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; Deby Mukendi; Emmanuel Bottieau; Jean Roger Kalo Lilo; Kristien Verdonck; Luigi Minikulu; Barbara Barbé; Philippe Gillet; Cédric P Yansouni; François Chappuis; Pascal Lutumba

doi:10.1016/j.ebiom.2017.10.032

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, Deby Mukendi, Emmanuel Bottieau, Jean Roger Kalo Lilo, Kristien Verdonck, Luigi Minikulu, Barbara Barbé, Philippe Gillet, Cédric P Yansouni, François Chappuis, Pascal Lutumba

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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.

Original language	English
Journal	EBioMedicine
Volume	27
Pages (from-to)	11-17
Number of pages	7
ISSN	2352-3964
DOIs	https://doi.org/10.1016/j.ebiom.2017.10.032
Publication status	Published - 2018

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Journal Article

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Boelaert, M., Mukendi, D., Bottieau, E., Kalo Lilo, J. R., Verdonck, K., Minikulu, L., Barbé, B., Gillet, P., Yansouni, C. P., Chappuis, F., & Lutumba, P. (2018). 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. EBioMedicine, 27, 11-17. https://doi.org/10.1016/j.ebiom.2017.10.032

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title = "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",

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.",

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author = "Marleen Boelaert and Deby Mukendi and Emmanuel Bottieau and {Kalo Lilo}, {Jean Roger} and Kristien Verdonck and Luigi Minikulu and Barbara Barb{\'e} and Philippe Gillet and Yansouni, {C{\'e}dric P} and Fran{\c c}ois Chappuis and Pascal Lutumba",

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doi = "10.1016/j.ebiom.2017.10.032",

language = "English",

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journal = "EBioMedicine",

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Boelaert, M, Mukendi, D, Bottieau, E, Kalo Lilo, JR, Verdonck, K, Minikulu, L, Barbé, B, Gillet, P, Yansouni, CP, Chappuis, F & Lutumba, P 2018, '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', EBioMedicine, vol. 27, pp. 11-17. https://doi.org/10.1016/j.ebiom.2017.10.032

TY - JOUR

T1 - 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

AU - Boelaert, Marleen

AU - Mukendi, Deby

AU - Bottieau, Emmanuel

AU - Kalo Lilo, Jean Roger

AU - Verdonck, Kristien

AU - Minikulu, Luigi

AU - Barbé, Barbara

AU - Gillet, Philippe

AU - Yansouni, Cédric P

AU - Chappuis, François

AU - Lutumba, Pascal

N1 - FTX; DOAJ

PY - 2018

Y1 - 2018

N2 - 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.

AB - 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.

KW - Journal Article

U2 - 10.1016/j.ebiom.2017.10.032

DO - 10.1016/j.ebiom.2017.10.032

M3 - A1: Web of Science-article

C2 - 29246478

SN - 2352-3964

VL - 27

SP - 11

EP - 17

JO - EBioMedicine

JF - EBioMedicine

ER -

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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