Diagnostic accuracy of rK28-based immunochromatographic rapid diagnostic tests for visceral leishmaniasis: a prospective clinical cohort study in Sudan

Maowia Mukhtar; Asim Abdoun; Abdallah E Ahmed; Hashim Ghalib; Steven G Reed; Marleen Boelaert; Joris Menten; Musa M Khair; Randall F Howard

doi:10.1093/trstmh/trv060

Diagnostic accuracy of rK28-based immunochromatographic rapid diagnostic tests for visceral leishmaniasis: a prospective clinical cohort study in Sudan

Maowia Mukhtar, Asim Abdoun, Abdallah E Ahmed, Hashim Ghalib, Steven G Reed, Marleen Boelaert, Joris Menten, Musa M Khair, Randall F Howard

Clinical Trial Centre

Research output: Contribution to journal › A1: Web of Science-article › peer-review

Abstract

BACKGROUND: Rapid diagnostic tests (RDTs) for visceral leishmaniasis (VL) based on rK39 antigen showed suboptimal sensitivity in East Africa. A prospective clinical cohort study in Sudan was designed to validate a novel rK28-based RDT for Leishmania donovani VL.

METHODS: Patients (n=285) suspected of VL by residency, fever for ≥2 weeks, splenomegaly with no prior reported VL, and negative for malaria were consecutively enrolled at three Sudanese sites in 2012-2013 and informed consent obtained. Two human readers, who were blinded to the clinical status and other RDT results, evaluated patient whole blood (WB) and serum on the rK28 RDT. Based on Leishmania parasite detection in lymph node or bone marrow aspirates (Giemsa-stained smears or culture in Novy-MacNeal-Nicolle medium), patients were categorized as VL cases (n=200) or VL controls (n=85).

RESULTS: The rK28 RDT had high specificity using either WB (100% [85/85]) or serum (97.6% [83/85]) and exhibited greater sensitivity (WB, 92.5% [185/200]; serum, 94.5% [189/200]) than a direct agglutination test performed with the same sera (92.9% [79/85] and 83.5% [167/200] for specificity and sensitivity, respectively). Two blinded readers scored a given WB or serum sample the same on the rK28 RDT 99.6% and 100% of the time, respectively. A reader scored each individual donor's paired WB and serum rK28 RDT results the same 97.2% of the time.

CONCLUSIONS: An inexpensive rK28 RDT that performs robustly with WB or serum will be valuable for diagnosing cases of VL in East Africa.

Original language	English
Journal	Transactions of the Royal Society of Tropical Medicine and Hygiene
Volume	109
Issue number	9
Pages (from-to)	594-600
Number of pages	7
ISSN	0035-9203
DOIs	https://doi.org/10.1093/trstmh/trv060
Publication status	Published - 2015

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Mukhtar, M., Abdoun, A., Ahmed, A. E., Ghalib, H., Reed, S. G., Boelaert, M., Menten, J., Khair, M. M., & Howard, R. F. (2015). Diagnostic accuracy of rK28-based immunochromatographic rapid diagnostic tests for visceral leishmaniasis: a prospective clinical cohort study in Sudan. Transactions of the Royal Society of Tropical Medicine and Hygiene, 109(9), 594-600. https://doi.org/10.1093/trstmh/trv060

@article{911f1c9814b74e74b8ae9190a98c91b8,

title = "Diagnostic accuracy of rK28-based immunochromatographic rapid diagnostic tests for visceral leishmaniasis: a prospective clinical cohort study in Sudan",

abstract = "BACKGROUND: Rapid diagnostic tests (RDTs) for visceral leishmaniasis (VL) based on rK39 antigen showed suboptimal sensitivity in East Africa. A prospective clinical cohort study in Sudan was designed to validate a novel rK28-based RDT for Leishmania donovani VL.METHODS: Patients (n=285) suspected of VL by residency, fever for ≥2 weeks, splenomegaly with no prior reported VL, and negative for malaria were consecutively enrolled at three Sudanese sites in 2012-2013 and informed consent obtained. Two human readers, who were blinded to the clinical status and other RDT results, evaluated patient whole blood (WB) and serum on the rK28 RDT. Based on Leishmania parasite detection in lymph node or bone marrow aspirates (Giemsa-stained smears or culture in Novy-MacNeal-Nicolle medium), patients were categorized as VL cases (n=200) or VL controls (n=85).RESULTS: The rK28 RDT had high specificity using either WB (100% [85/85]) or serum (97.6% [83/85]) and exhibited greater sensitivity (WB, 92.5% [185/200]; serum, 94.5% [189/200]) than a direct agglutination test performed with the same sera (92.9% [79/85] and 83.5% [167/200] for specificity and sensitivity, respectively). Two blinded readers scored a given WB or serum sample the same on the rK28 RDT 99.6% and 100% of the time, respectively. A reader scored each individual donor's paired WB and serum rK28 RDT results the same 97.2% of the time.CONCLUSIONS: An inexpensive rK28 RDT that performs robustly with WB or serum will be valuable for diagnosing cases of VL in East Africa.",

author = "Maowia Mukhtar and Asim Abdoun and Ahmed, {Abdallah E} and Hashim Ghalib and Reed, {Steven G} and Marleen Boelaert and Joris Menten and Khair, {Musa M} and Howard, {Randall F}",

note = "{\textcopyright} The Author 2015. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: [email protected].",

year = "2015",

doi = "10.1093/trstmh/trv060",

language = "English",

volume = "109",

pages = "594--600",

journal = "Transactions of the Royal Society of Tropical Medicine and Hygiene",

issn = "0035-9203",

publisher = "Oxford University Press",

number = "9",

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Mukhtar, M, Abdoun, A, Ahmed, AE, Ghalib, H, Reed, SG, Boelaert, M, Menten, J, Khair, MM & Howard, RF 2015, 'Diagnostic accuracy of rK28-based immunochromatographic rapid diagnostic tests for visceral leishmaniasis: a prospective clinical cohort study in Sudan', Transactions of the Royal Society of Tropical Medicine and Hygiene, vol. 109, no. 9, pp. 594-600. https://doi.org/10.1093/trstmh/trv060

