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.”

Dara Lo, Medical Device Analyst at GlobalData, a leading data and analytics company, offers her view:

“Being first to market with pooled testing, Quest Diagnostics, who at the peak of the pandemic, accounted for nearly half of all COVID-19 testing across the US, will continue to hold strong as a market leader of COVID-19 testing in the US.”

“In pooled testing, patient samples are still individually collected, but then combined into small batches, or pools, by the lab. A negative result means that all patients in that pool are considered negative; if a positive result occurs, each specimen is then individually retested.

“In the US. since the outbreak began, 47,313,367 COVID-19 tests have been performed with 4,370,863 positive tests reported, reports the CDC as of July 20. This means that the vast majority of tests were negative for COVID-19. Moving from testing patient samples one-by-one to a pooled sample approach will greatly increase the speed at which testing can be done, and turnaround of tests results to patients. This pooled approach to COVID-19 testing is a boone as cases of COVID-19 continue to increase in the US.”

“It is worth noting that the high infectivity and morbidity of COVID-19 makes testing absolutely essential to quarantine infected individuals and conduct contact tracing to stop further spread of the disease.”