FDA Authorizes New Saliva Test For Covid-19 Coronavirus, NBA Tests It

SalivaDirect sounds like a bank that can quickly give you lots of saliva. But thankfully it isn’t.

Instead, it is a new saliva test to help diagnose a Covid-19 coronavirus infection. The U.S. Food and Drug Administration has issued emergency use authorization (EUA) for this test to the Yale School of Public Health. The test doesn’t check for the amount of saliva that you generate when someone asks you if you are infected with the Covid-19 coronavirus. Rather if you provide a sample of saliva in a sterile container, the SalivaDirect test can check for the presence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) genetic material. It’s now the fifth saliva test that has received such authorization from the FDA. What makes this test unique is that you don’t have to take an extra step to separate the genetic material or nucleic acid from the sample.

More saliva tests being available should be good news if you happen to not like having long cotton swabs stuck up your nose or to the back of throat, the so-called nasopharyngeal (NP) and oropharyngeal (OP) tests. You may happen to like the feeling up a cotton swab doing the Futsal Shuffle dance into your brain. But most people don’t. Plus, saliva tests don’t require cotton swabs, which are in short supply along with toilet paper and basically every thing that’s needed during this pandemic.

More saliva tests being available can help health care workers too. NP does not stand for no problemo. After all, unless the cotton swabs are six feet long, health care workers typically have to get close to patients’ noses and mouths to perform the more traditional NP tests. Being less than one Denzel Washington (Washington is about six feet tall) away from patients can put health care workers at greater risk for getting infected. Saliva test then would allow health care workers to provide a receptacle for patients to spit into and return to the health care worker, all while staying one Denzel away.

As Michael Greenwood described for the Yale News, the National Basketball Association (NBA) has helped fund development of the test and has been helping test the test. This month, the NBA has been finishing its 2020 season in a bubble, not an enormous soap bubble but rather a social bubble. That means players, coaches, and staff have been staying separate from the rest of the world in Orlando, Florida, facilities. The NBA is trying to keep the Covid-19 coronavirus from entering this bubble so that players, coaches, and staff can continue to interact with each other. Therefore, a key part of this bubbling has been testing everyone on an almost daily basis. This has been an opportunity for people to get both the traditional NP tests and the SalivaDirect tests and compare the performance of both types of tests. Yes, these days dribbling has multiple meanings in Orlando.

The concern about saliva tests is that they may yield variable performance. The virus, which typically infects and reproduces in your respiratory tract, has to make its way into your saliva. Additionally, the amount of saliva that you produce can vary quite significantly depending on a range of different factors such as the distance that you happen to be from avocado toast at the time. The Yale team that developed the SalivaDirect test has posted a pre-print publication on medRxiv reporting on a study testing of their SalivaDirect test. The study compared the saliva test with NP test using the ThermoFisher Scientific TaqPath COVID-19 combo kit and found that results were comparable over 94% of the time. Keep in mind that a pre-print has not gone through peer-review and has not been published in a reputable pee-reviewed scientific journal yet. In other words, it’s still in the pre-game warm ups rather than the prime time. So take all of the results with a hoop-ful of salt.

In order to make the testing more widely available, the Yale team is making the testing protocol “open source.” That means laboratories can follow the available protocol without having to use any special proprietary equipment or testing components. The research team has a established a web site with details about the test. The test is relatively inexpensive too, costing between $1.29 and $4.37 per sample, according to the pre-print publication. That’s less than a scalp massager or or a geometric triangle hair clip on Amazon.