OIE Reference Laboratory Reports Activities

Transcription

1 OIE Reference Laboratory Reports Activities Activities in 2014 This report has been submitted : :22:25 Name of disease (or topic) for which you are a designated OIE Reference Laboratory: Swine vesicular disease Address of laboratory: Istituto Zooprofilattico Sperimentale della Lombardia e dell'emilia Romagna (IZSLER) Via A. Bianchi N Brescia ITALY Tel.: Fax: address: emiliana.brocchi@izsler.it Website: Name (including Title) of Head of Laboratory (Responsible Official): Prof. Stefano Cinotti, General Director of IZSLER Name (including Title and Position) of OIE Reference Expert: Dr. Emiliana Brocchi, Head of Vesicular Diseases National Reference Centre and Dpt. Biotechnology Which of the following defines your laboratory? Check all that apply: Governmental OIE Reference Laboratory Reports Activities,

2 ToR 1: To use, promote and disseminate diagnostic methods validated according to OIE Standards 1. Did your laboratory perform diagnostic tests for the specified disease/topic for purposes such as disease diagnosis, screening of animals for export, surveillance, etc.? (t for quality control, proficiency testing or staff training) Diagnostic Test Indicated in OIE Manual (/) Total number of test performed last year Indirect diagnostic tests Nationally Internationally Competitive ELISA (OIE prescribed test for screening) yes (ref lab) (other regional labs) 36 IgG-specific ELISA yes IgM-specific ELISA yes Virus Neutralization Test yes Direct diagnostic tests Nationally Internationally Virus Isolation (cell culture) yes 16 0 Conventional RT-PCR (3D-fragment) yes Realtime RT-PCR (3D-fragment) yes Sandwich ELISA (mabs-based) yes 36 0 Sequencing (3D region) yes 3 0 Sequencing (VP1 yes 3 0 Sequencing (IRES) no 3 0 Complete genome sequencing no 10 0 ToR 2: To develop reference material in accordance with OIE requirements, and implement and promote the application of OIE Standards. 2 OIE Reference Laboratory Reports Activities, 2014

3 To store 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 supply imported standard reference reagents officially recognised by the OIE? 3. Did your laboratory supply standard reference reagents (non OIE-approved) and/or other diagnostic reagents to OIE Member Countries? Type of reagent available Related diagnostic test Produced/ provide Amount supplied nationally (ml, mg) Amount supplied internationally (ml, mg). of recipient OIE Member Countries Region of recipients Assembled reagents for competitive ELISA (capture and conjugated mabs, antigen, control sera) CompetitiveELISA (OIEprescribed test for Ab detection) Produced and provided For testing of 440,000 sera (regional labs) (NRL) For testing of 4300 sera 1 Africa Americ as Asia and Pacific Europe Middle East 4. Did your laboratory produce vaccines? 5. Did your laboratory supply vaccines to OIE Member Countries? ToR 3: To develop, standardise and validate, according to OIE Standards, new procedures for diagnosis and control of the designated pathogens or diseases 6. Did your laboratory develop new diagnostic methods validated according to OIE Standards for the designated pathogen or disease? 7. Did your laboratory develop new vaccines according to OIE Standards for the designated pathogen or disease? OIE Reference Laboratory Reports Activities,

