COVID-19 Saliva Test Partly Funded by NBA Gets FDA Emergency Use Approval
A saliva-based COVID-19 Test received emergency-use approval from the U.S. Food and Drug Administration (FDA) on Saturday.
The COVID-19 Test processes saliva samples and doesn't require special swabs or collection devices said a Bloomberg report.
It is called SalivaDirect, a non-invasive, and requires just a small sample, reported USA Today. This process makes the healthcare workers collecting samples less at risk of contracting COVID-19.
It is also a more straightforward and less expensive test than the traditional method for COVID-19 testing, known as nasopharyngeal (N.P.) swabbing. So far, results have found that it is a highly sensitive test and gives results that are like the N.P. swabbing, Yale News reported.
A report from Forbes said it could detect the presence of the SARS-CoV2 genetic material in saliva.
FDA Commissioner Stephen Hahn said in a statement that the saliva test is "groundbreaking" in terms of efficiency and dodging shortages for tests. It is now the fifth to get the emergency use approval from the FDA.
Cost of Yale Saliva Test
Research on the test was done by Yale University's School of Public Health. It received partial funding from the National Basketball Association (NBA) and the union representing NBA players.
According to the FDA, while they have seen "variable performance" in saliva tests, Yale's SalivaDirect is accurate enough to get emergency approval. The approval was done based on data submitted.
The university plans to give the test protocol to interested labs under an "open source" arrangement. It won't rely on any proprietary equipment from Yale, said the FDA.
Anne Wyllie, an associate research scientist at Yale, said she expects labs to charge about $10 for the tests. But Yale researchers said they don't seek to gain profits from the test method.
Scott Gottlieb, former FDA head, said in an August 8 tweet that this test method could be the "lowest cost test to hit the market with the ability to be pooled."
With the low price tag that comes with the test, it is possible to test people on a more usual basis. It will be most helpful to reopening schools and businesses.
NBA's Use of SalivaDirect
Back in June, NBA players opted in to the test program and gave samples for the study.
The league is keeping itself away from the rest of the world in its Florida bubble. So, they try their best to keep COVID-19 from entering the bubble.
They want players, coaches, and staff to continue to interact without worry about the virus. A key part of this process is making sure all of them get tests on an almost daily basis.
The effort to keep COVID-19 from entering the bubble became an opportunity to test both the N.P. Tests and the saliva tests. In the bubble, both tests were compared in terms of performance.
The NBA study was dubbed SWISH, or Surveillance with Improved Screening and Health.
Nathan Grubaugh, assistant professor at Yale School of Public Health, talked about the NBA's role in the study. He said the league did have a strong desire to give back to the public, especially those in low-income communities.
"It became immediately clear that our interests were aligned," said Grubaugh.
SalivaDirect will most likely roll out in some labs in the coming days.
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