OIE RL for « Swine Vesicular Disease » – «EmilianaBrocchi » – «Italy»
OIE Reference Laboratory Reports
Activities in 2012
Address of laboratory / Istituto Zooprofilattico Sperimentale della Lombardia e dell’Emilia Romagna (IZSLER)
Via A. Bianchi 7/9, Brescia, Italy
Tel.: / +39 030 2290310
Fax: / +39 030 2290369
e-mail address: /
website: /
Name (including Title) of Head of Laboratory (Responsible Official): / Dr. Stefano Cinotti
IZSLER General Director
Name(including Title and Position) of OIE Reference Expert: / Dr. Emiliana Brocchi
Head of the National Reference Centre for Vesicular Diseases
Head of the Dpt. of Biotechnology
Date of submission to the OIE / 25/01/2013
Instructions
This form should be used by an OIE Reference Laboratory to report activities that took place from January through December of the past year (2012), unless otherwise stated, and must be submitted by the end of January every year.
Only those activities that concern the disease (or topic) for which the laboratory is recognised by the OIE should be mentioned. The questionnaire structure follows the Terms of Reference (ToRs) for OIE Reference Laboratories, available at:
EachToR(blueitalicised text)has been placed as a heading covering the group of questions related to it.
Please note the reditalicisedtext is given as guidance and should be deleted from your report and substitute with your data. Examples are based onpast Annual Reports or have been invented.
The questionnaire represents a means of gathering information on activities carried out by OIE Reference Laboratories and making it available to OIE Member Countries and to the OIE Reference Laboratory network.
This annual report will remain available for consultation on the OIE web site:
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ToR:To use, promote and disseminate diagnostic methods validated according to OIE Standards
Test recommended by the OIE / Total number of test performed last yearIndirect diagnostic tests / Nationally / Internationally
Competitive ELISA
(OIE prescribed test for screening) / 97,976
(plus further 270,000 tests in regional labs) / None (no request)
IgG-specific ELISA / 932 / None (no request)
IgM-specific ELISA / 932 / None (no request)
VNT / 900 / None (no request)
Direct diagnostic tests / Nationally / Internationally
IB-RS2 cell culture / 17 / None (no request)
RT-PCR SVDV
3D-fragment (all genotypes) / 2,501 / None (no request)
Sandwich ELISA (mAbs-based) / 16 / None (no request)
Sequencingregion3D
SequencingregionIRES / 6(from outbreaks 2011-2012)
20(from outbreaks of 2012 and previous years analysed for retrospective studies) / None (no request)
ToR:To develop reference material in accordance with OIE requirements, and implement and promote the application of OIE Standards.
Tostore and distribute to national laboratories biological reference products and any other reagents used in the diagnosis and control of the designated pathogens or disease.
2.Did your laboratory produce or store imported standard reference reagentsofficially recognised by the OIE or other international bodies?
X Yes No
3.Did your laboratory supply standard reference reagentsto OIE Member Countries?
X Yes No
Type of reagent available / Related diagnostic test / Produced/stored / Amount supplied nationally
(ml, mg) / Amount supplied internationally
(ml, mg) / Name of recipient OIE Member Countries and of institutions
All reagents
(capture and conj. mAbs, antigen, control sera) / cELISA
(Ab detect) / Produced / For testing 450,000 sera (regional labs) / For testing 8,600 sera / National Veterinary Research Institute POLAND
5B7 catching monoclonal Ab / cELISA
(Ab detect) / Produced / 40 ml / Canadian Food Inspection Agency-National center Foreign Animal Diseases
CANADA
5B7 peroxidase-conjugated mAb / cELISA
(Ab detect) / Produced / 60 ml / Canadian Food Inspection Agency-National center Foreign Animal Diseases
CANADA
SVDV inactivatedantigen / cELISA
(Ab detect) / Produced / 800 ml / Private Company for kit preparation
All above reagents are reference biological materials to perform the OIE prescribed screening ELISA for antibody detection.
4.Did your laboratory produce diagnostic reagents other than the OIE-approved standard reference reagents?
X Yes No
5.Did your laboratory produce vaccines?
YesX No (no vaccine exists for SVD)
6.Did your laboratory supply vaccines to OIE Member Countries?
YesX No
Since vaccination against SVD is not practised, no need for vaccine production and quality control exists
ToR:To develop, standardise and validate, according to OIE Standards, new procedures for diagnosis and control of the designated pathogens or diseases
7.Did your laboratory develop new diagnostic methods validated according to OIE Standards for the designated pathogen or disease?
