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Field Evaluation of rK39 Test and Direct Agglutination Test for Diagnosis of Visceral Leishmaniasis in a Population with High Prevalence of Human Immunodeficiency Virus in Ethiopia

Accuracy of an rK39 rapid diagnostic test (DiaMed-IT-Leish ^®) for visceral leishmaniasis (VL) was compared with splenic aspiration and the direct agglutination test (DAT) in a population with a high prevalence of infection with human immunodeficiency virus (HIV) in Ethiopia. There were 699 patients clinically suspected of having VL (153 parasitologically confirmed, 482 DAT confirmed, and 130 DAT negative), and 97 DAT-negative controls. A total of 84% were tested for HIV and 34% were HIV positive. Sensitivity of the rK39 test in parasitologically confirmed VL patients was 84% (77% in HIV positive and 87% in HIV negative; P = 0.25). Sensitivity of the DAT was higher (94%; P = 0.01), 89% in HIV-positive patients and 95% in HIV-negative patients; P = 0.27). Specificity of the rK39 test was 99% in DAT-negative controls and 92% in DAT-negative patients clinically suspected of having VL. A diagnostic algorithm combining DAT and the rK39 test had a sensitivity of 98% in HIV-positive VL patients and 99% in HIV-negative VL patients. Despite the lower sensitivity in a population with a high prevalence of HIV, the DiaMed-IT-Leish ^® rK39 test enables decentralization of diagnosis. Patients clinically suspected of having VL who show negative results on the rK39 antigen test should undergo follow-up DAT testing, especially if they are HIV positive.

Received August 18, 2008. Accepted for publication February 28, 2009.

Acknowledgments: We thank the Tigray Bureau of Health; the Kahsay Abera Hospital in Humera; the Ethiopian Health and Nutrition Research Institute in Addis Ababa; Médecins Sans Frontières staff in Humera, Addis Ababa, and Amsterdam; and all participants for valuable contributions.

Financial support: This study was supported by Médecins Sans Frontières.

^* Address correspondence to Koert Ritmeijer, Médecins Sans Frontières Holland, PO Box 10014, 1001EA, Amsterdam, The Netherlands. E-mail: Koert.ritmeijer{at}amsterdam.msf.org

Authors’ addresses: Rachel ter Horst and Koert Ritmeijer, Médecins Sans Frontières Holland, PO Box 10014, 1001EA, Amsterdam, The Netherlands, E-mail: Koert.ritmeijer{at}amsterdam.msf.org. Tewodros Tefera, Kahsay Abera Hospital Humera, Tigray Regional Bureau of Health, PO Box 7, Mekele, Ethiopia. Gessesse Assefa, Ethiopian Health and Nutrition Research Institute, PO Box 5654, Addis Ababa, Ethiopia. Abdurazik Z. Ebrahim, Médecins Sans Frontières, PO Box 9, Humera, Ethiopia. Robert N. Davidson, Department of Infection and Tropical Medicine, Lister Unit, Northwick Park Hospital, Harrow, Middlesex, HA1 3UJ, United Kingdom.