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The technique used and the interpretation of results must have been validated in accordance with the principles laid down in Chapter 1.1.3 of the OIE Manual of Standards for Diagnostic Tests and Vaccines, Fourth Edition, 2000, and should at least include laboratory and diagnostic studies.
a 1/150 pre-dilution (1) of the OIEISS or a 1/2 pre-dilution of the OIEELISA WP SS or a 1/16 pre-dilution of the OIEELISA SP SS made up in a negative serum (or in a negative pool of sera) should give a positive reaction;
a 1/600 pre-dilution of the OIEISS or a 1/8 pre-dilution of the OIEELISA WP SS or a 1/64 pre-dilution of the OIEELISA SP SS made up in a negative serum (or in a negative pool of sera) should give a negative reaction;
the OIEELISA N SS should always give a negative reaction.
a 1/150 pre-dilution of the OIEISS or a 1/2 pre-dilution of the OIEELISA WP SS or a 1/16 pre-dilution of the OIEELISA SP SS made up in a negative serum (or in a negative pool of sera) and again diluted in negative sera by the number of samples making up the pool should give a positive reaction;
the OIEELISA N SS should always give a negative reaction;
the test must be adequate to detect evidence of infection in a single animal of the group of animals, of which samples of serum have been pooled.
a 1/1000 pre-dilution of the OIEISS or a 1/16 pre-dilution of the OIEELISA WP SS or a 1/125 pre-dilution of the OIEELISA SP SS made up in a negative serum (or in a negative pool of sera) and again diluted 1/10 in negative milk should give a positive reaction;
the OIEELISA N SS diluted 1/10 in negative milk should always give a negative reaction;
the test must be adequate to detect evidence of infection in a single animal of the group of animals, of which samples of milk or whey have been pooled.
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