Coronavirus: FDA approves Yale’s COVID-19 saliva test for emergency use
The US Food and Drug Administration on Saturday granted emergency use authorization to Yale School of Public Health’s saliva test to detect COVID-19, after a trial on National Basketball Association players and staff.
SalivaDirect, the fifth saliva test approved by the FDA for the disease, requires no swab or collection device and uses spit from people suspected of having the coronavirus, the agency said.
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FDA Commissioner Stephen Hahn called the test “groundbreaking” in its efficiency and in being unaffected by crucial component shortages.
SalivaDirect is seen as a cheap, simpler and less invasive testing method that requires no extraction of nucleic acid and can use several readily available reagents.
The NBA has used the test in a program involving asymptomatic players, coaches and staff from various teams, after partnering with Yale in June, the school said in a separate statement.
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“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,” Nathan Grubaugh, assistant professor at Yale School of Public Health, said.
One of the goals of the research team was to eliminate the need for expensive saliva collection tubes, and a separate study found that the virus is stable in saliva for prolonged periods at warm temperatures, and that preservatives or special test tubes were not necessary, Yale said.
The FDA said the test could lower the risk to healthcare workers from collecting samples as it is self-collected under the observation of a healthcare professional.
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