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An updated roadmap for MERS-CoV research and product development: focus on diagnostics
  1. Cassandra Kelly-Cirino1,
  2. Laura T Mazzola1,
  3. Arlene Chua2,3,
  4. Christopher J Oxenford4,
  5. Maria D Van Kerkhove5
  1. 1 Emerging Threats Programme, FIND, Geneva, Switzerland
  2. 2 Department of Information, Evidence and Research, WHO, Geneva, Switzerland
  3. 3 Medecins Sans Frontières, Geneva, Switzerland
  4. 4 Health Emergencies Programme, WHO, Lyon, France
  5. 5 Health Emergencies Programme, WHO, Geneva, Switzerland
  1. Correspondence to Dr Maria D Van Kerkhove; vankerkhovem{at}who.int

Abstract

Diagnostics play a central role in the early detection and control of outbreaks and can enable a more nuanced understanding of the disease kinetics and risk factors for the Middle East respiratory syndrome-coronavirus (MERS-CoV), one of the high-priority pathogens identified by the WHO. In this review we identified sources for molecular and serological diagnostic tests used in MERS-CoV detection, case management and outbreak investigations, as well as surveillance for humans and animals (camels), and summarised the performance of currently available tests, diagnostic needs, and associated challenges for diagnostic test development and implementation. A more detailed understanding of the kinetics of infection of MERS-CoV is needed in order to optimise the use of existing assays. Notably, MERS-CoV point-of-care tests are needed in order to optimise supportive care and to minimise transmission risk. However, for new test development, sourcing clinical material continues to be a major challenge to achieving assay validation. Harmonisation and standardisation of laboratory methods are essential for surveillance and for a rapid and effective international response to emerging diseases. Routine external quality assessment, along with well-characterised and up-to-date proficiency panels, would provide insight into MERS-CoV diagnostic performance worldwide. A defined set of Target Product Profiles for diagnostic technologies will be developed by WHO to address these gaps in MERS-CoV outbreak management.

  • middle east respiratory syndrome-coronavirus
  • MERS-CoV
  • in vitro diagnostics
  • outbreak

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: http://creativecommons.org/licenses/by-nc/4.0

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Footnotes

  • Handling editor Seye Abimbola

  • Contributors CK-C contributed insight into the diagnostic needs for outbreak pathogens. LTM provided the background research for the manuscript. AC, CJO and MDVK contributed to drafting the manuscript. All authors reviewed, edited and approved the final version of the manuscript.

  • Funding Publication of this article was funded by FIND. FIND was funded for this work by UK Aid from the UK Government.

  • Competing interests None declared.

  • Patient consent Not required.

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

  • Data statement No additional data are available.

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