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Peer-reviewedCC BY 4.0PLOS Neglected Tropical Diseases

A target product profile and roadmap for Japanese encephalitis diagnostics in endemic areas in the context of other flaviviruses

48 more authors
40 affiliations
  1. 1The Francis Crick Institute, London, United Kingdom
  2. 2Department of Infectious Diseases, Imperial College Healthcare NHS Trust, London, United Kingdom
  3. 3Department of Infectious Diseases, Imperial College London, London, United Kingdom
  4. 4London School of Hygiene & Tropical Medicine (LSHTM), London, United Kingdom
  5. 5Deggendorf Institute of Technology, Deggendorf, Germany
  6. 6Department of Virology, Christian Medical College, Vellore, India
  7. 7Emerging Infectious Diseases Research Unit, Research Department, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
  8. 8National Public Health Laboratory, Department of Health Services, Kathmandu, Nepal
  9. 9Department of Neurovirology, National Institute of Mental Health and Neuroscience (NIMHANS), Bengaluru, India
  10. 10National Institute of Virology (NIV), Indian Council of Medical Research (ICMR), Pune, India
  11. 11Unité des Virus Émergents (UVE: Aix-Marseille Univ, Università di Corsica, IRD 190, Inserm, IRBA), Marseille, France
  12. 12Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
  13. 13Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Laos
  14. 14Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom
  15. 15Insitut Pasteur du Cambodge, Phnom Penh, Cambodia
  16. 16Encephalitis International, Malton, United Kingdom
  17. 17Department of Clinical Infection, Microbiology & Immunology, Institute of Infection, Veterinary & Ecological Sciences, University of Liverpool, Liverpool, United Kingdom
  18. 18World Health Organization (WHO), Western Pacific Region, Manila, Philippines
  19. 19Indian Council of Medical Research (ICMR), New Delhi, India
  20. 20Pham Ngoc Thach University of Medicine, Ho Chi Minh City, Vietnam
  21. 21Indian Council of Medical Research (ICMR) - Regional Medical Research Centre, Dibrugarh, India
  22. 22Department of Paediatric Neurology, Indira Gandhi Institute of Child Health (IGICH), Bengaluru, India
  23. 23King Institute of Preventive Medicine and Research, Chennai, India
  24. 24Laboratory of Arboviruses, Department of Virology 1, National Institute of Infectious Diseases, Japan Institute for Health Security (JIHS), Tokyo, Japan
  25. 25Department of Immunology and Molecular Medicine, Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka
  26. 26Department of Neurosciences, Christian Medical College, Vellore, India
  27. 27Department of Immunizations, Vaccines and Biologicals, WHO, Geneva, Switzerland
  28. 28National Institute of Virology (NIV), Indian Council of Medical Research (ICMR), Bengaluru, India
  29. 29Department of Infectious Diseases, Christian Medical College, Vellore, India
  30. 30Department of Paediatrics, Sarawak General Hospital, Sarawak, Malaysia
  31. 31Institute of Health and Community Medicine, Universiti Malaysia Sarawak, Kota Samarahan, Malaysia
  32. 32UK Health Security Agency (UKHSA), Porton Down, United Kingdom
  33. 33Division of Adult Neurology, Department of Neurosciences, College of Medicine and Philippine General Hospital, University of the Philippines, Manila, Philippines
  34. 34Department of Microbiology, King George's Medical University, Lucknow, India
  35. 35Department of Infectious Diseases, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, India
  36. 36WHO, South-East Asia Region, New Delhi, India
  37. 37Department of Emergency Medicine, National Children's Hospital, Faculty of Medicine, University of Health Sciences, Vientiane, Laos
  38. 38Department of Pathology and Laboratory Medicine, Aga Khan University Hospital, Karachi, Pakistan
  39. 39Vijayanagar Institute of Medical Sciences, Bellary, Karnataka, India
  40. 40Department of Virology, Institute of Epidemiology Disease Control & Research (IEDCR), Dhaka, Bangladesh

