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Performance of a rapid diagnostic test for the detection of visceral leishmaniasis in a large urban setting.
Rev Soc Bras Med Trop; 46(5): 589-93, 2013 Sep-Oct.
Artigo em Inglês | MEDLINE | ID: mdl-24270249


Rapid diagnostic tests (RDTs) may improve the early detection of visceral leishmaniasis (VL), but their real-world performance requires additional study. Therefore, we evaluated the performance of an rK39-based RDT (Kalazar Detect™) for the detection of VL in an endemic, large urban area.


Data were collected from a registry of rK39 RDT performed at 11 emergency care units in Belo Horizonte, Brazil, and from a national database of reportable communicable diseases of the Sistema de Informação de Agravos de Notificação (SINAN).


The rapid rK39 test was performed in 476 patients, with 114 (23.9%) positive results. The analysis of rK39 RDT performance was based on 381 (80%) cases reported to the SINAN database, of which 145 (38.1%) were confirmed cases. Estimates for sensitivity and specificity were 72.4% (95% CI: 64.6-79%) and 99.6% (95%CI: 97.6-99.9%), respectively. Positive and negative predictive values were estimated at 99.1% (95%CI: 94.9-99.8%) and 85.5% (95%CI: 80.8-89.1%), respectively. In addition, close agreement between the rK39 RDT and indirect immunofluorescence was observed.


In summary, the rK39 RDT showed a high specificity but only moderate sensitivity. In endemic areas for VL, treatment may be considered in cases with clinical manifestations and a positive rK39 RDT, but those with a negative test should be subjected to further investigation.





Texto completo: Disponível Coleções: Bases de dados internacionais Base de dados: MEDLINE Assunto principal: Kit de Reagentes para Diagnóstico / Leishmania donovani / Anticorpos Antiprotozoários / Proteínas de Protozoários / Leishmaniose Visceral / Antígenos de Protozoários Tipo de estudo: Evaluation_studies Aspecto clínico: Diagnóstico / Predição / Prognóstico Limite: Adolescente / Adulto / Idoso / Criança / Criança, pré-escolar / Feminino / Humanos / Lactente / Masculino / Meia-Idade País/Região como assunto: América do Sul / Brasil Idioma: Inglês Revista: Rev Soc Bras Med Trop Ano de publicação: 2013 Tipo de documento: Artigo