Effect of rK39 testing in guiding treatment initiation and outcome in patients with visceral leishmaniasis in Ethiopia: A prospective cohort study.

<h4>Background</h4>The rapid diagnostic test (RDT) rK39 is currently being used for routine diagnosis of visceral leishmaniasis (VL) in East Africa. However, continuous monitoring of the performance of the assay, in particular its impact on the clinical decision in initiating anti-leishm...

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Autores principales:	Dawit Gebreegzabher Hagos, Yazezew Kebede, Mahmud Abdulkader, Etsay Nigus, Zekarias Gessesse Arefaine, Gebreab Nega, Henk D F Schallig, Dawit Wolday
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/0ed5277950444eebb42138d7d3ff23e4
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spelling	oai:doaj.org-article:0ed5277950444eebb42138d7d3ff23e42021-12-02T20:10:41ZEffect of rK39 testing in guiding treatment initiation and outcome in patients with visceral leishmaniasis in Ethiopia: A prospective cohort study.1932-620310.1371/journal.pone.0253303https://doaj.org/article/0ed5277950444eebb42138d7d3ff23e42021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0253303https://doaj.org/toc/1932-6203<h4>Background</h4>The rapid diagnostic test (RDT) rK39 is currently being used for routine diagnosis of visceral leishmaniasis (VL) in East Africa. However, continuous monitoring of the performance of the assay, in particular its impact on the clinical decision in initiating anti-leishmanial treatment and outcomes remains needed as there are concerns about the diagnostic performance of this test.<h4>Methods</h4>VL patients prospectively enrolled in a diagnostic trial and with rK39 RDT were included. We evaluated the effect of rK39 testing in guiding treatment initiation and outcome. On the basis of rK39 RDT test result as well as clinical case definition for VL and microscopy examination, the clinicians decide whether to initiate VL therapy or not. Poisson regression models were used to identify factors associated with a decision to initiate VL therapy. In addition, treatment outcomes of those who received VL therapy were compared to those who received non-VL treatment.<h4>Results</h4>Of 324 VL suspects enrolled, 184 (56.8%) were rK39+ and 140 (43.2%) were rK39‒. In addition, microscopy exam was done on tissue aspirates from a sub-population (140 individuals), which is 43.2% of the suspected cases, comprising of 117 (63.6%) rK39+ and only 23 (16.4%) rK39‒ cases. Of those with microscopy examination, only 87 (62.1%) were found positive. Among 184 (56.8%) patients without microscopy, 67 (36.4%) were rK39+, of whom 83 (65.9%) were positive by microscopy, 21 (16.7%) were negative by microscopy and 22 (17.5%) had no microscopy results. On the other hand, of those who did not receive VL treatment 58/189 (30.7%) were rK39+ and 131 (69.3%) were rK39‒. Of the rK39+ cases who did not receive VL therapy, only 1 (1.7%) patient was microscopy positive, 12 (20.7%) were negative and 45 (77.6%) patients had no microscopy result. Of the rK39‒ cases (n = 131) who did not receive VL treatment, 16 were microscopy negative and 115 without microscopy exams. Whereas positive rK39 result [adjusted Relative Risk (aRR) 0.69; 95% CI: 0.49-0.96, p = 0.029] and positive microscopy results (aRR 0.03; 95% CI: 0.00-0.24, p = 0.001) were independently associated with VL treatment, having confirmed diagnosis other than VL (aRR 1.64; 95% CI: 1.09-2.46, p = 0.018) was independently associated with initiation of non-VL therapy. The proportion of rK39+ patients who received non-VL treatment with no improvement outcome was significantly higher when compared to those who received VL treatment (24.1%, 95% CI: 14.62-37.16 vs. 11.9%, 95%CI: 7.26-18.93; p<0.0001).<h4>Conclusion</h4>The study shows that a significant proportion of patients with rK39+ results were undertreated. Failure to do microscopy was associated with lack of improved clinical outcome. Including an additional simple point-of-care assay in the diagnostic work-up is urgently needed to correctly identify VL cases and to prevent morbidity and mortality associated with the disease.Dawit Gebreegzabher HagosYazezew KebedeMahmud AbdulkaderEtsay NigusZekarias Gessesse ArefaineGebreab NegaHenk D F SchalligDawit WoldayPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 6, p e0253303 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Dawit Gebreegzabher Hagos Yazezew Kebede Mahmud Abdulkader Etsay Nigus Zekarias Gessesse Arefaine Gebreab Nega Henk D F Schallig Dawit Wolday Effect of rK39 testing in guiding treatment initiation and outcome in patients with visceral leishmaniasis in Ethiopia: A prospective cohort study.
