FDA Issues Emergency Use Authorization For Potential Game-Changing COVID-19 Saliva Test
PHILADELPHIA (CBS) -- COVID-19 is now the No. 3 cause of death in the United States. The Food and Drug Administration has issued an emergency use authorization for a saliva test that can easily detect COVID-19.
The technology is being described as a potential game-changer.
This is what many have been waiting for -- a quick, non-invasive and inexpensive way to find out if they've been infected with the coronavirus.
The newest saliva COVID-19 test to get the nod from the FDA was developed by researchers at Yale University and funded by the National Basketball Association, which also uses the test that's called SalivaDirect.
"It doesn't need the same re-agents and swabs that have been the limiting steps to create testing at scale in this country. It really could be a game-changer if we can deploy it," said epidemiologist Dr. Abdul El-Sayed.
The test was developed for people who don't have symptoms.
It's thought to be about 90% as accurate as other tests using nose and throat swabs, the developers expect up to 200,000 samples a day could be processed.
"I think it will take weeks, if not longer, for this test to become more widely available, but as it comes online, I think people will like it much better than the more intrusive nasal swab test," said Dr. William Schaffner of Vanderbilt University.
In addition to being less invasive, the saliva test is cheaper and quicker.
Officials say results can be determined in under three hours, which is considered critical in containing the virus.
"This virus is still spreading widely in the communities, it's not under control yet over much of the United States, I'm afraid," said Dr. Schaffner.
According to the COVID Tracking Project, testing is down in 17 states. There have been supply shortages and experts say that virus fatigue is growing and people are not bothering to get tested.
"We've really under-invested in public health for decades now and continue to do so during this entire period and haven't done the work necessary to contain the virus," said medical analyst Dr. Céline Gounder.
The Yale saliva test is the fifth to be cleared by the FDA. One had been developed by researchers at Rutgers University in New Jersey.
The question now is how quickly the tests would be made available and where?
