Accelerating the fight against COVID-19 with real-world data on tests

Almost every aspect of the fight against COVID-19 depends on the ability to determine whether an individual is or has been infected with SARS-CoV-2, but more than six months into the pandemic there is still uncertainty about the accuracy of widely used PCR-based diagnostics and serological antibody tests. The Reagan-Udall Foundation for the FDA and Friends of Cancer Research have launched an initiative, the COVID-19 Diagnostics Evidence Accelerator, that is intended to reduce that uncertainty by collecting and analyzing real-world data about test performance.

Knowledge about how tests actually perform, as opposed to data from in vitro studies that show how they could perform under idealized conditions, could be one of the keys to taming the pandemic. ...