Trypanosome spliced leader RNA for diagnosis of acoziborole treatment outcome in gambiense human African trypanosomiasis: a longitudinal follow-up study

Ipos Ngay Lukusa, Nick Van Reet, Dieudonné Mumba Ngoyi, Erick Mwamba Miaka, Justin Masumu, Pati Patient Pyana, Wilfried Mutombo, Digas Ngolo, Vincent Kobo, Felix Akwaso, Médard Ilunga, Lewis Kaninda, Sylvain Mutanda, Dieudonné Mpoyi Muamba, Olaf Valverde Mordt, Antoine Tarral, Sandra Rembry, Philippe Büscher, Veerle Lejon

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BACKGROUND: Detection of spliced leader (SL)-RNA allows sensitive diagnosis of gambiense human African trypanosomiasis (HAT). We investigated its diagnostic performance for treatment outcome assessment.

METHODS: Blood and cerebrospinal fluid (CSF) from a consecutive series of 97 HAT patients, originating from the Democratic Republic of the Congo, were prospectively collected before treatment with acoziborole, and during 18 months of longitudinal follow-up after treatment. For treatment outcome assessment, SL-RNA detection was compared with microscopic trypanosome detection and CSF white blood cell count. The trial was registered under NCT03112655 in

FINDINGS: Before treatment, respectively 94.9% (92/97; CI 88.5-97.8%) and 67.7% (65/96; CI 57.8-76.2%) HAT patients were SL-RNA positive in blood or CSF. During follow-up, one patient relapsed with trypanosomes observed at 18 months, and was SL-RNA positive in blood and CSF at 12 months, and CSF positive at 18 months. Among cured patients, one individual tested SL-RNA positive in blood at month 12 (Specificity 98.9%; 90/91; CI 94.0-99.8%) and 18 (Specificity 98.9%; 88/89; CI 93.9-99.8%).

INTERPRETATION: SL-RNA detection for HAT treatment outcome assessment shows ≥98.9% specificity in blood and 100% in CSF, and may detect relapses without lumbar puncture.

FUNDING: The DiTECT-HAT project is part of the EDCTP2 programme, supported by Horizon 2020, the European Union Funding for Research and Innovation (grant number DRIA-2014-306-DiTECT-HAT).

Original languageEnglish
Article number104376
Number of pages12
Publication statusPublished - 2022


  • Animals
  • Antiprotozoal Agents/therapeutic use
  • Follow-Up Studies
  • Humans
  • RNA, Spliced Leader
  • Treatment Outcome
  • Trypanosoma
  • Trypanosoma brucei gambiense/genetics
  • Trypanosomiasis, African/diagnosis

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