US FDA issues EUA for saliva Covid-19 testing
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for the virus.
SalivaDirect does not require any special type of swab or collection device, Xinhua news agency reported citing the FDA as saying on Saturday.
A saliva sample can be collected in any sterile container.
The 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, said the FDA in a release.
Being able to perform a test without these kits enhances the capacity for increased testing, while reducing the strain on available resources, said the release.
“The SalivaDirect test for rapid detection of SARS-CoV-2 is yet another testing innovation game changer that will reduce the demand for scarce testing resources,” said Assistant Secretary for Health and Covid-19 Testing Coordinator Admiral Brett Giroir.
“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.
This is the fifth test the FDA has authorized that uses saliva as a sample for testing.