FDA issues first EUA for sample pooling in dx testing

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August 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. It is the first COVID-19 diagnostic test to be authorized for use with pooled samples.

The Quest test, initially authorized on March 17, remains authorized to test individual samples from people with suspected COVID-19 infection. The test is authorized for use with individual nasal swab specimens that are self-collected at home or in a health care setting using an authorized home-collection kit when determined to be appropriate by a health care provider.