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Tasks

Responsibilities and tasks of European Union reference laboratories


Official Control Regulation (OCR) 2017/625, article 94
  • European Union reference laboratories shall contribute to the improvement and harmonisation of methods of analysis, test or diagnosis to be used by official laboratories designated in accordance with Article 37(1) and of the analytical, testing and diagnostic data generated by them.
  • European Union reference laboratories designated in accordance with Article 93(1) shall be responsible for the following tasks insofar as they are included in the reference laboratories' annual or multiannual work programmes that have been established in conformity with the objectives and priorities of the relevant work programmes adopted by the Commission in accordance with Article 36 of Regulation (EU) No 652/2014:
    1. providing national reference laboratories with details and guidance on the methods of laboratory analysis, testing or diagnosis, including reference methods;
    2. providing reference materials to national reference laboratories;
    3. coordinating the application by the national reference laboratories and, if necessary, by other official laboratories of the methods referred to in point (a), in particular, by organising regular inter-laboratory comparative testing or proficiency tests and by ensuring appropriate follow-up of such comparative testing or proficiency tests in accordance, where available, with internationally accepted protocols, and informing the Commission and the Member States of the results and follow-up to the inter-laboratory comparative testing or proficiency tests;
    4. coordinating practical arrangements necessary to apply new methods of laboratory analysis, testing or diagnosis, and informing national reference laboratories of advances in this field;
    5. conducting training courses for staff from national reference laboratories and, if needed, from other official laboratories, as well as of experts from third countries;
    6. providing scientific and technical assistance to the Commission within the scope of their mission;
    7. providing information on relevant national, Union and international research activities to national reference laboratories;
    8. collaborating within the scope of their mission with laboratories in third countries and with the European Food Safety Authority (EFSA), the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC);
    9. assisting actively in the diagnosis of outbreaks in Member States of foodborne, zoonotic or animal diseases, or of pests of plants, by carrying out confirmatory diagnosis, characterisation and taxonomic or epizootic studies on pathogen isolates or pest specimens;
    10. coordinating or performing tests for the verification of the quality of reagents and lots of reagents used for the diagnosis of foodborne, zoonotic or animal diseases and pests of plants;
    11. where relevant for their area of competence, establishing and maintaining:
      • reference collections of pests of plants and/or reference strains of pathogenic agents;
      • reference collections of materials intended to come into contact with food used to calibrate analytical equipment and provide samples thereof to national reference laboratories;
      • up-to-date lists of available reference substances and reagents and of manufacturers and suppliers of such substances and reagents; and
    12. where relevant for their area of competence, cooperate among themselves and with the Commission, as appropriate, to develop methods of analysis, testing or diagnosis of high standards.

    13. As regards point (i) of point (k), the European Union reference laboratory may establish and maintain those reference collections and reference strains by contractual outsourcing to other official laboratories and to scientific organisations.

  • European Union reference laboratories shall publish the list of the national reference laboratories designated by the Member States in accordance with Article 100(1).

Specific responsibilities and tasks for the EU-RL for Bovine Tuberculosis


Commission Regulation (EU) No 415/2013
  • The EU reference laboratory for bovine tuberculosis shall coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing bovine tuberculosis, in particular by:
    1. typing, storing and supplying strains of Mycobacterium sp. causing tuberculosis in animals;

    2. preparing, controlling and supplying reference reagents to the national reference laboratories in order to standardize the tests and reagents used in the Member States;
    3. validating reference reagents including antigens and tuberculins submitted by the national reference laboratories for bovine tuberculosis;

    4. building up and maintaining a collection of Mycobacterium sp. causing tuberculosis in animals, and maintaining a database of strains isolated across the Community including typing;
    5. organising periodical comparative tests of diagnostic procedures at Union level and operating laboratory proficiency tests of national reference laboratories;
    6. collecting and collating data and information on the methods of diagnosis used and the results of tests carried out in the Union;

    7. characterising Mycobacterium sp. causing tuberculosis in animals by the most up-to-date methods available to allow a greater understanding of the epidemiology of that disease;

    8. keeping abreast of developments in bovine tuberculosis surveillance, epidemiology and prevention throughout the world;

    9. acquiring a thorough knowledge of the preparation and use of the products of veterinary immunology used to eradicate and control bovine tuberculosis including the evaluation of vaccines.

