Volume 70, Issue 1
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645


A new direct agglutination test (DAT) for use with urine samples for the diagnosis of visceral leishmaniasis (VL) has been developed and compared with the conventional DAT with serum samples and our previously reported enzyme-linked immunosorbent assay (ELISA) with urine samples (urine ELISA). The new DAT, in which anti-human IgG was used as enhancing antibody, was tested with urine samples from 75 VL patients and 225 non-VL patients and healthy people. The sensitivity of the new DAT (90.7%), was almost the same as that of the conventional DAT (91.0%) and the urine ELISA (93.3%). The specificity of the new DAT (96.4%) was nearly identical with that of the urine ELISA (97.3%). A urine-based DAT has several advantages over the conventional DAT: sample collection is non-invasive and it can process larger numbers of samples with smaller amounts of antigen.


Article metrics loading...

Loading full text...

Full text loading...



  1. Mauricio IL, Stotthard JR, Miles MA, 2000. The strange case of Leishmania chagasi. Parasitol Today 16 : 188–189.
  2. Ashford R W, Desjeux P, de Raadt P, 1992. Estimation of population at risk of infection and number of cases of leishmaniasis. Parasitol Today 8 : 104–105.
  3. Wijeyarante PM, Arsenault LK, Murphy CJ, 1994. Endemic disease and development: the leishmaniasis. Acta Trop 56 : 349–364.
  4. Zijlstra EE, Ali MS, el-Hassan AM, el-Toum IA, Satti M, Ghalib HW, Kager PA, 1992. Kala-azar: a comparative study of parasitological methods and the direct agglutination test in diagnosis. Trans R Soc Trop Med Hyg 86 : 505–507.
  5. Cerf BJ, Jones TC, Badaro R, Sampaio D, Teixeira R, Jr Johnson WD, 1987. Malnutrition as a risk factor for severe visceral leishmaniasis. J Infect Dis 156 : 1030–1033.
  6. Ghose AC, Haldar JP, Pal SC, Mishra BP, Mishra KK, 1980. Serological investigations on Indian kala-azar. Clin Exp Immunol 40 : 318–326.
  7. Amin ERME, Wright PA, Kager PA, Laarman JJ, Pondman KW, 1985. ELISA using intact promastigotes for immunodiagnosis of kala-azar. Trans R Soc Trop Med Hyg 79 : 344–350.
  8. Fargeas C, Hommel M, Maingon R, Dourado C, Monsigny M, Mayer R, 1996. Synthetic peptide-based enzyme-linked immunosorbent assay for serodiagnosis of visceral leishmaniasis. J Clin Microbiol 34 : 241–248.
  9. Jaffe CL, McMahon-Pratt D, 1987. Serodiagnostic assay for visceral leishmaniasis employing monoclonal antibodies. Trans R Soc Trop Med Hyg 81 : 587–594.
  10. Kaul P, Malla N, Kaur S, Mahajan RC, Ganguly NK, 2000. Evaluation of a 200-kDa amastigote-specific antigen of L. donovani by enzyme-linked immunosorbent assay (ELISA) for the diagnosis of visceral leishmaniasis. Trans R Soc Trop Med Hyg 94 : 173–175.
  11. Raj VS, Ghosh A, Dole VS, Madhubala R, Myler PJ, Stuart KD, 1999. Serodiagnosis of leishmaniasis with recombinant ORFF antigen. Am J Trop Med Hyg 61 : 482–487.
  12. Zijlstra EE, Daifalla NS, Kager PA, Khalil EAG, Hassan AME, S. G. Reed, H. W. Ghalib. 1998. rK39 enzyme-linked immunosorbent assay for diagnosis of Leishmania donovani infection. Clin Diagn Lab Immunol 5 : 717–720.
  13. Harith AE, Kolk AHJ, Leeuwenburg J, Muigai R, Kiugu S, Kiugu S, Laarman JJ, 1986. A simple and economical direct agglutination test for serodiagnosis and sero-epidemiological studies of visceral leishmaniasis. Trans R Soc Trop Med Hyg 80 : 583–587.
  14. Harith AE, Kolk AHJ, Leeuwenburg J, Muigai R, Huigen E, Jelsma T, Kager PA, 1988. Improvement of a direct agglutination test for field studies of visceral leishmaniasis. J Clin Microbiol 26 : 1321–1325.
