FDA issues first emergency authorization for sample pooling in diagnostic testing

FDA announced Saturday it has 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 swab specimens collected under observation. The agency noted this is the first COVID-19 test to be authorized for use with pooled samples. Sample pooling allows for more people to be tested quickly using fewer testing resources. Such a testing strategy is more efficient in areas with low prevalence, FDA said, meaning that most test results are expected to be negative. “This EUA for sample pooling is an important step forward in getting more COVID-19 tests to more Americans more quickly while preserving testing supplies,” said FDA Commissioner Stephen M. Hahn, MD. “Sample pooling becomes especially important as infection rates decline and we begin testing larger portions of the population.”