Quest Diagnostics’ SARS-CoV-2 rRT-PCR Test Becomes First COVID-19 Diagnostic Test to Receive FDA EUA for Sample Pooling

The US Food and Drug Administration has reissued an emergency use authorization (EUA) to Quest Diagnostics (Secaucus, NJ, USA) to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples.

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. The samples collected from these four individuals are tested in a pool or “batch” using one test, rather than running each individual sample on its own test. If the pool is positive, it means that one or more of the individuals tested in that pool may be infected, so each of the samples in that pool are tested again individually. Because the samples are pooled, it is expected that fewer tests are run overall, meaning fewer testing supplies are used and more tests can be run at the same time allowing patients to receive their results more quickly in most cases. This testing strategy is most efficient in areas with low prevalence, meaning most results are expected to be negative.

Quest’s validation data demonstrates that its test correctly identified all of the pooled samples that contained a positive sample. The Quest SARS-CoV-2 rRT-PCR test, initially authorized on March 17, 2020, remains authorized to test individual samples collected by their health care provider from people with suspected COVID-19 infection. The test is also still 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.

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

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