EURL for Bovine Tuberculosis

Designation of European Union reference laboratories

Official Control Regulation (OCR) 2017/625, article 93(3)

3. European Union reference laboratories shall:

operate in accordance with standard EN ISO/IEC 17025 and be accredited in accordance with that standard by a national accreditation body, operating in accordance with Regulation (EC) No 765/2008. The scope of that accreditation:

shall include all the methods of laboratory analysis, test or diagnosis required to be used by the laboratory when it operates as a European Union reference laboratory;
may comprise one or more methods of laboratory analysis, test or diagnosis or groups of methods;
may be defined in a flexible manner, so as to allow the scope of the accreditation to include modified versions of the methods used by the European Union reference laboratory when the accreditation was granted or new methods in addition to those methods, on the basis of the laboratory's own validations without a specific assessment, prior to the use of those modified or new methods, by the national accreditation body of the Member State where the European Union reference laboratory is located;

be impartial, free from any conflict of interest, and in particular not be in a situation which may, directly or indirectly, affect the impartiality of their professional conduct as regards the exercise of their tasks as European Union reference laboratories;
have, or have contractual access to, suitably qualified staff with adequate training in analytical, testing and diagnostic techniques applied in their area of competence, and support staff as appropriate;
possess, or have access to, the infrastructure, equipment and products necessary to carry out the tasks assigned to them;
ensure that their staff and any contractually engaged staff have good knowledge of international standards and practices and that the latest developments in research at national, Union and international level are taken into account in their work;
be equipped, or have access to, the necessary equipment to perform their tasks in emergency situations; and
where relevant, be equipped to comply with relevant biosecurity standards.

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:

providing national reference laboratories with details and guidance on the methods of laboratory analysis, testing or diagnosis, including reference methods;
providing reference materials to national reference laboratories;
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;
coordinating practical arrangements necessary to apply new methods of laboratory analysis, testing or diagnosis, and informing national reference laboratories of advances in this field;
conducting training courses for staff from national reference laboratories and, if needed, from other official laboratories, as well as of experts from third countries;
providing scientific and technical assistance to the Commission within the scope of their mission;
providing information on relevant national, Union and international research activities to national reference laboratories;
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);
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;
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;
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

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.

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 (Annex II)

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:

typing, storing and supplying strains of Mycobacterium sp. causing tuberculosis in animals;
preparing, controlling and supplying reference reagents to the national reference laboratories in order to standardize the tests and reagents used in the Member States;
validating reference reagents including antigens and tuberculins submitted by the national reference laboratories for bovine tuberculosis;
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;
organising periodical comparative tests of diagnostic procedures at Union level and operating laboratory proficiency tests of national reference laboratories;
collecting and collating data and information on the methods of diagnosis used and the results of tests carried out in the Union;
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;
keeping abreast of developments in bovine tuberculosis surveillance, epidemiology and prevention throughout the world;
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:.

facilitate the harmonization of techniques throughout the Union, in particular specifying standard test methodologies
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
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:

carrying out or collaborating with national reference laboratories in carrying out test validation trials;
providing scientific advice to the Commission and collecting information and reports associated with the activities of the EU reference laboratory.

Scientific staff

Dr. Beatriz Romero (Director)
bromerom@visavet.ucm.es
Phone: +34913944033

Dr. Javier Bezos (Deputy Director)
jbezosga@visavet.ucm.es
Phone: +34913943910

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

Dr. Julio Álvarez (Epidemiologist)
jalvarez@visavet.ucm.es
Phone: +34913943992

Dr. Antonio Rodríguez (Pathologist)
arbertos@visavet.ucm.es
Phone: +34913944096

Technical staff

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

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.

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).
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.
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

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

Union financial aid

2021-2022. Grant Agreement. Project EURLs-EURCs 2021/20222/SI2.870665-Activities of the EU Reference Laboratories and EU Reference Centres in 2021-2022 [EURLs-EURCs 2021-2022].
2019-2020. Grant decision for an action regarding the EU Reference Laboratory for Bovine Tuberculosis - SI2.80022179
2018. Grant decision for an action regarding the EU Reference Laboratory for Bovine Tuberculosis - SI2.777731
2016-2017. Grant decision for an action regarding the EU Reference Laboratory for Bovine Tuberculosis - SI2.726254
2015. Grant decision for an action regarding the EU Reference Laboratory for Bovine Tuberculosis - SI2.700480
2014. Commission Implementing Decision of 17 January 2014 on a Union financial aid for the year 2014 to European Union reference laboratories
2013. Commission Implementing Decision of 22 March 2013 as regards a Union financial aid for the year 2013 to European Union reference laboratories
2012. Commission Implementing Decision of 21 December 2011 as regards a Union financial aid for the year 2012 to European Union reference laboratories
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
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
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
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

The EURL

Tasks