Target product profile: Trypanosoma brucei gambiense test for low-prevalence settings

Gerardo Priotto, Jose Ramon Franco, Veerle Lejon, Philippe Büscher, Enock Matovu, Joseph M Ndung'u, Sylvain Biéler, Dieudonné Mumba, Nick Van Reet, Paul Verlé, Vincent Jamonneau, Pere P Simarro, Augustin Kadima Ebeja, Dieudonné Sankara, Daniel Argaw Dagne

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Abstract

Having caused devastating epidemics during the 20th century, the incidence of life-threatening human African trypanosomiasis has fallen to historically low levels as a result of sustained and coordinated efforts over the past 20 years. Humans are the main reservoir of one of the two pathogenic trypanosome subspecies, Trypanosoma brucei gambiense, found in western and central Africa. The expected advent of a safe and easy-to-use treatment to be given to seropositive but microscopically unconfirmed individuals would lead to further depletion; in the meantime, the presence of T. b. gambiense infection in the community must be monitored to allow the control strategy to be adapted and the elimination status to be assessed. The World Health Organization has therefore developed a target product profile that describes the optimal and minimal characteristics of an individual laboratory-based test to assess T. b. gambiense infection in low-prevalence settings. Development of the target product profile involved the formation of a Neglected Tropical Diseases Diagnostics Technical Advisory Group and a subgroup on human African trypanosomiasis diagnostic innovation needs, and an analysis of the available products and development pipeline. According to the product profile, the test should ideally: (i) require a minimally invasive or non-invasive specimen, collectable at peripheral facilities by minimally trained health workers; (ii) demonstrate good sensitivity and high specificity; (iii) have a stability of samples allowing transfer to reference laboratories preferably without cold chain; (iv) be stable over a wide range of environmental conditions for more than 2 years; and (v) after marketing, be available at low cost for at least 7 years.

Original languageEnglish
JournalBulletin of the World Health Organization
Volume101
Issue number8
Pages (from-to)541-545
Number of pages5
ISSN0042-9686
DOIs
Publication statusPublished - 2023

Keywords

  • Animals
  • Humans
  • Trypanosoma brucei gambiense
  • Trypanosomiasis, African/diagnosis
  • Prevalence
  • Incidence

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