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2002/106/EC: Commission DecisionDangos y teitl llawn

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)

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  1. Introductory Text

  2. Article 1.(1) The Secretary of State, with the consent of each...

  3. Article 2.Annexes I and IV to Council Directive 80/217/EEC of 22...

  4. Article 3.This Decision shall apply from 1 November 2002.

  5. Article 4.This Decision is addressed to the Member States.

  6. Signature

    1. ANNEX

      CLASSICAL SWINE FEVER DIAGNOSTIC MANUAL

      1. CHAPTER I Introduction, objectives and definitions

        1. 1. In order to ensure uniform procedures to diagnose classical swine...

          1. (a) provides guidelines and minimum requirements on diagnostic procedures, sampling methods...

          2. (b) establishes minimum bio-safety requirements and quality standards to be observed...

          3. (c) establishes the laboratory tests to be used for the diagnosis...

        2. 2. This Manual is principally directed towards the authorities responsible for...

        3. 3. For the purpose of this Manual, in addition to the...

          1. (a) "suspected holding" means any pig holding which contains one or...

          2. (b) "singleton reactors" means any pig which yields a positive result...

          3. (c) "epidemiological sub-unit" or "sub-unit" means the building, place or land...

          4. (d) "in-contact pigs" means the pigs which lived in a holding...

      2. CHAPTER II Description of classical swine fever with emphasis on differential diagnosis

        1. A. Introduction

          1. 1. Classical swine fever is caused by an enveloped RNA virus...

          2. 2. Classical swine fever virus is relatively stable in moist excretions...

          3. 3. The main natural route of infection is oro-nasal by direct...

          4. 4. The incubation period in individual animals is about one week...

          5. 5. The clinical signs of classical swine fever are extremely variable...

          6. 6. Acute, chronic and prenatal forms of classical swine fever can...

        2. B. Acute form

          1. 1. Weaners and fattening pigs most often display the acute form...

          2. 2. Classical swine fever virus causes severe leukopenia and immunosuppression, which...

          3. 3. Pathological changes visible on post-mortem examination are most frequently observed...

          4. 4. In general the acute form of African swine fever leads...

          5. 5. Classical swine fever virus is shed in saliva, urine and...

        3. C. Chronic form

          1. 1. The chronic course of infection occurs when pigs are not...

          2. 2. Pathological changes are less typical, especially haemorrhages in organs and...

          3. 3. As clinical signs of chronic classical swine fever are rather...

        4. D. Prenatal form and late onset of disease

          1. 1. Classical swine fever virus is able to pass across the...

          2. 2. Detection of classical swine fever may be particularly difficult in...

      3. CHAPTER III Guidelines on main criteria to be considered for the recognition of a holding as a classical swine fever suspected holding

      4. CHAPTER IV Checking and sampling procedures

        1. A. Guidelines and procedures for clinical examination and sampling on pigs...

          1. 1. The appropriate Minister shall ensure that appropriate clinical examinations, sampling...

          2. 2. When an official veterinarian visits a suspected holding to confirm...

          3. 3. When reference is made to this paragraph, the clinical examination...

          4. 4. If dead or moribund pigs are detected in a suspected...

          5. 5. If further clinical signs or lesions that may suggest classical...

          6. 6. If the suspicion of classical swine fever in the holding...

          7. 7. If, after the examination carried out in a suspected holding,...

        2. B. Sampling procedures in a holding when pigs are killed following...

          1. 1. In order that the manner of introduction of classical swine...

          2. 2. The minimum number of pigs to be sampled must allow...

          3. 3. However, in case of secondary outbreaks, the competent authority may...

        3. C. Sampling procedures when pigs are killed as a preventive measure...

          1. 1. In order that classical swine fever may be confirmed or...

          2. 2. Sampling must primarily concern:

        4. D. Checking and sampling procedures before authorisation is given to move...

          1. 1. Without prejudice to the provisions of Article 11(1)(f), second subparagraph...

          2. 2. In the case of pigs to be moved to another...

          3. 3. In case of pigs to be moved to a slaughterhouse,...

          4. 4. When the pigs referred to in subparagraph 3 are slaughtered...

          5. 5. However, if clinical signs or post-mortem lesions suggesting classical swine...

        5. E. Checking and sampling procedures in a holding in relation to...

          1. 1. When pigs are re-introduced into a holding in accordance with...

          2. 2. After re-introduction of pigs, the competent authority shall ensure that...

        6. F. Sampling procedures in holdings in the protection zone before lifting...

          1. 1. In order that the measures referred to in Article 10...

          2. 2. The minimum number of blood samples to be taken must...

