Validation of a Recombinant Based Antibody ELISA for Diagnosis of Human and Canine Leishmaniasis

• Published in: Journal of immunoassay & immunochemistry Vol. 29; no. 3; pp. 244 - 256
• Main Authors: Daprà, Franco, Scalone, Aldo, Mignone, Walter, Ferroglio, Ezio, Mannelli, Alessandro, Biglino, Alberto, Zanatta, Renato, Gradoni, Luigi, Rosati, Sergio
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis Group 01-01-2008
• Subjects: Animals; Antibodies, Protozoan - blood; Antigens, Protozoan - immunology; Canine sera; Chimeric antigen; Dog Diseases - diagnosis; Dog Diseases - immunology; Dogs; ELISA; Enzyme-Linked Immunosorbent Assay - methods; Human sera; Humans; IFAT; Leishmania - immunology; Leishmaniasis; Leishmaniasis - diagnosis; Leishmaniasis - immunology; Leishmaniasis - veterinary; Recombinant Fusion Proteins - immunology; Sensitivity and Specificity
• ISSN: 1532-1819; 1532-4230
• DOI: 10.1080/15321810802116006

In this study, a recombinant chimeric antigen (CA) ELISA was validated as a single test for both human and dog leishmaniasis. Serum panels included 327 human and 339 canine IFAT-positive and 1113 human and 1078 canine IFAT-negative samples. CA-ELISA was carried out using the same serum dilution, and labelled protein A as secondary reagent. Test performances were calculated using ROC analysis. For the human panel, the test showed diagnostic accuracy (DA) 0.974, specificity (Sp) 97.12%, sensitivity (Se) 91.44%, and concordance (K) 0.88. The dog panel showed DA 0.998, Sp 99.54%, Se 98.54%, and K 0.98. The proposed method is the best recombinant antigen-based ELISA, and can be used as IFAT substitute for mass screening.