Following the news that Quest Diagnostics received emergency use authorization (EUA) from the Food and Drug Administration (FDA) for its sample pooling-based COVID-19 test;
Brian Hicks, Medical Devices Analyst at GlobalData, a leading data and analytics company, offers his view:
At a time when more COVID-19 tests are being conducted, yet negative results are generally outnumbering positive results, the need for improving the capacity to identify positive cases has considerably grown. Sample pooling has increasingly been promoted as a solution to reduce the time, supplies and general resources required for testing all patients, however, no test has received FDA authorization to incorporate this technique until recently.
The recent EUA for Quest Dianostics fortunately addresses this issue by authorizing its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples for the first time. This undoubtedly provides immediate relief for testing centers already using the Quest test that had previously received an EUA, but only for individual sample analyses. Combining up to four patient samples into a single pool for subsequent analyses can thus correspondingly reduce the testing time and resources by up to four times, provided no positive results be detected. Keeping up with the high demand of COVID-19 testing has proven to be a challenge for healthcare centers across the world. Among the 184 COVID-19 tests currently under EUAs, GlobalData expects Quest Diagnostics to make the most significant impact in reducing testing time, supply usage, and resource allocation specifically towards negative tests.”