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Diagnostics to support the control of scabies-Development of two target product profiles.
oleh: Michael Marks, Jodie McVernon, James S McCarthy, Wendemagegn Enbiale, Christopher Hanna, Olivier Chosidow, Daniel Engelman, Kingsley Asiedu, Andrew Steer
| Format: | Article |
|---|---|
| Diterbitkan: | Public Library of Science (PLoS) 2022-08-01 |
Deskripsi
<h4>Background</h4>Scabies was added to the WHO NTD portfolio in 2017 and targets for the control of scabies were included in the 2021-2030 WHO NTD roadmap. A major component of scabies control efforts a strategy based on mass drug administration (MDA) with ivermectin. Currently diagnosis of scabies relies on clinical examination with a limited role for diagnostic testing. Under the recommendation of the WHO Diagnostic Technical Advisory Group (DTAG) for Neglected Tropical Diseases, a working group was assembled and tasked with agreeing on priority use cases for and developing target product profiles (TPPs) for new diagnostics tools for scabies.<h4>Methodology and principal findings</h4>The working group convened three times and established two use cases: establishing if the 10% threshold for mass drug administration had been reached and if the 2% threshold for stopping mass drug administration has been achieved. One subgroup assessed the current diagnostic landscape for scabies 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. The group considered the use of the tests as a single step process or as part of a two step process following initial clinical examination. When used a single step test (the ideal scenario) for starting MDA a new diagnostic required a sensitivity of ≥92% and a specificity of ≥98%. When used a single step test (the ideal scenario) for stopping MDA a new diagnostic required a sensitivity of ≥80% and a specificity of ≥99%.<h4>Conclusions</h4>The TPPs developed will provide test developers with guidance to ensure that novel diagnostic tests meet identified public health needs.