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

Marleen Boelaert a,⁎,1 ,DebyMukendi b,1, EmmanuelBottieau a, Jean Roger Kalo Lilo c ,Luigi Minikulu a d, Barbara Barbé a , Philippe Gillet a , Cédric P. Yansouni e, Kristien Verdonck, François Chappuis fa, PascalLutumba b

a Institute of Tropical Medicine, Nationalestraat 155, Antwerp B-2000, Belgium
b Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of the Congo
c Programme National de Lutte contre la Trypanosomiase Humaine Africaine, Kinshasa, Democratic Republic of the Congo
d Hôpital Général de Mosango, Ministry of Health, Democratic Republic of the Congo
e McGill University Health Centre, Montreal, QC H4A 3J1, Canada
f Geneva University Hospitals, Geneva 1205, Switzerland


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 fluidANDwhitebloodcellcountinCSFN5/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.
© 2017 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license

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