Diagnostics to support the control of scabies– Development of Two Target Product Profiles
Authors: Marks Michael , McVernon Jodie , McCarthy James S. , Enbiale Wendemagegn , Hanna Christopher , Chosidow Olivier , Engelman Daniel , Asiedu Kingsley , Steer Andrew 
Published: June 2022

Background

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.

Methodology and principal findings

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%.

Conclusions

The TPPs developed will provide test developers with guidance to ensure that novel diagnostic tests meet identified public health needs.

Author summary

Accurate diagnostic tests are needed to aid scabies control efforts. In particular they might aid decisions about when to start and stop treatment of whole communities (mass drug administration). Currently most diagnosis is based on clinical examination only and there is a need to establish what criteria new diagnostic tests should meet for them to be of public health use. To aid with this, we determined the programmatic areas of greatest need (use cases) and then developed a shortlist of product requirements (target product profiles, or TPPs) for each scenario. These TPPs can then be used by product developers to ensure that novel diagnostic tools in development are fit for purpose. There were two programmatic use cases for which scabies TPPs were developed. The first TPP focused on diagnostics to determine if the community prevalence of scabies was above 10% - the threshold at which mass drug administration is recommended. The second TPP focused on diagnostics to determine if the community prevalence of scabies is below 2% - the threshold at which mass drug administration can be stopped.