Alliance for Pandemic Preparedness

March 10, 2020

Diagnostic Testing for the Novel Coronavirus



  • Sharfstein et al discuss the race against time to discover new and better diagnostic tools and the technical challenges of the tests developed by CDC for diagnosis of COVID-19. They discuss the regulatory structures for diagnostic tests and draw distinction between testing capacity for public surveillance and clinical care. Some of the challenges encountered by the labs included difficulty verifying results as some came back as inconclusive or invalid due to lack of negative control. The paper further highlights the controversial area of public policy on tests, major gaps in oversight of test accuracy and validity during declared public health emergencies, and ability of FDA to identify and quickly address testing errors by labs.

Sharfstein et al. (Mar 9, 2020). Diagnostic Testing for the Novel Coronavirus. JAMA.