Diagnostic accuracy of rK28-based immunochromatographic rapid diagnostic tests for visceral leishmaniasis: a prospective clinical cohort study in Sudan. / Mukhtar, Maowia; Abdoun, Asim; Ahmed, Abdallah E et al.
In: Transactions of the Royal Society of Tropical Medicine and Hygiene, Vol. 109, No. 9, 2015, p. 594-600.

Research output: Contribution to journal › A1: Web of Science-article › peer-review

TY - JOUR

T1 - Diagnostic accuracy of rK28-based immunochromatographic rapid diagnostic tests for visceral leishmaniasis

T2 - a prospective clinical cohort study in Sudan

AU - Mukhtar, Maowia

AU - Abdoun, Asim

AU - Ahmed, Abdallah E

AU - Ghalib, Hashim

AU - Reed, Steven G

AU - Boelaert, Marleen

AU - Menten, Joris

AU - Khair, Musa M

AU - Howard, Randall F

PY - 2015

Y1 - 2015

N2 - BACKGROUND: Rapid diagnostic tests (RDTs) for visceral leishmaniasis (VL) based on rK39 antigen showed suboptimal sensitivity in East Africa. A prospective clinical cohort study in Sudan was designed to validate a novel rK28-based RDT for Leishmania donovani VL.METHODS: Patients (n=285) suspected of VL by residency, fever for ≥2 weeks, splenomegaly with no prior reported VL, and negative for malaria were consecutively enrolled at three Sudanese sites in 2012-2013 and informed consent obtained. Two human readers, who were blinded to the clinical status and other RDT results, evaluated patient whole blood (WB) and serum on the rK28 RDT. Based on Leishmania parasite detection in lymph node or bone marrow aspirates (Giemsa-stained smears or culture in Novy-MacNeal-Nicolle medium), patients were categorized as VL cases (n=200) or VL controls (n=85).RESULTS: The rK28 RDT had high specificity using either WB (100% [85/85]) or serum (97.6% [83/85]) and exhibited greater sensitivity (WB, 92.5% [185/200]; serum, 94.5% [189/200]) than a direct agglutination test performed with the same sera (92.9% [79/85] and 83.5% [167/200] for specificity and sensitivity, respectively). Two blinded readers scored a given WB or serum sample the same on the rK28 RDT 99.6% and 100% of the time, respectively. A reader scored each individual donor's paired WB and serum rK28 RDT results the same 97.2% of the time.CONCLUSIONS: An inexpensive rK28 RDT that performs robustly with WB or serum will be valuable for diagnosing cases of VL in East Africa.

AB - BACKGROUND: Rapid diagnostic tests (RDTs) for visceral leishmaniasis (VL) based on rK39 antigen showed suboptimal sensitivity in East Africa. A prospective clinical cohort study in Sudan was designed to validate a novel rK28-based RDT for Leishmania donovani VL.METHODS: Patients (n=285) suspected of VL by residency, fever for ≥2 weeks, splenomegaly with no prior reported VL, and negative for malaria were consecutively enrolled at three Sudanese sites in 2012-2013 and informed consent obtained. Two human readers, who were blinded to the clinical status and other RDT results, evaluated patient whole blood (WB) and serum on the rK28 RDT. Based on Leishmania parasite detection in lymph node or bone marrow aspirates (Giemsa-stained smears or culture in Novy-MacNeal-Nicolle medium), patients were categorized as VL cases (n=200) or VL controls (n=85).RESULTS: The rK28 RDT had high specificity using either WB (100% [85/85]) or serum (97.6% [83/85]) and exhibited greater sensitivity (WB, 92.5% [185/200]; serum, 94.5% [189/200]) than a direct agglutination test performed with the same sera (92.9% [79/85] and 83.5% [167/200] for specificity and sensitivity, respectively). Two blinded readers scored a given WB or serum sample the same on the rK28 RDT 99.6% and 100% of the time, respectively. A reader scored each individual donor's paired WB and serum rK28 RDT results the same 97.2% of the time.CONCLUSIONS: An inexpensive rK28 RDT that performs robustly with WB or serum will be valuable for diagnosing cases of VL in East Africa.

U2 - 10.1093/trstmh/trv060

DO - 10.1093/trstmh/trv060

M3 - A1: Web of Science-article

C2 - 26246251

SN - 0035-9203

VL - 109

SP - 594

EP - 600

JO - Transactions of the Royal Society of Tropical Medicine and Hygiene

JF - Transactions of the Royal Society of Tropical Medicine and Hygiene

IS - 9

ER -

Diagnostic accuracy of rK28-based immunochromatographic rapid diagnostic tests for visceral leishmaniasis: a prospective clinical cohort study in Sudan

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