title: Diagnostic tests for kala-azar: a multi-centre study of the freeze-dried DAT, rK39 strip test and KAtex in East Africa and the Indian subcontinent.
abstract: Three diagnostic tests for visceral leishmaniasis (VL), the freeze-dried direct agglutination test (FD-DAT), the rK39 dipstick and a urine latex antigen test (KAtex), were evaluated for use in primary care in East Africa and the Indian subcontinent. Clinical suspects were prospectively recruited and tissue, blood and urine samples were taken. Direct microscopic examination of tissue smear, and FD-DAT, rK39 and KAtex were performed. Sensitivity and specificity with 95% credible intervals were estimated using Bayesian latent class analysis. On the Indian subcontinent both the FD-DAT and the rK39 strip test exceeded the 95% sensitivity and 90% specificity target, but not so in East Africa. Sensitivity of the FD-DAT was high in Ethiopia and Kenya but lower in Sudan, while its specificity was below 90% in Kenya. Sensitivity of the rK39 was below 80% in the three countries, and its specificity was only 70% in Ethiopia. KAtex showed moderate to very low sensitivity in all countries. FD-DAT and rK39 can be recommended for clinical practice on the Indian subcontinent. In East Africa, their clinical use should be carefully monitored. More work is needed to improve existing formats, and to develop better VL diagnostics.
authors.affiliation: Epidemiology and Disease Control Unit, Institute of Tropical Medicine, Nationalestraat 155, 2000 Antwerp, Belgium. mboelaert@itg.be
authors.forename: M
authors.initials: M
authors.lastname: Boelaert
authors.forename: S
authors.initials: S
authors.lastname: El-Safi
authors.forename: A
authors.initials: A
authors.lastname: Hailu
authors.forename: M
authors.initials: M
authors.lastname: Mukhtar
authors.forename: S
authors.initials: S
authors.lastname: Rijal
authors.forename: S
authors.initials: S
authors.lastname: Sundar
authors.forename: M
authors.initials: M
authors.lastname: Wasunna
authors.forename: A
authors.initials: A
authors.lastname: Aseffa
authors.forename: J
authors.initials: J
authors.lastname: Mbui
authors.forename: J
authors.initials: J
authors.lastname: Menten
authors.forename: P
authors.initials: P
authors.lastname: Desjeux
authors.forename: R W
authors.initials: RW
authors.lastname: Peeling
mesh_terms: D000293:Adolescent; D000328:Adult; D000351:Africa, Eastern; D000372:Agglutination Tests / Q000592:standards*; D001211:Asia, Western; D016022:Case-Control Studies; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D007898:Leishmaniasis, Visceral / Q000175:diagnosis* / Q000469:parasitology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D011934:Reagent Strips / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D011933:Reagent Kits, Diagnostic; D011934:Reagent Strips