FDA issues first EUA for sample pooling in dx testing

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July 20, 2020—The FDA reissued on July 18 an emergency use authorization 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 Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples.

“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,” FDA commissioner Stephen M. Hahn, MD, said in a press statement. “Sample pooling becomes especially important as infection rates decline and we begin testing larger portions of the population.”