  • The EU reference laboratory for bovine tuberculosis shall also:.
    1. facilitate the harmonization of techniques throughout the Union, in particular specifying standard test methodologies

    2. organize workshops for the benefit of national reference laboratories as agreed in the work programme and estimated budget referred to in Article 2 of Implementing Regulation (EU) No 926/2011, including training of experts from the Member States and, as appropriate, from third countries, in new analytical methodologies
    3. provide technical assistance to the Commission and, upon its request, to participate in international forums relating to the diagnostic of bovine tuberculosis, concerning in particular the standardisation of analytical diagnostic methods and their implementation.
  • In addition, the EU reference laboratory shall perform research activities and, whenever possible, coordinate research activities directed towards the improved control and eradication of bovine tuberculosis, in particular by:

    1. carrying out or collaborating with national reference laboratories in carrying out test validation trials;

    2. providing scientific advice to the Commission and collecting information and reports associated with the activities of the EU reference laboratory.
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Staff

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Scientific staff


Dr. Lucía de Juan (Director)
dejuan@visavet.ucm.es
Phone: +34913944033


Dr. Beatriz Romero (Deputy Director)
bromerom@visavet.ucm.es
Phone: +34913943992


Dr. Javier Bezos (Field Studies)
jbezosga@visavet.ucm.es
Phone: +34913944096


Technical staff


Mr. Francisco Lozano
franlozano@visavet.ucm.es
Phone: +34913944002


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Facilities

Laboratories


The VISAVET Health Surveillance Centre is equipped with level 2 and 3 bio-safety (BSL-2 and BSL-3) laboratories to work with microorganisms included in risk groups 2 and 3, and one Class A room area.

  1. The BSL-2 laboratories are specifically designed for analysis of Group 2 biological agents. In this area there are separated working zones to protect the quality of the tests and to avoid cross contaminations (immunology laboratory, molecular laboratories, clinical test laboratory and other food-borne zoonoses laboratory).
  2. The BSL-3 area are devoted to microbiological analysis for diagnostic purposes and research projects with biological agents included in the group of risk 3 according to the list A of the OIE. The level 3 includes 5 laboratories, 1 media and material preparation room, 1 sterilization area (SAS and autoclave) and 1 technical area (Biowaste and laboratory HEPA filtration system). In addition, it has animal facilities (3 boxes, 1 storage room and 1 technical area) that allow in vivo experimentation with these pathogens.
  3. The Type A room area has been designed to guarantee that all the areas are confined, clean and controlled to optimize the protection of the product.

Animal facilities

  1. BSL-3 animal facilities: The VISAVET Health Surveillance Centre is equipped with 3 independent animal facilities includes in BLS-3 area.
  2. Farms: VISAVET Centre has several animal farms, one specified for experiments related to the EURL.
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Funding

Union financial aid

  1. 2019-2020. Grant decision for an action regarding the EU Reference Laboratory for Bovine Tuberculosis - SI2.80022179
  2. 2018. Grant decision for an action regarding the EU Reference Laboratory for Bovine Tuberculosis - SI2.777731
  3. 2016-2017. Grant decision for an action regarding the EU Reference Laboratory for Bovine Tuberculosis - SI2.726254
  4. 2015. Grant decision for an action regarding the EU Reference Laboratory for Bovine Tuberculosis - SI2.700480
  5. 2014. Commission Implementing Decision of 17 January 2014 on a Union financial aid for the year 2014 to European Union reference laboratories
  6. 2013. Commission Implementing Decision of 22 March 2013 as regards a Union financial aid for the year 2013 to European Union reference laboratories
  7. 2012. Commission Implementing Decision of 21 December 2011 as regards a Union financial aid for the year 2012 to European Union reference laboratories
  8. 2011. Commission Decision of 1 December 2010 on financial aid from the Union for the year 2011 for certain Community reference laboratories in the field of animal health and live animals
  9. 2010. Commission Decision of 14 December 2009 on financial aid from the Union for the year 2010 for certain Community reference laboratories in the field of animal health and live animals
  10. 2009. Commission Decision of 5 December 2008 on financial aid from the Community for the year 2009 for certain Community reference laboratories in the field of animal health and live animals
  11. 2008. Commission Decision of 21 October 2008 on financial aid from the Community for the second half of 2008 for certain Community reference laboratories in the field of animal health and live animals
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