Food and Drug Administration (FDA) commissioner Stephen Hahn called the development of a new and inexpensive saliva test for COVID-19 ”ground-breaking.” The new COVID test, which uses saliva instead of nasal swabs, is also a much less intrusive test than the nasal test.
The Food and Drug Administration on Saturday authorized emergency use of a new and inexpensive saliva test for Covid-19 that could greatly expand testing capacity. The new test is called SalivaDirect and was developed by researchers at the Yale School of Public Health.
The test method allows saliva samples to be collected in any sterile container. And, it is a much less invasive process than the nasal swabs currently used to test for the virus that causes Covid-19, but one that has so far yielded highly sensitive and similar results. This test is being further validated as a test for asymptomatic individuals through a program that tests players and staff from the National Basketball Association (NBA).
SalivaDirect is simpler, less expensive, and less invasive than the traditional method for nasal swab testing. Results so far have found that SalivaDirect is highly sensitive and yields similar outcomes as nasal swabbing.
“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,” said Nathan Grubaugh, a Yale assistant professor of epidemiology. “If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine.”
With the FDA’s emergency use authorization, the testing method is immediately available to other diagnostic laboratories that want to start using the new test, which can be scaled up quickly for use across the nation. A key component of SalivaDirect is that the method has been validated with reagents and instruments from multiple vendors.
References:
- https://khn.org/morning-breakout/fda-signs-off-on-fast-inexpensive-saliva-test/
- https://news.yale.edu/2020/08/15/yales-rapid-covid-19-saliva-test-receives-fda-emergency-use-authorization