{
  "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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  "affiliations": [
    "The Francis Crick Institute, London, United Kingdom",
    "Department of Infectious Diseases, Imperial College Healthcare NHS Trust, London, United Kingdom",
    "Department of Infectious Diseases, Imperial College London, London, United Kingdom",
    "London School of Hygiene & Tropical Medicine (LSHTM), London, United Kingdom",
    "Deggendorf Institute of Technology, Deggendorf, Germany",
    "Department of Virology, Christian Medical College, Vellore, India",
    "Emerging Infectious Diseases Research Unit, Research Department, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand",
    "National Public Health Laboratory, Department of Health Services, Kathmandu, Nepal",
    "Department of Neurovirology, National Institute of Mental Health and Neuroscience (NIMHANS), Bengaluru, India",
    "National Institute of Virology (NIV), Indian Council of Medical Research (ICMR), Pune, India",
    "Unité des Virus Émergents (UVE: Aix-Marseille Univ, Università di Corsica, IRD 190, Inserm, IRBA), Marseille, France",
    "Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India",
    "Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Laos",
    "Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom",
    "Insitut Pasteur du Cambodge, Phnom Penh, Cambodia",
    "Encephalitis International, Malton, United Kingdom",
    "Department of Clinical Infection, Microbiology & Immunology, Institute of Infection, Veterinary & Ecological Sciences, University of Liverpool, Liverpool, United Kingdom",
    "World Health Organization (WHO), Western Pacific Region, Manila, Philippines",
    "Indian Council of Medical Research (ICMR), New Delhi, India",
    "Pham Ngoc Thach University of Medicine, Ho Chi Minh City, Vietnam",
    "Indian Council of Medical Research (ICMR) - Regional Medical Research Centre, Dibrugarh, India",
    "Department of Paediatric Neurology, Indira Gandhi Institute of Child Health (IGICH), Bengaluru, India",
    "King Institute of Preventive Medicine and Research, Chennai, India",
    "Laboratory of Arboviruses, Department of Virology 1, National Institute of Infectious Diseases, Japan Institute for Health Security (JIHS), Tokyo, Japan",
    "Department of Immunology and Molecular Medicine, Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka",
    "Department of Neurosciences, Christian Medical College, Vellore, India",
    "Department of Immunizations, Vaccines and Biologicals, WHO, Geneva, Switzerland",
    "National Institute of Virology (NIV), Indian Council of Medical Research (ICMR), Bengaluru, India",
    "Department of Infectious Diseases, Christian Medical College, Vellore, India",
    "Department of Paediatrics, Sarawak General Hospital, Sarawak, Malaysia",
    "Institute of Health and Community Medicine, Universiti Malaysia Sarawak, Kota Samarahan, Malaysia",
    "UK Health Security Agency (UKHSA), Porton Down, United Kingdom",
    "Division of Adult Neurology, Department of Neurosciences, College of Medicine and Philippine General Hospital, University of the Philippines, Manila, Philippines",
    "Department of Microbiology, King George's Medical University, Lucknow, India",
    "Department of Infectious Diseases, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, India",
    "WHO, South-East Asia Region, New Delhi, India",
    "Department of Emergency Medicine, National Children's Hospital, Faculty of Medicine, University of Health Sciences, Vientiane, Laos",
    "Department of Pathology and Laboratory Medicine, Aga Khan University Hospital, Karachi, Pakistan",
    "Vijayanagar Institute of Medical Sciences, Bellary, Karnataka, India",
    "Department of Virology, Institute of Epidemiology Disease Control & Research (IEDCR), Dhaka, Bangladesh"
  ],
  "article_type": "Research Article",
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  "doi": "10.1371/journal.pntd.0014683",
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  "pmcid": null,
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  "published": "2026-09-08",
  "publisher": "Public Library of Science",
  "ris": "https://research.draconitic.com/paper/a2nekvy0sb97m.ris",
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  "title": "A target product profile and roadmap for Japanese encephalitis diagnostics in endemic areas in the context of other flaviviruses",
  "title_text": "A target product profile and roadmap for Japanese encephalitis diagnostics in endemic areas in the context of other flaviviruses",
  "type": "peer-reviewed",
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