Call for public consultation  ̶  Target Product Profile for a gambiense Human African Trypanosomiasis test to identify individuals to receive widened treatment

Deadline: 15 December 2021

16 November 2021
Call for consultation

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. In gambiense HAT serodiagnostic tests exist but are not confirmatory of infection, while parasitological confirmation is resource-demanding, and has limited sensitivity.

Gambiense HAT could be eliminated faster if seropositive but microscopically unconfirmed individuals could receive treatment (i.e. widened treatment), especially facilitated by a new effective, safer and easy-to-use medicine which is expected to be validated in the near future. A simple diagnostic tool to identify individuals eligible for this treatment would be the ideal complement for such elimination approach. This diagnostic tool would have a role to play even in the absence of a new medicine.

The World Health Organization (WHO) is asking for feedback on this TPP. Feedback is invited from experts in the industry, product development, parasitologists, the scientific community, NTD programme personnel and other technicians currently implementing.

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.

Please download and use the feedback form to provide your comments on the draft TPP. Submit it to neglected.diseases@who.int with copy to Gerardo Priotto (priottog@who.int) by email with the subject line “Comments on g-HAT diagnostic TPP”

Media Contacts

Ashok Moloo

Information Officer
WHO/UCN/NTD

Telephone: +41 22 791 16 37

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