title: A global comparative evaluation of commercial immunochromatographic rapid diagnostic tests for visceral leishmaniasis.
abstract: BACKGROUND
  Poor access to diagnosis stymies control of visceral leishmaniasis (VL). Antibody-detecting rapid diagnostic tests (RDTs) can be performed in peripheral health settings. However, there are many brands available and published reports of variable accuracy.
  
  
  METHODS
  Commercial VL RDTs containing bound rK39 or rKE16 antigen were evaluated using archived human sera from confirmed VL cases (n = 750) and endemic non-VL controls (n = 754) in the Indian subcontinent (ISC), Brazil, and East Africa to assess sensitivity and specificity with 95% confidence intervals. A subset of RDTs were also evaluated after 60 days' heat incubation (37°C, 45°C). Interlot and interobserver variability was assessed.
  
  
  RESULTS
  All test brands performed well against ISC panels (sensitivity range, 92.8%-100%; specificity range, 96%-100%); however, sensitivity was lower against Brazil and East African panels (61.5%-91% and 36.8%-87.2%, respectively). Specificity was consistently > 95% in Brazil and ranged between 90.8% and 98% in East Africa. Performance of some products was adversely affected by high temperatures. Agreement between lots and readers was good to excellent (κ > 0.73-0.99).
  
  
  CONCLUSIONS
  Diagnostic accuracy of VL RDTs varies between the major endemic regions. Many tests performed well and showed good heat stability in the ISC; however, reduced sensitivity against Brazilian and East African panels suggests that in these regions, used alone, several RDTs are inadequate for excluding a VL diagnosis. More research is needed to assess ease of use and to compare performance using whole blood instead of serum and in patients coinfected with human immunodeficiency virus.
authors.affiliation: UNICEF/UNDP/World Bank/World Health Organization Special Programme for Research and Training in Tropical Diseases, Geneva, Switzerland. cunninghamj@who.int
authors.forename: Jane
authors.initials: J
authors.lastname: Cunningham
authors.forename: Epco
authors.initials: E
authors.lastname: Hasker
authors.forename: Pradeep
authors.initials: P
authors.lastname: Das
authors.forename: Sayda
authors.initials: S
authors.lastname: El Safi
authors.forename: Hiro
authors.initials: H
authors.lastname: Goto
authors.forename: Dinesh
authors.initials: D
authors.lastname: Mondal
authors.forename: Margaret
authors.initials: M
authors.lastname: Mbuchi
authors.forename: Maowia
authors.initials: M
authors.lastname: Mukhtar
authors.forename: Ana
authors.initials: A
authors.lastname: Rabello
authors.forename: Suman
authors.initials: S
authors.lastname: Rijal
authors.forename: Shyam
authors.initials: S
authors.lastname: Sundar
authors.forename: Monique
authors.initials: M
authors.lastname: Wasunna
authors.forename: Emily
authors.initials: E
authors.lastname: Adams
authors.forename: Joris
authors.initials: J
authors.lastname: Menten
authors.forename: Rosanna
authors.initials: R
authors.lastname: Peeling
authors.forename: Marleen
authors.initials: M
authors.lastname: Boelaert
mesh_terms: D000351:Africa, Eastern; D000913:Antibodies, Protozoan / Q000097:blood; D000953:Antigens, Protozoan / Q000737:chemistry; D001938:Brazil; D016022:Case-Control Studies; D002846:Chromatography, Affinity / Q000379:methods* / Q000592:standards; D006801:Humans; D007159:Immunologic Tests / Q000379:methods* / Q000592:standards; D007194:India; D007898:Leishmaniasis, Visceral / Q000175:diagnosis*; D010274:Parasitology / Q000379:methods; D011897:Random Allocation; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D000913:Antibodies, Protozoan; D000953:Antigens, Protozoan; D011933:Reagent Kits, Diagnostic