Newly Approved Coronavirus Test Using Saliva Could Be Fastest, Cheapest Yet

A simple method that analyzes human saliva to quickly detect the virus that causes COVID-19 has been granted emergency use authorization by the U.S. Food and Drug Administration (FDA).

The painless, fast and cheap test called "SalivaDirect" was developed by researchers at the Yale School of Public Health. SalivaDirect detects the presence of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), the virus that causes COVID-19, in human saliva. It was developed to rapidly expand SARS-CoV-2 testing in large numbers of people throughout the country.

"The SalivaDirect test for rapid detection of SARS-CoV-2 [the novel coronavirus] is yet another testing innovation game changer that will reduce the demand for scarce testing resources," said Adm. Dr. Brett Giroir, Assistant Secretary for Health and the person in charge of the administration’s COVID-19 testing efforts.

SalivaDirect promises rapid and accurate testing for SARS-CoV-2 compared to the invasive and costly nasopharyngeal (NP) swabs commonly used to detect the virus. Receiving the EUA means SalivaDirect is immediately available to diagnostic laboratories nationwide that want to start using it. Yale said the test can be scaled-up quickly for use across the U.S. in the coming weeks

SalivaDirect has been validated with reagents and instruments from multiple vendors. This advantage enables continued testing if vendors encounter supply chain issues similar to those that hobbled tests early in the pandemic.

Yale said SalivaDirect is simpler, less expensive, and less invasive than traditional NP swabbing. Results so far reveal SalivaDirect is highly sensitive and yields outcomes similar to NP swabbing. Approval comes at a time when the U.S. is struggling with testing issues.

“This is a huge step forward to make testing more accessible,” said Chantal Vogels, a Yale postdoctoral fellow, who led the laboratory development and validation along with Doug Brackney, an adjunct assistant clinical professor. "We are delighted to make this contribution to the fight against coronavirus.”

Vogels said SalivaDirect started off as an idea in Yale's lab soon after researchers found saliva to be promising for the detection of SARS-CoV-2. Now, SalivaDirect has the potential to be used on a large scale to help protect public health

Research into SalivaDirect was spearheaded by Nathan Grubaugh and Anne Wyllie, assistant professor and associate research scientist, respectively, at Yale School of Public Health. They found saliva to be a promising sample type for SARS-CoV-2 detection and rushed to improve the method further.

“With saliva being quick and easy to collect, we realized it could be a game-changer in COVID-19 diagnostics,” said Wyllie.

Yale said SalivaDirect is being further validated as a test for asymptomatic individuals in a program that tests players and staff from the National Basketball Association (NBA). Research into SalivaDirect was funded by the NBA, the National Basketball Players Association, and a Fast Grant from the Emergent Ventures at the Mercatus Center, George Mason University.