Target product profile: diagnostic test for Trypanosoma brucei rhodesiense

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

Research output: Contribution to journalA1: Web of Science-articlepeer-review

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Abstract

Rhodesiense human African trypanosomiasis is a lethal parasitic infection caused by Trypanosoma brucei rhodesiense and transmitted by tsetse flies in eastern and southern Africa. It accounts for around 5% of all cases of human African trypanosomiasis. Currently, there is no simple serological test for rhodesiense human African trypanosomiasis and diagnosis relies on microscopic confirmation of trypanosomes in samples of blood or other tissues. The availability of a simple and accurate diagnostic test would aid the control, surveillance and treatment of the disease. A subcommittee of the World Health Organization's Neglected Tropical Diseases Diagnostics Technical Advisory Group has developed a target product profile for a diagnostic tool to identify T. b. rhodesiense infection. The optimum tool would have a sensitivity and specificity above 99% for detecting T. b. rhodesiense, but be simple enough for use by minimally trained health-care workers in unsophisticated peripheral health facilities or mobile teams in villages. The test should yield a qualitative result that can be easily observed and can be used to determine treatment. An antigen test would be preferable, with blood collected by finger-prick. Ideally, there should be no need for a cold chain, instrumentation or precision liquid handling. The test should be usable between 10 °C and 40 °C and between 10% and 88% relative humidity. Basic training should take under 2 hours and the test should involve fewer than five steps. The unit cost should be less than 1 United States dollar.

Original languageEnglish
JournalBulletin of the World Health Organization
Volume101
Issue number8
Pages (from-to)529-534
Number of pages6
ISSN0042-9686
DOIs
Publication statusPublished - 2023

Keywords

  • Animals
  • Humans
  • Trypanosoma brucei rhodesiense
  • Trypanosomiasis, African/diagnosis
  • Africa, Southern
  • Sensitivity and Specificity
  • Diagnostic Tests, Routine

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