A global comparative evaluation of commercial immunochromatographic rapid diagnostic tests for visceral leishmaniasis

Clin Infect Dis. 2012 Nov 15;55(10):1312-9. doi: 10.1093/cid/cis716. Epub 2012 Aug 31.


Background: Poor access to diagnosis stymies control of visceral leishmaniasis (VL). Antibody-detecting rapid diagnostic tests (RDTs) can be performed in peripheral health settings. However, there are many brands available and published reports of variable accuracy.

Methods: Commercial VL RDTs containing bound rK39 or rKE16 antigen were evaluated using archived human sera from confirmed VL cases (n = 750) and endemic non-VL controls (n = 754) in the Indian subcontinent (ISC), Brazil, and East Africa to assess sensitivity and specificity with 95% confidence intervals. A subset of RDTs were also evaluated after 60 days' heat incubation (37°C, 45°C). Interlot and interobserver variability was assessed.

Results: All test brands performed well against ISC panels (sensitivity range, 92.8%-100%; specificity range, 96%-100%); however, sensitivity was lower against Brazil and East African panels (61.5%-91% and 36.8%-87.2%, respectively). Specificity was consistently > 95% in Brazil and ranged between 90.8% and 98% in East Africa. Performance of some products was adversely affected by high temperatures. Agreement between lots and readers was good to excellent (κ > 0.73-0.99).

Conclusions: Diagnostic accuracy of VL RDTs varies between the major endemic regions. Many tests performed well and showed good heat stability in the ISC; however, reduced sensitivity against Brazilian and East African panels suggests that in these regions, used alone, several RDTs are inadequate for excluding a VL diagnosis. More research is needed to assess ease of use and to compare performance using whole blood instead of serum and in patients coinfected with human immunodeficiency virus.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Africa, Eastern
  • Antibodies, Protozoan / blood
  • Antigens, Protozoan / chemistry
  • Brazil
  • Case-Control Studies
  • Chromatography, Affinity / methods*
  • Chromatography, Affinity / standards
  • Humans
  • Immunologic Tests / methods*
  • Immunologic Tests / standards
  • India
  • Leishmaniasis, Visceral / diagnosis*
  • Parasitology / methods
  • Random Allocation
  • Reagent Kits, Diagnostic / standards*
  • Reproducibility of Results
  • Sensitivity and Specificity


  • Antibodies, Protozoan
  • Antigens, Protozoan
  • Reagent Kits, Diagnostic