Evaluation of a new recombinant K39 rapid diagnostic test for Sudanese visceral leishmaniasis

American Journal of Tropical Medicine and Hygiene

Volumn 74, Issue 1, 2006, Pages 76-80

  Ritmeijer, Koert ^a   Melaku, Yoseph ^a   Mueller, Marius ^a   Kipngetich, Sammy ^a   O'Keeffe, Caroline ^a   Davidson, Robert N ^b  

^a MÉDECINS SANS FRONTIÈRES   (Switzerland)

^b NORTHWICK PARK HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

AGGLUTINATION TEST; ARTICLE; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; RK39 RAPID DIPSTICK TEST; SCREENING TEST; SUDAN; VISCERAL LEISHMANIASIS; ANALYTICAL EQUIPMENT; BLOOD; PREDICTION AND FORECASTING; SENSITIVITY AND SPECIFICITY; TIME;

K39 ANTIGEN, LEISHMANIA; PARASITE ANTIGEN; PROTOZOAL PROTEIN; RECOMBINANT PROTEIN;

ANTIGENS, PROTOZOAN; HUMANS; LEISHMANIASIS, VISCERAL; PREDICTIVE VALUE OF TESTS; PROTOZOAN PROTEINS; REAGENT KITS, DIAGNOSTIC; RECOMBINANT PROTEINS; SENSITIVITY AND SPECIFICITY; SUDAN; TIME FACTORS;

EID: 33646012333     PISSN: 00029637     EISSN: None     Source Type: Journal    
DOI: 10.4269/ajtmh.2006.74.76     Document Type: Article

References (30)

