The FDA has granted emergency use authorization to the Yale School of Public Health in New Haven, Conn., for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples.
The test doesn’t require any special type of swab or collection device, and saliva samples can be collected in any sterile container. It also doesn’t require a nucleic extraction step, which is significant because extraction kits used in other types of tests have been in shortage.
The test has been authorized for use with different combinations of commonly used reagents and instruments, meaning it could be used broadly in most high-complexity labs.
For the test, saliva is self-collected under the observation of a healthcare professional.
Brett Giroir, MD, the assistant secretary for health, called the test a “game changer” for reducing demand for scarce testing supplies.
“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, MD.
Read the FDA’s full news release here.
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