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Today, we issued an emergency use authorization to @Yale for its SalivaDirect #COVID19 diagnostic test, which uses a new method of processing saliva samples. This is the 5th test FDA has authorized using saliva as a sample for testing. fda.gov/news-events/pr…
With this test, a saliva sample can be collected in any sterile container. The test doesn’t need a special swab or collection device, or a separate nucleic acid extraction step.
Being able to perform a test without extraction kits can increase testing capacity and reduce the strain on resources. Also, the test can be used more broadly with different combinations of commonly used reagents and instruments.
Since the saliva sample is self-collected under the observation of a health care professional, this test could also potentially lower the risk posed to health care workers responsible for sample collection.
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