title: Comparative evaluation of parasitology and serological tests in the diagnosis of visceral leishmaniasis in India: a phase III diagnostic accuracy study.
abstract: In this phase III trial for diagnostics for visceral leishmaniasis (VL) in India, we compared parasitological diagnosis with several serological tests: direct agglutination test (freeze dried; DAT-FD), rK-39 strip test, rK-26 strip test and a latex agglutination test for antigen detection in urine (KAtex) in 452 subjects from the endemic regions of Bihar, India. The subjects were segregated into four categories: 230 confirmed patients, 52 probable cases, 70 non-cases and 100 healthy endemic controls. The first two groups were used for estimating sensitivity, the latter two for specificity. Sensitivity of DAT-FD was 98.9%, rK-39: 98.9%, KAtex: 67.0% and rK-26: 21.3%. Sensitivity of DAT-FD on blood taken on filter paper (DAT-FDF) was 99.3%, which was comparable with that using serum. Specificity of serological tests was comparable and high (DAT-FD and DAT-FDF: 94%, rK-39 strip test: 97%, KAtex: 99% and rK-26 strip test: 100%). The classical 'gold standard' parasitological demonstration in splenic smear performed poorly as it missed 18.4% of cases that benefited from VL treatment. Reproducibility of the serological tests between field and central laboratories was excellent (kappa = 1.0, 0.99, 0.96 and 0.94 respectively for microscopy, DAT-FD, rK-39 strip test and rK-26 strip test). A high degree of agreement was observed between DAT-FD and rK-39 strip test (kappa = 0.986). Although DAT-FD and rK-39 strip test were highly sensitive with excellent specificity, the ease of use of the latter makes it most suitable for the diagnosis of VL in the field conditions.
authors.affiliation: Infectious Diseases Research Laboratory, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India. drshyamsundar@hotmail.com
authors.forename: S
authors.initials: S
authors.lastname: Sundar
authors.forename: R K
authors.initials: RK
authors.lastname: Singh
authors.forename: S K
authors.initials: SK
authors.lastname: Bimal
authors.forename: K
authors.initials: K
authors.lastname: Gidwani
authors.forename: A
authors.initials: A
authors.lastname: Mishra
authors.forename: R
authors.initials: R
authors.lastname: Maurya
authors.forename: S K
authors.initials: SK
authors.lastname: Singh
authors.forename: K D
authors.initials: KD
authors.lastname: Manandhar
authors.forename: M
authors.initials: M
authors.lastname: Boelaert
authors.forename: M
authors.initials: M
authors.lastname: Rai
mesh_terms: D000328:Adult; D000372:Agglutination Tests / Q000379:methods; D000953:Antigens, Protozoan / Q000652:urine; D002648:Child; D019353:Endemic Diseases; D006801:Humans; D007194:India / Q000453:epidemiology; D007898:Leishmaniasis, Visceral / Q000175:diagnosis* / Q000453:epidemiology / Q000469:parasitology; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods
chemical_list: D000953:Antigens, Protozoan