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Article History

Received: 20 June 2019

Accepted: 6 February 2020

First Online: 11 February 2020

Ethics approval and consent to participate

: The results of the field study reported in the manuscript were obtained by analyzing bovine sera that had been already screened by the IZS. According to the national Regulations O.M. 28/5/2015 and O.M. 11/5/2018, the IZS PB (Istituto Zooprofilattico di Puglia e Basilicata) is the Center responsible for collecting sera (from all farms located in Apulia and Basilicata) in order to perform the two official assays within the national brucellosis control plans. According to the above Regulations, the ethics approval was waived and the consent to participate and the permission to collect specimens are (not only) unnecessary but the owners must provide to the IZS all the samples required for the subsequent official, mandatory, screening. Once the sera have been collected and screened by the IZS PB, they are available for any additional research aimed at improving the specificity of brucellosis diagnosis (provided that the studies are conducted in collaboration with the IZS PB and are funded by the Ministry of Health). Indeed, the present study was funded by the Ministry of Health, was performed in collaboration with the IZS PB, all sera were employed to test a potential, new, ancillary diagnostic assay and, therefore, met all requirements predicted by the national laws and regulations.

: Not applicable.

: The authors declare that they have no competing interests.