Call for public consultation  ̶  Target Product Profile for two gambiense Human African Trypanosomiasis tests: (TPP3) individual test to assess infection in low prevalence settings; (TPP4) high-throughput test for verification of elimination

Human African trypanosomiasis (HAT) or sleeping sickness is a neglected tropical disease with major public health and economic impact in sub-Saharan Africa. There are two forms of the disease: an acute form, mainly in East and Southern Africa caused by Trypanosoma brucei rhodesiense (rhodesiense HAT) and a chronic form, mainly in West and Central Africa caused by Trypanosoma brucei gambiense (gambiense HAT).

HAT diagnosis relies on laboratory techniques because clinical signs and symptoms are unspecific. Serodiagnostic tests (gambiense HAT only) are not confirmatory of infection, while parasitological confirmation is resource-demanding, and has limited sensitivity.

Gambiense HAT could be eliminated faster if seropositive individuals could receive treatment without further labwork (i.e. widened treatment), which is a tangibly possible strategy in the near future. However, this creates the need of a tool to monitor the presence of Tbg infection in the community in order to adjust strategies, including their eventual stop (TPP3).

An additional tool needed is a high throughput test for verification of elimination of Trypanosoma brucei gambiense, where non-specialised personnel would collect numerous samples in remote rural areas, to be shipped to reference labs (TPP4).

The World Health Organization (WHO) is asking for feedback on these two TPPs. Feedback is invited from experts in the industry, product development, parasitologists, the scientific community, NTD programme personnel and other technicians involved directly or indirectly in the fight against NTDs.

Details of the TPP may be found in the linked documents.

Any proposed revisions during this public consultation will be considered by the WHO Technical Advisory Group for NTD Diagnostics (DTAG) specific subgroup. The final TPP will be posted in a dedicated WHO website.