title: Evaluation of rK-39 strip test using urine for diagnosis of visceral leishmaniasis in an endemic region of India.
abstract: The definitive diagnosis of visceral leishmaniasis (VL) requires invasive procedures for demonstration of parasites in tissue smear or culture. These procedures need expertise and laboratory supports and cannot be performed in the field. The aim of the present study was to evaluate the existing rK-39 immunochromatographic nitrocellulose strips test (ICT) with some modification in human urine for diagnosis of VL. The test was performed on both sera and urine samples on the same 786 subjects (365 confirmed VL and 421 control subjects). The sensitivity of the rK-39 ICT in serum was 100%, whereas the specificity was 93.8%, 100%, and 96.2% in healthy controls from endemic, non-endemic, and other infectious diseases, respectively. However, in urine samples, the test showed 96.1% sensitivity and 100% specificity. Considering sensitivity and feasibility of the test in the field, rK-39 ICT using urine samples can be an alternative to conventional invasive VL diagnosis.
authors.affiliation: Department of Molecular Biology, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India. singhd72@yahoo.co.in
authors.forename: Dharmendra
authors.initials: D
authors.lastname: Singh
authors.forename: Krishna
authors.initials: K
authors.lastname: Pandey
authors.forename: Vidya Nand Rabi
authors.initials: VN
authors.lastname: Das
authors.forename: Sushmita
authors.initials: S
authors.lastname: Das
authors.forename: Neena
authors.initials: N
authors.lastname: Verma
authors.forename: Alok
authors.initials: A
authors.lastname: Ranjan
authors.forename: Sekhar Chandra
authors.initials: SC
authors.lastname: Lal
authors.forename: Kamal Roshan
authors.initials: KR
authors.lastname: Topno
authors.forename: Shubhankar Kumar
authors.initials: SK
authors.lastname: Singh
authors.forename: Rakesh Bihari
authors.initials: RB
authors.lastname: Verma
authors.forename: Ashish
authors.initials: A
authors.lastname: Kumar
authors.forename: Abul Hasan
authors.initials: AH
authors.lastname: Sardar
authors.forename: Bidyut
authors.initials: B
authors.lastname: Purkait
authors.forename: Pradeep
authors.initials: P
authors.lastname: Das
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000913:Antibodies, Protozoan / Q000097:blood; D016022:Case-Control Studies; D002648:Child; D002675:Child, Preschool; D002846:Chromatography, Affinity; D005260:Female; D006801:Humans; D007194:India / Q000453:epidemiology; D007891:Leishmania / Q000302:isolation & purification / Q000472:pathogenicity; D007898:Leishmaniasis, Visceral / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology* / Q000652:urine*; D008297:Male; D008875:Middle Aged; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D000913:Antibodies, Protozoan