Passive surveillance of human African trypanosomiasis in the Democratic Republic of the Congo: clinical presentation, rapid diagnostic test results and reference laboratory test results (2017-2020)

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Lejon, Veerle; Makabuza, Jacquies; Ngay Lukusa, Ipos; Lumbala, Crispin; Mwamba Miaka, Erick; Nganzobo, Pathou; Fukinsia, Alain; Kwete, Jean; Bebronne, Nicolas; Buscher, Philippe; Mumba Ngoyi, Dieudonné, 2025, "Passive surveillance of human African trypanosomiasis in the Democratic Republic of the Congo: clinical presentation, rapid diagnostic test results and reference laboratory test results (2017-2020)", https://doi.org/10.23708/LTTOWL, DataSuds, V1, UNF:6:9rUrKesBII3C9SMI0UV6OA== [fileUNF]

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Description	In the last decade, the prevalence of Trypanosoma brucei gambiense human African trypanosomiasis (HAT) has fallen and HAT has been targeted for elimination. At low disease prevalence, integration of case finding into routine activities of peripheral health centres becomes crucial. However, HAT case detection by the peripheral health system with limited resources requires adapted diagnostic tests and test algorithms. The objective of the DiTECT-HAT-WP2 study was to determine the diagnostic performance and cost of rapid diagnostic tests (RDTs) performed on clinical suspects in peripheral health centres, whether or not followed by serological and/or molecular tests on filter paper done at regional reference centres. DiTECT-HAT has been registered in clinicaltrials.gov under ID NCT03356665, and is part of the DiTECT-HAT project, funded by EDCTP2-Horizon 2020- European Union. The DiTECT-HAT-WP2 study was conducted in centres for diagnosis and treatment and in sites for serological screening in Guinea, Côte d’Ivoire and DR Congo. In these centres and sites, clinical suspects were tested with several commercially available RDTs for HAT. Clinical suspects with at least 1 RDT positive result, 1° underwent parasitological examination and 2° blood collection on filter paper for reference analysis in trypanolysis, LAMP, ELISA and real-time PCR in the regional reference laboratory. If the reference laboratory tests and parasitological examinations were all negative, the suspect was considered free of HAT. If at least 1 reference test was positive, parasitological examinations were repeated at least twice at three months interval, unless trypanosomes were detected. The current version of the dataset provide the DiTECT-HAT-WP2 study protocol in French and English, the informed consent form, and test protocols, a data dictionnary and the de-identified study data in excel and as csv file of DiTECT-HAT-WP2 in the Democratic Republic of the Congo. DiTECT-HAT-WP2 data will be made available to qualified researchers upon request after signing a confidentiality agreement (Data use agreement template to be filled in included). Data requests may be sent to the Institut de Recherche pour le Développement (IRD) data administrator (data@ird.fr) and the authors. (2025-03-11)
Subject	Medicine, Health and Life Sciences
Keyword	neglected disease, Trypanosoma brucei gambiense, parasitology, Point-of-Care Testing, diagnosis, African trypanosomiasis, Serologic tests, Sensitivity and Specificity, False positive reactions
Related Publication	Makabuza J, Ngay Lukusa I, Lumbala C, Mwamba Miaka E, Nganzobo P, Fukinsia A, Kwete J, Bebronne N, Büscher P, Mumba Ngoyi D, Lejon V. Passive surveillance of human African trypanosomiasis in the Democratic Republic of the Congo: clinical presentation and prospective evaluation of rapid diagnostic and reference laboratory test accuracy. Manuscript in preparation
Notes	Data type: Survey data
License/Data Use Agreement	Custom Dataset Terms

