Commission Decision
of 4 July 2000
establishing diagnostic procedures, sampling methods and criteria for the evaluation of the results of laboratory tests for the confirmation and differential diagnosis of swine vesicular disease
(notified under document number C(2000) 1805)
(Text with EEA relevance)
(2000/428/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease(1), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Annex II, paragraph 3 thereof,
Whereas:
(1) It is necessary to lay down at Community level diagnostic procedures, sampling methods and criteria for the evaluation of the results of laboratory tests for the confirmation of swine vesicular disease and a rapid differentiation from foot-and-mouth disease, in order that an improved control of both diseases can be ensured.
(2) Annex III of Council Directive 92/119/EEC lays down the functions and duties of the Community reference laboratory for swine vesicular disease in order to coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing the disease; these functions and duties include the organisation of periodic comparative tests and the supplying of standard reagents at Community level.
(3) Laboratory tests have been recently developed to ensure that swine vesicular disease is quickly diagnosed and distinguished from foot-and-mouth disease.
(4) The results of the most recent comparative tests performed at Community level suggest, in particular, that reliable tests have been developed to detect the antigen or the genome of swine vesicular disease virus and that these tests can successfully supplement the virus isolation test for the virological diagnosis of swine vesicular disease.
(5) The experiences gained in the control of swine vesicular disease in recent years have resulted in the identification of the most suitable sampling procedures and criteria for evaluation of the results of the laboratory tests for a proper diagnosis of this disease in different situations.
(6) The opinion and recommendations of the Scientific Committee on animal health and welfare on swine vesicular disease have been taken into account.
(7) The measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,
HAS ADOPTED THIS DECISION:
Article 1
1. Member States shall ensure that the confirmation of swine vesicular disease and the differential diagnosis with foot-and-mouth disease are based on:
(a) the detection of clinical signs of disease;
(b) the detection of virus, antigen or genome in samples of epithelium tissue, vesicular fluid or faeces;
(c) the demonstration of a specific antibody response in serum samples,
in accordance with the procedures, sampling methods and criteria for evaluation of the results of laboratory tests laid down in the Manual annexed to this Decision.
2. However, the national diagnostic laboratories referred to in Annex II(5) to Directive 92/119/EEC may apply modifications to the laboratory tests referred to in the Manual annexed to this Decision or use different tests, provided that an equal sensitivity and specificity can be demonstrated.
The sensitivity and specificity of these modified or different tests must be evaluated in the framework of the periodic comparative tests organised by the Community Reference Laboratory for swine vesicular disease.
Article 2
This Decision shall apply from 1 October 2000.
Article 3
This Decision is addressed to the Member States.
Done at Brussels, 4 July 2000.