FDA grants emergency use authorization for saliva coronavirus test that has fast results

By | August 16, 2020

The Food and Drug Administration granted emergency use authorization for a saliva-based testing system that can return accurate results in less than three hours.

The SalivaDirect test is conducted using saliva collected in a container without a swab and has a sensitivity of results similar to nasal swabs, which have been used to test for COVID-19 since the start of the pandemic. The FDA announced its emergency use authorization on Saturday, according to CNN.

Another major advantage is that up to 92 samples can be tested at once. The price of the test is also relatively low, with the cost largely confined to the reagents used. Researchers have estimated a cost of about $ 10 per sample.

White House coronavirus testing coordinator Adm. Dr. Brett Giroir said that the emergency use authorization would buoy resources as the country continues to grapple with the virus. The FDA has previously authorized four other saliva-based tests for COVID-19.

“The SalivaDirect test for rapid detection of SARS-CoV-2 is yet another testing innovation game-changer that will reduce the demand for scarce testing resources,” Giroir said in a Saturday statement.

The U.S. has the most confirmed cases of coronavirus in the world, standing at around 5.3 million cases and nearly 170,000 deaths.


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