        7. G. Sampling procedures in holdings in the surveillance zone before lifting...

          1. 1. In order that the restrictions referred to in Article 11...

          2. 2. Whenever blood sampling for serological tests is carried out in...

        8. H. Serological monitoring and sampling procedures in areas where classical swine...

          1. 1. In the case of serological monitoring in feral pigs in...

          2. 2. If data on population density and size are not available,...

          3. 3. Without prejudice to the provisions of Article 15(2)(c) of Directive...

          4. 4. Collection of samples for virological tests from feral pigs shot...

          5. 5. All samples to be sent to the laboratory must be...

      5. CHAPTER V General procedures and criteria for collection and transport of samples

        1. A. General procedures and criteria

          1. 1. Before sampling is carried out in a suspected holding, a...

          2. 2. Each time that it is deemed that re-sampling of pigs...

          3. 3. Without prejudice to Chapter IV A. 5.b, samples for serological...

          4. 4. All samples must be sent to the laboratory accompanied by...

        2. B. Collection of samples for virological tests

          1. 1. For detection of classical swine fever virus, antigen or genome...

          2. 2. Anticoagulated blood or clotted blood samples must be collected from...

          3. 3. Virological tests are recommended in the case of sick animals....

        3. C. Transport of samples

          1. 1. It is recommended that all samples: are transported and stored...

          2. 2. The outside of the package must be labelled with the...

          3. 3. The laboratory receiving the samples must be informed in advance...

          4. 4. For air transport of samples to the Community Reference Laboratory...

      6. CHAPTER VI Principles and use of virological tests and evaluation of their results

        1. A. Detection of virus antigen

          1. 1. Fluorescent antibody test (FAT)

          2. 2. ELISA for antigen detection

        2. B. Virus isolation

          1. 1. Virus isolation is based on the incubation of sample material...

          2. 2. The preferred samples for isolation of classical swine fever virus...

          3. 3. Virus isolation is best suited for the investigation of samples...

          4. 4. It is recommended to perform virus isolation also in case...

          5. 5. All classical swine fever virus isolates from all primary outbreaks,...

        3. C. Detection of virus genome

          1. 1. The polymerase chain reaction (PCR) is applied to detect virus...

          2. 2. PCR can be used on small numbers of samples which...

          3. 3. Suitable sample material for diagnostic PCR are the organs described...

          4. 4. PCR can be performed within 48 hours. It requires appropriate...

        4. D. Evaluation of the results of virological tests

          1. 1. Virological tests are essential for the confirmation of classical swine...

          2. 2. A positive result for classical swine fever to a genome...

        5. E. Genetic typing of classical swine fever virus isolates

          1. 1. Genetic typing of classical swine fever virus isolates is achieved...

          2. 2. ...

      7. CHAPTER VII Principles and use of serological tests and evaluation of their results

        1. A. Basic principles and diagnostic value

          1. 1. In classical swine fever virus infected pigs, antibodies are usually...

          2. 2. The detection of antibodies against classical swine fever virus in...

        2. B. Recommended serological tests

          1. 1. The virus neutralisation test (VNT) and the ELISA are the...

          2. 2. The VNT is based on the determination of the virus...

          3. 3. The VNT is the most sensitive and reliable test to...

          4. 4. The pestiviruses strains to be used in the neutralisation tests...

          5. 5. Several ELISA techniques using specific monoclonal antibodies have been developed,...

          6. 6. Quality control on sensitivity and specificity of each batch of...

          7. 7. The sensitivity of the ELISA is regarded as lower than...

        3. C. Interpretation of serological results and differential diagnosis with infections due...

          1. 1. Without prejudice to the provisions of Article 4(3)(a) or Article...

          2. 2. If the comparative tests show antibodies to ruminant pestiviruses and...

          3. 3. If the comparative tests show a virus neutralisation titre in...

          4. 4. Without prejudice to the provisions of Article 4(3) of Directive...

          5. 5. However, if the further checks and tests referred to in...

      8. CHAPTER VIII Discriminatory tests in case of emergency vaccination

        1. A. Basic principles

          1. 1. A discriminatory serological ELISA test (discriminatory test) is available to...

          2. 2. The discriminatory test is a liquid phase blocking enzyme-linked immunoassay....

        2. B. Guidelines for the use of the discriminatory test in the...

      9. CHAPTER IX Minimum safety requirements for classical swine fever laboratories

        1. 1. The minimum requirements laid down in Table 1 must be...

        2. 2. The additional requirements laid down in Table 1 must be...

        3. 3. The requirements laid down in Table 2 must be fulfilled...

        4. 4. In any case, all stocks of classical swine fever virus...

        5. 5. It is recommended that the bio-safe unit for classical swine...

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