Division (b) BSE monitoringF1

Samples from bovine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part I shall be examined by a rapid test.

When the result of the rapid test is inconclusive or positive, the sample shall immediately be subjected to confirmatory examinations using at least one of the following methods and protocols laid down in the latest edition of the Manual:

1. (i)

   the immunohistochemical (IHC) method;

2. (ii)

   Western blot;

3. (iii)

   the demonstration of characteristic fibrils by electron microscopy;

4. (iv)

   histopathological examination;

5. (v)

   the combination of rapid tests as laid down in the fourth subparagraph.

Where the histopathological examination is inconclusive or negative, the tissues shall be submitted to a further examination by one of the other confirmatory methods and protocols.

Rapid tests may be used for both primary screening and, if inconclusive or positive, for subsequent confirmation, F2... by using a second rapid test, and provided that ’ :

1. (i)

   the confirmation is carried out in a national reference laboratory for TSEs; and

2. (ii)

   one of the two rapid tests is a Western blot; and

3. (iii)

   the second rapid test used:

   • includes a negative tissue control and a bovine BSE sample as positive tissue control,

   • is of a different type than the test used for the primary screening; and

4. (iv)

   if a rapid Western blot is used as the first test, the result of that test must be documented and the blot image submitted to the national reference laboratory for TSEs; and

5. (v)

   where the result of the primary screening is not confirmed by the subsequent rapid test, the sample must be subjected to an examination by one of the other confirmatory methods; where the histopathological examination is used for that purpose, but proves to be inconclusive or negative, the tissues must be submitted to a further examination by one of the other confirmatory methods and protocols.

An animal shall be regarded a positive BSE case if the result of the rapid test is inconclusive or positive, and at least one of the confirmatory examinations referred to in points (i) to (v) of the second subparagraph is positive.