Efficacy of a new rapid diagnostic test kit to diagnose Sri Lankan cutaneous leishmaniasis caused by Leishmania donovani

Silva, Gayani De; Somaratne, Vijani; Senaratne, Sujai; Vipuladasa, M.; Wickremasinghe, Rajitha; Wickremasinghe, Renu; Ranasinghe, Shalindra

doi:10.1371/journal.pone.0187024

Cited by 26 publications

(34 citation statements)

References 29 publications

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“…In Morocco, the current (2016) unit price of this RDT was US$ 8 per patient, which is not affordable in comparison with microscopy that costs less than US$ 1 per patient. However, a recent study in Sri Lanka using the same RDT for L. donovani mentioned a lower cost, US$ 4 per patient, 31 and future cost may evolve as a function of demand and offer.…”

Section: Discussionmentioning

confidence: 99%

“…In the Sri Lanka study, the low Se of the RDT (36%) was linked to the low expression of the peroxidoxin antigen in Sri Lankan L. donovani . 31 Alternatively, the species effect could simply be due to the differences in parasite load, which could obviously influence the assay’s performance. The moderate Se of the RDT in this study could also be explained by a low parasite yield within the sample taken by the small saws of a dental broach.…”

Section: Discussionmentioning

confidence: 99%

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Accuracy of a Rapid Diagnostic Test Based on Antigen Detection for the Diagnosis of Cutaneous Leishmaniasis in Patients with Suggestive Skin Lesions in Morocco

Bennis

Verdonck

Khalfaoui

et al. 2018

The American Journal of Tropical Medicine and Hygiene

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Abstract.In rural areas in Morocco, diagnosing cutaneous leishmaniasis (CL) can be challenging. We evaluated the accuracy of a rapid diagnostic test (RDT) based on antigen detection, CL Detect Rapid Test™ (Inbios International Inc., Seattle, WA), in this setting. We consecutively recruited patients with new skin ulcers in nine primary health centers. We took a dental broach sample for the RDT and two other tissue samples by scraping the border and center of the lesion with a scalpel and smearing it on a slide. We duplicated each smear by pressing a clean slide against it and processed the slides by microscopy, polymerase chain reaction (PCR) internal transcribed spacer 1, and kDNA minicircle PCR. In a subgroup with positive PCR, the Leishmania species was identified using PCR-restriction fragment length polymorphism and PCR-sequencing of hsp70 genes. A participant with positive microscopy and/or PCR was considered a confirmed CL case. We computed sensitivity (Se) and specificity (Sp) of the RDT compared with this reference standard (ClinicalTrials.gov registration: NCT02979002). Between December 2016 and July 2017, we included 219 patients, 50% of them were under 18 years old. Rapid diagnostic test Se was 68% [95% confidence interval (CI): 61–74], Sp 94% [95% CI: 91–97], positive predictive value 95% [95% CI: 92–98], and negative predictive value 64% [95% CI: 58–70]. Despite its low Se, this novel RDT is a useful addition to clinical management of CL in Morocco, especially in isolated localities. Rapid diagnostic test–positive lesions can be treated as CL; but when RDT negative, microscopy should be done in a second step. The Se of the RDT can probably be optimized by improving the sampling procedure.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Accuracy of a Rapid Diagnostic Test Based on Antigen Detection for the Diagnosis of Cutaneous Leishmaniasis in Patients with Suggestive Skin Lesions in Morocco

Bennis

Verdonck

Khalfaoui

et al. 2018

The American Journal of Tropical Medicine and Hygiene

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“…This RDT was first evaluated in Tunisia in a L. major endemic focus where it yielded >90% sensitivity and specificity [ 18 ]. A study in Sri Lanka, where CL is caused by L. donovani , returned a very low sensitivity (36%) but 100% specificity [ 19 ]. Another study conducted in Morocco also returned high specificity (94%), however the sensitivity was different in cases from L. tropica endemic regions (73%) and L. major endemic regions (59%) [ 20 ].…”

Section: Discussionmentioning

confidence: 99%

Evaluation of point-of-care tests for cutaneous leishmaniasis diagnosis in Kabul, Afghanistan

