The present document describes the requirements for validation (fitness for purpose) of antigen for Rose Bengal test (RBT) in brucellosis diagnostic.

The standardisation and validation are critical steps when a method is intended for routine diagnostic use in multiple laboratories. Therefore, customers can have confidence in the results produced by the test. All diagnostic assays should be validated for the species which they will be used for, according to the new OIE and EU principles and methods.

To validate a method, the manufacturer must submit a file to the National Reference Laboratory for Brucellosis (NRL) including a descriptive administrative part of the reagent(s) and a technical part. The evaluation criteria are described in the downloadable document (3. Criteria for Rose Bengal Antigen validation). The dossier will be reviewed by the NRL and a report will be returned to the manufacturer (Annex A).