Have saliva tests been approved by the FDA as a sample for the coronavirus disease testing?
With the many kinds of COVID-19 testing today, the most comfortable and easiest-to-perform test is the NAAT test that takes samples from your saliva.
But before scheduling a saliva test, many may wonder if it’s accurate or FDA-approved. Among the many types of COVID tests are being tested and regulated by the FDA, the saliva test is one of them. In fact, there is a list of FDA approved antigen tests and other COVID-19 tests.
The NAAT test is an FDA approved test for COVID-19. Let’s talk about the NAAT saliva test, its effectiveness, and its approval from the FDA.
Have saliva tests been approved by the FDA as a sample for the coronavirus disease testing?
Yes, as of August 15, 2020, the Nucleic Acid Amplification Test (NAAT) saliva test has been approved for emergency use by the FDA.
The NAAT COVID test is a version of a viral diagnostic test for COVID-19; it detects the presence of genetic material, known as nucleic acids. The NAATs designed specifically for COVID-19 identify the ribonucleic acid (RNA) sequences that make up the virus’s genetic material. The COVID-19 NAAT takes samples from a person’s saliva.
The FDA Commissioner Stephen M. Hahn, M.D., stated in a press release:
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.
Today’s authorization is another example of the FDA working with test developers to bring the most innovative technology to market in an effort to ensure access to testing for all people in America. The FDA encourages test developers to work with the agency to create innovative, effective products to help address the COVID-19 pandemic and to increase capacity and efficiency in testing.
Are saliva tests just as effective as nasal swabs to diagnose COVID19?
According to a study by investigators at McGill University that was published in January of 2021 in JAMA Internal Medicine, the saliva test for COVID-19 is as effective as the standard nasopharyngeal tests (the nasal swabs).
A corresponding author of the study, Guillaume Butler-Laporte, MD, of McGill University Health Center, said in an article by Contagion, “[The] biggest takeaway is that whether you perform a test using a nasopharyngeal swab or a saliva sample, you can trust the results equally. However, saliva tests are simpler, more comfortable, and don’t require a trained nurse. Hence, they represent an attractive alternative to our current best tests.”
What is the Covid saliva test false positive rate?
There are currently no officially confirmed numbers for the saliva test’s false positive rate. However, from the same study by investigators at McGill University, saliva-based testing has accurately detected positive COVID-19 infections 83% of the time. In comparison, nasal swab tests have shown 85% accuracy.
Dr. Keyur P. Patel, M.D., Ph.D., a molecular diagnosis expert, and the medical director, Molecular Diagnostics Laboratory at the University of Texas, speaks with the university’s MD Anderson Cancer Center about the accuracy of the saliva test.
In the interview, Dr. Patel states, “An appropriately designed saliva test can be highly accurate. The FDA has recently issued emergency use authorization for saliva-based tests for clinical use based on a high level of accuracy that’s comparable to COVID-19 nasal swab testing.”
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