Evaluation of the rapid test ALERE® leishmaniasis AC test in the diagnosis of canine visceral leishmaniasis

• Grant number: 18/07529-0
• Support type: Scholarships in Brazil - Scientific Initiation
• Effective date (Start): June 01, 2018
• Effective date (End): November 30, 2019
• Field of knowledge: Agronomical Sciences - Veterinary Medicine - Animal Clinics and Surgery
• Principal researcher: Wagner Luis Ferreira
• Grantee: Laryssa Taibo Conde Martinez Cardoso
• Home Institution: Faculdade de Medicina Veterinária (FMVA). Universidade Estadual Paulista (UNESP). Campus de Araçatuba. Araçatuba , SP, Brazil

Abstract

Visceral leishmaniasis is a zoonosis caused in Brazil by Leishmania infantum, and in the country, from 2012 to 2016, 16,233 cases of the disease were reported, with 1223 deaths. The dog acts as the main domestic reservoir of the parasite. It is estimated that the number of dogs infected in Brazil is in the order of millions, and there is an association between the occurrence of infection in dogs and the risk of the occurrence of the disease in humans. Identifying infected dogs is a challenge. The importance of the diagnosis of canine visceral leishmaniasis in Brazil lies in the fact that, among the control strategies of the disease is the elimination of the serologically positive dogs. Currently the methods used for the diagnosis are a rapid double-immunochromatographic test (TR DPP® LVC, Bio-Manguinhos, Fiocruz, Rio de Janeiro, Brazil), which has as antigen a recombinant protein (rk28) of L. infantum, as screening test, and an ELSIA, as a confirmatory test. The ease of using a commercial rapid diagnostic test, whether immunochromatographic or ELISA, have led many private clinicians to utilize these as the only diagnostic method. Among the rapid diagnostic kits commercially available in Brazil, the Alere® Leishmaniose Ac Test Kit (Alere S.A.) is routinely used by veterinary clinicians. However, the results of the literature are controversial regarding the sensitivity and specificity of the test, and the agreement with the results obtained when using DPP®. Due to the scarce literature regarding the evaluation of the use of the Alere® kit in the diagnosis of canine visceral leishmaniasis, the importance of a correct diagnosis of the disease and the disagreement between the two studies published so far, the present study aims to evaluate the sensitivity and specificity of the Alere® rapid test for the diagnosis of the disease, and to determine if there is an agreement between the results obtained through this test with that officially used by the Brazilian Ministry of Health (DPP®).