  15. Meredith SEO, Kroon NCM, Sondorp E, Seaman J, Goris MGA, van Ingen CW, Oosting H, Schoone GJ, Terpstra WJ, Oskam L, 1995. Leish-KIT, a stable direct agglutination test based on freeze-dried antigen for serodiagnosis of visceral leishmaniasis. J Clin Microbiol 33 : 1742–1745.
  16. Walton BC, Brooks VM, Arojone I, 1972. Serodiagnosis of American leishmaniasis by indirect fluorescent antibody test. Am J Trop Med Hyg 21 : 296–299.
  17. Mbati PA, Githure JI, Kagai JM, Kirigi G, Kibati F, Wasunna K, Koech D. K, 1999. Evaluation of a standardized direct agglutination test (DAT) for the diagnosis of visceral leishmaniasis in kenya. Ann Trop Med Parasitol 93 : 703–710.
  18. Addy M, Som DK, Das C, Bhattacharya S, Bowmik T, Rakshit P, Patra P, Nandy A Choudhury, AB, 1989. Evaluation of direct agglutination test (DAT) in the diagnosis and screening of kala-azar. Indian Med Gaz 123 : 184–187.
  19. Chowdhury MS, al Masum A, al Karim E, Semiao-Santos S, Rahman KM, Ar-Rashid H, el Harith A, 1993. Applicability of direct agglutination test (DAT) at a rural health setting in Bangladesh and feasibility of local antigen production. Arch Inst Pasteur Tunis 70 : 333–344.
  20. Chowdhury S, Haque F, Masum AA, Harith A, Karim E, 1991. Positive response to sodium antimony gluconate adminstration in visceral leishmaniasis seropositive patients. Am J Trop Med Hyg 44 : 390–393.
  21. Singla N, Singh GS, Sundar S, Vinayak VK, 1993. Evaluation of direct agglutination test as an immunodiagnostic tool for kala-azar in India. Trans R Soc Trop Med Hyg 87 : 276–278.
  22. Islam MZ, Itoh M, Shamsuzzaman SM, Mirza R, Matin F, Ahmed I, Choudhury AKMS, Hossain MA, Qiu XG, Begam N, Furuya M, Leafasia JL, Hashiguchi Y, Kimura E, 2002. Diagnosis of visceral leishmaniasis by ELISA using urine samples. Clin Diagn Lab Immunol 9 : 789–794.
  23. Badaro R, Jones TC, Lorenco R, Cerf BJ, Sampio D, Carvalho EM, Rocha H, Teixeira R, Jr Johnson WD, 1986. A prospective study of visceral leishmaniasis in an endemic area of Brazil. J Infect Dis 154 : 639–649.
  24. World Health Organization, 1984. Leishmaniasis. World Health Organ Tech Rep Ser 701.
  25. Shamsuzzaman SM, Furuya M, Choudhury AKMS, Korenaga M, Hashiguchi Y, 2000. Characterisation of Bangladeshi Leishmania isolated from kala-azar patients by isoenzyme electrophoresis. Parasitol Int 49 : 139–145.
  26. Badaro R, Jones TC, Carvalho EM, Sampaio D, Reed SG, Barral A, Teixeira R, Johnson WD Jr, 1986. New perspectives on a subclinical form of visceral leishmaniasis. J Infect Dis 154 : 1003–1011.
  27. Jha TK, Sundar S, Thakur CP, Backmann P, Karbwang J, Fischer C, Vos A, Berman J, 1999. Miltefosine, an oral agent, for the treatment of Indian visceral leishmaniasis. N Engl J Med 341 : 1795–1800.
  28. Boelaert M, El Safi S, Jacquet D, de Muynck A, van der Stuyft P, Le Ray D, 1999. Operational validation of the direct agglutination test for diagnosis of visceral leishmaniasis. Am J Trop Med Hyg 60 : 129–134.
  29. Carvalho SFG, Lemos EM, Core R, Dietze R, 2003. Performance of recombinant K39 antigen in the diagnosis of Brazilian visceral leishmaniasis. Am J Trop Med Hyg 68 : 321–324.
  30. Weerasooriya MV, Itoh M, Islam MZ, Qiu XG, Fujimaki Y, Kimura E, 2003. Prevalence and levels of filaria-specific urinary IgG4 among children less than five years of age and the association of the antibody positivity between the children and their mothers. Am J Trop Med Hyg 68 : 465–468.

Data & Media loading...

  • Received : 02 Jul 2003
  • Accepted : 09 Sep 2003

Most Cited This Month

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error