Observational studyBMC infectious diseases2026
Development and validation of a sample-to-result real time multiplex RT-PCR test for human African trypanosomiasis and arboviral febrile illnesses in the Democratic Republic of the Congo.
Observational study in BMC infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04760678 (Clinical Aspects, Severity, Management and Outcome of Febrile Illnesses in the Democratic Republic Congo), which is not on this map. Not yet cited in PubMed.
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Clinical Aspects, Severity, Management and Outcome of Febrile Illnesses in the Democratic Republic Congo (DRC).
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14 authors.
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Abstract
backgroundHuman African trypanosomiasis (HAT) is a fatal vector-borne disease caused by Trypanosoma brucei. Although HAT incidence has declined, meeting WHO's elimination targets remain difficult, particularly due to limited diagnostic sensitivity for low-parasite load-infections. Arboviruses such as dengue (DENV 1-4), chikungunya (CHIKV), and yellow fever (YFV) virus, present with nonspecific febrile symptoms similar to HAT and are underdiagnosed in Sub-Saharan Africa. Due to this overlap in symptoms and a suspected geographical overlap of vectors and pathogens in the Democratic Republic of the Congo (DRC) the pathogens were combined in a multiplex-PCR panel. Sample-to-result platforms (S2R) can reduce hands-on time and infrastructure requirements, making them ideal for peripheral laboratories. We developed a multiplex real-time RT-PCR assay on the ARIES
methodsA technical validation and retrospective sample testing (n = 242) were performed at the Institute of Tropical Medicine (ITM). Field validation took place in the DRC with retrospective samples from a CHIKV outbreak (n = 121) in Institut National pour la Recherche Biomédicale (INRB) Kinshasa and 52 prospective whole blood samples from acute febrile patients in Centre de Recherche en Santé de Kimpese (CRSK) in Kimpese.
resultsThe assay showed a slight loss of sensitivity, evidenced in the technical validation, and the non-detection of some T.b.gambiense and retrospective arboviral samples at ITM with low pathogen loads. CHIKV samples tested in Kinshasa showed a sensitivity of 89.4%. Although all samples tested in Kimpese were negative for the pathogens, it demonstrated how just a few days of training and the simplified workflows of a S2R-platform can enable robust diagnostics under challenging conditions.
conclusionEnsuring rapid, sensitive molecular diagnostics in resource-limited settings is critical for eliminating HAT and strengthening surveillance of emerging arboviruses. Despite the recent discontinuation of ARIES CLINICAL TRIAL: Clinicaltrials.gov NCT04760678, registered on February 17th, 2021.
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