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FDA grants emergency use authorization to new COVID-19 saliva test

Yale scientists say the test is ‘simpler, less expensive, and less invasive’ than the standard nasal swab test

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The FDA has granted emergency use approval to a “groundbreaking” COVID-19 saliva test used on NBA players and staff. 

The test, dubbed “SalivaDirect,” was developed by researchers at the Yale School of Public Health. It doesn’t rely on additional components, meaning it’s less likely to see the same testing shortages that have been seen with the standard coronavirus nasal swab test. 

The results of a June study on NBA players (chosen because they are tested regularly, are in close contact with one another, and don't wear face coverings) showed that the test was “simpler, less expensive, and less invasive than the traditional method for such testing.” 

SalivaDirect “is being further validated as a test for asymptomatic individuals through a program that tests players and staff from the National Basketball Association (NBA),” Yale said in a news release. “Results so far have found that SalivaDirect is highly sensitive and yields similar outcomes as NP swabbing.” 

Now that the FDA has issued emergency use authorization, the testing method has been made “immediately available to other diagnostic laboratories that want to start using the new test,” Yale said. 

Making testing more accessible 

Because saliva is quickly and easily collected, the new test can help decrease testing times and costs, the researchers said. 

“Wide-spread testing is critical for our control efforts. We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about $10 per sample. If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine,” said Nathan Grubaugh, associate research scientist at Yale. 

Grubaugh said he expects labs to charge about $10 per sample.

"If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine," Grubaugh said, according to the Yale news release.

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