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Importance of diagnostics in epidemic and pandemic preparedness
  1. Cassandra D Kelly-Cirino1,
  2. John Nkengasong2,
  3. Hannah Kettler3,
  4. Isabelle Tongio4,
  5. Françoise Gay-Andrieu4,
  6. Camille Escadafal1,
  7. Peter Piot5,
  8. Rosanna W Peeling5,
  9. Renuka Gadde6,
  10. Catharina Boehme1
  1. 1 Foundation for Innovative New Diagnostics, Geneva, Switzerland
  2. 2 Africa Centres for Disease Control and Prevention, Addis Ababa, Ethiopia
  3. 3 Bill & Melinda Gates Foundation, Seattle, Washington, USA
  4. 4 BioMérieux, Marcy l’Etoile, France
  5. 5 London School of Hygiene and Tropical Medicine, London, UK
  6. 6 Becton Dickinson (BD), Franklin Lakes, New Jersey, USA
  1. Correspondence to Dr Catharina Boehme; Catharina.Boehme{at}


Diagnostics are fundamental for successful outbreak containment. In this supplement, ‘Diagnostic preparedness for WHO Blueprint pathogens’, we describe specific diagnostic challenges presented by selected priority pathogens most likely to cause future epidemics.

Some challenges to diagnostic preparedness are common to all outbreak situations, as highlighted by recent outbreaks of Ebola, Zika and yellow fever. In this article, we review these overarching challenges and explore potential solutions. Challenges include fragmented and unreliable funding pathways, limited access to specimens and reagents, inadequate diagnostic testing capacity at both national and community levels of healthcare and lack of incentives for companies to develop and manufacture diagnostics for priority pathogens during non-outbreak periods. Addressing these challenges in an efficient and effective way will require multiple stakeholders—public and private—coordinated in implementing a holistic approach to diagnostics preparedness. All require strengthening of healthcare system diagnostic capacity (including surveillance and education of healthcare workers), establishment of sustainable financing and market strategies and integration of diagnostics with existing mechanisms. Identifying overlaps in diagnostic development needs across different priority pathogens would allow more timely and cost-effective use of resources than a pathogen by pathogen approach; target product profiles for diagnostics should be refined accordingly. We recommend the establishment of a global forum to bring together representatives from all key stakeholders required for the response to develop a coordinated implementation plan. In addition, we should explore if and how existing mechanisms to address challenges to the vaccines sector, such as Coalition for Epidemic Preparedness Innovations and Gavi, could be expanded to cover diagnostics.

  • outbreak
  • in vitro diagnostics
  • epidemic
  • WHO blueprint

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:

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  • Handling editor Seye Abimbola

  • Contributors The first draft was prepared by Rachel Wright, PhD, funded by FIND and under direction of the authors. All authors critically reviewed and edited the manuscript and approved the final version for submission.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests IT, FG-A, and RG are employed by private companies working on in vitro diagnostic development.

  • Patient consent Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement No additional data are available.

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