasive swab, SalivaDirect uses a saliva sample, which is more comfortable for patients, and safer for patients and staff alike.
  • Sample collection is easier. Instead of being collected by trained technicians, saliva samples can be collected by patients in the presence of a healthcare professional. This means multiple samples can be collected at once, making the process more efficient at scale.
  • It’s highly accurate. Results show that SalivaDirect is highly sensitive and accurate. It has 94.6% positive agreement and 100% negative agreement with the CDC test, which is comparable to results for other PCR tests.
  • It’s authorized for emergency use by the FDA. SalivaDirect has received an Emergency Use Authorization (EUA) from the U. S. Food and Drug Administration (FDA), which facilitates insurance reimbursement.

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Collection instructions

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Collection demonstration

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Fact sheet
for patients

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FAQs for patients

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SalivaDirect™ has not been FDA cleared or approved. It has been authorized by FDA under an EUA for use by authorized laboratories. This 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 diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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