Medtech Insight

Quest’s First Pooled Sample COVID-19 Diagnostic Test Could Save Time, Resources: FDA

20 Jul 2020

US regulators gave the thumbs-up to the first COVID-19 test that pools patient samples to determine if any one of the individuals in the pool may be infected. Despite concerns such tests may be diluted and make it harder to detect the SARS-CoV-2 virus, the FDA says validation data shows it works.

Over the weekend the US Food and Drug Administration again authorized Quest Diagnostics Incorporated’s Quest SARS-CoV-2 rRT-PCR test, but this time the authorization is to run multiple tests together to see if a patient within a pool of patients has COVID-19. The agency says the new method should save testing resources and help get results faster.

The agency on 18 July announced it gave emergency use authorization (EUA) for the first COVID-19 diagnostics test that can...