Things sure happen fast during a pandemic. While the U.S. Food and Drug Administration (FDA) has historically “encourage all test developers to reach out to [us] to discuss appropriate validation approaches,” the agency has remained largely silent on the practice of sample pooling allowing for the testing of multiple individuals with a single test. But that all changed on June 16 when the agency issued new guidance outlining its “validation expectations” for use of specimen pooling either to develop a new test for Emergency Use Authorization (EUA) or expand the use of a current EUA product. And barely one month later, the FDA pushed the button on the latter by extending the EUA of an existing test to allow for pool sampling to detect the coronavirus. The Quest SARS-CoV-2 Test On July 18, the announcement came that Quest Diagnostics’ SARS-CoV-2 RNA test had become the first coronavirus test cleared by the FDA for pooled sampling. Technically, the approval is a reissued version of the existing EUA issued back in March expanded to allow for use of the test with pooled upper respiratory specimens in sample pools comprised of four individuals.  Pooling and the COVID-19 Diagnostic Challenge Pooling involves mixing sub-samples […]