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FDA grants emergency use authorization to Yale School for SalivaDirect COVID-19 diagnostic test

The Food and Drug Administration (FDA) has granted emergency use authorization to Yale School of Public Health’s SalivaDirect COVID-19 diagnostic test on Saturday.

“The SalivaDirect test for rapid detection of SARS-CoV-2 [the novel coronavirus] is yet another testing innovation game changer that will reduce the demand for scarce testing resources,” said Adm. Brett Giroir, the US official in charge of COVID-19 testing efforts.

Unlike some other tests, SalivaDirect does not require any special type of swab or collection device as a saliva sample can be collected in any sterile container, the FDA said.

“We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about $10 per sample,” said Nathan Grubaugh, a Yale assistant professor of epidemiology.

“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,” the DFA said.

It also said that 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.

“Testing saliva eliminates the need for nasopharyngeal swabs, which have also been prone to shortages, and alleviates the patient discomfort associated with these swabs.”

The FDA added that it could also potentially lower the risk posed to healthcare workers responsible for sample collection as the saliva sample is self-collected under the observation of a healthcare professional.

Yale plans to provide its protocol as “open-source,” meaning designated labs could follow the protocol to perform their own tests according to Yale’s instructions, the FDA said.

The National Basketball Association was among the groups that helped fund the research for the test and currently uses it to test for non-symptomatic carriers of the virus.


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