The US Food and Drug Administration (FDA) has granted an emergency use authorisation (EUA) to SalivaDirect Covid-19 diagnostic test developed by Yale School of Public Health.
The test uses a new method of processing saliva samples when testing for coronavirus infection.
SalivaDirect eliminates the need for swab or collection device and the samples can be collected in any sterile container. Additionally, the test does not require a separate nucleic acid extraction step.
The extraction kits used for nucleic acid extraction in other tests have been prone to shortages in the past. The elimination of kits from the testing process is expected to boost capacity for increased testing and reduce the strain on available resources.
FDA Commissioner Stephen Hahn MD said: “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 authorisation 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.”
Yale plans to offer the SalivaDirect protocol to interested laboratories as an ‘open-source’ protocol. The move will enable designated laboratories to follow the protocol to secure the required components and perform the test in their lab based on Yale’s instructions for use.
Furthermore, the test can be performed using a number of commercially available testing components, which can be assembled and used in high-complexity labs throughout the country.