Coronavirus (COVID-19) Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing | FDA

Coronavirus (COVID-19) Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing | FDA

COVID-19 Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing

Today, the U.S. Food and Drug Administration (FDA) reissued an Emergency Use Authorization (EUA) to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual upper respiratory swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples. Sample pooling allows a lab to combine and test samples in a “batch.” Ultimately, pooling is expected to require fewer tests, meaning fewer testing supplies are used and more tests can be run at the same time allowing patients to receive their results more quickly in most cases.

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