Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: 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.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2021
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
_version_ 1784607192565940224
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
work_keys_str_mv AT wonkimberlyy diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT gasskatherine diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT biamontemarco diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT dagnedanielargaw diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT duckercamilla diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT hannachristopher diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT hoeraufachim diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT lammiepatrickj diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT njengasammym diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT noordinrahmah diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT ramaiahkapad diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT ramzyreda diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT scholteronaldogcarvalho diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT solomonanthonyw diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT souzaashleya diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT tapperojordan diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT toubaliemily diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT weilgaryj diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT williamsstevena diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles
AT kingjonathand diagnosticstosupporteliminationoflymphaticfilariasisdevelopmentoftwotargetproductprofiles