X Yes No
8.Didyour laboratory develop new vaccines according to OIE Standards for the designated pathogen or disease?
YesX No
Name of the new test or diagnostic method or vaccine developed / Description and References (Publication, website, etc.)One-step Real time PCR target on 3D / The test developed is a one-step Real time PCR for the amplification of a 3D segment using the same primers of the conventional 3D RT-PCR (OIE Manual) associated with two TaqMan probes,designed to match sequences of the two circulating SVDV lineages. Protocol isavailable at this OIE laboratory.
Improved Real time PCR target on IRES / A considerable proportion of SVDV field viruses is not detected by two previously described 5’UTR Real time PCRs, due to mismatching either within the primers sequence (set 2B-IR) or in the probe sequence (3-IR). Both tests were modified, by introducing 2B-IR primers (2B-IR deg) and the 3-IR probe (3-IR deg) degenerated in critical sites; modifications enabled both tests to detect all SVD viruses of the two circulating genomic lineages.
D. Benedetti, G. Pezzoni, S. Grazioli, E. Brocchi. Improvement of a one-step real time RT-PCR for the detection of any swine vesicular disease virus variants. EPIZONE 6th Annual Meeting, Brighton 12-14 June 2012.
ToR:To provide diagnostic testing facilities, and, where appropriate, scientific and technical advice on disease control measures to OIE Member Countries
9.Did your laboratory carry out diagnostic testing for other OIE Member Countries?
YesX No (no request received)
10.Did your laboratory provide expert advice in technical consultancies on the request of an OIE Member Country?
X Yes No
Name of the OIE Member Country receiving a technical consultancy / Purpose / How the advice was providedITALY / Eradication of the disease in not free areas and implementation of biosecurity in pig industry / Constitution of a task force with regular inspections in affected regions
Evaluation of the virucidal efficacy on SVDV of a new disinfectant / Laboratory assays performed in compliance with the UNI EN 14675 2006
ToR:To carry out and/or coordinate scientific and technical studies in collaboration with other laboratories, centres or organisations
11.Did your laboratory participate in international scientific studies in collaboration with OIE Member Countries other than the own?
X Yes No
Title of the study / Duration / Purpose of the study / Partners (Institutions) / OIE Member Countries involved other than your countryCurrent epidemiological situation with regard to SVD and its impact on susceptible livestock, with scientific advice for better targeted and modulated surveillance and proportionate protection measures / 2011-2012 / Provision of a scientific opinion to the EU Commission on the current epidemiological situation with regard to SVD and its impact on susceptible livestock, with scientific advice for better targeted and modulated surveillance and proportionate protection measures / EU Commission
EFSA
OIE / Working group of experts constituted by EFSA
ToR:To collect, process, analyse, publish and disseminate epizootiological data relevant to the designated pathogens or diseases
12.Didyour Laboratory collect epizootiologicaldata relevant to international disease control?
YesX No
The disease is officially reported only in Italy. See answer to the following question.
13.Didyour laboratory disseminate epizootiologicaldata that had been processed and analysed?
X Yes No
The disease is officially reported only from Italy. During 2012 seven new SVD outbreaks were notified in Italy. Data and epidemiological information relevant to SVD outbreaks and results of the national surveillance plan were regularly reported to international bodies (EU Commission, etc.).
A dedicated Integrated Information System is maintained for the collection and analysis of data of the surveillance activities for SVD in Italy ( It provides an archive of laboratory results since 2000.
14.What method of dissemination of information is most often used by your laboratory?
(Indicate in the appropriate box the number by category)
The data reported below are only referred to 2012.
a)Articles published in peer-reviewed journals:......
b)International conferences:...... 1
c)National conferences:......
d)Other:...... web site, reports
Dennis Benedetti, Giulia Pezzoni, SantinaGrazioli, EmilianaBrocchi.Improvement of a one step real time RT-PCR for the detection of any swine vesicular disease virus variants. EPIZONE 6th Annual Meeting "Viruses on the move" Brighton 12-14 June 2012
ToR: To provide scientific and technical training for personnel from OIE Member Countries
To recommend the prescribed and alternative tests or vaccines as OIE Standards
15.Did your laboratory provide scientific and technical training to laboratory personnel from other OIE Member Countries?
YesX No (no request received in 2012)
a)Technical visits:......
b)Seminars:......
c)Hands-on training courses:......
d)Internships (>1 month):......
