title: 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.
abstract: 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.
authors.affiliation: World Health Organization Collaborating Center for Leishmaniasis, National Center of Microbiology, Instituto de Salud Carlos III, Madrid, Spain. ccanave@isciii.es,
authors.forename: Carmen
authors.initials: C
authors.lastname: Cañavate
authors.forename: Merce
authors.initials: M
authors.lastname: Herrero
authors.forename: Javier
authors.initials: J
authors.lastname: Nieto
authors.forename: Israel
authors.initials: I
authors.lastname: Cruz
authors.forename: Carmen
authors.initials: C
authors.lastname: Chicharro
authors.forename: Pilar
authors.initials: P
authors.lastname: Aparicio
authors.forename: Abate
authors.initials: A
authors.lastname: Mulugeta
authors.forename: Daniel
authors.initials: D
authors.lastname: Argaw
authors.forename: Anna J
authors.initials: AJ
authors.lastname: Blackstock
authors.forename: Jorge
authors.initials: J
authors.lastname: Alvar
authors.forename: Caryn
authors.initials: C
authors.lastname: Bern
mesh_terms: D000293:Adolescent; D000328:Adult; D000372:Agglutination Tests / Q000379:methods*; D016022:Case-Control Studies; D002648:Child; D002675:Child, Preschool; D058872:Epidemics; D005002:Ethiopia / Q000453:epidemiology; D005260:Female; D019084:Fluorescent Antibody Technique, Indirect / Q000379:methods*; D006801:Humans; D007898:Leishmaniasis, Visceral / Q000175:diagnosis* / Q000453:epidemiology*; D008297:Male; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D011933:Reagent Kits, Diagnostic