FDA Grants Emergency Authorization for COVID-19 Specimen Pooling

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Quest Diagnostics for specimen pooling via its proprietary molecular diagnostic test for coronavirus 2019 (COVID-19).

With the emergency indication granted this weekend, Quest Diagnostics is now the first lab in the US to receive FDA authorization for COVID-19 specimen pooling testing.

Pooling testing calls for the combination of individual specimen vials into small batches by laboratory investigators—creating an outcome of either a negative or positive result. If the batch is negative, all patients pooled in the test are considered negative. If the results are positive, each specimen is then retested individually.

Through this, Quest Diagnostics could more efficiently evaluate samples from persons in regions or populations reporting low rates of COVID-19 spread. The practice is common in blood blanking, among other fields.

In a clinical trial assessing the benefit of the Quest laboratory’s pooling system, investigators reported that none of the 3091 total specimens from a population in the tenth percentile of COVID-19 prevalence rate would have been incorrectly determined as negative (95% CI, 0.0-0.1).

Jay G. Wohlgemuth, MD, senior vice president and chief medical officer of Quest Diagnostics, applauded the FDA for taking what he called an “important step” to allow the laboratory network increased capacity for testing.

"Pooling will help expand testing capacity but it is not a magic bullet, and testing times will continue to be strained as long as soaring COVID-19 test demand outpaces capacity,” Wohlgemuth said in a statement. “Each of us can practice behaviors that will reduce COVID-19 infections in our communities, so our national healthcare system can better respond to this crisis."