Validación de la prueba de ELISA indirecto como herramienta de diagnóstico para el programa nacional de brucelosis bovina en el Ecuador

Abstract

Bovine brucellosis is one of the major zoonotic diseases in the world caused by the bacterium Brucella abortus. This disease has caused damage to public health and great economic losses. In the present work, an indirect Elisa test was validated as a diagnostic tool for the National Bovine Brucellosis Program in Ecuador. Using as international reference material 1 positive serum and 1 negative serum from IDvet and as national reference material 30 negative sera from livestock breeding sites free of brucellosis, certified by AGROCALIDAD and 11 positive sera to brucellosis certified by the International Center for Zoonoses (CIZ). Data from the ELISA test were analyzed according to the OIE Manual and ISO / IEC 17025: 2005. The specificity and diagnostic sensitivity of the test were 100 percent at a cutoff point of 121.13 (M / P percent) corroborated by the analysis of receiver operating characteristics (ROC) at the dilution 1/32 last dilution in the which showed positivity. The ELISA test proved to be specific for B. abortus. Both positive and negative predictive values were 100 percent. A 100 percent accuracy (repeatability and reproducibility) was estimated, an accuracy of 97 percent with a Kappa index of 0.927, no trawl contamination, and test uncertainty was 4.8 percent. The results demonstrated that the indirect ELISA test is highly sensitive and specific and can be used as a tool for the diagnosis of bovine brucellosis in Ecuador.