Performance of clinical signs and symptoms, rapid and reference laboratory diagnostic tests for diagnosis of human African trypanosomiasis by passive screening in Guinea: a prospective diagnostic accuracy study.

"Declarations Ethics approval and consent to participateThe study in Guinea was part of the multi-country diagnostic clinical trial “Diagnostic tools for human African trypanosomiasis elimination and clinical trials work package 2, passive case detection” (DiTECT-HAT-WP2), registered on ClinicalTrials.Gov under identifier NCT03356665. Before initiation of the study, DiTECT-HAT-WP2 received ethical clearance from the Advisory Committee on Deontology and Ethics of the French National Institute for Research on Sustainable Development (plenary meeting of 17–20 October 2016), of the Institutional Review Board of the Institute of Tropical Medicine in Antwerp Belgium (reference 1133/16), and of the Ethics Committee of the University of Antwerp (Belgian registration number B300201730927). In Guinea, DiTECT-HAT-WP2 was approved by the Comité National d’Ethique pour la Recherche en Santé (CNERS, reference 025/CNERS/17). Potential study participants were informed how and why the study was carried out, and gave their written informed consent before inclusion in the study. For minor participants, an assent was obtained and written informed consent was provided by the parents or legal guardians. All clinical investigations were conducted according to the Declaration of Helsinki. Consent for publicationNot applicable. Competing interestsThe authors declare that they have no competing interests. Competing interests The authors declare that they have no competing interests."

"Funding This study was funded by the EDCTP2 programme supported by the Horizon 2020 European Union funding for Research and Innovation (Grant Number DRIA-2014-306-DiTECT-HAT). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript."

"Trial registration The trial was registered under NCT03356665 in clinicaltrials.gov (November 29, 2017, retrospectively registered https://clinicaltrials.gov/ct2/show/NCT03356665 )"