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Evaluating diagnostic tests during outbreaks: challenges and lessons learnt from COVID-19
  1. Camille Escadafal1,
  2. Rossella Baldan2,
  3. Margaretha De Vos3,
  4. III Ryan Jose Ruiz2,
  5. Devy M Emperador1,
  6. Alltalents T Murahwa1,
  7. Aurélien Macé4,
  8. Daniel G Bausch5,
  9. Aurélia Vessière1,
  10. Jilian A Sacks1
  1. 1 Pandemic Threats programme, FIND, Geneva, Switzerland
  2. 2 Clinical trial unit, FIND, Geneva, Switzerland
  3. 3 Tuberculosis programme, FIND, Geneva, Switzerland
  4. 4 Data science unit, FIND, Geneva, Switzerland
  5. 5 Global Health Security programme, FIND, Geneva, Switzerland
  1. Correspondence to Dr Camille Escadafal; camille.escadafal{at}

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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.


Diagnostic tests have played a crucial role in COVID-19 management worldwide. In particular, antigen-detection rapid diagnostic tests (RDTs) have been used at an unprecedented scale, including outside of healthcare settings, to limit spread of SARS-CoV-2.1 These tests were developed rapidly, with availability initially driven by the time needed to generate data on the relevance of this detection method for this novel pathogen. Global access to quality-assured COVID-19 RDTs has been limited at times, hindered by disruptions in global supply chains and competing interests for initially limited supply, as well as challenges encountered during clinical performance evaluations leading to delayed availability of data. Earlier access to such tests may have further reduced disease spread, potentially saving lives.

The 100 Days Mission is an ambitious goal introduced by governments and industry leaders to improve response to future pandemic threats using lessons learnt from COVID-19 and previous epidemics.1 The aim is to provide safe, effective and affordable rapid diagnostics, therapeutics, and vaccines within 100 days of a declaration …

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