FDA approves saliva test for COVID-19

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Over the weekend, the FDA issued emergency use authorization (EUA) for the Yale School of Public Health’s SalivaDirect COVID-19 test.

Yale’s diagnostic test uses a new method of processing saliva samples when testing for COVID-19 infection without requiring a special swab or collection device, as the saliva can be collected in any sterile container. The test also does not require a separate nucleic acid extraction step.

According to a news release, the SalivaDirect methodology could increase the capacity for testing and reduce the strain on available resources.

Yale plans to offer the test’s protocol to interested laboratories as an open-source protocol, allowing the labs to obtain the required components and perform the test in their lab.

The FDA has already authorized four previous saliva tests, which, because they are self-collected, could potential…

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