Yale School of Public Health has secured emergency use authorisation (EUA) from the US Food and Drug Administration for its SalivaDirect Covid-19 diagnostic test.
The laboratory diagnostic test uses a new method for the processing of saliva samples with suspected patients of Covid-19 infection.
FDA commissioner Stephen Hahn said: “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.”
SalivaDirect test avoids the use of a separate nucleic acid extraction step
SalivaDirect test will not use any special type of swab or collection device and can be collected in any sterile container. The test also avoids the use of a separate nucleic acid extraction step.
The SalivaDirect methodology has also been validated and authorised for use with different combinations of commonly used reagents and instruments, helping to easily use the test in high-complexity labs.
According to the Yale School of Public Health, the SalivaDirect is simpler, less expensive, and less invasive than the traditional nasopharyngeal (NP) swabbing method for such testing.
The SARS-CoV-2 is found to be stable in saliva for prolonged periods at warm temperatures in a separate study conducted by assistant professor and associate research scientist Anne Wyllie and the team at the Yale School of Public Health.
Wyllie said: “With saliva being quick and easy to collect, we realized it could be a game-changer in Covid-19 diagnostics.”
In June this year, genomics company Phosphorus secured FDA EUA status for its at-home saliva test for Covid-19 disease.
