Target product profile for a test for rhodesiense human African trypanosomiasis diagnosis usable in peripheral health facilities

Overview

The development of this target product profile (TPP) was led by the WHO Department of Control of Neglected Tropical Diseases (NTD) following standard WHO guidance for TPP development. In order to identify and prioritize diagnostic needs, a WHO NTD Diagnostics Technical Advisory Group (DTAG) was formed, and different subgroups were created to advise on specific NTDs, including a subgroup working on the human African trypanosomiasis (HAT) diagnostic innovation needs. This group of independent experts included leading scientists, public health officials and endemic-country end-user representatives. Standard WHO Declaration of Interest procedures were followed. A landscape analysis of the available products and of the development pipeline was conducted, and the salient areas with unmet needs were identified. Through meetings and remote consultations, the subgroup developed use-cases for the hypothetical tools considered as the main gaps, and gave them an order of priority. A template adapted to the HAT context was agreed and used for the development of the first draft of this TPP (priority N° 1) which underwent several rounds of review by the subgroup members. The ensuing version was reviewed by the DTAG members.