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PERFORMANCE OF RECOMBINANT K39 ANTIGEN IN THE DIAGNOSIS OF BRAZILIAN VISCERAL LEISHMANIASIS

This study evaluated the performance of recombinant K39 (rK39) antigen in a immunochromatographic format (strip test) and a crude antigen enzyme-linked immunosorbent assay in the diagnosis of Brazilian visceral leishmaniasis (VL) in 128 consecutive patients with parasitologically proven infections (by microscopy and/or culture). For each patient, a medical history was obtained and a complete physical examination was performed. Controls included 10 healthy volunteers and 50 patients with other diseases: malaria (10), leprosy (9), Chagas’ disease (10), tuberculosis (10), and cutaneous leishmaniasis (11). The sensitivities of the rK39 antigen strip test and the ELISA were 90% and 89%, respectively, while the specificities were 100% and 98%, respectively. Our study confirms the accuracy of the rK39 antigen strip test in the diagnosis of VL in a high prevalence population.

Received August 7, 2002. Accepted for publication December 9, 2002.

Acknowledgments: We thank Dr. Syamal Raychaudhuri (InBios International, Seattle, WA) for providing the Kalazar Detect^® test, and Dr. Rodrigo Ribeiro Rodrigues and Dr. Moisés Palaci for providing serum samples from patients with tuberculosis and Chagas’ disease.

Financial support: This study was supported by Conselho Nacional de Desenvolvimento Científico e Tecnológico – CNPq.

Authors’ addresses: Sílvio F. Guimarães Carvalho, Universidade Estadual de Montes Claros, Montes Claros, Minas Gerais, Brazil. Elenice Moreira Lemos and Reynaldo Dietze, Núcleo de Doenças Infecciosas, Centro Biomédico, Universidade Federal do Espírito Santo Av. Marechal Campos 1468, Maruípe Vitória, Espírito Santo, Brazil CEP 29040-091, Telephone: 55-27-3335-2704, Fax: 55-27-3335-7206, E-mail: rdietze{at}ndi.ufes.br. Ralph Corey, Department of Medicine, Duke University Medical Center, Durham, NC 27710.

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