description	<h4>Background</h4>The rapid diagnostic test (RDT) rK39 is currently being used for routine diagnosis of visceral leishmaniasis (VL) in East Africa. However, continuous monitoring of the performance of the assay, in particular its impact on the clinical decision in initiating anti-leishmanial treatment and outcomes remains needed as there are concerns about the diagnostic performance of this test.<h4>Methods</h4>VL patients prospectively enrolled in a diagnostic trial and with rK39 RDT were included. We evaluated the effect of rK39 testing in guiding treatment initiation and outcome. On the basis of rK39 RDT test result as well as clinical case definition for VL and microscopy examination, the clinicians decide whether to initiate VL therapy or not. Poisson regression models were used to identify factors associated with a decision to initiate VL therapy. In addition, treatment outcomes of those who received VL therapy were compared to those who received non-VL treatment.<h4>Results</h4>Of 324 VL suspects enrolled, 184 (56.8%) were rK39+ and 140 (43.2%) were rK39‒. In addition, microscopy exam was done on tissue aspirates from a sub-population (140 individuals), which is 43.2% of the suspected cases, comprising of 117 (63.6%) rK39+ and only 23 (16.4%) rK39‒ cases. Of those with microscopy examination, only 87 (62.1%) were found positive. Among 184 (56.8%) patients without microscopy, 67 (36.4%) were rK39+, of whom 83 (65.9%) were positive by microscopy, 21 (16.7%) were negative by microscopy and 22 (17.5%) had no microscopy results. On the other hand, of those who did not receive VL treatment 58/189 (30.7%) were rK39+ and 131 (69.3%) were rK39‒. Of the rK39+ cases who did not receive VL therapy, only 1 (1.7%) patient was microscopy positive, 12 (20.7%) were negative and 45 (77.6%) patients had no microscopy result. Of the rK39‒ cases (n = 131) who did not receive VL treatment, 16 were microscopy negative and 115 without microscopy exams. Whereas positive rK39 result [adjusted Relative Risk (aRR) 0.69; 95% CI: 0.49-0.96, p = 0.029] and positive microscopy results (aRR 0.03; 95% CI: 0.00-0.24, p = 0.001) were independently associated with VL treatment, having confirmed diagnosis other than VL (aRR 1.64; 95% CI: 1.09-2.46, p = 0.018) was independently associated with initiation of non-VL therapy. The proportion of rK39+ patients who received non-VL treatment with no improvement outcome was significantly higher when compared to those who received VL treatment (24.1%, 95% CI: 14.62-37.16 vs. 11.9%, 95%CI: 7.26-18.93; p<0.0001).<h4>Conclusion</h4>The study shows that a significant proportion of patients with rK39+ results were undertreated. Failure to do microscopy was associated with lack of improved clinical outcome. Including an additional simple point-of-care assay in the diagnostic work-up is urgently needed to correctly identify VL cases and to prevent morbidity and mortality associated with the disease.
format	article
author	Dawit Gebreegzabher Hagos Yazezew Kebede Mahmud Abdulkader Etsay Nigus Zekarias Gessesse Arefaine Gebreab Nega Henk D F Schallig Dawit Wolday
author_facet	Dawit Gebreegzabher Hagos Yazezew Kebede Mahmud Abdulkader Etsay Nigus Zekarias Gessesse Arefaine Gebreab Nega Henk D F Schallig Dawit Wolday
author_sort	Dawit Gebreegzabher Hagos
title	Effect of rK39 testing in guiding treatment initiation and outcome in patients with visceral leishmaniasis in Ethiopia: A prospective cohort study.
title_short	Effect of rK39 testing in guiding treatment initiation and outcome in patients with visceral leishmaniasis in Ethiopia: A prospective cohort study.
title_full	Effect of rK39 testing in guiding treatment initiation and outcome in patients with visceral leishmaniasis in Ethiopia: A prospective cohort study.
title_fullStr	Effect of rK39 testing in guiding treatment initiation and outcome in patients with visceral leishmaniasis in Ethiopia: A prospective cohort study.
title_full_unstemmed	Effect of rK39 testing in guiding treatment initiation and outcome in patients with visceral leishmaniasis in Ethiopia: A prospective cohort study.
title_sort	effect of rk39 testing in guiding treatment initiation and outcome in patients with visceral leishmaniasis in ethiopia: a prospective cohort study.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/0ed5277950444eebb42138d7d3ff23e4
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Effect of rK39 testing in guiding treatment initiation and outcome in patients with visceral leishmaniasis in Ethiopia: A prospective cohort study.

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