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Diagnosis of Visceral Leishmaniasis in an Elimination Setting: A Validation Study of the Diagnostic Algorithm in India

Visceral leishmaniasis (VL) is on the verge of elimination on the Indian subcontinent. Nonetheless, the currently low VL-incidence setting brings along new challenges, one of which is the validity of the diagnostic algorithm, based on a combination of suggestive clinical symptoms in combination with...

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Autores principales: Cloots, Kristien, Singh, Om Prakash, Singh, Abhishek Kumar, Kushwaha, Anurag Kumar, Malaviya, Paritosh, Kansal, Sangeeta, Hasker, Epco, Sundar, Shyam
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8947297/
https://www.ncbi.nlm.nih.gov/pubmed/35328223
http://dx.doi.org/10.3390/diagnostics12030670
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author Cloots, Kristien
Singh, Om Prakash
Singh, Abhishek Kumar
Kushwaha, Anurag Kumar
Malaviya, Paritosh
Kansal, Sangeeta
Hasker, Epco
Sundar, Shyam
author_facet Cloots, Kristien
Singh, Om Prakash
Singh, Abhishek Kumar
Kushwaha, Anurag Kumar
Malaviya, Paritosh
Kansal, Sangeeta
Hasker, Epco
Sundar, Shyam
author_sort Cloots, Kristien
collection PubMed
description Visceral leishmaniasis (VL) is on the verge of elimination on the Indian subcontinent. Nonetheless, the currently low VL-incidence setting brings along new challenges, one of which is the validity of the diagnostic algorithm, based on a combination of suggestive clinical symptoms in combination with a positive rK39 Rapid Diagnostic Test (RDT). With this study, we aimed to assess the positive predictive value of the diagnostic algorithm in the current low-endemic setting in India by re-assessing newly diagnosed VL patients with a qPCR analysis on venous blood as the reference test. In addition, we evaluated the specificity of the rK39 RDT by testing non-VL cases with the rK39 RDT. Participants were recruited in Bihar and Uttar Pradesh, India. VL patients diagnosed based on the diagnostic algorithm were recruited through six primary health care centers (PHCs); non-VL cases were identified through a door-to-door survey in currently endemic, previously endemic, and non-endemic clusters, and tested with rK39 RDT, as well as—if positive—with qPCR on peripheral blood. We found that 95% (70/74; 95% CI 87–99%) of incident VL cases diagnosed at the PHC level using the current diagnostic algorithm were confirmed by qPCR. Among 15,422 non-VL cases, 39 were rK39 RDT positive, reflecting a specificity of the test of 99.7% (95% CI 99.7–99.8%). The current diagnostic algorithm combining suggestive clinical features with a positive rK39 RDT still seems valid in the current low-endemic setting in India.
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spelling pubmed-89472972022-03-25 Diagnosis of Visceral Leishmaniasis in an Elimination Setting: A Validation Study of the Diagnostic Algorithm in India Cloots, Kristien Singh, Om Prakash Singh, Abhishek Kumar Kushwaha, Anurag Kumar Malaviya, Paritosh Kansal, Sangeeta Hasker, Epco Sundar, Shyam Diagnostics (Basel) Article Visceral leishmaniasis (VL) is on the verge of elimination on the Indian subcontinent. Nonetheless, the currently low VL-incidence setting brings along new challenges, one of which is the validity of the diagnostic algorithm, based on a combination of suggestive clinical symptoms in combination with a positive rK39 Rapid Diagnostic Test (RDT). With this study, we aimed to assess the positive predictive value of the diagnostic algorithm in the current low-endemic setting in India by re-assessing newly diagnosed VL patients with a qPCR analysis on venous blood as the reference test. In addition, we evaluated the specificity of the rK39 RDT by testing non-VL cases with the rK39 RDT. Participants were recruited in Bihar and Uttar Pradesh, India. VL patients diagnosed based on the diagnostic algorithm were recruited through six primary health care centers (PHCs); non-VL cases were identified through a door-to-door survey in currently endemic, previously endemic, and non-endemic clusters, and tested with rK39 RDT, as well as—if positive—with qPCR on peripheral blood. We found that 95% (70/74; 95% CI 87–99%) of incident VL cases diagnosed at the PHC level using the current diagnostic algorithm were confirmed by qPCR. Among 15,422 non-VL cases, 39 were rK39 RDT positive, reflecting a specificity of the test of 99.7% (95% CI 99.7–99.8%). The current diagnostic algorithm combining suggestive clinical features with a positive rK39 RDT still seems valid in the current low-endemic setting in India. MDPI 2022-03-09 /pmc/articles/PMC8947297/ /pubmed/35328223 http://dx.doi.org/10.3390/diagnostics12030670 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Cloots, Kristien
Singh, Om Prakash
Singh, Abhishek Kumar
Kushwaha, Anurag Kumar
Malaviya, Paritosh
Kansal, Sangeeta
Hasker, Epco
Sundar, Shyam
Diagnosis of Visceral Leishmaniasis in an Elimination Setting: A Validation Study of the Diagnostic Algorithm in India
title Diagnosis of Visceral Leishmaniasis in an Elimination Setting: A Validation Study of the Diagnostic Algorithm in India
title_full Diagnosis of Visceral Leishmaniasis in an Elimination Setting: A Validation Study of the Diagnostic Algorithm in India
title_fullStr Diagnosis of Visceral Leishmaniasis in an Elimination Setting: A Validation Study of the Diagnostic Algorithm in India
title_full_unstemmed Diagnosis of Visceral Leishmaniasis in an Elimination Setting: A Validation Study of the Diagnostic Algorithm in India
title_short Diagnosis of Visceral Leishmaniasis in an Elimination Setting: A Validation Study of the Diagnostic Algorithm in India
title_sort diagnosis of visceral leishmaniasis in an elimination setting: a validation study of the diagnostic algorithm in india
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8947297/
https://www.ncbi.nlm.nih.gov/pubmed/35328223
http://dx.doi.org/10.3390/diagnostics12030670
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