et al. 2018

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BackgroundKabul (Afghanistan) is a major focus of cutaneous leishmaniasis (CL) caused by Leishmania tropica. Microscopy remains the reference test for diagnosis despite its low performance. We evaluated whether Loopamp™ Leishmania Detection Kit (Loopamp) and CL Detect™ Rapid Test (CL Detect), detecting Leishmania DNA and antigen, respectively could improve CL diagnosis.MethodsA diagnostic accuracy study with prospective inclusion was conducted in a leishmaniasis reference clinic in Kabul. Slit skin samples from CL suspects were analysed by microscopy. Samples taken with a dental broach were tested with CL Detect, Loopamp, and PCR. All samples were transferred to the Academic Medical Center (AMC, the Netherlands) for PCR and Loopamp analyses. The diagnostic performance of the tests was evaluated against a reference combining microscopy and PCR.Findings274 CL suspects were included in the study. In Kabul, CL Detect had a 65·4% sensitivity [95% Confidence Interval (CI): 59.2–71.2%] and a 100% specificity [95% CI: 80.5–100%], while these were 87.6% [95%CI: 82.9–91.3%] and 70.6% [95% CI: 44.0–89.7%] for Loopamp. At AMC the Loopamp's sensitivity (92.2% [95% CI: 88.2–95.2%]) and specificity (94.1% [95% CI: 71.3–99.8%]) were higher. An algorithm where CL Detect negative suspects would be tested by Loopamp yielded a 93.4% sensitivity [95% CI: 89.6–96.1%] and a 94.1% specificity [95% CI: 71.3–99.8%] when Loopamp's performance at AMC was used.InterpretationThe high specificity of CL Detect and the performance of Loopamp allow their use in a diagnostic algorithm that would minimize the number of CL patients referred for confirmation.FundFederal Ministry of Education and Research, Germany.

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“…Also, the diagnosis of the patients suspected for VL and MCL should be confirmed by PCR and culture [61]. Negative skin slit smears are recommended to combine with PCR for confirmation [64]. Loop-mediated isothermal amplification (LAMP) assay optimized under the local conditions can also be used as a diagnostic tool.…”

Section: Diagnosismentioning

confidence: 99%

“…Sri Lankan L. donovani strain shows low expression of peroxidoxin antigen in amastigotes and low parasite counts in skin lesions. Therefore, a currently available commercial kit; the rapid diagnostic immunochromatographic strip (CL-Detect™ IC-RDT) is not successful in the diagnosis of CL in Sri Lankan patients [64]. Thus, the development of a rapid diagnostic tool to detect L. donovani strain in Sri Lanka is an essential requirement to diagnose CL more efficiently.…”

Section: Diagnosismentioning

confidence: 99%

A Comprehensive Review of Cutaneous Leishmaniasis in Sri Lanka and Identification of Existing Knowledge Gaps

Amarasinghe

Wickramasinghe

2020

Acta Parasit.

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Purpose Sri Lanka is endemic to cutaneous leishmaniasis and reported as the latest focus of leishmaniasis in the Asian subcontinent. Annually, the number of leishmaniasis cases is increasing; therefore, more efficient diagnostic tools, treatment methods and effective prevention measures are indispensable. For this reason, many studies were conducted regarding leishmaniasis infections in Sri Lanka; however, some areas need more attention. Thus, in this review, we comprehensively discussed the studies on leishmaniasis carried out in Sri Lanka. Methods Published articles on leishmaniasis in Sri Lanka were searched on PubMed, Google Scholar and ResearchGate databases. Inclusion criteria for the articles were based on keyword searches including 'Leishmaniasis in Sri Lanka', 'Leishmaniasis vector in Sri Lanka', 'Sandfly species in Sri Lanka', 'Leishmaniasis epidemiology in Sri Lanka' which are publicly accessible as of 15th July 2019. Results In this study, we evaluated and summarized the leishmaniasis reports in Sri Lanka and mainly focused on clinical presentation of leishmaniasis infection, genetic characteristics of Leishmania donovani Sri Lankan strain, geographical distribution and associated environmental factors, immunological aspects of the infection, vector, reservoir host, risk factors, diagnosis and treatment, and prevention and control. Furthermore, we identified the areas where further research is needed to fill the essential knowledge gaps. Conclusions Leishmaniasis has become a critically important parasitic infection in Sri Lanka, whereas the significant clinical form is cutaneous leishmaniasis. Prevalence of the leishmaniasis infections is reported from all the districts of the country. Therefore, more studies are essential to be carried out to fill the existing knowledge gaps emphasized in this review.

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Efficacy of a new rapid diagnostic test kit to diagnose Sri Lankan cutaneous leishmaniasis caused by Leishmania donovani

Cited by 26 publications

References 29 publications

Accuracy of a Rapid Diagnostic Test Based on Antigen Detection for the Diagnosis of Cutaneous Leishmaniasis in Patients with Suggestive Skin Lesions in Morocco

Accuracy of a Rapid Diagnostic Test Based on Antigen Detection for the Diagnosis of Cutaneous Leishmaniasis in Patients with Suggestive Skin Lesions in Morocco

Evaluation of point-of-care tests for cutaneous leishmaniasis diagnosis in Kabul, Afghanistan

A Comprehensive Review of Cutaneous Leishmaniasis in Sri Lanka and Identification of Existing Knowledge Gaps

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