Sensitivity of acidified tamponed antigens in quality control test validation methodologies

Abstract

Brucellosis is responsible for great economic losses and because it is a zoonotic, chronic, infectious, contagious disease, there is a great interest in its eradication in the cattle rearing in Brazil. One of the most effective measures to combat it is the vaccination of the animals and the diagnosis of positive animals, which contributes to the sanitation of the rearing. For this, it is necessary to use a practical, accessible, rapid and sensitive diagnostic methodology. The objective of this study was to evaluate the uncertainty of the test of relative activity (sensitivity) for acidified tamponed antigen (ATA). This antigen is used for the diagnosis of Brucellosis caused by smooth strains of Brucella ssp. Thus, we verified the efficacy of some parameters such as selectivity, precision (limit of detection and intermediate accuracy) and reproducibility. In the analyzes performed in the tests, the performances of standard antigens were considered. It was verified that the acidified tamponed antigen quality control method showed adequate selectivity, limit of detection, intermediate accuracy, repeatability and reproducibility in the verification of sensitivity tests for brucellosis antigens in the LFDA-MG. No difference was verified in the results of the various replicates. The ATA test, using a stable and sensitive antigen that shows high agreement with the confirmatory test, has a high potential to contribute to the identification of positive animals and sanitation of the herd, as well as to reduce the frequency of brucellosis and its subsequent eradication of the bovine herd.