FDA Approves Saliva Test for COVID-19

The FDA has issued an emergency use authorization for the SalivaDirect COVID-19 diagnostic test, developed by the Yale School of Public Health. The new test allows for saliva samples to be collected in any sterile container, rather than a nasal swab, and does not require a separate nucleic acid extraction step, unlike other COVID-19 diagnostics. It can run approximately 90 samples in less than three hours in a lab, and that number can be increased through automation.

The SalivaDirect test has been authorized for use with different combinations of commonly used reagents and instruments available at most high-complexity labs, and has so far yielded highly sensitive and similar results to nasal swab tests, according to results pre-published on medRxiv. The test does not rely on any proprietary components, so Yale intends to provide its “open source” SalivaDirect protocol to laboratories across the U.S., provided they comply with the conditions of authorization.

“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,” said FDA Commissioner Stephen Hahn, MD.

Sources: FDA press release, August 17, 2020; STAT, August 17, 2020; Vogels, CBF, Brackney D, Wang J, et al. SalivaDirect: Simple and sensitive molecular diagnostic test for SARS-CoV-2 surveillance. medRxiv preprint. August 4, 2020.