Brucellosis EURL Specifications for validation of antigen for Rose Bengal Test
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).
Brucellosis EURL Specifications for the initial validation of antigen for complement fixation test (CFT)
The present document describes the requirements for validation (fitness for purpose) of antigen for complement fixation test (CFT) 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 method (3. Criteria for Complement Fixation Antigen validation). The dossier will be reviewed by the NRL and a report will be returned to the manufacturer.
Brucellin skin test
The Brucellin Skin Test (BST) is a cell-mediated immune assay which is based on the use of purified and standardised protein allergen, almost completely devoid of lipopolysaccharide. The BST relies on the delayed-type hypersensitivity reaction whose results are interpreted 48 and 72 hours post brucellin injection in small Ruminants and Cattle respectively.
Therefore an animal is restrained twice: to administer brucellin, and to read the result.
Control of iELISA kits for the detection of antibodies specific to smooth Brucella species (especially B. abortus, B. melitensis and B. suis) in bovine tank milk.
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 tank milk.