National Reference Laboratory
National Reference Laboratory for Foodborne Viruses
The Department of Food Safety, Nutrition and Veterinary Public Health (DSANV) of the Istituto Superiore di Sanità (ISS) has been designated by the Italian Ministry of Health as the National Reference Laboratory (NRL) for Foodborne Viruses. The designation was made by the Directorate General for Food Hygiene, Food Safety and Nutrition through its letter of 5 October 2018 (Ref. DGISAN 0038195-P-05/10/2018).
The designation reflects the requirement set out in Regulation (EU) 2017/625 for each Member State to designate one or more National Reference Laboratories to support the activities of the relevant European Union Reference Laboratories (EURLs). The NRL operates in accordance with Article 100 of Regulation (EU) 2017/625 and contributes to the network of official laboratories established under the EU framework for official controls.
Tasks and responsibilities
In accordance with Article 101 of Regulation (EU) 2017/625, the National Reference Laboratory for Foodborne Viruses performs the following tasks:
- collaborates with the European Union Reference Laboratory for Foodborne Viruses (EURL), hosted by the Swedish Food Agency (Livsmedelsverket), Uppsala, Sweden, and participates in training activities, proficiency tests and interlaboratory comparisons organised by the EURL;
- provides scientific and technical support to the competent authorities in the investigation of foodborne outbreaks and in the development and implementation of monitoring programmes for viral contamination of food;
- coordinates the activities of the official laboratories performing virological analyses on food matrices, with the aim of promoting harmonised analytical approaches and ensuring the consistent application of validated methods;
- disseminates technical and scientific information, guidance documents and recommendations issued by the EURL to the competent authorities and the laboratories of the Italian National Health Service (Servizio Sanitario Nazionale, SSN);
- organises interlaboratory comparison studies and proficiency testing schemes for relevant virological analyses, evaluates laboratory performance, ensures appropriate follow-up of the outcomes and reports the results to the competent authorities;
- develops procedures and criteria for the preparation, characterisation and qualification of reference materials required for virological testing;
- prepares and distributes reference materials to official laboratories upon request;
- organises training activities for laboratory personnel involved in the detection and characterisation of foodborne viruses.
Quality Management System
The National Reference Laboratory operates within the Quality Management System (QMS) of the DSANV, which is accredited by ACCREDIA, the Italian national accreditation body, in accordance with UNI CEI EN ISO/IEC 17025 (Accreditation No. 00510).
Accreditation provides formal recognition of the laboratory's technical competence to perform specific testing activities within its accredited scope, including both fixed and flexible scopes of accreditation, as applicable. Accreditation does not imply endorsement by ACCREDIA of individual test results or of any interpretations derived from them.
Through its technical expertise, quality system and coordination activities, the National Reference Laboratory contributes to the harmonisation of official controls, the continuous improvement of analytical capacity and the effective implementation of EU legislation on food safety.
