Brucellosis Specifications for validation of ELISA kits (i-ELISA and c-ELISA)
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).
Bovine Brucellosis Control of indirect ELISA kits (Individual & pooled serum samples)
The present document describes a standard technique aiming at controlling the fulfilment of OIE and EU requirements regarding the standardisation of indirect enzyme-linked immunosorbent assays (iELISA) kits for the detection of antibodies specific to smooth Brucella species (especially B. abortus, B. melitensis and B. suis) in bovine individual sera or pools of sera.
Animal Brucellosis Control of Rose Bengal, Complement Fixation and Milk Ring-test antigens
The present document describes a standard technique aiming at controlling the fulfilment of OIE and EU requirements regarding the standardisation of diagnostic antigens for the detection of antibodies specific of smooth Brucella species (especially B. abortus, B. melitensis and B. suis):
- in animal individual sera by the Rose Bengal Test (RBT) and the Complement Fixation Test (CFT);
- in bovine pooled milk samples by the Milk Ring-Test (MRT).
Ovine contagious Epididymitis (Brucella ovis) Complement Fixation Test
The present document describes a standard technique aiming at detecting antibodies specific of Brucella ovis by the complement fixation test in ovine sera.