ELISA with recombinant rKRP42 antigen using urine samples: a tool for predicting clinical visceral leishmaniasis cases and its outbreak

Am J Trop Med Hyg. 2012 Oct;87(4):658-62. doi: 10.4269/ajtmh.2012.12-0168. Epub 2012 Aug 6.


We reported a highly sensitive and specific enzyme-linked immunosorbent assay (ELISA) that detects immunoglobulin G (IgG) in urine using rKRP42 antigen for the diagnosis of visceral leishmaniasis (VL). The ELISA was applied to study chronological change in antibody titers in five study areas in Rajshahi district, Bangladesh. A total of 585 subjects without a past VL history were examined at least three times in the 30-month follow-up period; of these subjects, 137 (23.4%) subjects became ELISA-positive at least one time during the study. Among the positive cases, 40 (29.2%) subjects developed clinical VL, and 31 (77.5%) of these subjects showed IgG titers of ≥ 1,000 U more than one time in the study period. Considering only the first ELISA results, 22 subjects with IgG titers of ≥ 1,000 U could be found, and 21 (95.5%) of these subjects turned out to be clinical cases. The high urinary IgG titers (≥ 1,000 U) will help predict possible clinical VL cases and thus, identify an outbreak in its earlier stage.

Publication types

  • Evaluation Study

MeSH terms

  • Antibodies, Protozoan / urine
  • Antigens, Protozoan* / genetics
  • Antigens, Protozoan* / immunology
  • Bangladesh / epidemiology
  • Disease Outbreaks*
  • Enzyme-Linked Immunosorbent Assay / methods*
  • Female
  • Humans
  • Immunoglobulin G / immunology
  • Immunoglobulin G / urine*
  • Leishmania donovani / genetics
  • Leishmania donovani / immunology*
  • Leishmaniasis, Visceral / diagnosis*
  • Leishmaniasis, Visceral / epidemiology
  • Leishmaniasis, Visceral / parasitology
  • Leishmaniasis, Visceral / urine
  • Male
  • Predictive Value of Tests
  • Recombinant Proteins* / genetics
  • Recombinant Proteins* / immunology
  • Sensitivity and Specificity


  • Antibodies, Protozoan
  • Antigens, Protozoan
  • Immunoglobulin G
  • Recombinant Proteins