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Multicentre evaluation of a direct agglutination test prototype kit (DAT-LPC) for diagnosis of visceral leishmaniasis

Published online by Cambridge University Press:  24 July 2017

E. OLIVEIRA ,
D. OLIVEIRA ,
F. A. CARDOSO ,
J. R. BARBOSA ,
A. P. MARCELINO ,
T. DUTRA ,
T. ARAUJO ,
L. FERNANDES ,
D. DUQUE  and
A. RABELLO
E. OLIVEIRA*
Affiliation:
Clinical Research and Public Politics in Infectious and Parasitic Diseases of the Centro de Pesquisas René Rachou-Oswaldo Cruz Foudation, Av. Augusto de Lima, 1715, Barro Preto, 30190.002, Belo Horizonte, Minas Gerais, Brazil
D. OLIVEIRA
Affiliation:
Clinical Research and Public Politics in Infectious and Parasitic Diseases of the Centro de Pesquisas René Rachou-Oswaldo Cruz Foudation, Av. Augusto de Lima, 1715, Barro Preto, 30190.002, Belo Horizonte, Minas Gerais, Brazil
F. A. CARDOSO
Affiliation:
Parasitic Diseases Service of the Ezequiel Dias Foundation, Rua Conde Pereira Carneiro, 80, Gameleira, 30510-010, Belo Horizonte, Minas Gerais, Brazil
J. R. BARBOSA
Affiliation:
Parasitic Diseases Service of the Ezequiel Dias Foundation, Rua Conde Pereira Carneiro, 80, Gameleira, 30510-010, Belo Horizonte, Minas Gerais, Brazil
A. P. MARCELINO
Affiliation:
Parasitic Diseases Service of the Ezequiel Dias Foundation, Rua Conde Pereira Carneiro, 80, Gameleira, 30510-010, Belo Horizonte, Minas Gerais, Brazil
T. DUTRA
Affiliation:
Laboratory of the Eduardo de Menezes Hospital/Fundação Hospitalar do Estado de Minas Gerais, Rua Dr Cristiano Rezende, 2213, Bonsucesso, 30622-020, Belo Horizonte – MG 30622-020, Brazil
T. ARAUJO
Affiliation:
Laboratory of the Eduardo de Menezes Hospital/Fundação Hospitalar do Estado de Minas Gerais, Rua Dr Cristiano Rezende, 2213, Bonsucesso, 30622-020, Belo Horizonte – MG 30622-020, Brazil
L. FERNANDES
Affiliation:
Municipal Laboratory of Ribeirão das Neves, Rua Pedro Pereira, 101, São Pedro 33880-000, Ribeirão das Neves, Minas Gerais, Brazil
D. DUQUE
Affiliation:
Municipal Laboratory of Ribeirão das Neves, Rua Pedro Pereira, 101, São Pedro 33880-000, Ribeirão das Neves, Minas Gerais, Brazil
A. RABELLO
Affiliation:
Clinical Research and Public Politics in Infectious and Parasitic Diseases of the Centro de Pesquisas René Rachou-Oswaldo Cruz Foudation, Av. Augusto de Lima, 1715, Barro Preto, 30190.002, Belo Horizonte, Minas Gerais, Brazil
*
*Correspondent author: Clinical Research and Public Politics in Infectious and Parasitic Diseases of the Centro de Pesquisas René Rachou-Oswaldo Cruz Foudation, Av. Augusto de Lima, 1715, Barro Preto, 30190.002, Belo Horizonte, Minas Gerais, Brazil. E-mail: edwardjo@cpqrr.fiocruz.br
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Summary

In this study, we assessed the sensitivity, specificity, and diagnostic accuracy of a previously developed direct agglutination test (DAT) using a freeze-dried antigen derived from Leishmania infantum promastigotes and composed in a prototype kit for visceral leishmaniasis (VL) diagnosis, named DAT-LPC. To evaluate DAT-LPC reproducibility, the kit was used to analyse 207 serum samples from VL patients and 80 serum samples from patients with other parasitic infections or healthy subjects in four laboratories from different public health institutions in Brazil. DAT-LPC showed sensitivity between 96·2 and 99·5% (P = 0·14), specificity ranging from 96·2 to 97·5% (P = 0·95), and diagnostic accuracy ranging from 96·5 to 99% (P = 0·34). The inter-laboratory reproducibility of qualitative results was classified as excellent (κ index: 0·94–0·97). The reproducibility of the end-titre results in relation to the reference laboratory, ranged from 31 to 85%. These results demonstrate an excellent performance of the DAT-LPC, and validate it for the diagnosis of VL that could replace the immunofluorescent antibody test as the routine diagnostic test in the Brazilian public health system.

Keywords

Visceral leishmaniasisSerological diagnosisPrototype kitDAT-LPC
Type
Research Article
Information
Parasitology , Volume 144 , Issue 14 , December 2017 , pp. 1964 - 1970
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Copyright
Copyright © Cambridge University Press 2017 

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