FDA grants first coronavirus clearance for sample pooling to Quest

By LabPulse.com staff writers

July 20, 2020 -- The U.S. Food and Drug Administration has granted Quest Diagnostics the first emergency use authorization for a SARS-CoV-2 molecular diagnostic for testing pooled samples.

The Quest SARS-CoV-2 real-time reverse transcription polymerase chain reaction (RT-PCR) test was granted clearance on July 18 for use in testing specimens for up to four individuals. It was previously granted clearance for testing individual samples in March.

Sample pooling allows more people to be tested and uses fewer testing resources. If a pool of specimens tests positive, each sample is then tested again individually. The FDA issued guidance on pooling this month and the method has become an important part of testing strategy for the White House Coronavirus Task Force as a means of boosting throughput. Quest has reported challenges in meeting demand for testing with quick turnaround in recent weeks.

"The FDA continues to work with a number of diagnostic test developers to facilitate new approaches and get additional tests to more Americans more quickly," the agency said in a statement.

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Copyright © 2020 LabPulse.com

Last Updated eh 7/20/2020 4:09:43 PM



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