Getting easy, accurate, and widely accessible COVID-19 testing has been a challenge in the U.S. But, with the addition of a new COVID-19 saliva test, labs may be able to use widely available materials, making this test faster, cheaper, and more accessible.
There are a few different types of COVID-19 tests. The most common type of diagnostic test for COVID-19, meaning it can tell you if you have an active infection, is a nasal or throat swab, SELF explained previously. These tests can detect the presence of viral RNA, which is an indicator of COVID-19 infection.
However, these tests have a few notable drawbacks. For one thing, they can be uncomfortable (who really wants a giant swab all the way up their nose?). It can also take a while—a few days or even weeks—to get the results, depending on how many tests the lab has to get through. And, increasingly, labs are dealing with shortages of the chemical reagents required to run the tests as well as the swabs themselves, the New York Times reports.
All of these are reasons why the approval of the new test, which was developed by researchers at the Yale School of Public Health and authorized by the Food and Drug Administration (FDA) earlier this week, is so promising. (This is actually the fifth saliva test the FDA has authorized for coronavirus testing. For instance, previously, the FDA authorized an at-home saliva test created by Rutgers Clinical Genomics Laboratory back in May, which costs at least $100 per test.)
The new COVID-19 saliva test for viral RNA, called SalivaDirect, is unique in a few helpful ways. First off, you don’t need any special container to run the test—you can spit into any sterile container, the FDA says. Second, it doesn’t require the kind of swabs or reagent chemicals that are experiencing shortages right now because, unlike other tests, the RNA does not need to be extracted from the sample before testing with SalivaDirect.
Essentially, the test is a new, fast, and inexpensive way of identifying COVID-19 cases with chemicals and equipment that many labs already have. So, technically, SalivaDirect is not a kit or product, it’s a protocol—and it’s available to any interested and sufficiently equipped lab in the country.
The researchers were able to cut down costs further thanks to their own research, which found that the expensive chemicals or containers needed to preserve saliva before testing aren’t required for this. Additionally, the researchers found that different chemicals and equipment from different companies can still perform the test, allowing more flexibility for labs that may not all have the same supplies on hand.
SalivaDirect does appear to be accurate at diagnosing coronavirus infections. The researchers tested its effectiveness against another widely used COVID-19 test and found the results to be comparable, they say in a study published in pre-print (meaning it has not yet been peer-reviewed). The test was also verified in NBA players and was partially funded by the NBA and the National Basketball Players Association.
However, the FDA authorization notes that a negative result from a SalivaDirect test may need to be verified with another type of test in some cases. And, whether the result is positive or negative, it should not be the only information used in making treatment plans—a person’s symptoms should also be taken into account.
So far, experts have been excited about the development. “Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” FDA Commissioner Stephen M. Hahn, M.D., said in a press release. “This could be one the first major game changers in fighting the pandemic,” Andy Slavitt, the former acting administrator of the Centers for Medicare and Medicaid Services for the Obama administration, said on Twitter. “Rarely am I this enthusiastic.”
It’s estimated that labs should charge about $10 per test, STAT reports, but we won’t really know how much the tests cost until they’re more widely used. Still, the test was designed specifically to be inexpensive, its creators say. And, any for-profit lab that wants to use the test is required to get in touch with them to negotiate how much they should charge. Hopefully, the introduction of this new test gets the U.S. back on track towards providing the widespread testing we need to really fight this outbreak.
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