FDA Signs Off On Fast, Inexpensive Saliva Test
FDA commissioner Stephen Hahn called the development ''groundbreaking." The test is also much less intrusive test than the nasal test.
Stat:
FDA Clears Saliva Test For Covid-19, Opening Door To Wider Testing
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, which is called SalivaDirect and was developed by researchers at the Yale School of Public Health, allows saliva samples to be collected in any sterile container. 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. (Silverman and Joseph, 8/15)
The Wall Street Journal:
The FDA Authorizes A Cheap, Fast Saliva Test—And The NBA Is Involved
Chantal Vogels studies bugs. A medical entomologist at the Yale School of Public Health, her expertise is mosquitoes, ticks and the nasty viruses they spread. “Human research is new to me,” she said. But she went from studying the very small to the very tall as part of a Yale team trying to solve the biggest problem in the United States through an improbable population of research subjects: NBA players. (Cohen and Radnofsky, 8/15)
Yale News:
Yale’s Rapid COVID-19 Saliva Test Receives FDA Emergency Use Authorization
A saliva-based laboratory diagnostic test developed by researchers at the Yale School of Public Health to determine whether someone is infected with the novel coronavirus has been granted an emergency use authorization by the U.S. Food and Drug Administration (FDA). The method, called SalivaDirect, 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 such testing, known as nasopharyngeal (NP) swabbing. Results so far have found that SalivaDirect is highly sensitive and yields similar outcomes as NP swabbing. (Greenwood, 8/15)
CNN:
US Coronavirus: Saliva-Based Covid-19 Test Could Be A 'Game Changer'
"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." (Yan and Maxouris, 8/16)
