A newly developed COVID-19 test that can determine if someone has the novel coronavirus by testing their saliva has been approved by the Food and Drug Administration.
The FDA on Saturday authorized emergency use of the test developed by scientists at the Yale School of Public Health.
According to researchers, the test, called SalivaDirect, allows samples of saliva to be collected in a sterile container as opposed to the use of nasal swabs that must be inserted high into a person’s nasal cavity to collect a sample.
The tests, according to Yale scientists, are inexpensive and quick. The FDA’s emergency authorization for use allows diagnostic laboratories to immediately begin using SalivaDirect for COVID-19 testing.
The test is less expensive than the nasal swab test and skips the step of extracting the virus’ DNA from nasal swab tests.
“With saliva being quick and easy to collect, we realized it could be a game-changer in COVID-19 diagnostics,” Anne Wyllie, associate research scientist at Yale School of Public Health said in a statement released by the school. Wyllie and Nathan Grubaugh, an assistant professor at Yale School of Public Health, headed the research team.
Yale intends to provide its “open source” testing protocol to laboratories around the country.
In addition to a quick turnaround and the ease of sample collection, a major advantage to the test is its low-cost point. Yale researchers say they imagine labs should charge around $10 per sample.
“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,” FDA Commissioner Stephen Hahn said in a statement.
The test is being seen as a major step in expanding testing for the virus.
“Widespread testing is critical for our control efforts,” Yale researcher Nathan Grubaugh said in a statement. “If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine.”
The research team has partnered with the NBA, according to the statement. The researchers tested SalivaDirect on NBA players, coaches, and staff.
Cox Media Group
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