Covid-19: Yale’s saliva-based test receives emergency use authorisation by USFDA

Hemai Sheth Mumbai | Updated on August 16, 2020

Representative image   -  Bloomberg

The method requires no extraction of nucleic acid and uses several readily available reagents

A quick and cheap saliva-based laboratory diagnostic test for Covid-19 developed by researchers at the Yale School of Public Health has received emergency approval by the United States (US) Food and Drug Administration (FDA) on Saturday.

The emergency use authorisation by the USFDA will enable the method, called SalivaDirect to be used by diagnostic laboratories across the country to scale up testing.

The method is being further validated through a research study on asymptomatic individuals involving players and staff from the National Basketball Association (NBA).

“SalivaDirect is simpler, less expensive, and less invasive than the traditional method for such testing, known as nasopharyngeal (NP) swabbing. Results so far have found that SalivaDirect is highly sensitive and yields similar outcomes as NP swabbing,” read an official Yale news release.

The method requires no extraction of nucleic acid and uses several readily available reagents.

“This test is also unique because it does not require a separate nucleic acid extraction step,” the FDA said. “This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past. Being able to perform a test without these kits enhances the capacity for increased testing, while reducing the strain on available resources.”

“Wide-spread testing is critical for our control efforts. We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about $10 per sample. If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine,” said Nathan Grubaugh assistant professor at Yale and part of the team of researchers who led the program.

Yale will be partnering up with the Jackson Laboratory for Genomic Medicine in Farmington, Connecticut to explore the implementation of the test for a broader audience.

Researchers behind the test are not looking to commercialize it, rather provide it to those who need it the most.

The related research was funded by the NBA, National Basketball Players Association, and a Fast Grant from the Emergent Ventures at the Mercatus Center, George Mason University, said Yale.

Published on August 16, 2020

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