Leish-KIT, a stable direct agglutination test based on freeze-dried antigen for serodiagnosis of visceral leishmaniasis

J Clin Microbiol. 1995 Jul;33(7):1742-5. doi: 10.1128/jcm.33.7.1742-1745.1995.

Abstract

In order to increase the application potential of the direct agglutination test (DAT) for the detection of anti-Leishmania antibodies in human serum samples, we developed an antigen based on stained and freeze-dried Leishmania donovani promastigotes. We describe here the evaluation of the performance of the DAT based on this freeze-dried antigen. It was shown that the freeze-dried antigen remains fully active, even after storage at 56 degrees C for 18 months. With a cutoff value of 1:1,600, the sensitivity of the DAT was shown to be 92% and the specificity of the test was 99.7%, which were comparable with the results found for the DAT based on liquid antigen. The major advantages of the freeze-dried antigen are that the production of a large batch of this antigen allows reproducible results in the DAT over a long period of time and that the freeze-dried antigen can be stored at ambient temperature, which, as was shown, makes the test a valuable diagnostic tool for use in the field.

Publication types

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

MeSH terms

  • Agglutination Tests / methods*
  • Agglutination Tests / statistics & numerical data
  • Animals
  • Antibodies, Protozoan / blood
  • Antigens, Protozoan* / isolation & purification
  • Freeze Drying
  • Humans
  • Leishmania donovani / immunology*
  • Leishmaniasis, Visceral / diagnosis*
  • Leishmaniasis, Visceral / immunology
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Serologic Tests / methods
  • Serologic Tests / statistics & numerical data
  • Temperature

Substances

  • Antibodies, Protozoan
  • Antigens, Protozoan