FDA Authorizes New Saliva COVID-19 Test

Carolyn Crist

August 17, 2020

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

The FDA authorized a new type of saliva-based coronavirus test on Saturday, which could cut down on the cost of testing and the time it takes to process results.

A nurse holds a COVID-19 saliva test kit at the coronavirus testing drive-thru testing center in Edison, New Jersey, April 17, 2020. Developed by Rutgers University and approved by the FDA, it is the first saliva-based test and is expected to dramatically increase the number of people who can be tested and diagnosed with results available in 24 to 48 hours. Sipa USA/Alamy

The emergency use authorization is for SalivaDirect, a diagnostic test created by the Yale School of Public Health. The test doesn't require a special type of swab or collection tube — saliva can be collected in any sterile container, according to the FDA announcement.

The new test is "yet another testing innovation game changer that will reduce the demand for scarce testing resources," Admiral Brett Giroir, MD, the assistant secretary for health and the COVID-19 testing coordinator, said in the statement.

The test also doesn't require a special type of extractor, which is helpful because the extraction kits used to process other tests have faced shortages during the pandemic. The test can be used with different types of reagents and instruments already found in labs.

"Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents," Stephen Hahn, MD, the FDA commissioner, also said in the statement.

Yale will provide the instructions to labs as an "open source" protocol. The test doesn't require any proprietary equipment or testing components, so labs across the country can assemble and use it based on the FDA guidelines. The testing method is available immediately and could be scaled up quickly in the next few weeks, according to a statement from Yale.

"This is a huge step forward to make testing more accessible," Chantal Vogels, a postdoctoral fellow at Yale who led the lab development and test validation efforts, said in the statement.

The Yale team is further testing whether the saliva method can be used to find coronavirus cases among people who don't have any symptoms and has been working with players and staff from the NBA. So far, the results have been accurate and similar to the nasal swabs for COVID-19, according to a preprint study published on medRxiv.

The research team wanted to get rid of the expensive collection tubes that other companies use to preserve the virus during processing, according to the Yale statement. They found that the virus is stable in saliva for long periods of time at warm temperatures and that special tubes aren't necessary.

The FDA has authorized other saliva-based tests, according to ABC News, but SalivaDirect is the first that doesn't require the extraction process used to test viral genetic material. Instead, the Yale process breaks down the saliva with an enzyme and applied heat. This type of testing could cost about $10, the Yale researchers said, and people can collect the saliva themselves under supervision.

"This, I hope, is a turning point," Anne Wyllie, PhD, one of the lead researchers at Yale, told the news station. "Expand testing capacity, inspire creativity and we can take competition to those labs charging a lot and bring prices down."

Sources

FDA, "FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect, Which Uses New Method of Saliva Sample Processing."

Yale University, "Quick and affordable saliva-based COVID-19 test developed by Yale scientists receives FDA Emergency Use Authorization."

MedRxiv, "SalivaDirect: Simple and sensitive molecular diagnostic test for SARS-CoV-2 surveillance."

ABC News, "FDA authorizes faster, cheaper COVID test in push to pioneer progress."

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