title: A multicentric evaluation of the recombinant Leishmania infantum antigen-based immunochromatographic assay for the serodiagnosis of canine visceral leishmaniasis.
abstract: BACKGROUND
  Visceral leishmaniasis (VL) is a serious public health challenge in Brazil and dogs are considered to be the main urban reservoir of the causative agent. The culling of animals to control VL in some countries makes the accurate diagnosis of canine VL (CVL) essential. Recombinant antigens rLci1A and rLci2B were selected from a cDNA library of Leishmania infantum amastigotes due to their strong potential as candidates in diagnostic testing for CVL. The present multicentric study aimed to evaluate the sensitivity of a prototype test using these antigens (DPP rLci1A/rLci2B) against 154 sera obtained from symptomatic dogs within three endemic areas of VL in Brazil. The specificity was evaluated using 40 serum samples from negative dogs and dogs infected with other pathogens. Sensitivity and specificity rates of DPP rLci1A/rLci2B prototype were compared to rates from other diagnostic tests currently in use by the Brazilian Ministry of Health, including DPPLVC, EIELVC.
  
  
  RESULTS
  DPP rLci1A/rLci2B prototype offered similar performance to that offered by DPPLVC rapid test, as follows: sensitivity of 87% (CI 81-91) and 88% (CI 82-93) and specificity of 100% (CI 91-100) and 97% (CI 87-100), respectively for DPP rLci1A/rLci2B and DPPLVC. When results of these two tests were considered concomitantly, sensitivity increased to 93.5% (CI 89-96).
  
  
  CONCLUSIONS
  The recombinant antigens rLci1A and rLci2B represent promising candidates for use in a multi-antigen rapid test for CVL. The inclusion of novel antigens to the DPP rLci1A/rLci2B prototype model could offer additionally enhanced sensitivity to detect animals infected by L. infantum.
authors.forename: Deborah Bittencourt Mothé
authors.initials: DB
authors.lastname: Fraga
authors.forename: Edimilson Domingos
authors.initials: ED
authors.lastname: da Silva
authors.forename: Luciano Vasconcellos
authors.initials: LV
authors.lastname: Pacheco
authors.forename: Lairton Souza
authors.initials: LS
authors.lastname: Borja
authors.forename: Isaac Queiroz
authors.initials: IQ
authors.lastname: de Oliveira
authors.forename: Wendel
authors.initials: W
authors.lastname: Coura-Vital
authors.forename: Glória Regina
authors.initials: GR
authors.lastname: Monteiro
authors.forename: Geraldo Gileno de Sá
authors.initials: GG
authors.lastname: Oliveira
authors.forename: Selma Maria Bezerra
authors.initials: SM
authors.lastname: Jerônimo
authors.forename: Alexandre Barbosa
authors.initials: AB
authors.lastname: Reis
authors.affiliation: Laboratório de Patologia e Biointervenção, Centro de Pesquisa Gonçalo Moniz, FIOCRUZ, Salvador, Bahia, Brazil. pveras@bahia.fiocruz.com.
authors.forename: Patrícia Sampaio Tavares
authors.initials: PS
authors.lastname: Veras
mesh_terms: D000818:Animals; D000913:Antibodies, Protozoan / Q000097:blood; D000953:Antigens, Protozoan / Q000276:immunology* / Q000378:metabolism; D002846:Chromatography, Affinity / Q000379:methods / Q000662:veterinary*; D004283:Dog Diseases / Q000097:blood / Q000175:diagnosis / Q000469:parasitology*; D004285:Dogs; D018314:Leishmania infantum / Q000502:physiology*; D007898:Leishmaniasis, Visceral / Q000097:blood / Q000175:diagnosis / Q000662:veterinary*; D011994:Recombinant Proteins; D012680:Sensitivity and Specificity
chemical_list: D000913:Antibodies, Protozoan; D000953:Antigens, Protozoan; D011994:Recombinant Proteins