Evaluating diagnostic tests during outbreaks: challenges and lessons learnt from COVID-19

Summary box

  • Timely access to quality-assured diagnostic tests during a pandemic or outbreak is essential to support public health measures and limit the spread of disease; independent test evaluation studies are necessary to provide objective evidence on assay performance, but challenges in study implementation can contribute to delays.
  • Challenges encountered during implementation of evaluation studies for COVID-19 diagnostic tests included logistical and resource-related constraints, delays in building partnerships and obtaining ethical approvals, continuous changes in COVID-19 incidence, and travel restrictions impeding in-person training, monitoring visits and delivery of supplies.
  • Opportunities exist to address these challenges through ensuring access to resources and building networks of partners sharing harmonised practices that can be rapidly mobilised and activated in emergency situations.
  • Investment in the development of such systems is required in advance of the next public health emergency.