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Clinical Trial
. 2018 Jan:27:11-17.
doi: 10.1016/j.ebiom.2017.10.032. Epub 2017 Dec 6.

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  1 , Deby Mukendi  2 , Emmanuel Bottieau  3 , Jean Roger Kalo Lilo  4 , Kristien Verdonck  5 , Luigi Minikulu  6 , Barbara Barbé  7 , Philippe Gillet  8 , Cédric P Yansouni  9 , François Chappuis  10 , Pascal Lutumba  11
Affiliations
Clinical Trial

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 et al. EBioMedicine. 2018 Jan.

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.

Keywords: Diagnostic accuracy; Human African trypanosomiasis; Rapid diagnostic test; Sensitivity& specificity; Trypanosoma brucei gambiense.

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Figures

Fig. 1
Fig. 1
Patient flow diagram.
See this image and copyright information in PMC

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