The present document describes the requirements for validation (fitness for purpose) of ELISA kits for brucellosis diagnostic. The fulfilment of the OIE and EU requirements regarding the validation of indirect and competitive enzyme-linked immunosorbent assays (I-ELISA and C-ELISA) kits for the detection of antibodies specific to smooth Brucella species (especially B. abortus, B. melitensis and B. suis) in sera/milk samples from various animal species. 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. For validation, 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 document (3. Criteria for ELISA kits validation).