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2002/106/EC: Commission Decision of 1 February 2002 approving a Diagnostic Manual establishing diagnostic procedures, sampling methods and criteria for evaluation of the laboratory tests for the confirmation of classical swine fever (Text with EEA relevance) (notified under document number C(2002) 381)

EU Decision 2002/106 · Adopted 1 February 2002 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

Commission Decision

of 1 February 2002

approving a Diagnostic Manual establishing diagnostic procedures, sampling methods and criteria for evaluation of the laboratory tests for the confirmation of classical swine fever

(notified under document number C(2002) 381)

(Text with EEA relevance)

(2002/106/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine feverf1, and in particular Article 17(3) and Article 29(1) 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 classical swine fever.

(2)

Annex IV to Directive 2001/89/EC lays down the functions and duties of the Community Reference Laboratory for classical swine fever 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)

Classical swine fever virus is not considered to be a hazard for human health.

(4)

Laboratory tests have been recently developed to ensure a quick diagnosis of classical swine fever.

(5)

The experience gained in the control of classical swine fever in recent years has 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 measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,

HAS ADOPTED THIS DECISION:

Annotations to the whole text

Footnotes

f1

OJ L 316, 1.12.2001, p. 5.

Contents

  1. 1Article 1
  2. 2Article 2
  3. 3Article 3
  4. 4Article 4 Repealed
  5. Signature
  6. Annex: CLASSICAL SWINE FEVER DIAGNOSTIC MANUAL
  7. Chapter I: Introduction, objectives and definitions
  8. 1Division 1
  9. (a)Division (a)
  10. (b)Division (b)
  11. (c)Division (c)
  12. 2Division 2
  13. 3Division 3
  14. (a)Division (a)
  15. (b)Division (b)
  16. (c)Division (c)
  17. (d)Division (d)
  18. 4Division 4
  19. Chapter II: Description of classical swine fever with emphasis on differential diagnosis
  20. Introduction
  21. 1Division 1
  22. 2Division 2
  23. 3Division 3
  24. 4Division 4
  25. 5Division 5
  26. 6Division 6
  27. Acute form
  28. 1Division 1
  29. 2Division 2
  30. 3Division 3
  31. 4Division 4
  32. 5Division 5
  33. Chronic form
  34. 1Division 1
  35. 2Division 2
  36. 3Division 3
  37. Prenatal form and late onset of disease
  38. 1Division 1
  39. 2Division 2
  40. IIIGuidelines on main criteria to be considered for the recognition of a holding as a classical swine fever suspected holding
  41. Chapter IV: Checking and sampling procedures
  42. Guidelines and procedures for clinical examination and sampling on pigs in suspected holdings
  43. 1Division 1
  44. 2Division 2
  45. 3Division 3
  46. 4Division 4
  47. 5Division 5
  48. 6Division 6
  49. 7Division 7
  50. Sampling procedures in a holding when pigs are killed following confirmation of disease
  51. 1Division 1
  52. 2Division 2
  53. 3Division 3
  54. Sampling procedures when pigs are killed as a preventive measure on a suspected holding
  55. 1Division 1
  56. 2Division 2
  57. Checking and sampling procedures before authorisation is given to move pigs from holdings located in protection or surveillance zones and in case these pigs are slaughtered or killed
  58. 1Division 1
  59. 2Division 2
  60. 3Division 3
  61. 4Division 4
  62. 5Division 5
  63. Checking and sampling procedures in a holding in relation to re-population
  64. 1Division 1
  65. 2Division 2
  66. Sampling procedures in holdings in the protection zone before lifting restrictions
  67. 1Division 1
  68. 2Division 2
  69. Sampling procedures in holdings in the surveillance zone before lifting restrictions
  70. 1Division 1
  71. 2Division 2
  72. Serological monitoring and sampling procedures in areas where classical swine fever is suspected to occur or has been confirmed in feral pigs
  73. 1Division 1
  74. 2Division 2
  75. 3Division 3
  76. 4Division 4
  77. 5Division 5
  78. Chapter V: General procedures and criteria for collection and transport of samples
  79. General procedures and criteria
  80. 1Division 1
  81. 2Division 2
  82. 3Division 3
  83. 4Division 4
  84. Collection of samples for virological tests
  85. 1Division 1
  86. 2Division 2
  87. 3Division 3
  88. Transport of samples
  89. 1Division 1
  90. 2Division 2
  91. 3Division 3
  92. 4Division 4
  93. Chapter VI: Principles and use of virological tests and evaluation of their results
  94. Detection of virus antigen
  95. 1Fluorescent antibody test (FAT)
  96. 2ELISA for antigen detection
  97. Virus isolation
  98. 1Division 1
  99. 2Division 2
  100. 3Division 3
  101. 4Division 4
  102. 5Division 5
  103. Detection of virus genome
  104. 1Division 1
  105. 2Division 2
  106. 3Division 3
  107. 4Division 4
  108. Evaluation of the results of virological tests
  109. 1Division 1
  110. 2Division 2
  111. Genetic typing of classical swine fever virus isolates
  112. 1Division 1
  113. 2Division 2
  114. Chapter VII: Principles and use of serological tests and evaluation of their results
  115. Basic principles and diagnostic value
  116. 1Division 1
  117. 2Division 2
  118. Recommended serological tests
  119. 1Division 1
  120. 2Division 2
  121. 3Division 3
  122. 4Division 4
  123. 5Division 5
  124. 6Division 6
  125. 7Division 7
  126. Interpretation of serological results and differential diagnosis with infections due to ruminant pestiviruses (BVDV and BDV)
  127. 1Division 1
  128. 2Division 2
  129. 3Division 3
  130. 4Division 4
  131. 5Division 5
  132. Chapter VIII: Discriminatory tests in case of emergency vaccination
  133. Basic principles
  134. 1Division 1
  135. 2Division 2
  136. BGuidelines for the use of the discriminatory test in the context of an emergency vaccination with a marker vaccine in pig holdings in the framework of Article 19 of Directive 2001/89/EC
  137. IXMinimum safety requirements for classical swine fever laboratories
  138. The minimum requirements laid down in Table 1 must be fulfilled in any laboratory where classical swine fever virus is to be manipulated, even if only in a small amount, as required by the virus isolation and neutralisation tests. However, post-mortem examinations, processing of tissues for FAT and serology using inactivated antigen, may be carried out at a lower containment level provided that basic hygiene and post-operational disinfection with safe disposal of tissues and sera apply.
  139. The additional requirements laid down in Table 1 must be fulfilled by any laboratory where procedures involving extensive multiplication of virus are carried out.
  140. The requirements laid down in Table 2 must be fulfilled by any laboratory where animal experiments with classical swine fever virus are carried out.
  141. In any case, all stocks of classical swine fever virus must be kept in secure storage, whether deep-frozen or freeze-dried. It is recommended that freezers and refrigerators are not used for viruses other than classical swine fever, or for other materials unrelated to classical swine fever diagnosis. All individual ampoules must be clearly labelled, and comprehensive records maintained of virus stocks together with dates and results of quality-control checks. Records must also be kept of viruses added to stock, with details of the source, and of viruses issued to other laboratories.
  142. It is recommended that the bio-safe unit for classical swine fever virus work should be supported by areas where classical swine fever virus is not manipulated. These other areas should be available for the preparation of glassware and media, the maintenance and preparation of non-infected cell cultures, the processing of sera and serological testing (other than methods using live classical swine fever virus), and the provision of administrative and clerical support.