title: Field evaluation of FD-DAT, rK39 dipstick and KATEX (urine latex agglutination) for diagnosis of visceral leishmaniasis in northwest Ethiopia.
abstract: Three novel diagnostic tests for visceral leishmaniasis (VL), namely FD-DAT, rK39 dipstick and KATEX, were evaluated under field conditions using 101 clinical cases suspected of having VL enrolled in a trial either by active (63 patients) or passive (38 patients) surveillance. VL was confirmed in 49 patients: 35 by both aspirate smear microscopy and NNN culture, 10 by NNN culture alone and 4 by aspirate smear microscopy alone. Based on tests performed in the field, sensitivity for FD-DAT, rK39 dipstick and KATEX was determined to be 95.3% (95% CI 82.9-99.2%), 71.7% (95% CI 56.3-83.5%) and 57.4% (95% CI 42.3-71.4%), respectively. Similarly, the specificity was determined to be 62.7% (95% CI 48.1-75.5%), 82.4% (95% CI 68.6-91.1%) and 84.3% (95% CI 70.9-92.5%), respectively. A higher sensitivity of KATEX (73.9% vs. 41.7%) and higher specificity of FD-DAT (100.0% vs. 48.6%) were demonstrated under passive case detection compared with active case detection. FD-DAT is recommended for confirmation of VL diagnosis in hospital settings, whereas its use in the field will be limited to exclude VL in clinical suspects. The sensitivity of KATEX and rK39 dipstick tests needs to be improved to promote their use as first-line diagnostic tests in the field setting of northwestern Ethiopia.
authors.affiliation: Gondar University, Amhara Regional State, Gondar, Ethiopia.
authors.forename: Ermias
authors.initials: E
authors.lastname: Diro
authors.forename: Yoseph
authors.initials: Y
authors.lastname: Techane
authors.forename: Tedros
authors.initials: T
authors.lastname: Tefera
authors.forename: Yibeltal
authors.initials: Y
authors.lastname: Assefa
authors.forename: Tadesse
authors.initials: T
authors.lastname: Kebede
authors.forename: Abebe
authors.initials: A
authors.lastname: Genetu
authors.forename: Yenew
authors.initials: Y
authors.lastname: Kebede
authors.forename: Abiye
authors.initials: A
authors.lastname: Tesfaye
authors.forename: Bahiru
authors.initials: B
authors.lastname: Ergicho
authors.forename: Asfawesen
authors.initials: A
authors.lastname: Gebre-Yohannes
authors.forename: Getahun
authors.initials: G
authors.lastname: Mengistu
authors.forename: Howard
authors.initials: H
authors.lastname: Engers
authors.forename: Abraham
authors.initials: A
authors.lastname: Aseffa
authors.forename: Philippe
authors.initials: P
authors.lastname: Desjeux
authors.forename: Marleen
authors.initials: M
authors.lastname: Boelaert
authors.forename: Asrat
authors.initials: A
authors.lastname: Hailu
mesh_terms: D019353:Endemic Diseases; D005002:Ethiopia / Q000453:epidemiology; D005260:Female; D006801:Humans; D007841:Latex Fixation Tests / Q000379:methods*; D007898:Leishmaniasis, Visceral / Q000175:diagnosis* / Q000382:microbiology / Q000401:mortality; D008297:Male; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012423:Rural Health; D012680:Sensitivity and Specificity
chemical_list: D011933:Reagent Kits, Diagnostic