FDA Approval – SalivaDirect

The Food and Drug Administration on Saturday authorized emergency use of a new and inexpensive saliva test for Covid-19 that could greatly expand testing capacity.

The new test, which is called SalivaDirect and was developed by researchers at the Yale School of Public Health, allows saliva samples to be collected in any sterile container. It is a much less invasive process than the nasal swabs currently used to test for the virus that causes Covid-19, but one that has so far yielded highly sensitive and similar results. The test also avoids a key step that has caused shortages of chemical reagents used in other tests.

The research team validated SalivaDirect in part by testing NBA players, coaches, and staff, and Yale said the test is now being studied in asymptomatic people through the program with the NBA and its players union.

FDA clears saliva test for Covid-19, opening door to wider testing

Get tested and wear a mask.

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To understand why this is a potential game changer this article on rapid screening tests.

First, frequent testing catches the vast majority of cases. Someone who is infected but gets a false-negative and slips through the cracks is likely to be caught the next time they’re tested. For a test that misses 20% of positive cases, the chance of an infected person getting two false negatives in a row may be as low as 4%. It’s like bailing a boat with a leaky bucket: You just have to bail more quickly to get the job done.

Second, most people who get false-negative results are unlikely to be contagious. Antigen-based screening tests are good at detecting the high virus levels needed to be contagious. By design, screening tests sacrifice accuracy where it matters least to achieve low costs, speed and ease of use.

AND I learned that the SalivaDirect test was funded by the NBA.

“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?”

The NBA, Yale and the players’ association do not intend to take royalties from any use of the testing method, Grubaugh and others said. The NBA and union contributed more than $500,000 combined to fund the Yale work, sources told ESPN.

Saliva-based coronavirus test funded by NBA, NBPA gets emergency authorization from FDA

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