title: Evaluation of diagnostic performance of rK28 ELISA using urine for diagnosis of visceral leishmaniasis.
abstract: Recombinant fusion proteins are now commonly used to detect circulating antibodies for the serodiagnosis of visceral leishmaniasis (VL) in Asia, Africa and the Americas. Although simple, these tests still require blood collection and their use in remote settings can be limited due to the need of collection devices, serum fractionation instrument and generation of biohazardous waste. The development of an accurate and non-invasive diagnostic algorithm for VL, such as could be achieved with urine, is desirable.
  
  
  
  We enrolled 87 VL patients and 81 non-VL individuals, including 33 healthy endemic controls, 16 healthy non-endemic controls, 16 disease controls and 16 tuberculosis (TB) patients. We compared the efficacy of recombinant antigens rK28, rK39 and rKRP42 for the diagnosis of VL when either serum or urine were used to develop antibody-detection ELISA.
  
  
  
  As expected, each of the antigens readily detected antibodies in the serum of VL patients. rK28 ELISA showed the highest sensitivity (98.9 %), followed by rK39 and rKRP42 ELISA (97.7 and 94.4 %, respectively); overall specificity was > 96 %. When urine was used as the test analyte, only a marginal drop in sensitivity was observed, with rK28 ELISA again demonstrating the greatest sensitivity (95.4 %), followed by rK39 and rKRP42 ELISA, respectively. Again, the overall specificity was > 96 %.
  
  
  
  Our data indicate the potential for using urine in the diagnosis of VL. Detection of antibodies against rK28 demonstrated the greatest sensitivity. Together, our results indicate that rK28-based antibody detection tests using urine could provide a completely non-invasive tool amenable for diagnosis of VL in remote locations.
authors.affiliation: Laboratory Sciences Division, International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.
authors.forename: Prakash
authors.initials: P
authors.lastname: Ghosh
authors.affiliation: Department of Biochemistry, University of Utah, Salt Lake City, USA.
authors.forename: Khondaker R H
authors.initials: KR
authors.lastname: Bhaskar
authors.affiliation: Laboratory Sciences Division, International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.
authors.forename: Faria
authors.initials: F
authors.lastname: Hossain
authors.affiliation: Laboratory Sciences Division, International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.
authors.forename: Md Anik Ashfaq
authors.initials: MA
authors.lastname: Khan
authors.affiliation: Infectious Disease Research Institute, Seattle, USA.
authors.forename: Aarthy C
authors.initials: AC
authors.lastname: Vallur
authors.affiliation: Infectious Disease Research Institute, Seattle, USA.
authors.forename: Malcolm S
authors.initials: MS
authors.lastname: Duthie
authors.affiliation: Department of Parasitology, Institute of Tropical Medicine Nagasaki University, Nagasaki, Japan.|Global COE programme, Nagasaki University, Nagasaki, Japan.
authors.forename: Shinjiro
authors.initials: S
authors.lastname: Hamano
authors.affiliation: Department of Basic Medical Sciences, College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Jeddah, KSA, Saudi Arabia.
authors.forename: Md Abdus
authors.initials: MA
authors.lastname: Salam
authors.affiliation: Laboratory Sciences Division, International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.
authors.forename: M Mamun
authors.initials: MM
authors.lastname: Huda
authors.affiliation: Department of Pediatrics Immunology Division Faculty of Medicine and Health Science, University of Sherbrooke, Sherbrooke, QC, Canada.
authors.forename: Md Gulam Musawwir
authors.initials: MG
authors.lastname: Khan
authors.affiliation: Infectious Disease Research Institute, Seattle, USA.
authors.forename: Rhea N
authors.initials: RN
authors.lastname: Coler
authors.affiliation: Infectious Disease Research Institute, Seattle, USA.
authors.forename: Steven G
authors.initials: SG
authors.lastname: Reed
authors.affiliation: Laboratory Sciences Division, International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh. din63d@icddrb.org.
authors.forename: Dinesh
authors.initials: D
authors.lastname: Mondal
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D000913:Antibodies, Protozoan / Q000097:blood / Q000652:urine*; D000953:Antigens, Protozoan / Q000276:immunology*; D002648:Child; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D006801:Humans; D007893:Leishmania donovani / Q000276:immunology* / Q000302:isolation & purification; D007898:Leishmaniasis, Visceral / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D015800:Protozoan Proteins / Q000276:immunology*; D011993:Recombinant Fusion Proteins; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D000913:Antibodies, Protozoan; D000953:Antigens, Protozoan; D015800:Protozoan Proteins; D011993:Recombinant Fusion Proteins
keywords: Bangladesh; Diagnosis; ELISA; Serum; Urine; Visceral leishmaniasis; rK28; rK39; rKRP42