ToR:To maintain a system of quality assurance, biosafety and biosecurity relevant for the pathogen and the disease concerned
16.Does your laboratory have a Quality Management System certified according to an International Standard?
X Yes No
Quality management system adoptedISO 17025
17.Is your laboratory accredited by an international accreditation body?
X Yes No
Test for which your laboratory is accredited / Accreditation bodyCompetitive ELISA
(OIE prescribed test for screening) / ACCREDIA (n.148) ILAC-MRA
IgG-specific ELISA / ACCREDIA (n.148) ILAC-MRA
IgM-specific ELISA / ACCREDIA (n.148) ILAC-MRA
VNT / ACCREDIA (n.148) ILAC-MRA
RT-PCR SVDV
3D-fragment (all genotypes) / ACCREDIA (n.148) ILAC-MRA
Sandwich ELISA forantigendetection (mAbs-based) / ACCREDIA (n.148) ILAC-MRA
18.Does your laboratory maintain a “biorisk management system” for the pathogen and the disease concerned? (See Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2012, Chapter 1.1.3 orManual of Diagnostic Tests for Aquatic Animals 2012, Chapter 1.1.1)
X Yes No
Laboratories where live SVDV is handled comply with the provisions of the “Minimum standards for laboratories working with FMDV in vitro/in vivo”, as adopted by the 38th General Session of the European Commission for the Control of Foot-and-mouth Disease (EuFMD), 2009. These laboratories correspond to OIE biosecurity level 4, with the exception of single HEPA filtration for exhaust air and not filtered input air.
ToR:To organise and participate in scientific meetings on behalf of the OIE
19.Did your laboratory organise scientific meetings on behalf of the OIE?
YesX No
20.Did your laboratory participate in scientific meetings on behalf of the OIE?
YesX No (no request received in 2012)
ToR:To establish and maintain a network with other OIE Reference Laboratories designated for the same pathogen or disease and organise regular inter-laboratory proficiency testing to ensure comparability of results
21.Did your laboratory exchange information with other OIE Reference Laboratories designated for the same pathogen or disease?
X Yes No
There are only two OIE reference laboratories designated for SVD. A standing collaboration and regular exchange of information is maintained between the two laboratories.
22.Was your laboratory involved in maintaining a network with OIE Reference Laboratories designated for the same pathogen or disease by organising or participating in proficiency tests?
YesX No
23.Did your laboratory collaborate with other OIE Reference Laboratories for the same disease on scientific research projects for the diagnosis or control of the pathogen of interest?
X Yes No
Title of the project or contact / Scope / Name(s) of relevant OIE Reference LaboratoriesResearch agreement / Characterization of SVDV isolates (virulence, genomic and antigenic variation, molecular epidemiology and evolution) and development/validation of new diagnostic tools. / The Pirbright Institute, UK
ToR:To organise inter-laboratory proficiency testing with laboratories other than OIE Reference Laboratories for the same pathogens and diseases to ensure equivalence of results.
24.Did your laboratory organiseor participate in inter-laboratory proficiency tests with laboratories other than OIE Reference Laboratories for the same disease?
X Yes No
Purpose for inter-laboratory test comparisons[1] / No. participating laboratories / Participating OIE Member CountriesParticipation at the international FMD/SVD combined Inter-laboratory proficiency testing exercise, that is annually organised by the SVD/FMD European Reference Laboratory and FMD WRL as one of its duty.
In-house serological assays (VNT, 5B7-competitive ELISA,IgG/IgM specific ELISAs) andvirologicaltests (antigen detection ELISA, virus isolation and different PCR procedures) are evaluated with proficiency panels of samples, including sera, epithelium and faecal suspensions. / More than 30 / Invited participants: all EU national Laboratories, other countries of strategic importance for EU, plus additonal countries expressing interest.
Organisation of the annual inter-laboratory test to monitor the harmonisation and performance of the 5B7-competitive ELISA carried out in Italianregional laboratories for the national surveillance plan / 13 regional laboratories in Italy / ITALY
ToR:To place expert consultants at the disposal of the OIE
25.Did your laboratory place expert consultants at the disposal of the OIE?
X Yes No
Kind of consultancy / Location / Subject (facultative )Provision of the revision / Revision of the SVD chapter for the OIE Diagnostic Manual
Annual reports of OIE Reference Laboratories, 20121
[1]See Interlaboratory test comparisons in: Laboratory Proficiency Testing at:
see point 1.3