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Diagnostics to support elimination of lymphatic filariasis—Development of two target product profiles
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8629375/ https://www.ncbi.nlm.nih.gov/pubmed/34780503 http://dx.doi.org/10.1371/journal.pntd.0009968 |
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author | Won, Kimberly Y. Gass, Katherine Biamonte, Marco Dagne, Daniel Argaw Ducker, Camilla Hanna, Christopher Hoerauf, Achim Lammie, Patrick J. Njenga, Sammy M. Noordin, Rahmah Ramaiah, Kapa D. Ramzy, Reda Scholte, Ronaldo G. Carvalho Solomon, Anthony W. Souza, Ashley A. Tappero, Jordan Toubali, Emily Weil, Gary J. Williams, Steven A. King, Jonathan D. |
author_facet | Won, Kimberly Y. Gass, Katherine Biamonte, Marco Dagne, Daniel Argaw Ducker, Camilla Hanna, Christopher Hoerauf, Achim Lammie, Patrick J. Njenga, Sammy M. Noordin, Rahmah Ramaiah, Kapa D. Ramzy, Reda Scholte, Ronaldo G. Carvalho Solomon, Anthony W. Souza, Ashley A. Tappero, Jordan Toubali, Emily Weil, Gary J. Williams, Steven A. King, Jonathan D. |
author_sort | Won, Kimberly Y. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-8629375 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-86293752021-11-30 Diagnostics to support elimination of lymphatic filariasis—Development of two target product profiles Won, Kimberly Y. Gass, Katherine Biamonte, Marco Dagne, Daniel Argaw Ducker, Camilla Hanna, Christopher Hoerauf, Achim Lammie, Patrick J. Njenga, Sammy M. Noordin, Rahmah Ramaiah, Kapa D. Ramzy, Reda Scholte, Ronaldo G. Carvalho Solomon, Anthony W. Souza, Ashley A. Tappero, Jordan Toubali, Emily Weil, Gary J. Williams, Steven A. King, Jonathan D. PLoS Negl Trop Dis Research Article 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. Public Library of Science 2021-11-15 /pmc/articles/PMC8629375/ /pubmed/34780503 http://dx.doi.org/10.1371/journal.pntd.0009968 Text en https://creativecommons.org/publicdomain/zero/1.0/This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 (https://creativecommons.org/publicdomain/zero/1.0/) public domain dedication. |
spellingShingle | Research Article Won, Kimberly Y. Gass, Katherine Biamonte, Marco Dagne, Daniel Argaw Ducker, Camilla Hanna, Christopher Hoerauf, Achim Lammie, Patrick J. Njenga, Sammy M. Noordin, Rahmah Ramaiah, Kapa D. Ramzy, Reda Scholte, Ronaldo G. Carvalho Solomon, Anthony W. Souza, Ashley A. Tappero, Jordan Toubali, Emily Weil, Gary J. Williams, Steven A. King, Jonathan D. Diagnostics to support elimination of lymphatic filariasis—Development of two target product profiles |
title | Diagnostics to support elimination of lymphatic filariasis—Development of two target product profiles |
title_full | Diagnostics to support elimination of lymphatic filariasis—Development of two target product profiles |
title_fullStr | Diagnostics to support elimination of lymphatic filariasis—Development of two target product profiles |
title_full_unstemmed | Diagnostics to support elimination of lymphatic filariasis—Development of two target product profiles |
title_short | Diagnostics to support elimination of lymphatic filariasis—Development of two target product profiles |
title_sort | diagnostics to support elimination of lymphatic filariasis—development of two target product profiles |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8629375/ https://www.ncbi.nlm.nih.gov/pubmed/34780503 http://dx.doi.org/10.1371/journal.pntd.0009968 |
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