The US Food and Drug Administration (FDA) 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 (NBA) players and staff, which has sparked hope that it will be a game-changer for the NFL season.
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.
The NBA and the players union combined to contribute more than $500,000 for the Yale research that led to the test.
FDA Commissioner Stephen Hahn called the test ‘groundbreaking’ in its efficiency and in being unaffected by crucial component shortages.
‘A lot of sports leagues and larger organizations were thinking, “OK, we’re shut down, so what can we do? We are going to have to be testing our population – players – all the time if we want to play again. How can we do that?”‘ Nathan Grubaugh, assistant professor at Yale School of Public Health, said.
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.
‘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,’ Grubaugh.
NBA players and staff were tested with both a SalivaDirect test and a nasal swab test before the league’s return to play.
When the results were compared, almost all of them matched. The nasal swab test, developed at Rutgers, can cost as much as $150, ESPN said.
Results of the SalivaDirect test can be back within 24 hours.
According to Yahoo News, the test is expected to be a game-changer for the general public and professional sports, including the NFL.
Testing for players and team employees would become an affordable and consistent occurrence.
It could also help fans keep themselves safe before and after event attendance.
‘There we go,’ one NFL general manager told Yahoo News. ‘I hope that ends up being the route the league goes!’
One of the goals of the research team was to eliminate the need for expensive saliva collection tubes.
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.