FDA Issues An Emergency Authorization for NBA, NBPA-Funded COVID-19 Testing

Saturday, the U.S. Food and Drug Administration issued an emergency authorization to allow the public use of a saliva-based test for COVID-19, funded by the NBA and the National Basketball Players Association, and developed at Yale University.

The test, better known as SalivaDirect, was designed for widespread public screening. The price to use the exam could cost between $15 to $20, according to outlets, which is much cheaper than another saliva test developed at a Rutgers University lab in April that cost up to $150.

The Rutgers test can be taken at home and returns results in 24 to 48 hours, Andrew Brooks, an associate professor at Rutgers and chief operating officer of RUCDR Infinite Biologics, the lab behind the test, said.

Reports state that multiple NBA teams were using the Rutgers test, which was given the same authorization by the FDA in June. Those teams flew the saliva samples to one of several labs — including the Rutgers lab in New Jersey, which added time and cost. But now, there is a new test that may not be as costly or time-consuming.

The Yale test funded by the league and players’ union is simple enough to be used by labs everywhere, provided they go through required accreditation processes, according to Grubaugh, an assistant professor of epidemiology at Yale.

“Through some miracle, this is working,” he added. “It’s sensitive. It’s cheap. And now it’s getting approval. I’m not quite sure how we ended up here from April.”

“(The Yale test) loses a little bit of sensitivity, but what we gain is speed and that it should be up to 10 times cheaper. The Yale test replaces the extraction step with the introduction of a reagent — chemicals mixed with the saliva sample — and a short heating process that releases the virus genome. The team found successful results using reagents that are commonly available, meaning labs everywhere could implement the Yale protocol.”

According to ESPN, the Yale-NBA partnership ignited after the University’s team released preliminary research indicating saliva tests taken on COVID-19 patients and health care workers were as efficient as nasal swab tests. “That was a critically important paper,” said Martin Burke, a chemistry professor at the University of Illinois whose team developed a similar direct saliva test. “It was inspiring to us.”

Illinois is now administering its test to returning faculty and staff — tens of thousands of people. They intend to test people twice per week, Burke said.

“My goal is not to test athletes,” Grubaugh said. “That’s not my target population. My target population is everybody. There were concerns about partnering with the NBA when all these other people need testing. But the simple answer ended up being the NBA was going to do all this testing anyway, so why not partner with them and try to create something for everyone?”

 

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