About our 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.