Health
FDA issues emergency permit for COVID-19 saliva test
SalivaDirect eliminates the need for nucleic acid extraction kits and increases testing potential.
The US Food and Drug Administration (FDA) has issued Saliva Direct’s Emergency Use Authorization (EUA). this is, Coronavirus disease 2019 (COVID-19 (New Coronavirus Infection) (# If there is no character limit, add brackets when first appearing).
The new test, developed by the Yale School of Public Health, does not require a special kind of swab or collector and instead can be collected in any sterile container.
SalivaDirect also eliminates the need for a separate nucleic acid extraction step, which has traditionally been lacking when used for another type of COVID-19 test.
The ability to run tests without the Nucleic Acid Extraction Kit increases your ability to increase your tests and reduce the strain on your available resources.
The SalivaDirect methodology has been validated and approved for use with a variety of commonly used reagents and instruments, suggesting that this test can be widely used in most complex laboratories.
Yale will provide the test protocol as an “open source” protocol to the relevant labs so that the designated labs can obtain the required components according to the protocol and perform the tests in the lab according to Yale’s instructions.
SalivaDirect is independent of its own equipment and can use a variety of off-the-shelf test components, allowing it to be assembled and used in complex labs throughout the United States.
SalivaDirect is the fifth FDA-approved test to use saliva as a sample for testing. Since saliva samples are self-collected under the supervision of a health care professional, they may also potentially reduce the risk presented to the healthcare professional responsible for collecting the sample.
“Providing this type of flexibility to process saliva samples and test for COVID-19 infections is a breakthrough in efficiency, avoiding the shortage of critical test components such as reagents. FDA Commissioner, Stephen M. Hahn, MD statement.. “The FDA encourages test developers to work with institutions to help them address the COVID-19 pandemic and create innovative and effective products that improve test capacity and efficiency. doing.”
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