Division 2 Standardisation and sensitivity of testF1F2

The sensitivity of the ELISA shall be of such a level that the E05 serum is scored positive when diluted 10 times (serum samples) or 250 times (milk samples) more than the dilution obtained of individual samples when these are included in pools. In assays where samples (serum and milk) are tested individually, the E05 serum diluted 1 to 10 (in negative serum) or 1 to 250 (in negative milk) shall be scored positive when tested in the same assay dilution as used for the individual test samples. The institutes referred to in point 2 of Section A shall be responsible for checking the quality of the ELISA, and in particular for determining, for each production batch, the number of samples to be pooled on the basis of the count obtained for the E05 serum.