Evaluation of two rK39 dipstick tests, direct agglutination test, and indirect fluorescent antibody test for diagnosis of visceral leishmaniasis in a new epidemic site in highland Ethiopia

Am J Trop Med Hyg. 2011 Jan;84(1):102-6. doi: 10.4269/ajtmh.2011.10-0229.

Abstract

We assessed the performance characteristics of two rK39 immunochromatographic tests, a direct agglutination test (DAT), and an indirect immunofluorescent antibody test (IFAT) in the site of a new epidemic of visceral leishmaniasis (VL) in northwestern Ethiopia. The study population was composed of 179 patients with suspected VL and 67 controls. The sensitivities of Kalazar Detect(®), DiaMed-IT Leish(®), DAT, and IFAT in 35 polymerase chain reaction-confirmed VL cases were 94.3%, 91.4%, 91.4%, and 100%, respectively, and the specificities were 98.5%, 94%, 98.5%, and 98.5%, respectively. In a Bayesian latent class analysis of all 246 specimens, the estimated sensitivities were 90.5%, 89%, 88.8%, and 96% for Kalazar Detect(®), DiaMed-IT Leish(®), DAT, and IFAT, respectively; DAT showed the highest estimated specificity (97.4%). Both rK39 immunochromatographic tests perform as well as DAT, and are suitable for VL diagnosis in first-level health centers in this area of Ethiopia.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Agglutination Tests / methods*
  • Case-Control Studies
  • Child
  • Child, Preschool
  • Epidemics*
  • Ethiopia / epidemiology
  • Female
  • Fluorescent Antibody Technique, Indirect / methods*
  • Humans
  • Leishmaniasis, Visceral / diagnosis*
  • Leishmaniasis, Visceral / epidemiology*
  • Male
  • Reagent Kits, Diagnostic*
  • Sensitivity and Specificity
  • Young Adult

Substances

  • Reagent Kits, Diagnostic