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	Data_Use_Agreement.docx DiTECT-HAT-WP2/MS Word - 19.6 KB Published Mar 21, 2025 0 Downloads MD5: 3951705fca701ba9ad6b6f5b3cf09b81 Data use agreement template. The form must be downloaded, completed and returned to the authors of the dataset and data@ird.fr before access to the data files is granted. Documentation	Access File File Access Public Download Options MS Word Download Metadata Data File Citation EndNote XML RIS BibTeX
	DiTECT-HAT-WP2-ICF_AF-V1_1F-17-01-09.pdf DiTECT-HAT-WP2/Adobe PDF - 622.3 KB Published Mar 21, 2025 0 Downloads MD5: e6859745e7c41a5ae93828d3588cdf59 Informed Consent form and ascent form DiTECT-HAT-WP2 study Documentation	Preview "DiTECT-HAT-WP2/DiTECT-HAT-WP2-ICF_AF-V1_1F-17-01-09.pdf" Access File File Access Public Download Options Adobe PDF Download Metadata Data File Citation EndNote XML RIS BibTeX
	DiTECT-HAT-WP2-Protocol-V1_2E-17-01-09.pdf DiTECT-HAT-WP2/Adobe PDF - 1.9 MB Published Mar 21, 2025 0 Downloads MD5: ff5e9506b784d9bdb8b63ca3809d5238 Study protocol DiTECT-HAT-WP2 in English Documentation	Preview "DiTECT-HAT-WP2/DiTECT-HAT-WP2-Protocol-V1_2E-17-01-09.pdf" Access File File Access Public Download Options Adobe PDF Download Metadata Data File Citation EndNote XML RIS BibTeX
	DiTECT-HAT-WP2-Protocol-V1_2F-17-01-09.pdf DiTECT-HAT-WP2/Adobe PDF - 2.2 MB Published Mar 21, 2025 0 Downloads MD5: b26bfac54b600072c0a232905b78aaac Study protocol DiTECT-HAT-WP2 in French Documentation	Preview "DiTECT-HAT-WP2/DiTECT-HAT-WP2-Protocol-V1_2F-17-01-09.pdf" Access File File Access Public Download Options Adobe PDF Download Metadata Data File Citation EndNote XML RIS BibTeX
	DiTECT-HAT-WP2-RDC-1.tab DiTECT-HAT-WP2/Tabular Data - 372.4 KB Published Mar 21, 2025 0 Downloads 46 Variables, 3113 Observations UNF:6:J496+4B6ttLYt8DcjXAGpA== data DiTECT-HAT-WP2 from RD Congo in tab format Données	Access File File Access Restricted Request Access Download Metadata Data File Citation EndNote XML RIS BibTeX
	DiTECT-HAT-WP2-RDC.tab DiTECT-HAT-WP2/Tabular Data - 481.4 KB Published Mar 21, 2025 0 Downloads 46 Variables, 3113 Observations UNF:6:J496+4B6ttLYt8DcjXAGpA== data DiTECT-HAT-WP2 from RD Congo in excel format Données	Access File File Access Restricted Request Access Download Metadata Data File Citation EndNote XML RIS BibTeX
	DiTECT-HAT-WP2-RDC_data_dictionnary.pdf DiTECT-HAT-WP2/Adobe PDF - 130.9 KB Published Mar 21, 2025 0 Downloads MD5: f6af11e806e65bf430b5e99a2ed5b1e6 Explanation variables DiTECT-HAT-WP2-RDC data file Documentation	Preview "DiTECT-HAT-WP2/DiTECT-HAT-WP2-RDC_data_dictionnary.pdf" Access File File Access Public Download Options Adobe PDF Download Metadata Data File Citation EndNote XML RIS BibTeX
	ReadMe.txt DiTECT-HAT-WP2/Plain Text - 3.1 KB Published Mar 21, 2025 0 Downloads MD5: 860e0ae165d63bc191399a9da8e4e449 Data citation, description and terms of use Documentation	Preview "DiTECT-HAT-WP2/ReadMe.txt" Access File File Access Public Download Options Plain Text Download Metadata Data File Citation EndNote XML RIS BibTeX
	SOP-FLOW-01-Flowchart-WP2-V1_1-2017-05-03.pdf DiTECT-HAT-WP2/Adobe PDF - 635.5 KB Published Mar 21, 2025 0 Downloads MD5: f2b7221682600de225ab86740537e8a7 Standard Operating Procedure explaining flow of study participants Documentation	Preview "DiTECT-HAT-WP2/SOP-FLOW-01-Flowchart-WP2-V1_1-2017-05-03.pdf" Access File File Access Public Download Options Adobe PDF Download Metadata Data File Citation EndNote XML RIS BibTeX
	SOP-LAB-06-Extraction-DNA-from-Whatman-4-filter-paper-V1_2-2017-07-3.pdf DiTECT-HAT-WP2/Adobe PDF - 312.3 KB Published Mar 21, 2025 0 Downloads MD5: f35ae808c13f79b652606b1640e2030c Standard Operating Procedure DNA extraction from dried blood spots Documentation	Preview "DiTECT-HAT-WP2/SOP-LAB-06-Extraction-DNA-from-Whatman-4-filter-paper-V1_2-2017-07-3.pdf" Access File File Access Public Download Options Adobe PDF Download Metadata Data File Citation EndNote XML RIS BibTeX