4 Name of the new test or diagnostic method or vaccine developed Description and References (Publication, website, etc.) Improved real time PCR (3D gene) Benedetti D., Pezzoni G., Grazioli S., Bugnetti M., Brocchi E. Detection of Swine Vesicular Disease Virus (SVDV) by a new 3D gene one-step real time PCR assay. 16th International Symposium of WAVLD - Berlin, Germany, June 5-8, The test is a new one-step realtime PCR assay using TaqMan probes for amplification of a 3D gene fragment. The test was developed to improve the diagnostic sensitivity of the real-time PCR targeted on 5 UTR regions, that doenot detect all variants of the two circulating SVDV lineages. The new real-time RT-PCR, reported in 2013 report, was validated by testing 308 SVDV negative field fecal samples and 73 SVDV positive field fecal samples, each collected from a different outbreak recorded in Italy in the period , proving diagnostic specificity (100%) and sensitivity (100%) equivalent to those of the conventional, reference RT-PCR. However, due to the occurrence of nucleotide substitutions in the most recent SVDV strains that affected virus detection, studies are in progress to further improve the test by using degenerated TaqMan probes. ToR 4: To provide diagnostic testing facilities, and, where appropriate, scientific and technical advice on disease control measures to OIE Member Countries 8. Did your laboratory carry out diagnostic testing for other OIE Member Countries? Name of OIE Member Country seeking assistance Date (month). samples received for provision of diagnostic support. samples received for provision of confirmatory diagnoses BELGIUM vember sera 9. Did your laboratory provide expert advice in technical consultancies on the request of an OIE Member Country? Name of the OIE Member Country receiving a technical consultancy Purpose How the advice was provided ITALY Eradication of the disease in not free areas and implementation of biosecurity in pig industry Monitoring of surveillance results and regular inspections in non-accredited regions ToR 5: To carry out and/or coordinate scientific and technical studies in collaboration with other laboratories, centres or organisations 10. Did your laboratory participate in international scientific studies in collaboration with OIE Member Countries 4 OIE Reference Laboratory Reports Activities, 2014

5 other than the own? Title of the study Duration Purpose of the study Partners (Institutions) Improvement of available real-time RT- PCR 2 years Improve diagnostic sensitivity of real-time RT-PCR in order to cover nucleotide variations observed along the primers/probe target regions The Pirbright Institute, UK ToR 6: To collect, process, analyse, publish and disseminate epizootiological data relevant to the designated pathogens or diseases 11. Did your Laboratory collect epizootiological data relevant to international disease control? 12. Did your laboratory disseminate epizootiological data that had been processed and analysed? 13. What method of dissemination of information is most often used by your laboratory? (Indicate in the appropriate box the number by category) a) Articles published in peer-reviewed journals: 0 b) International conferences: 0 c) National conferences: 1 Dennis Benedetti, Giulia Pezzoni, Chiara Chiapponi, Santina Grazioli, Stefano Pongolini, Emiliana Brocchi Epidemiologia molecolare dei virus della Malattia Vescicolare del Suino in Italia nel periodo V Workshop Nazionale di Virologia Veterinaria, Teramo, giugno 2014 d) Other: (Provide website address or link to appropriate information) 4 Presentations at the Annual meeting for SVD National Reference Laboratories of the EU, May 2014 in Woking, UK: Grazioli S.: Epidemiology of SVD in Italy end results of the national surveillance Plan Brocchi E.: Evidence of a recombination event in SVDV. Epidemiological information on SVD in Italy and results of the SVD National Surveillance and Eradication Plan are 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 OIE Reference Laboratory Reports Activities,

6 ToR 7: To provide scientific and technical training for personnel from OIE Member Countries To recommend the prescribed and alternative tests or vaccines as OIE Standards 14. Did your laboratory provide scientific and technical training to laboratory personnel from other OIE Member Countries? ToR 8: To maintain a system of quality assurance, biosafety and biosecurity relevant for the pathogen and the disease concerned 15. Does your laboratory have a Quality Management System certified according to an International Standard? Quality management system adopted ISO Certificate scan (PDF, JPG, PNG format) CERTIFICATO_ACCREDITAMENTO.pdf 16. Is your laboratory accredited by an international accreditation body? Test for which your laboratory is accredited Competitive ELISA (OIE prescribed test for screening) Virus Neutralizazion Test Sandwich ELISA for antigen detection (mabs-based) Conventional RT-PCR 3D-gene Real Time RT PCR 3D-gene Virus Isolation Accreditation body planned for accreditation 17. 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 2014, Chapter 1.1.3a) 6 OIE Reference Laboratory Reports Activities, 2014

