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

PLoS One. 2017 Nov 14;12(11):e0187024. doi: 10.1371/journal.pone.0187024. eCollection 2017.


Background: Cutaneous leishmaniasis (CL) in Sri Lanka is caused by Leishmania donovani. This study assessed the diagnostic value of a new rapid diagnostic immunochromatographic strip (CL-Detect™ IC-RDT), that captures the peroxidoxin antigen of Leishmania amastigotes.

Methodology/principal findings: We sampled 74 clinically suspected CL lesions, of which 59 (79.7%) were positive by PCR, 43 (58.1%) by Giemsa stained slit skin smear (SSS) and 21 (28.4%) by the new IC-RDT. All samples which were positive either by SSS or IC-RDT or both were positive by PCR. The sensitivities of the IC-RDT and SSS compared to PCR were 36% and 73%, respectively. Fifteen patients from this endemic region were negative by all three tests. Twenty two clinically non-CL skin lesions from a CL non-endemic region were also negative by all three methods. Specificity and PPV of both IC-RDT and SSS compared to PCR were 100%; the NPVs of IC-RDT and SSS were 37% and 58%, respectively. The median parasite grading of the 59 PCR positive samples was 2+ (1-10 parasites/100 HPFs) and IC-RDT positive lesions was 3+ (1-10 parasites /10HPFs). The duration of the lesion was not associated with IC-RDT positivity.

Conclusions/significance: The median parasite grade of Sri Lankan CL lesions is low. The low sensitivities of SSS and CL Detect™ IC-RDT may be due to low parasite counts or low expression of peroxidoxin antigen in amastigotes of the Sri Lankan L. donovani strain. Our results indicate that negative SSS has to be combined with PCR for confirmation of CL in Sri Lanka. The current commercially available IC-RDT is not suitable to diagnose CL in Sri Lanka; an IC-RDT with improved sensitivity to detect L. donovani would be a valuable addition in the diagnostic tool kit for Sri Lanka.

MeSH terms

  • Adolescent
  • Child
  • Child, Preschool
  • Chromatography, Affinity / instrumentation
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Leishmania donovani / genetics
  • Leishmania donovani / isolation & purification*
  • Leishmaniasis, Cutaneous / diagnosis*
  • Leishmaniasis, Cutaneous / epidemiology
  • Leishmaniasis, Cutaneous / parasitology
  • Male
  • Polymerase Chain Reaction
  • Reagent Kits, Diagnostic*
  • Sensitivity and Specificity
  • Sri Lanka / epidemiology


  • Reagent Kits, Diagnostic

Grant support

SR was funded by University of Sri Jayewardenepura Sri Lanka Grant number ASP/06/RE/MED/2012/30 and RW was funded by University of Sri Jayewardenepura Sri Lanka Grant number ASP/06/RE/MED/2013/37, http://research.sjp.ac.lk/rersearch-grant/. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.