Evaluation of the direct agglutination test based on freeze-dried Leishmania donovani promastigotes for the serodiagnosis of visceral leishmaniasis in Sudanese patients

Trop Med Int Health. 2004 Oct;9(10):1127-31. doi: 10.1111/j.1365-3156.2004.01308.x.

Abstract

The direct agglutination test (DAT) based on freeze-dried (FD) Leishmania donovani antigen was evaluated for the serodiagnosis of kala-azar in a rural setting in eastern Sudan. The performance of the FD-DAT was compared with standard liquid antigen (LQ) by testing serum samples and blood samples collected on filter paper of microscopically and PCR-confirmed VL patients, apparently healthy endemic controls and patients with other relevant infectious diseases for the region. In the present study, the FD-DAT had a sensitivity of 96.8% and a specificity of 96.2%. The LQ-DAT had a sensitivity of 91.0% and a specificity of 96.6%. A high degree of agreement (97.3%; r-value 0.94) was observed between the FD-DAT and the LQ-DAT, as well as between the FD-DAT performed on serum samples and corresponding blood samples collected on filter paper (agreement 97.8%; r-value 0.79). The FD-DAT is very suitable as diagnostic test for kala-azar in remote rural conditions as it is sensitive, specific and stable. The antigen is affordable, reproducible and available, which contributes to the sustainability of the DAT as a diagnostic test for VL.

Publication types

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

MeSH terms

  • Agglutination Tests / methods
  • Animals
  • Antibodies, Protozoan / blood
  • Antigens, Protozoan / immunology
  • Freeze Drying
  • Humans
  • Leishmania donovani / immunology*
  • Leishmaniasis, Visceral / diagnosis*
  • Polymerase Chain Reaction
  • Reproducibility of Results
  • Sensitivity and Specificity

Substances

  • Antibodies, Protozoan
  • Antigens, Protozoan