1. Zijlstra EE, Siddig Ali M, 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.
2. Harith AE, Kolk AH, Kager PA, Leeuwenburg J, Muigai R, Kiugu S, Laarman JJ, 1986. A simple and economical direct agglutination test for the serodiagnosis and sero-epidemiological studies of visceral leishmaniasis. Trans R Soc Trop Med Hyg 80: 583-586.
3. Zijlstra EE, El-Hassan AM, Ismael A, Ghalib HW, 1994. Endemic kala-azar in eastern Sudan: a longitudinal study on the incidence of clinical and subclinical infection and post kalaazar dermal leishmaniasis. Am J Trop Med Hyg 51: 826-836.
4. Khalil EAG, Zijlstra EE, Kager PA, El Hassan AM, 2002. Epidemiology and clinical manifestations of Leishmania donovani infection in two villages in an endemic area in eastern Sudan. Trop Med Int Health 7: 35-44.
5. Boelaert M, El Safi S, Jacquet D, De Muynk A, van der Stuyft P, Le Ray D, 1999. Operational validation of the DAT for diagnosis of visceral leishmaniasis. Am J Trop Med Hyg 60: 129-134.
6. Medecins sans Frontieres, 2004. MSF Manual for the Diagnosis and Treatment of Visceral Leishmaniasis (Kala-Azar) under Field Conditions. Amsterdam: MSF-Holland.
7. Meredith SE, Kroon NC, Sondorp E, Seaman J, Goris MG, Ingen van 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.
8. Singh S, Gilman-Sachs A, Chang KP, Reed SG, 1995. Diagnostic and prognostic value of K39 recombinant antigen in Indian leishmaniasis. J Parasitol 81: 1000-1003.
9. Badaro R, Benson D, Eulalio MC, Freire M, Cunha S, Netto EM, Pedral-Sampaio D, Madureira C, Burns JM, Houghton RL, David JR, Reed SG, 1996. rK39: a cloned antigen of Leishmania chagasi that predicts active visceral leishmaniasis. J Infect Dis 173: 758-761.
10. Ozensoy S, Ozbel Y, Turgay N, Alkan MZ, Gul K, Gilman-Sachs A, Chang KP, Reed SG, Ozcel MA, 1998. Serodiagnosis and epidemiology of visceral leishmaniasis in Turkey. Am J Trop Med Hyg 59: 363-369.
11. Medrano FJ, Canavate C, Leal M, Rey C, Lissen E, Alvar J, 1998. The role of serology in the diagnosis and prognosis of visceral leishmaniasis in patients co-infected with human immunodeficiency virus type 1. Am J Trop Med Hyg 59: 155-162.
12. Houghton RL, Petrescu M, Benson DR, Skeiky YA, Scalone A, Badaro R, Reed SG, Gradoni L, 1998. A cloned antigen (recombinant K39) of Leishmania chagasi diagnostic for visceral leishmaniasis in human immunodeficiency virus type 1 patients and a prognostic indicator for monitoring patients undergoing drug therapy. J Infect Dis 177: 1339-1344.
13. Maalej IA, Chenik M, Louzir H, Ben Salah A, Bahloul C, Amri F, Dellagi K, 2003. Comparative evaluation of ELISAs based on ten recombinant or purified Leishmania antigens for the serodiagnosis of Mediterranean visceral leishmaniasis. Am J Trop Med Hyg 68: 312-320.
14. Sundar S, Reed SG, Singh VP, Kumar PC, Murray HW, 1998. Rapid accurate field diagnosis of Indian visceral leishmaniasis. Lancet 351: 563-565.
15. Chappuis F, Rijal S, Singh R, Acharya P, Karki BMS, Das ML, Bovier PA, Desjeux P, Le Ray D, Koirala S, Loutan L, 2003. Prospective evaluation and comparison of the direct agglutination test and an rK39-antigen-based dipstick test for the diagnosis of suspected kala-azar in Nepal. Trop Med Int Health 8: 277-285.
16. Singh S, Kumari V, Singh N, 2002. Predicting kala-azar disease manifestations in asymptomatic patients with latent Leishmania donovani infection by detection of antibody against recombinant K39 antigen. Clin Diagn Lab Immunol 9: 568-572.
17. Bern C, Jha SN, Joshi AB, Thakur GD, Bista MB, 2000. Use of the recombinant K39 dipstick test and the direct agglutination test in a setting endemic for visceral leishmaniasis in Nepal. Am J Trop Med Hyg 63: 153-157.
18. Boelaert M, Rijal S, Regmi S, Singh R, Karki B, Jacquet D, Chappuis F, Campino L, Desjeux P, Le Ray D, Koirala S, van der Stuyft P, 2004. A comparative study of the effectiveness of diagnostic tests for visceral leishmaniasis. Am J Trop Med Hyg 70: 72-77.
19. Sarker CB, Momen A, Jamal MF, Siddiqui NI, Siddiqui FM, Chowdhury KS, Rahman S, Talukder SI, 2003. Immunochromatographic (rK39) strip test in the diagnosis of visceral leishmaniasis in Bangladesh. Mymensingh Med J 12: 93-97.
20. Carvalho SF, Lemos EM, Corey R, Dietze R, 2003. Performance of recombinant K39 antigen in the diagnosis of Brazilian visceral leishmaniasis. Am J Trop Med Hyg 68: 321-324.
21. Zijlstra EE, Daifalla NS, Kager PA, Khalil EA, El Hassan AM, Reed SG, Ghalib HW, 1998. rK39 enzyme-linked immunosorbent assay for diagnosis of Leishmania donovani infection. Clin Diagn Lab Immunol 5: 717-720.
22. Zijlstra EE, Nur Y, Desjeux P, Khalil EA, El-Hassan AM, Groen J, 2001. Diagnosing visceral leishmaniasis with the recombinant K39 strip test: experience from the Sudan. Trop Med Int Health 6: 108-113.
23. Veeken H, Ritmeijer K, Seaman J, Davidson RN, 2003. Comparison of an rK39 dipstick rapid test with direct agglutination test and splenic aspiration for the diagnosis of kala-azar in Sudan. Trop Med Int Health 8: 164-167.
24. Ritmeijer K, Davidson RN, 2003. Médecins Sans Frontières interventions against kala-azar in the Sudan, 1989-2003. Trans R Soc Trop Med Hyg 97: 609-613.
25. World Health Organization, 1996. Manual on Visceral Leishmaniasis Control. Geneva: World Health Organization. WHO/Leish/96.40.
26. Chulay JD, Bryceson AD, 1983. Quantitation of amastigotes of Leishmania donovani in smears of splenic aspirates from patients with visceral leishmaniasis. Am J Trop Med Hyg 32: 475-479.
27. Zijlstra EE, Ali MS, el-Hassan AM, el-Toum IA, Satti M, Ghalib HW, Kager PA, 1991. Direct agglutination test for diagnosis and sero-epidemiological survey of kala-azar in the Sudan. Trans R Soc Trop Med Hyg 85: 474-476.
28. Boelaert M, el Safi S, Goetghebeur E, Gomes-Pereira S, Le Ray D, Van der Stuyft P, 1999. Latent class analysis permits unbiased estimates of the validity of DAT for the diagnosis of visceral leishmaniasis. Trop Med Int Health 4: 395-401.
29. Zijlstra EE, el-Hassan AM, 2001. Leishmaniasis in Sudan. Visceral leishmaniasis. Trans R Soc Trop Med Hyg 95(Suppl 1): S27-S58.
30. Collin S, Davidson RN, Ritmeijer K, Keus K, Melaku Y, Kipngetich S, Davies C, 2004. Conflict and kala-azar: determinants of adverse outcomes of kala-azar among patients in southern Sudan. Clin Infect Dis 38: 612-619.