FDA reissues EUA for Quest Diagnostic’s COVID-19 test

The U.S. Food and Drug Administration (FDA) reissued an emergency use authorization (EUA) to Quest Diagnostics for its COVID-19 test.

The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples containing up to four individual swab specimens collected under observation. This allows for four individuals to be tested at once. The samples from the four individuals are then tested in a pool using one test as opposed to running tests on each individual sample. If the pool is positive, it means that one or more of the individuals tested in that pool may be infected. If that’s the case, they are each tested again individually. The pooled samples result in fewer tests being run.

“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 Hahn said. “Sample pooling becomes especially important as infection rates decline, and we begin testing larger portions of the population.”

Quest’s validation data demonstrates that its test correctly identified all of the pooled samples that contained a positive sample. Quest remains authorized to test individual samples collected by health care providers from people with suspected COVID-19 infection, per an EUA initially authorized on March 17. This is part of the FDA’s strategy to get additional tests to more Americans more quickly.