NDLI: 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

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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

Content Provider	Directory of Open Access Journals (DOAJ)
Author	Jean Roger Kalo Lilo Philippe Gillet Emmanuel Bottieau Cédric P. Yansouni François Chappuis Luigi Minikulu Deby Mukendi Kristien Verdonck Pascal Lutumba Barbara Barbé Marleen Boelaert
Abstract	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.
Related Links	http://www.sciencedirect.com/science/article/pii/S2352396417304383
ISSN	23523964
DOI	10.1016/j.ebiom.2017.10.032
Journal	EBioMedicine
Issue Number	C
Volume Number	27
Language	English
Publisher	Elsevier
Publisher Date	2018-01-01
Publisher Place	Netherlands
Access Restriction	Open
Subject Keyword	Medicine Medicine (general) Diagnostic Accuracy Sensitivity& Specificity Rapid Diagnostic Test Human African Trypanosomiasis Trypanosoma Brucei Gambiense
Content Type	Text
Resource Type	Article
Subject	Medicine Biochemistry, Genetics and Molecular Biology

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