A Phase III Diagnostic Accuracy Study of a Rapid Diagnostic Test for Diagnosis of Second-Stage Human African Trypanosomiasis in the Democratic Republic of the Congo.

Autor:	Boelaert M; Institute of Tropical Medicine, Nationalestraat 155, Antwerp B-2000, Belgium. Electronic address: mboelaert@itg.be., Mukendi D; Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of the Congo. Electronic address: debymukendi@yahoo.fr., Bottieau E; Institute of Tropical Medicine, Nationalestraat 155, Antwerp B-2000, Belgium. Electronic address: ebottieau@itg.be., Kalo Lilo JR; Programme National de Lutte contre la Trypanosomiase Humaine Africaine, Kinshasa, Democratic Republic of the Congo. Electronic address: lilo.kalo@yahoo.fr., Verdonck K; Institute of Tropical Medicine, Nationalestraat 155, Antwerp B-2000, Belgium. Electronic address: tverdonck@itg.be., Minikulu L; Hôpital Général de Mosango, Ministry of Health, Democratic Republic of the Congo. Electronic address: luigiminikulu@yahoo.fr., Barbé B; Institute of Tropical Medicine, Nationalestraat 155, Antwerp B-2000, Belgium. Electronic address: bbarbe@itg.be., Gillet P; Institute of Tropical Medicine, Nationalestraat 155, Antwerp B-2000, Belgium. Electronic address: philippegillet@proximus.be., Yansouni CP; McGill University Health Centre, Montreal, QC H4A 3J1, Canada. Electronic address: cedric.yansouni@mail.mcgill.ca., Chappuis F; Geneva University Hospitals, Geneva 1205, Switzerland. Electronic address: Francois.Chappuis@hcuge.ch., Lutumba P; Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of the Congo. Electronic address: plutumba@taskforce.org.
Jazyk:	angličtina
Zdroj:	EBioMedicine [EBioMedicine] 2018 Jan; Vol. 27, pp. 11-17. Date of Electronic Publication: 2017 Dec 06.
DOI:	10.1016/j.ebiom.2017.10.032
Abstrakt:	Objectives: To estimate the diagnostic accuracy of HAT Sero K-SeT for the field diagnosis of second-stage human African trypanosomiasis (HAT). Design: A phase III diagnostic accuracy design. Consecutive patients with symptoms clinically suggestive of HAT were prospectively enrolled. We compared results of the index test HAT Sero K-SeT with those of a composite reference standard: demonstration of trypanosomes in cerebrospinal fluid (CSF), or trypanosomes detected in any other body fluid AND white blood cell count in CSF >5/μl. Setting: Rural hospital in the Democratic Republic of the Congo. Participants: All patients above five years old presenting at Mosango hospital with a neurological problem of recent onset at the exclusion of trauma. Interventions: n.a. Main Outcome Measures: Sensitivity and specificity of HAT Sero K-SeT test. Results: The sensitivity of the HAT Sero K-SeT was 8/8 or 100.0% (95% confidence interval: 67.6 to 100.0%) and the specificity was 258/266 or 97.0% (94.2% to 98.5%). Conclusion: The high sensitivity of the HAT Sero K-SeT is in line with previously published estimates, though the sample of HAT cases in this study was small. The specificity estimate was very high and precise. This test, when negative, allows the clinician to rule out HAT in a clinical suspect in a hospital setting in this endemic region. (Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze:	MEDLINE
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