COVID-19 Saliva Test Gets Emergency Approval From the FDA
The US Food and Drug Administration recently granted an emergency use authorization of a saliva-based laboratory diagnostic test which Yale School of Public Health researchers developed.
The U.S. Food and Drug Administration recently granted an emergency use authorization of a saliva-based laboratory diagnostic test developed by Yale School of Public Health researchers.
According to a report from Yale University, the test could determine if an individual is infected with COVID-19.
Called SalivaDirect, the method is being further verified as a test for asymptomatic people through a program that examines both National Basketball Association players and staff.
This latest development is described as a simpler, cheaper and less intrusive test compared to the traditional testing method—nasopharyngeal or NP swabbing.
So far, results have found that SalivaDirect is extremely sensitive and produces the same results as NP swabbing.
ALSO READ: Researchers Find Adverse Effects of COVID-19 Outside the Lungs
Instant Availability of the SalivaDirect
Now with the authorization for emergency use from the FDA, SalivaDirect is instantly available to other diagnostic laboratories with the desire to use a new testing method that can be scaled-up fast for employment and application nationwide.
SalivaDirect's key element is that the procedure has been verified with reagents and instruments coming from various vendors.
Such flexibility allows continued analysis if there are vendors who would encounter issues in the supply chain, as what many encountered during the early stages of this pandemic.
According to Yale postdoctoral fellow, Chantal Vogels, this development is a "huge step ahead" in making COVID-19 testing more accessible.
Vogels, who also headed the laboratory development and validation together with an adjunct assistant clinical professor, Doug Brackney, added that the project started as an idea in their laboratory. And soon after, they discovered that saliva could be a potential type of sample to detect COVID-19 infection.
The research team says the test has the potential to be used on a greater scale to help in protecting the public.
Vogels shared that they are delighted to make such a contribution to combat COVID-19. Yale University reported that the preprint on SalivaDirect's development and validation recently has came out.
DON'T MISS THIS: COVID-19 Update: Recent Developments Regarding the Infectious Disease
Saliva Test for Further Improvement
SalivaDirect's development as a medium of quickly expanding the test for COVID-19 was reportedly spearheaded by assistant professor Nathan Grubaugh and associate research scientist Anne Wyllie, both from Yale School of Public Health.
Wyllie said, with saliva being fast and easy to collect, they realized that it could be a game-changer in diagnosing COVID-19. More so, with a test that's urgently needed, the scientists were determined to reduce the times and costs of testing, to make it widely accessible.
According to Grubaugh, they simplified the test so it just costs a few dollars for reagents. He added that they expect that laboratories will only charge people roughly $10 per sample.
If less expensive substitutes such as SalivaDirect can be employed across the nation, the assistant professor elaborated, "We may finally manage this pandemic," saying that it can be done even before the occurrence of a vaccine.
Yale Pathology chair, Professor Chen Liu, said that the use of SalivaDirect will help their laboratory double the capacity for testing. Liu is also set to offer the saliva-based diagnostic test as a testing option in their clinical lab in the near future.
IN CASE YOU MISSED THIS: Young People in the U.S. Are Increasingly Contracting COVID-19
Check out more news and information on COVID-19 on MD News Daily.
Aug 17, 2020 12:46 AM EDT