Citation Metadata

Persistent Identifier	doi:10.23708/LTTOWL
Publication Date	2025-03-21
Title	Passive surveillance of human African trypanosomiasis in the Democratic Republic of the Congo: clinical presentation, rapid diagnostic test results and reference laboratory test results (2017-2020)
Subtitle	DiTECT-HAT-WP2-RD Congo
Alternative URL	https://clinicaltrials.gov/study/NCT03356665?cond=African%20Trypanosomiasis&term=ditect-hat&rank=1
Author	Lejon, Veerle (UMR INTERTRYP - IRD, CIRAD, University of Montpellier - France) - ORCID: 0000-0002-6795-0962 Makabuza, Jacquies (Programme National de Lutte contre la Trypanosomiase Humaine Africaine, Kinshasa - DR Congo) Ngay Lukusa, Ipos (Institut National de Recherche Biomédicale, Kinshasa - DR Congo) Lumbala, Crispin (Programme National de Lutte contre la Trypanosomiase Humaine Africaine, Kinshasa - DR Congo) - ORCID: 0000-0001-8892-1610 Mwamba Miaka, Erick (Programme National de Lutte contre la Trypanosomiase Humaine Africaine, Kinshasa - DR Congo) - ORCID: 0000-0001-7624-7905 Nganzobo, Pathou (Programme National de Lutte contre la Trypanosomiase Humaine Africaine, Kinshasa - DR Congo) Fukinsia, Alain (Programme National de Lutte contre la Trypanosomiase Humaine Africaine, Kinshasa - DR Congo) Kwete, Jean (Programme National de Lutte contre la Trypanosomiase Humaine Africaine, Kinshasa - DR Congo) Bebronne, Nicolas (Institute of Tropical Medicine, Antwerpen - Belgium) - ORCID: 0000-0003-3542-309X Buscher, Philippe (Institute of Tropical Medicine- Belgium) - ORCID: 0000-0002-1926-7472 Mumba Ngoyi, Dieudonné (Institut National de Recherche Biomedicale - DR Congo) - ORCID: 0000-0002-5886-2004
Point of Contact	Use email button above to contact. Lejon, Veerle (UMR INTERTRYP - IRD, CIRAD, University of Montpellier - France)
Description	In the last decade, the prevalence of Trypanosoma brucei gambiense human African trypanosomiasis (HAT) has fallen and HAT has been targeted for elimination. At low disease prevalence, integration of case finding into routine activities of peripheral health centres becomes crucial. However, HAT case detection by the peripheral health system with limited resources requires adapted diagnostic tests and test algorithms. The objective of the DiTECT-HAT-WP2 study was to determine the diagnostic performance and cost of rapid diagnostic tests (RDTs) performed on clinical suspects in peripheral health centres, whether or not followed by serological and/or molecular tests on filter paper done at regional reference centres. DiTECT-HAT has been registered in clinicaltrials.gov under ID NCT03356665, and is part of the DiTECT-HAT project, funded by EDCTP2-Horizon 2020- European Union. The DiTECT-HAT-WP2 study was conducted in centres for diagnosis and treatment and in sites for serological screening in Guinea, Côte d’Ivoire and DR Congo. In these centres and sites, clinical suspects were tested with several commercially available RDTs for HAT. Clinical suspects with at least 1 RDT positive result, 1° underwent parasitological examination and 2° blood collection on filter paper for reference analysis in trypanolysis, LAMP, ELISA and real-time PCR in the regional reference laboratory. If the reference laboratory tests and parasitological examinations were all negative, the suspect was considered free of HAT. If at least 1 reference test was positive, parasitological examinations were repeated at least twice at three months interval, unless trypanosomes were detected. The