FDA Issues Emergency Authorization for COVID-19 Saliva Test

SalivaDirect eliminates the need for nucleic acid extraction kits, enhancing the potential capacity for testing.

The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for SalivaDirect, a new diagnostic test for the coronavirus disease 2019 (COVID-19).

The new test, developed by the Yale School of Public Health, does not require any special type of swab or collection device, instead can be collected in any sterile container.

SalivaDirect also does not require a separate nucleic acid extraction step, which have been prone to shortages in the past when used for other types of COVID-19 tests.

Being able to perform a test without the nucleic acid extraction kits enhances the capacity for increased testing and reduces the strain on available resources.

The SalivaDirect methodology has been validated and authorized for use with different combinations of commonly used reagents and instruments, suggesting the test could be used broadly in most high-complexity labs.

Yale intends to provide the test protocol to interested laboratories as an “open source” protocol, allowing designated laboratories to follow the protocol to obtain the required components and perform the test in their lab according to Yale’s instructions.

Because SalivaDirect does not rely on proprietary equipment and can use a variety of commercially available testing components, it can be assembled and used in high-complexity labs throughout the US.

SalivaDirect represents the fifth test the FDA has authorized that uses saliva as a sample for testing. Since the saliva sample is self-collected under the observation of a healthcare professional, it could also potentially lower the risk posed to healthcare workers responsible for sample collection.

“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, MD, said in a statement. “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.”