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Journal of Clinical Microbiology, Jul 1995, 1742-1745, Vol 33, No. 7
Copyright © 1995 by the American Society for Microbiology. All rights reserved.

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

SE Meredith, NC Kroon, E Sondorp, J Seaman, MG Goris, CW van Ingen, H Oosting, GJ Schoone, WJ Terpstra and L Oskam
Department of Biomedical Research, Royal Tropical Institute, Amsterdam, The Netherlands.

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.

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