The U.S. Food and Drug Administration has issued an emergency use authorization for a new saliva-based test to detect coronavirus infection.
The test, which was developed by Yale School of Public Health, is less invasive than the usual nasopharyngeal (NP) and oropharyngeal (OP) tests which involves cotton swabs gathering samples up the nose or to the back of throat. It just requires a sample of saliva in a sterile container to check for severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) genetic material.
The National Basketball Association has actually been largely involved in the development of this test – they provided funds alongside a Fast Grant from the Emergent Ventures at the Mercatus Center, George Mason University. They also became part of the study to determine the saliva test’s effectiveness at detecting the virus.
In case you missed it, the NBA resumed their 2019-2020 season on July 30 – following the suspension announced in March. Players coaches and staff have been living in a bubble – an isolation zone with strict rules that the NBA set up to help keep everyone involved in the games coronavirus-free – which includes regular testing for COVID-19 prior to and throughout the season restart, wearing a face covering or mask, and social distancing to prevent an outbreak of COVID-19 from occurring.
The study, which has been coined the Surveillance with Improved Screening and Health (SWISH) study, has allowed the NBA to use SalivaDirect alongside the more usual NP test – a ThermoFisher Scientific TaqPath COVID-19 combo kit – to be able to compare the results. The Yale team that developed the test has posted a pre-print publication on medRxiv of the study, which showed the results were comparable over 94% of the time. However, the study done has not undergone per-review yet. It’s also important to note that, so far, the NBA has reported no positive cases.
“This, I hope, is a turning point,” Dr. Anne Wyllie, associate research scientist at the Yale School of Public Health and one of the leads on SalivaDirect, told ABC News. “Expand testing capacity, inspire creativity and we can take competition to those labs charging a lot, and bring prices down. And that we can show people what can be done.”
Former FDA commissioner, Dr. Scott Gottlieb, has called the test “highly significant.”
“It’s also been cross-validated on just about every popular platform for doing testing,” Dr. Gottlieb said on Squawk Box. “So it’s easy to use. It’s unlikely to be in limited because of shortages in the testing supply chain.”
“It’s something that we can roll out on a very wide fashion,” he added.
He also anticipates more coronavirus tests will be available in the U.S. soon.
“What you’re going to see is a lot of this innovation come on the market all at once. This has been worked on for months, and it takes time to move this through the development process,” Dr. Gottlieb said.
“But I think we’re coming at the point right now that you’re going to see a real explosion in testing opportunities and you’re not going to be so dependent on lab-based testing, which what has been in short supply,” he added.
