FDA authorizes Covid-19 saliva test for emergency use

Laboratory technician hold coronavirus test tube for COVID-19 test

The US Food and Drug Administration has authorized a saliva test for “emergency use” for diagnosing Covid-19. Rutgers University, where the test was developed in collaboration with other groups, announced the FDA authorization on Tuesday after formally receiving it over the weekend.

Using saliva to diagnose novel coronavirus infections could expand testing capacities across the United States. So far testing for Covid-19 has usually involved nose or throat swabs.
 
“It means we no longer have to put health care professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections,” Andrew Brooks, chief operating officer and director of technology development at the university’s RUCDR Infinite Biologics lab, said in a news release on Tuesday.
 
“We can preserve precious personal protective equipment for use in patient care instead of testing. We can significantly increase the number of people tested each and every day as self-collection of saliva is more quick and scalable than swab collections,” Brooks said. “All of this combined will have a tremendous impact on testing in New Jersey and across the United States.”
 
According to Rutgers University’s news release, this is the first such saliva test to receive emergency use authorization from the FDA. Brooks, a professor at the university, called the impact of the authorization “significant.”
 
Rutgers University has partnered with the RWJBarnabas Health network and Middlesex County in New Jersey to make the saliva tests available beginning on Wednesday to residents through a drive-thru testing facility in Edison, New Jersey.
 
US Food and Drug Administration Commissioner Dr. Stephen Hahn, emphasized on “Fox & Friends” Tuesday morning that the new saliva-based Covid-19 test that received an emergency use authorization is not a test that can be done at home.
 
“This is not an at-home test. This still has to be performed with a provider, but it does provide great advantages moving forward and expands the opportunities for testing,” Hahn said.
 
“It highlights the great innovation that we’ve seen around the country in response to the outbreak,” he aid. “You can use saliva rather than the swab in the nose. It’s more comfortable for the patient. Obviously, it can be repeated multiple times and it’s actually safer for the health care provider in terms of collection.”
 
At this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19. The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space.

Our resources are now devoted to COVID-19 clinical research

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