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 makes...
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ftdoajarticles:oai:doaj.org/article:3054b819f2024f34b6ea6ad590e8e268 2023-05-15T15:15:01+02:00 Diagnostics to support the eradication of yaws-Development of two target product profiles. Noah Fongwen Becca L Handley Diana L Martin Camila Beiras Louise Dyson Michael Frimpong Oriol Mitja Kingsley Asiedu Michael Marks 2022-09-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0010554 https://doaj.org/article/3054b819f2024f34b6ea6ad590e8e268 EN eng Public Library of Science (PLoS) https://doi.org/10.1371/journal.pntd.0010554 https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0010554 https://doaj.org/article/3054b819f2024f34b6ea6ad590e8e268 PLoS Neglected Tropical Diseases, Vol 16, Iss 9, p e0010554 (2022) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2022 ftdoajarticles https://doi.org/10.1371/journal.pntd.0010554 2022-12-30T19:44:14Z 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 ... Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLOS Neglected Tropical Diseases 16 9 e0010554 |
institution |
Open Polar |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
language |
English |
topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
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Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Noah Fongwen Becca L Handley Diana L Martin Camila Beiras Louise Dyson Michael Frimpong Oriol Mitja Kingsley Asiedu Michael Marks Diagnostics to support the eradication of yaws-Development of two target product profiles. |
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Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
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 ... |
format |
Article in Journal/Newspaper |
author |
Noah Fongwen Becca L Handley Diana L Martin Camila Beiras Louise Dyson Michael Frimpong Oriol Mitja Kingsley Asiedu Michael Marks |
author_facet |
Noah Fongwen Becca L Handley Diana L Martin Camila Beiras Louise Dyson Michael Frimpong Oriol Mitja Kingsley Asiedu Michael Marks |
author_sort |
Noah Fongwen |
title |
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_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_sort |
diagnostics to support the eradication of yaws-development of two target product profiles. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2022 |
url |
https://doi.org/10.1371/journal.pntd.0010554 https://doaj.org/article/3054b819f2024f34b6ea6ad590e8e268 |
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Arctic |
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Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 16, Iss 9, p e0010554 (2022) |
op_relation |
https://doi.org/10.1371/journal.pntd.0010554 https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0010554 https://doaj.org/article/3054b819f2024f34b6ea6ad590e8e268 |
op_doi |
https://doi.org/10.1371/journal.pntd.0010554 |
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PLOS Neglected Tropical Diseases |
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16 |
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e0010554 |
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