SalivaDirect does not require any special type of swab or collection device; a saliva sample can be collected in any sterile container. This test is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past. Being able to perform a test without these kits enhances the capacity for increased testing, while reducing the strain on available resources. Additionally, the SalivaDirect methodology has been validated and authorized for use with different combinations of commonly used reagents and instruments, meaning the test could be used broadly in most high-complexity labs.

 

The new test, which is called SalivaDirect and was developed by Yale University researchers, allows saliva samples to be collected in any sterile container. It is a much less invasive process than the nasal swabs currently used to test for the virus that causes Covid-19, but one that has so far yielded highly sensitive and similar results. The test also avoids a key step that has caused shortages of chemical reagents used in other tests.

 

Yale intends to provide its “open source” testing protocol to laboratories around the country. Other labs can now adopt the method while using a variety of commercially available testing components that can reduce costs and speed turnaround times, according to the FDA. The Yale researchers have estimated it should cost about $10 to run a test.

Read more: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-yale-school-public-health