Abstract

Japanese encephalitis (JE) virus (JEV) is a leading cause of neurological infection in the Asia-Pacific region with devastating socioeconomic consequences. We aimed to develop a target product profile (TPP) for JE diagnostics in endemic areas in the context of other flaviviruses, to better define improvements needed for patient management and public health. Thematic experts were identified from a scoping review, World Health Organization and Encephalitis International databases, as well as author networks. Initial interviews were performed with selected experts to inform a draft TPP document and start a Delphi process, aiming for consensus of ≥75% on each characteristic. A one-day meeting facilitated in-depth discussion, with breakout groups and electronic voting to develop the final TPP document. In total, 460 participants were invited. Five interviews enabled drafting a TPP. Two iterative surveys were completed by 44 respondents, including clinicians, scientists, and public health experts from 15 countries. A hybrid meeting was attended by 42 participants. Seven priority characteristics were discussed, and consensus was achieved for six; no clear consensus was reached for the preferred test sensitivity and specificity, with 73% agreement. Discussion points and areas of expert consensus were consolidated into a roadmap for development and implementation to guide future work. A diverse group of health professionals agreed that improved diagnostics for JE are needed, and that a priority is a test for patient management that detects JE alongside other relevant flavivirus infections. There was a mandate for a rapid diagnostic test (RDT), and it was suggested that this could be implemented in a two-tiered diagnostic algorithm. The final TPP is presented in the paper; this aims to help define the updates needed to better support patient management and public health interventions, to provide a strategic reference document to drive innovation and improve clarity for JE diagnostic test developers. Author summary: Japanese encephalitis virus (JEV) is a mosquito-transmitted virus that can infect the brain with devastating consequences. JEV occurs in 25 countries in the Asia-Pacific region, and represents a leading cause of neurological infection in these areas. A major limiting step in making progress to control the disease is the poor accuracy of existing diagnostic methods, and the lack of a rapid diagnostic test (pregnancy/ COVID-style rapid dipstick method) that could be performed in rural areas without laboratory capacity where JEV exists. We sought to draw on experts to systematically define the requirements ‘target product profile’ of future JEV diagnostic tests. We invited 460 participants from different disciplines and countries, started with online interviews of five participants, drafted a TPP, refined it with two rounds of online surveys and then a hybrid meeting. The final TPP is presented in the paper; this aims to help define the updates needed to better support patient management and public health interventions, to provide a strategic reference document to drive innovation and improve clarity for JE diagnostic test developers.