7 ToR 9: To organise and participate in scientific meetings on behalf of the OIE 18. Did your laboratory organise scientific meetings on behalf of the OIE? 19. Did your laboratory participate in scientific meetings on behalf of the OIE? Title of event Date (mm/yy) Location Role (speaker, presenting poster, short communications) Title of the work presented Third Global Conference of OIE Reference Centres: "Challenges and expectations for the future October 2014 Incheon (Seoul), Republic of Korea Designated expert for OIE/FAO reference lab // ToR 10: 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 20. Did your laboratory exchange information with other OIE Reference Laboratories designated for the same pathogen or disease? 21. 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? OIE Reference Laboratory Reports Activities,

8 Purpose of the proficiency tests: 1 Role of your Reference Laboratory (organiser/ participant). participants Participating OIE Ref. Labs/ organising OIE Ref. Lab. Monitoring harmonization of the competitive ELISA for Ab detection Organiser 1 Participant: The Pirbright Institute, UK / Organiser:IZSLER, Italy Combined FMD/SVD Proficiency Testing Scheme 2014, aimed at evaluating capability for differential diagnosis of FMD and SVD outbreaks and carrying out post outbreak surveillance using virological and serological methods. All serological assays (VNT, competitive ELISA and isotypespecific ELISAs) and virological test (Virus Isolation, Antigen detection ELISA, conventional and Realtime RT-PCRs) regularly used in the lab are used to test the proficiency panels of samples (panel 1- live virus, panel 2-on-infectious material for virus genome/antigen detection by RT-PCR and Ag ELISA, panel 4-sera for SVD serology). Participant more than 30 (NRLs) Participating: IZSLER, Italy / Organiser: The Pirbright Institute, UK 1 validation of a diagnostic protocol: specify the test; quality control of vaccines: specify the vaccine type, etc. 22. 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? Title of the project or contract Scope Name(s) of relevant OIE Reference Laboratories Improvement of available realtime RT-PCR (as in point 10) Improve diagnostic sensitivity of real-time RT- PCR in order to cover nucleotide variations observed along the primers/probe target regions The Pirbright Institute, UK Development of ready-to-use ELISA kits for SVD diagnosis Stabilization of in-house MAbs-based ELISA for Ag detection for inclusion in ready-to-use ELISA kits for FMD/SVD differential diagnosis The Pirbright Institute, UK ToR 11: To organise inter-laboratory proficiency testing with laboratories other than OIE Reference Laboratories for the same pathogens and diseases to ensure equivalence of results 23. Did your laboratory organise or participate in inter-laboratory proficiency tests with laboratories other than OIE Reference Laboratories for the same disease? 8 OIE Reference Laboratory Reports Activities, 2014

9 te: See Interlaboratory test comparisons in: Laboratory Proficiency Testing at: see point 1.3 Purpose for inter-laboratory test comparisons 1. participating laboratories Region(s) of participating OIE Member Countries Participation at the Combined FMD/SVD Proficiency Testing Scheme 2014, aimed at evaluating capability for differential diagnosis of FMD and SVD outbreaks and carrying out post outbreak surveillance using virological and serological methods. All serological assays (VNT, competitive ELISA and isotype-specific ELISAs) and virological test (Virus Isolation, Antigen detection ELISA, conventional and Realtime RT-PCRs) regularly used in the lab are used to test the proficiency panels of samples (panel 1-live virus, panel 2-non-infectious material for virus genome/antigen detection by RT-PCR and Ag ELISA, panel 4-sera for SVD serology). more than 30 (NRLs) Africa Americas Asia and Pacific Europe Middle East Organisation of the annual inter-laboratory test to monitor the harmonisation and performance of the 5B7-competitive ELISA carried out in Italian regional laboratories for the national surveillance plan. 10 regional labs in Italy Africa Americas Asia and Pacific Europe Middle East ToR 12: To place expert consultants at the disposal of the OIE 24. Did your laboratory place expert consultants at the disposal of the OIE? Kind of consultancy Location Subject (facultative) Answering an OIE questionnaire for the potential interest in a Biobank of veterinary biological products. Answering an OIE questionnaire for the potential interest in a database of genomic sequences connected to WAHIS. 25. Additional comments regarding your report: OIE Reference Laboratory Reports Activities,