The official website of the European Union Reference Laboratory (EURL) for Escherichia coli, including Shiga toxin-producing E. coli (STEC), hosted by the Istituto Superiore di Sanità, is meant to inform the National Reference Laboratories (NRLs) participating in the network but is also of interest and a source of references to the laboratories dealing with pathogenic E. coli detection and control worldwide.
The Istituto Superiore di Sanità was designated as Reference Laboratory for STEC by the European Commission on July the 1st, 2006.
The EURL-VTEC mainly focuses its activity on STEC and other pathogenic E. coli infection that have either a foodborne or a zoonotic origin. From 2019, also acts a reference laboratory for the tasks related with the presence and enumeration of E. coli in Live Bivalve Molluscs, following the closure of the European Union Reference Laboratory for monitoring the viral and bacteriological contamination of bivalve molluscs in the UK due to the BREXIT. This transfer is ratified with the EU Regulation 222/2018.
The Microbiological food safety and food-borne diseases Unit, which hosts the EURL-VTEC has been accredited as part of the Department of Food Safety, Nutrition and Veterinary Public Health and since December 2007 by ACCREDIA, the Italian accreditation body, according to the ISO/IEC 17025 international standard. The accreditation (certificate No. 0779) refers both to fixed scope and to flexible scope of accreditation and it is submitted to a convention and recognizes the technical competence of the laboratory to perform specific analytical methods. Nevertheless, the accreditation body doesn't assume any responsibility related to the results of the assays or their interpretation.
Basic EU Legislation
The EURL-VTEC was established in accordance with the following EU legislation:
- Directive 2003/99/EC of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC
- Regulation (EC) No 882/2004 of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and welfare rules
- Regulation (EC) No 776/2006 of 23 May 2006 amending Annex VII to Regulation (EC) No 882/2004 as regards a list of Community Reference Laboratories
Additional important legislation:
- Commission Decision 2000/96/EC on the communicable diseases to be covered by epidemiological surveillance in the European Community
- COMMISSION REGULATION (EU) No 208/2011 of 2 March 2011 amending Annex VII to Regulation (EC) No 882/2004 of the European Parliament and of the Council and Commission Regulations (EC) No 180/2008 and (EC) No 737/2008 as regards lists and names of EU reference laboratories
- COMMISSION REGULATION (EU) No 209/2013 of 11 March 2013 amending Regulation (EC) No 2073/2005 as regards microbiological criteria for sprouts and the sampling rules for poultry carcases and fresh poultry meat
- Commission Regulation (EU) 2018/222 of 15 February 2018 amending Annex VII to Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the European Union reference laboratory for monitoring the viral and bacteriological contamination of bivalve molluscs
- Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC
The general functions and duties of the European Reference Laboratory for feed and food are described in Article 94 of Regulation (EC) No. 625/2017.
They shall be responsible for the following main activities:
- Co-operation with international organisations and NRLs
The EURL-VTEC will cooperate with EC, World Organisation for Animal Health (OIE), World Health Organisation (WHO), and agencies such as the European Food Safety Authority (EFSA) and the European Centre for Disease Prevention and Control working in the field of human and animal health. In particular, the EURL-VTEC will cooperate with Enter-net, the Community network for epidemiological surveillance and control of salmonella and STEC infections, in defining common database for food isolates and joint proficiency tests on strain typing. The EURL-VTEC will strongly cooperate and support the NRLs. The work programme of the EURL-VTEC will provide support to the NRLs, the Commission and developing countries in the diagnosis, epidemiology, control and training in the field of STEC infections.
- Methods of laboratory analysis, testing or diagnosis, including reference methods
Development of analytical methods for the detection, identification and typing of STEC and other pathogenic E. coli in animals, food and in other relevant matrices.
Development and validation of serological methods to detect serogroup-specific antibodies in human beings with STEC infections.
Sub-typing of STEC strains by using molecular methods will be a major activity.
Coordinating practical arrangements necessary to apply new methods of laboratory analysis, testing or diagnosis, and informing national reference laboratories of advances in this field.
- Production and collection of reference materials and methods
Development and maintenance of a collection of relevant reference strains.
Preparation of antigens to be used in serological assays.
Development of standard operating procedures for detection of pathogenic Escherichia coli in animals, food and in other relevant matrices and for typing of the isolated strains.
- Organisation of proficiency tests and ring trials
Proficiency tests and ring trials on detection and typing methods will be organised and conducted for the designated NRLs for E. coli, the EU Candidate Countries and certain third countries. A full evaluation report of each test will be prepared for the Commission and the NRLs. The results of the proficiency tests will be discussed during a workshop to be organised annually.
- Collaboration with laboratories responsible for E. coli infections in third countries
On request from institutions of developing countries, training courses or visits will be organised at the EURL-VTEC on detection and typing methods. When available, reference materials will be provided to institutions of developing countries. Monitoring programmes and epidemiological surveys could be organised in collaboration with local institutions. Typing and sub-typing of strains collected in endemic countries could also be performed.
Conducting training courses for staff from national reference laboratories and, if needed, from other official laboratories, as well as of experts from third countries
- Technical and scientific support to the Commission
The personnel of the EURL-VTEC will support Member States for the diagnoses of E. coli infections; on a specific request of member states, the personnel of EURL-VTEC will support local authorities in field studies carried out to face epidemic outbreaks. The EURL-VTEC will mainly focus its activity on STEC. However, EURL-VTEC will deal with any pathogenic E. coli infection that will have either a foodborne or a zoonotic origin.
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.