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Abstract
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.
ACKNOWLEDGMENTS
The authors are grateful to Associazione Volontari Italiana Sangue section of Torino (AVIS: Italian Association of Volunteer Blood Donors) that provided contribution to collect large panel of human sera from healthy blood donors.
This work was supported by Regione Piemonte, Ricerca Scientifica Applicata 2003.
Notes
Source: TP: true positive, positive response vs both IFAT and ELISA. FN: false negative, positive to IFAT and negative to ELISA. TN: true negative, negative response vs both IFAT and ELISA. FP: false positive, negative to IFAT and positive to ELISA. PV + : positive predictive value calculated as VP + = TP/(TP + FP). PV − : negative predictive value calculated as VP − = TN/(FN + TN). Ef test efficiency calculated as Ef = P · Se + (1 − P) Sp, where P is the Prevalence of disease in target population.