Diagnostics to support elimination of lymphatic filariasis-Development of two target product profiles

Autor: Sammy M. Njenga, Camilla Ducker, Steven A. Williams, Marco A. Biamonte, Jordan W. Tappero, Anthony W. Solomon, Ashley A Souza, Katherine Gass, Christopher Hanna, Reda M. R. Ramzy, Jonathan D. King, Ronaldo G. Carvalho Scholte, Rahmah Noordin, Achim Hoerauf, Kapa D. Ramaiah, Emily Toubali, Patrick J. Lammie, Gary J. Weil, Daniel Argaw Dagne, Kimberly Y. Won
Rok vydání: 2021
Předmět:
Nematoda
Computer science
Physiology
RC955-962
Biochemistry
Medical Conditions
Arctic medicine. Tropical medicine
Immune Physiology
Medicine and Health Sciences
Use case
Public and Occupational Health
Brugia Malayi
education.field_of_study
Immune System Proteins
Eukaryota
Filariasis
Body Fluids
Infectious Diseases
Blood
Risk analysis (engineering)
Helminth Infections
Neglected tropical diseases
Public Health
Public aspects of medicine
RA1-1270
Anatomy
Wuchereria
Research Article
Neglected Tropical Diseases
Process (engineering)
Population
Immunology
MEDLINE
Context (language use)
World Health Organization
Antibodies
Elephantiasis
Filarial
Diagnostic Medicine
Parasitic Diseases
Brugia
Humans
Animals
Product (category theory)
education
Diagnostic Tests
Routine
Lymphatic Filariasis
Public Health
Environmental and Occupational Health
Equity (finance)
Organisms
Biology and Life Sciences
Proteins
Wuchereria Bancrofti
Tropical Diseases
Invertebrates
Zoology
Zdroj: PLoS Neglected Tropical Diseases
PLoS Neglected Tropical Diseases, Vol 15, Iss 11, p e0009968 (2021)
ISSN: 1935-2735
Popis: 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.
Author summary High quality diagnostic tools are an essential component of lymphatic filariasis (LF) programs. Currently, diagnostic tools are used by national programs to establish baseline endemicity, monitor progress of program interventions, determine when interventions can be stopped, and surveillance. For years, LF programs have relied on diagnostic tools that have been central to informing key program decisions but were not necessarily designed to undertake the roles for which they are used. Known limitations of existing diagnostic tools make it challenging to have confidence that program endpoints have been achieved. Target product profiles (TPP) provide product requirements to guide developers and manufacturers in their efforts to design tools fit for purpose. However, development of diagnostic tools used in public health programs requires consideration of aspects beyond those considered when developing diagnostic tools used for clinical diagnosis. The TPP process for two LF use cases brought to the forefront the importance of linking use case, program platform and diagnostic performance characteristics when defining required criteria for diagnostic tools.
Databáze: OpenAIRE
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