Diagnosis

(1) The diagnostic tests referred to under subsection (1) may include immunological and bacteriological tests or any other tests as may be authorized by the Authority. (2) The diagnostic tests referred to under subsection (1) may include immunological and bacteriological tests or any other tests as many be authorised by the Authority. (3) The following immunological tests established by the Authority shall be conducted by an official or accredited veterinarian for smooth species. (a) the card test, (b) the rivanol, (c) the ELISA test, (d) the complement fixation, (e) the milk ring test, (4) the immunological tests referred to under subregulation (3) shall be conducted as follows (a) the card test and the milk ring test shall be carried out by an official or accredited veterinarian or at an approved laboratory in a accordance with subregulation (5) below, (b) the rivanol test, complement fixation and double immunodiffusion, shall be carried out at an approved laboratory. (5) An accredited veterinarian performing immunological tests under this Regulation shall conduct the card test in the field while an approved laboratory shall perform proficiency tests and are required to have the minimum infrastructure necessary that 630 guarantees the accuracy of the test and it shall record all tests and reagents used. (6) All laboratory results required under this Regulation shall be issued by the official veterinarian or accredited veterinarian on all brucellosis diagnostics conducted. (7) Laboratories shall store serum samples for a period of 3 months after testing in freezers that comply with requirement established by Authority. (8) An accredited veterinarian conducting testing under Regulation shall inform the Authority on all diagnostic activities specifying the reagents and the test performed, including laboratory used, lot number and expiry date product used. (9) Where a card test is conducted under this Regulation it shall be conducted– (a) with non-haemolysed serum, (b) with an antigen authorized by the Authority that fulfils the following characteristics– (i) elaborated with strain 1 1 1 9-3 of Brucella abortu, (ii) strained with rose Bengal in lactic acid, (iii) pH of 3.65 (± 0.05), (iv) with cellular concentration of 8% for cattle and (10) The results of a card test conducted under this Regulation shall be interpreted as are either positive of negative, depending on the presence or absence of agglutination. (11) The rivanol test conducted under this Regulation shall be performed only on bovine serum (a) with non-haemolysed serum, positive to the card test, (b) with an antigen authorized by the Authority and with rivanol reagent (2 etoxi lactate 6,9 diamino acridine), (c) with an antigen elaborated with strain 1 1 1 9- 3 of Brucella abortus shall comply with the following characteristics (i) strained with a mixture of fluorescent green and violet crystal, (ii) pH of 5.8 to 6.2, (iii) cellular concentration of 4%. (12) (a) The result of a rivanol test conducted under this Regulation shall be interpreted as either positive or negative sera where positive are the sera of animals that present a reaction of complete agglutination in whichever of the following dilutions, from 1/25 to 1/400. In the case of a vaccinated animal a complete agglutination of a dilution greater or equal to 1/50 will be a positive test. (12) (b) The ELISA test may be used in addition or in place of Rivanol Testing as described in 12(a). (13) (a) A complement fixation test conducted under this Regulation shall be conducted with a non-haemolysed serum that has tested positive to the card and rivanol tests. An antigen authorized by the Authority to be used for this test, shall be prepared with the strain 1119-3 of Brucella abortus, without straining but in conformance with the following specifications632 (a) pH 6.8 to 7.0, (b) cellular concentration of 4.5%. (13) (b) For the purpose of this Regulation, sera shall be classified as positives or negative where positives are titres greater than 1/16 (cool) or greater than 1/8 (warm). (14) (a) The milk ring test conducted under this Regulation shall be conducted as a surveillance test and results are to be confirmed with serological tests. This test shall be performed on fresh milk, fluids, with antigen authorized by the Authority and the test shall fulfill the following characteristics (i) strained with haematoxylin, (ii) pH between 4.0 and 4.3, (iii) cellular concentration of 4%. (14) (b) For bovines, the results of the milk ring test shall be interpreted as negative in the absence of a strained ring or positive if present on the surface (15) The bacteriological study required to be conducted under this Regulation shall be performed on milk, blood, body fluids or tissue fragments placed in sterile containers with hermetic lid for submission to an approved laboratory for diagnosis. The presence of Brucella specie signifies a positive animal, even if serological testing methods indicate absence of antibodies. (16) Animals in which bovine brucellosis has been diagnosed shall trigger an epidemiological investigation, where the sampling of all adjacent farms including animals that have come in contact with positive animals shall be conducted. (17) Further to testing under subregulation (16) above, animals exposed to bovine brucellosis shall remain in the farms where found unless a veterinary certificate is issued by the Authority for movement directly to a slaughterhouse or to a