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BibTeX
@article{bharucha2026target,
  title = {{A target product profile and roadmap for Japanese encephalitis diagnostics in endemic areas in the context of other flaviviruses}},
  author = {Tehmina Bharucha and Laura Stokes and Dorcas Anane-Amponsah and Asha Mary Abraham and Prasert Auewarakul and Balkrishna Awal and Ashwin Y. Belludi and Vijay Bondre and Tina Damodar and Xavier de Lamballerie and Rahul Dhodapkar and Audrey Dubot-Pérès and Veasna Duong and Ava Easton and Roger Evans and Varja Grabovac and Nivedita Gupta and Nguyen Hoang Thien Huong and Siraj Ahmed Khan and Uddhava V. Kinhal and Kaveri Krishnasamy and Chang-Kweng Lim and Lonika Lodha and Gathsaurie Neelika Malavige and Shoba Mammen and Mayfong Mayxay and Angel Miraclin T. and Labanya Mukhopadhyay and Mick Mulders and Ashok Munivenkatappa and Adrian Keith Noronha and Mong How Ooi and Ashley Otter and Paul Pasco and Sakib Akther Pattassery and Shruti Radera and Vykuntaraju K. Gowda and Vijayalakshmi Reddy and Priscilla Rupali and Kavitha Saravu and Lucky Sangal and Sanyalack Saysanasongkham and Sadia Shakoor and Krishna Srinavasan and Sharmin Sultana and Aswini M. A. and Bhagteshwar Singh and Tom Solomon and Ava Kristy S. Y. and Le Van Tan and Kevin K. A. Tetteh and Trieu Huynh Trung and Lance Turtle and Ravi Vasanthapuram and Manjunatha M. Venkataswamy and Nguyen Thanh Vu and Robert J. Wilkinson and Sangay Zangmo and Reeta Mani and Sabine Dittrich},
  journal = {PLOS Neglected Tropical Diseases},
  year = {2026},
  month = sep,
  doi = {10.1371/journal.pntd.0014683},
  url = {https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0014683},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - A target product profile and roadmap for Japanese encephalitis diagnostics in endemic areas in the context of other flaviviruses
AU  - Tehmina Bharucha
AU  - Laura Stokes
AU  - Dorcas Anane-Amponsah
AU  - Asha Mary Abraham
AU  - Prasert Auewarakul
AU  - Balkrishna Awal
AU  - Ashwin Y. Belludi
AU  - Vijay Bondre
AU  - Tina Damodar
AU  - Xavier de Lamballerie
AU  - Rahul Dhodapkar
AU  - Audrey Dubot-Pérès
AU  - Veasna Duong
AU  - Ava Easton
AU  - Roger Evans
AU  - Varja Grabovac
AU  - Nivedita Gupta
AU  - Nguyen Hoang Thien Huong
AU  - Siraj Ahmed Khan
AU  - Uddhava V. Kinhal
AU  - Kaveri Krishnasamy
AU  - Chang-Kweng Lim
AU  - Lonika Lodha
AU  - Gathsaurie Neelika Malavige
AU  - Shoba Mammen
AU  - Mayfong Mayxay
AU  - Angel Miraclin T.
AU  - Labanya Mukhopadhyay
AU  - Mick Mulders
AU  - Ashok Munivenkatappa
AU  - Adrian Keith Noronha
AU  - Mong How Ooi
AU  - Ashley Otter
AU  - Paul Pasco
AU  - Sakib Akther Pattassery
AU  - Shruti Radera
AU  - Vykuntaraju K. Gowda
AU  - Vijayalakshmi Reddy
AU  - Priscilla Rupali
AU  - Kavitha Saravu
AU  - Lucky Sangal
AU  - Sanyalack Saysanasongkham
AU  - Sadia Shakoor
AU  - Krishna Srinavasan
AU  - Sharmin Sultana
AU  - Aswini M. A.
AU  - Bhagteshwar Singh
AU  - Tom Solomon
AU  - Ava Kristy S. Y.
AU  - Le Van Tan
AU  - Kevin K. A. Tetteh
AU  - Trieu Huynh Trung
AU  - Lance Turtle
AU  - Ravi Vasanthapuram
AU  - Manjunatha M. Venkataswamy
AU  - Nguyen Thanh Vu
AU  - Robert J. Wilkinson
AU  - Sangay Zangmo
AU  - Reeta Mani
AU  - Sabine Dittrich
PY  - 2026
DA  - 2026/09/08
JO  - PLOS Neglected Tropical Diseases
DO  - 10.1371/journal.pntd.0014683
UR  - https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0014683
AB  - Japanese encephalitis (JE) virus (JEV) is a leading cause of neurological infection in the Asia-Pacific region with devastating socioeconomic consequences. We aimed to develop a target product profile (TPP) for JE diagnostics in endemic areas in the context of other flaviviruses, to better define improvements needed for patient management and public health. Thematic experts were identified from a scoping review, World Health Organization and Encephalitis International databases, as well as author networks. Initial interviews were performed with selected experts to inform a draft TPP document and start a Delphi process, aiming for consensus of ≥75% on each characteristic. A one-day meeting facilitated in-depth discussion, with breakout groups and electronic voting to develop the final TPP document. In total, 460 participants were invited. Five interviews enabled drafting a TPP. Two iterative surveys were completed by 44 respondents, including clinicians, scientists, and public health experts from 15 countries. A hybrid meeting was attended by 42 participants. Seven priority characteristics were discussed, and consensus was achieved for six; no clear consensus was reached for the preferred test sensitivity and specificity, with 73% agreement. Discussion points and areas of expert consensus were consolidated into a roadmap for development and implementation to guide future work. A diverse group of health professionals agreed that improved diagnostics for JE are needed, and that a priority is a test for patient management that detects JE alongside other relevant flavivirus infections. There was a mandate for a rapid diagnostic test (RDT), and it was suggested that this could be implemented in a two-tiered diagnostic algorithm. The final TPP is presented in the paper; this aims to help define the updates needed to better support patient management and public health interventions, to provide a strategic reference document to drive innovation and improve clarity for JE diagnostic test developers. Author summary: Japanese encephalitis virus (JEV) is a mosquito-transmitted virus that can infect the brain with devastating consequences. JEV occurs in 25 countries in the Asia-Pacific region, and represents a leading cause of neurological infection in these areas. A major limiting step in making progress to control the disease is the poor accuracy of existing diagnostic methods, and the lack of a rapid diagnostic test (pregnancy/ COVID-style rapid dipstick method) that could be performed in rural areas without laboratory capacity where JEV exists. We sought to draw on experts to systematically define the requirements ‘target product profile’ of future JEV diagnostic tests. We invited 460 participants from different disciplines and countries, started with online interviews of five participants, drafted a TPP, refined it with two rounds of online surveys and then a hybrid meeting. The final TPP is presented in the paper; this aims to help define the updates needed to better support patient management and public health interventions, to provide a strategic reference document to drive innovation and improve clarity for JE diagnostic test developers.
SN  - 1935-2735
ER  -