3 hr 29 min ago

FDA grants emergency use authorization to quick, inexpensive saliva-based Covid-19 diagnostic test

From CNN Health’s Lauren Mascarenhas

Sarah Silbiger/Getty Images

The US Food and Drug Administration announced Saturday that it has granted emergency use authorization to a Covid-19 diagnostic test that uses a new, inexpensive method of processing saliva samples.

The test, called SalivaDirect, has been found to be highly sensitive, yielding similar outcomes to nasopharyngeal swabbing. Under the observation of a health care worker, saliva is self-collected in a sterile container without the use of a specific swab or collection device.

The molecular diagnostic test can yield results in under three hours, researchers said, and up to 92 samples can be tested at once. Researchers said the test costs only a couple dollars for reagents, and they expect labs to charge only about $10 per sample.

The method is being used by the National Basketball Association to test asymptomatic people for coronavirus. The NBA was among the groups that funded the research.

“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," Adm. Dr. Brett Giroir, the White House Covid-19 testing coordinator, said in a statement.

Looking to the future: The FDA has authorized four other coronavirus tests which use saliva samples.

Emergency use authorization allows the FDA to greenlight a product to test for coronavirus on an expedited basis.

https://www.cnn.com/world/live-news/...ntl/index.html