Fongwen, Noah, Handley, Becca L., Martin, Diana L., Beiras, Camila, Dyson, Louise, Frimpong, Michael, Mitja, Oriol, Asiedu, Kingsley and Marks, Michael (2022) Diagnostics to support the eradication of yaws : development of two target product profiles. PLoS Neglected Tropical Diseases, 16 (9). e0010554. doi:10.1371/journal.pntd.0010554 ISSN 1935-2727.

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Abstract

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.

Item Type:	Journal Article
Subjects:	R Medicine > RC Internal medicine
Divisions:	Faculty of Science, Engineering and Medicine > Science > Life Sciences (2010- ) Faculty of Science, Engineering and Medicine > Science > Mathematics
Library of Congress Subject Headings (LCSH):	Yaws , Yaws -- Prevention -- Simulation methods, Yaws -- Serodiagnosis
Journal or Publication Title:	PLoS Neglected Tropical Diseases
Publisher:	Public Library of Science
ISSN:	1935-2727
Official Date:	1 September 2022
Dates:	Date Event 1 September 2022 Published 15 August 2022 Accepted 1 June 2022 Submitted
Volume:	16
Number:	9
Number of Pages:	8
Article Number:	e0010554
DOI:	10.1371/journal.pntd.0010554
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access (Creative Commons)
Date of first compliant deposit:	20 September 2022
Date of first compliant Open Access:	20 September 2022

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