current version of the dataset provide the DiTECT-HAT-WP2 study protocol in French and English, the informed consent form, and test protocols, a data dictionnary and the de-identified study data in excel and as csv file of DiTECT-HAT-WP2 in the Democratic Republic of the Congo. DiTECT-HAT-WP2 data will be made available to qualified researchers upon request after signing a confidentiality agreement (Data use agreement template to be filled in included). Data requests may be sent to the Institut de Recherche pour le Développement (IRD) data administrator (data@ird.fr) and the authors. (2025-03-11)
Subject	Medicine, Health and Life Sciences
Keyword	neglected disease (mesh) https://www.ncbi.nlm.nih.gov/mesh/68058069 Trypanosoma brucei gambiense (mesh) https://www.ncbi.nlm.nih.gov/mesh/68014347 parasitology (mesh) https://www.ncbi.nlm.nih.gov/mesh/68010274 Point-of-Care Testing (mesh) https://www.ncbi.nlm.nih.gov/mesh/2009759 diagnosis (mesh) https://www.ncbi.nlm.nih.gov/mesh/68003933 African trypanosomiasis (mesh) https://www.ncbi.nlm.nih.gov/mesh/68014353 Serologic tests (mesh) https://www.ncbi.nlm.nih.gov/mesh/68012698 Sensitivity and Specificity (mesh) https://www.ncbi.nlm.nih.gov/mesh/68012680 False positive reactions (mesh) https://www.ncbi.nlm.nih.gov/mesh/68005189
Scientific Theme	Medical entomology, parasitology and virology (NumeriSud) https://uri.ird.fr/so/kos/tnu/052
Related Publication	Makabuza J, Ngay Lukusa I, Lumbala C, Mwamba Miaka E, Nganzobo P, Fukinsia A, Kwete J, Bebronne N, Büscher P, Mumba Ngoyi D, Lejon V. Passive surveillance of human African trypanosomiasis in the Democratic Republic of the Congo: clinical presentation and prospective evaluation of rapid diagnostic and reference laboratory test accuracy. Manuscript in preparation
Notes	Data type: Survey data
Language	English; French
Producer	Makabuza, Jacquies (Programme National de Lutte contre la Trypanosomiase Humaine Africaine, Kinshasa - DR Congo) Ngay Lukusa, Ipos (Institut National de Recherche Biomédicale, Kinshasa - DR Congo) Lejon, Veerle (UMR INTERTRYP - IRD, CIRAD, University of Montpellier - France)
Production Date	2022-12-19
Production Location	Kinshasa, DR Congo; Kwilu, DR Congo
Contributor	Data Collector : Makabuza, Jacquies Researcher : Ngay Lukusa, Ipos Supervisor : Lumbala, Crispin Supervisor : Mwamba Miaka, Erick Project Member : Nganzobo, Pathou Project Member : Fukinsia, Alain Related Person : Kwete, Jean Related Person : Bebronne, Nicolas Data Manager : Buscher, Philippe Work Package Leader : Mumba Ngoyi, Dieudonné Project Leader : Lejon, Veerle
Funding Information	EDCTP2 Horizon 2020 European Union: DRIA-2014-306-DiTECT-HAT
Distributor	Lejon, Veerle (UMR INTERTRYP - IRD, CIRAD, University of Montpellier - France) https://umr-intertryp.cirad.fr/
Distribution Date	2025-03-11
Depositor	LEJON, Veerle
Deposit Date	2025-03-11
Time Period	Start Date: 2017-10-30 ; End Date: 2020-12-31
Date of Collection	Start Date: 2017-10-30 ; End Date: 2020-12-31
Series	DiTECT-HAT-WP2
Software	excel
Related Material	https://www.clinicaltrials.gov/ct2/show/NCT03356665?term=DiTECT-HAT&draw=2&rank=2
Related Dataset	https://doi.org/10.23708/ZDD0OW; https://doi.org/10.23708/FNZDMZ

Geospatial Metadata

Geographic Coverage	Congo, the Democratic Republic of the Kinshasa Congo, the Democratic Republic of the Kwilu
Geographic Bounding Box	15.164794949814679 18.95507815293968 -3.162455028089534 -5.129242989529025

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