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Council Directive 2003/85/EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC (Text with EEA relevance)
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The protocols specified in the OIE Manual provide reference procedures for virus isolation, antigen detection and antibody detection for vesicular diseases.
The standards for detecting foot-and-mouth disease virus antigen shall be established in accordance with the procedure referred to in Article 89(2) after consultation of the Community Reference Laboratory.
Standardised, inactivated antigens of all seven serotypes are available from the OIE/FAO World Reference Laboratory for foot-and-mouth disease (WRL).
National Laboratories should ensure that their antigen detection system complies with these minimum standards. They shall where necessary receive advice from the Community Reference Laboratory on the dilutions of these antigens to be used as strong and weak positive controls.
The standards for foot-and-mouth disease virus detection shall be established in accordance with the procedure referred to in Article 89(2) after consultation of the Community Reference Laboratory.
Isolates of foot-and-mouth disease virus are available from the WRL.
National Laboratories shall ensure that the tissue culture systems in use for foot-and-mouth virus isolation are sensitive to the full range of serotypes and strains for which the laboratory maintains a diagnostic capacity.
The standards for the detection of foot-and-mouth disease viral RNA shall be established in accordance with the procedure referred to in Article 89(2) after consultation of the Community Reference Laboratory.
The Commission may arrange that for future standardisation, comparative testing of the sensitivity of RNA detection methods is carried out between National Laboratories.
The Commission may arrange that, taking into account the practical difficulties of storing nucleic acids for prolonged periods of time, standardised quality assurance reagents for the detection of foot-and-mouth viral RNA will become available from the Community Reference Laboratory.
The standards for the detection of antibody to foot-and-mouth disease virus shall be established in accordance with the procedure referred to in Article 89(2) after consultation of the Community Reference Laboratory.
Standardised antisera for foot-and-mouth disease virus types O1-Manisa, A22-Iraq and C-Noville have been defined by the ‘FAO Phase XV Standardisation Exercise in foot-and-mouth disease antibody detection’ in 1998.
The Commission may arrange that standardised reference sera for all the main antigenic variants of foot-and-mouth disease virus are adopted as a result of standardisation exercises between the Community Reference Laboratory and the National Laboratories. These reference sera will be adopted as the standards for use by National Laboratories within the Community.
The standards for the detection of antibody to foot-and-mouth disease virus shall be established in accordance with the procedure referred to in Article 89(2) after consultation of the Community Reference Laboratory.
The Commission may arrange that standardised reference sera are adopted as a result of standardisation exercises between the Community Reference Laboratory and the National Laboratories. These reference sera will be adopted as the standards for use by National Laboratories within the Community.
Diagnosis of SVD must be carried out in accordance with Decision 2000/428/EC.
Where necessary, the Commission may arrange that standards for the laboratory diagnosis of vesicular stomatitis or vesicular exanthema of swine are established in accordance with the procedure referred to in Article 89(2).
Member States may maintain the laboratory capacity to diagnose the vesicular virus diseases other than foot-and-mouth disease and SVD, i.e. vesicular stomatitis and vesicular exanthema of swine.
National Laboratories wishing to maintain a diagnostic capacity for these viruses can obtain reference reagents from the WRL, Pirbright or from the relevant OIE Reference Laboratory.
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