• 1 Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America
  • 2 Neglected Tropical Diseases Support Center, Task Force for Global Health, Decatur, Georgia, United States of America
  • 3 Drugs & Diagnostics for Tropical Diseases, San Diego, California, United States of America
  • 4 Department of Control of Neglected Tropical Diseases, World Health Organization, Geneva, Switzerland
  • 5 Global Project Partners, Oakland, California, United States of America
  • 6 Institute of Medical Microbiology, Immunology and Parasitology, University of Bonn, Bonn, Germany
  • 7 Eastern and Southern Africa Centre of International Parasite Control, Kenya Medical Research Institute, Nairobi, Kenya
  • 8 Institute for Research in Molecular Medicine, Universiti Sains Malaysia, Penang, Malaysia
  • 9 Consultant LF Epidemiologist, Pondicherry, India
  • 10 National Nutrition Institute, Cairo, Egypt
  • 11 Neglected, Tropical and Vector-Borne Diseases Unit, Pan American Health Organization, World Health Organization, Washington, D.C., United States of America
  • 12 Global Health, Bill and Melinda Gates Foundation, Seattle, Washington, United States of America
  • 13 Neglected Tropical Diseases Division, United States Agency for International Development, Washington, D.C., United States of America
  • 14 Infectious Diseases Division, Washington University School of Medicine, St. Louis, Missouri, United States of America
  • 15 Department of Biological Sciences, Smith College, Northampton, Massachusetts, United States of America
PLoS Negl Trop Dis, 2021 11;15(11):e0009968.
PMID: 34780503 DOI: 10.1371/journal.pntd.0009968


As lymphatic filariasis (LF) programs move closer to established targets for validation elimination of LF as a public health problem, diagnostic tools capable of supporting the needs of the programs are critical for success. Known limitations of existing diagnostic tools make it challenging to have confidence that program endpoints have been achieved. In 2019, the World Health Organization (WHO) established a Diagnostic Technical Advisory Group (DTAG) for Neglected Tropical Diseases tasked with prioritizing diagnostic needs including defining use-cases and target product profiles (TPPs) for needed tools. Subsequently, disease-specific DTAG subgroups, including one focused on LF, were established to develop TPPs and use-case analyses to be used by product developers. Here, we describe the development of two priority TPPs for LF diagnostics needed for making decisions for stopping mass drug administration (MDA) of a triple drug regimen and surveillance. Utilizing the WHO core TPP development process as the framework, the LF subgroup convened to discuss and determine attributes required for each use case. TPPs considered the following parameters: product use, design, performance, product configuration and cost, and access and equity. Version 1.0 TPPs for two use cases were published by WHO on 12 March 2021 within the WHO Global Observatory on Health Research and Development. A common TPP characteristic that emerged in both use cases was the need to identify new biomarkers that would allow for greater precision in program delivery. As LF diagnostic tests are rarely used for individual clinical diagnosis, it became apparent that reliance on population-based surveys for decision making requires consideration of test performance in the context of such surveys. In low prevalence settings, the number of false positive test results may lead to unnecessary continuation or resumption of MDA, thus wasting valuable resources and time. Therefore, highly specific diagnostic tools are paramount when used to measure low thresholds. The TPP process brought to the forefront the importance of linking use case, program platform and diagnostic performance characteristics when defining required criteria for diagnostic tools.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.