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A new rK39 rapid diagnostic dipstick test (DiaMed-IT-Leish®) was compared with aspiration and a direct agglutination test (DAT) for diagnosis of visceral leishmaniasis (VL) in 201 parasitologically confirmed cases, 133 endemic controls, and in 356 clinical suspects in disease-endemic and -epidemic areas in Sudan. The sensitivity of the rK39 test in parasitologically confirmed VL cases was 90%, whereas the specificity in disease-endemic controls was 99%. The sensitivity of the DAT was 98%. In clinically suspected cases, the sensitivity of the rK39 test was 81% and the specificity was 97%. When compared with the diagnostic protocol based on the DAT and aspiration used by Médecins sans Frontières in epidemic situations, the positive predictive value was 98%, and the negative predictive value was 71%. This rK39 rapid diagnostic test is suitable for screening as well as diagnosis of VL. Further diagnostic work-up of dipstick-negative patients with clinically suspected VL is important. The ease and convenience of the dipstick test will allow decentralization and improved access to care in disease-endemic areas in Sudan.
Received December 17, 2004. Accepted for publication September 1, 2005.
Acknowledgments: We thank the MSF teams in the field in Sudan for their enthusiastic co-operation in this study, Dr. Patrick Jacquier (DiaMed AG) for providing the DiaMed-IT-Leish® tests, and Professor Piet Kager (University of Amsterdam) for the critical review of this manuscript. DiaMed AG provided 500 free VL diagnostic tests to MSF-Holland for this study, but had no involvement with the study design, data gathering, or analysis, and have provided no financial contribution to anyone associated with the study.
Financial support: This study was supported by Médecins sans Frontières-Holland.
* Address correspondence to Koert Ritmeijer, Médecins sans Frontiéres-Holland, P.O. Box 10014, 1001 EA, Amsterdam, The Netherlands. E-mail: koert.ritmeijer{at}amsterdam.msf.org
Authors’ addresses: Koert Ritmeijer, Médecins sans Frontières-Holland, P.O. Box 10014, 1001 EA, Amsterdam, The Netherlands, Telephone: 31-20-5208700, Fax: 31-20-6205170, E-mail: koert.ritmeijer{at}amsterdam.msf.org. Yoseph Melaku and Sammy Kipngetich, Médecins sans Frontières-Holland, Fourth Floor, Chaka Place off Argwings Khodhek Road, Hurlingham, P.O. Box 40643, Nairobi, Kenya. Marius Mueller and Caroline O’Keeffe, Médecins sans Frontières-Holland, Steet 33, Amarat, P.O. Box 3319, Khartoum, Sudan. Robert N. Davidson, Infection and Tropical Medicine, Northwick Park Hospital, Harrow HA1 3UJ, United Kingdom.
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