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Evaluation of Two rK39 Dipstick Tests, Direct Agglutination Test, and Indirect Fluorescent Antibody Test for Diagnosis of Visceral Leishmaniasis in a New Epidemic Site in Highland Ethiopia

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  • World Health Organization Collaborating Center for Leishmaniasis, National Center of Microbiology, and National Center of Tropical Medicine, Instituto de Salud Carlos III, Madrid, Spain; Disease Prevention and Control Programmes, World Health Organization, Addis Ababa, Ethiopia; Médecins Sans Frontières–Ethiopia, Operational Centre Barcelona–Athens, Addis Zemen, Ethiopia; Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia; Atlanta Research and Education Foundation, Decatur, Georgia; Department for the Control of Neglected Tropical Diseases, Leishmaniasis Control Program, World Health Organization, Geneva, Switzerland

We assessed the performance characteristics of two rK39 immunochromatographic tests, a direct agglutination test (DAT), and an indirect immunofluorescent antibody test (IFAT) in the site of a new epidemic of visceral leishmaniasis (VL) in northwestern Ethiopia. The study population was composed of 179 patients with suspected VL and 67 controls. The sensitivities of Kalazar Detect®, DiaMed-IT Leish®, DAT, and IFAT in 35 polymerase chain reaction–confirmed VL cases were 94.3%, 91.4%, 91.4%, and 100%, respectively, and the specificities were 98.5%, 94%, 98.5%, and 98.5%, respectively. In a Bayesian latent class analysis of all 246 specimens, the estimated sensitivities were 90.5%, 89%, 88.8%, and 96% for Kalazar Detect®, DiaMed-IT Leish®, DAT, and IFAT, respectively; DAT showed the highest estimated specificity (97.4%). Both rK39 immunochromatographic tests perform as well as DAT, and are suitable for VL diagnosis in first-level health centers in this area of Ethiopia.

Author Notes

*Address correspondence to Caryn Bern, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Mailstop F22, Atlanta, GA 30341. E-mail: cxb9@cdc.gov

Authors' addresses: Carmen Cañavate, Javier Nieto, Israel Cruz, and Carmen Chicharro, World Health Organization Collaborating Center for Leishmaniasis, National Center of Microbiology, Instituto de Salud Carlos III, Madrid, Spain, E-mails: ccanave@isciii.es, fjnieto@isciii.es, cruzi@isciii.es, and cchichar@isciii.es. Merce Herrero, Disease Prevention and Control Programmes, World Health Organization, Addis Ababa, Ethiopia and Médecins Sans Frontières-Ethiopia, Operational Centre Barcelona-Athens, Addis Zemen, Ethiopia, E-mail: herreromerce@gmail.com. Pilar Aparicio, National Center of Tropical Medicine, Instituto de Salud Carlos III, Madrid, Spain, E-mail: paparicio@isciii.es. Abate Mulugeta and Daniel Argaw, Disease Prevention and Control Programmes, World Health Organization, Addis Ababa, Ethiopia, E-mails: abatem@et.afro.who.int and daniel@who.int. Anna J. Blackstock, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA and Atlanta Research and Education Foundation, Decatur, GA, E-mail: hyp9@cdc.gov. Jorge Alvar, Department for the Control of Neglected Tropical Diseases, Leishmaniasis Control Program, World Health Organization, Geneva, Switzerland, E-mail: alvarj@who.int. Caryn Bern, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, E-mail: cxb9@cdc.gov.

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