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Diagnostics to support the eradication of yaws—Development of two target product profiles

BACKGROUND: Yaws is targeted for eradication by 2030, using a strategy based on mass drug administration (MDA) with azithromycin. New diagnostics are needed to aid eradication. Serology is currently the mainstay for yaws diagnosis; however, inaccuracies associated with current serological tests make...

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Autores principales: Fongwen, Noah, Handley, Becca L., Martin, Diana L., Beiras, Camila, Dyson, Louise, Frimpong, Michael, Mitja, Oriol, Asiedu, Kingsley, Marks, Michael
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9473620/
https://www.ncbi.nlm.nih.gov/pubmed/36048897
http://dx.doi.org/10.1371/journal.pntd.0010554
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author Fongwen, Noah
Handley, Becca L.
Martin, Diana L.
Beiras, Camila
Dyson, Louise
Frimpong, Michael
Mitja, Oriol
Asiedu, Kingsley
Marks, Michael
author_facet Fongwen, Noah
Handley, Becca L.
Martin, Diana L.
Beiras, Camila
Dyson, Louise
Frimpong, Michael
Mitja, Oriol
Asiedu, Kingsley
Marks, Michael
author_sort Fongwen, Noah
collection PubMed
description BACKGROUND: Yaws is targeted for eradication by 2030, using a strategy based on mass drug administration (MDA) with azithromycin. New diagnostics are needed to aid eradication. Serology is currently the mainstay for yaws diagnosis; however, inaccuracies associated with current serological tests makes it difficult to fully assess the need for and impact of eradication campaigns using these tools. Under the recommendation of the WHO Diagnostic Technical Advisory Group (DTAG) for Neglected Tropical Diseases(NTDs), a working group was assembled and tasked with agreeing on priority use cases for developing target product profiles (TPPs) for new diagnostics tools. METHODOLOGY AND PRINCIPAL FINDINGS: The working group convened three times and established two use cases: identifying a single case of yaws and detecting azithromycin resistance. One subgroup assessed the current diagnostic landscape for yaws and a second subgroup determined the test requirements for both use cases. Draft TPPs were sent out for input from stakeholders and experts. Both TPPs considered the following parameters: product use, design, performance, configuration, cost, access and equity. To identify a single case of yaws, the test should be able to detect an analyte which confirms an active infection with at least 95% sensitivity and 99.9% specificity. The high specificity was deemed important to avoid a high false positive rate which could result in unnecessary continuation or initiation of MDA campaigns. If used in settings where the number of suspected cases is low, further testing could be considered to compensate for imperfect sensitivity and to improve specificity. The test to detect azithromycin resistance should be able to detect known genetic resistance mutations with a minimum sensitivity and specificity of 95%, with the caveat that all patients with suspected treatment failure should be treated as having resistant yaws and offered alternative treatment. CONCLUSIONS: The TPPs developed will provide test developers with guidance to ensure that novel diagnostic tests meet identified public health needs.
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spelling pubmed-94736202022-09-15 Diagnostics to support the eradication of yaws—Development of two target product profiles Fongwen, Noah Handley, Becca L. Martin, Diana L. Beiras, Camila Dyson, Louise Frimpong, Michael Mitja, Oriol Asiedu, Kingsley Marks, Michael PLoS Negl Trop Dis Research Article BACKGROUND: Yaws is targeted for eradication by 2030, using a strategy based on mass drug administration (MDA) with azithromycin. New diagnostics are needed to aid eradication. Serology is currently the mainstay for yaws diagnosis; however, inaccuracies associated with current serological tests makes it difficult to fully assess the need for and impact of eradication campaigns using these tools. Under the recommendation of the WHO Diagnostic Technical Advisory Group (DTAG) for Neglected Tropical Diseases(NTDs), a working group was assembled and tasked with agreeing on priority use cases for developing target product profiles (TPPs) for new diagnostics tools. METHODOLOGY AND PRINCIPAL FINDINGS: The working group convened three times and established two use cases: identifying a single case of yaws and detecting azithromycin resistance. One subgroup assessed the current diagnostic landscape for yaws and a second subgroup determined the test requirements for both use cases. Draft TPPs were sent out for input from stakeholders and experts. Both TPPs considered the following parameters: product use, design, performance, configuration, cost, access and equity. To identify a single case of yaws, the test should be able to detect an analyte which confirms an active infection with at least 95% sensitivity and 99.9% specificity. The high specificity was deemed important to avoid a high false positive rate which could result in unnecessary continuation or initiation of MDA campaigns. If used in settings where the number of suspected cases is low, further testing could be considered to compensate for imperfect sensitivity and to improve specificity. The test to detect azithromycin resistance should be able to detect known genetic resistance mutations with a minimum sensitivity and specificity of 95%, with the caveat that all patients with suspected treatment failure should be treated as having resistant yaws and offered alternative treatment. CONCLUSIONS: The TPPs developed will provide test developers with guidance to ensure that novel diagnostic tests meet identified public health needs. Public Library of Science 2022-09-01 /pmc/articles/PMC9473620/ /pubmed/36048897 http://dx.doi.org/10.1371/journal.pntd.0010554 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
Fongwen, Noah
Handley, Becca L.
Martin, Diana L.
Beiras, Camila
Dyson, Louise
Frimpong, Michael
Mitja, Oriol
Asiedu, Kingsley
Marks, Michael
Diagnostics to support the eradication of yaws—Development of two target product profiles
title Diagnostics to support the eradication of yaws—Development of two target product profiles
title_full Diagnostics to support the eradication of yaws—Development of two target product profiles
title_fullStr Diagnostics to support the eradication of yaws—Development of two target product profiles
title_full_unstemmed Diagnostics to support the eradication of yaws—Development of two target product profiles
title_short Diagnostics to support the eradication of yaws—Development of two target product profiles
title_sort diagnostics to support the eradication of yaws—development of two target product profiles
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9473620/
https://www.ncbi.nlm.nih.gov/pubmed/36048897
http://dx.doi.org/10.1371/journal.pntd.0010554
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