OIE Reference Laboratory Reports Activities Activities in 2014 This report has been submitted : 2015-01-16 19:10:23 Name of disease (or topic) for which you are a designated OIE Reference Laboratory: Brucellosis (Brucella melitensis) Address of laboratory: Via Campo Boario 64100 Teramo ITALY Tel.: +390-861 33 24 05 Fax: +390-861 33 22 51 E-mail address: m.scacchia@izs.it Website: www.izs.it Name (including Title) of Head of Laboratory (Responsible Official): Dr. Fernando Arnolfo, Director General Name (including Title and Position) of OIE Reference Expert: Massimo Scacchia, DVM Head of the Animal Health Department Which of the following defines your laboratory? Check all that apply: Governmental OIE Reference Laboratory Reports Activities, 2014 1
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 RBT YES 213,822 202 CFT YES 11,578 202 ELISA YES 2 6 Direct diagnostic tests Nationally Internationally PCR-RFLP (identification) YES 157 - Bacterial isolation YES 145 - PCR YES 137 - ToR 2: To develop reference material in accordance with OIE requirements, and implement and promote the application of OIE Standards. 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? 2 OIE Reference Laboratory Reports Activities, 2014
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 RB antigen RBT Produced 177,480 ml 200 ml 3 Asia and Pacific Middle East CF antigen CFT Provide 0 60 ml 1 Asia and Pacific Middle East Positive sheep serum RBT CFT Produced 48 ml 0 0 Asia and Pacific Middle East Negative sheep serum RBT CFT Produced 28 ml 0 0 Asia and Pacific 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? OIE Reference Laboratory Reports Activities, 2014 3
7. Did your laboratory develop new vaccines according to OIE Standards for the designated pathogen or disease? 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? 9. Did your laboratory provide expert advice in technical consultancies on the request of an OIE Member Country? 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 other than the own? Title of the study Duration Purpose of the study Partners (Institutions) Scientific Assessment- ELISA Kits for Brucella sp. 3 years Evaluation of four commercial ELISA diagnostic kits for the detection of Brucella sp. antibodies OIE RL Italy, Argentina, Germany, France ANIHWA:Brucellosis in wildlife and domestic animals: development of a direct diagnostic method and assessment of genetic diversity of Brucella melitensis and Brucella suis biovar 2 strains in the EU 3 years Research project OIE RL Italy, France, NRL Spain EMIDA:Brucella melitensis: byotiping and differential diagnostic 3 years Research project OIE RL Italy and Israel, NRL Greece 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? 4 OIE Reference Laboratory Reports Activities, 2014
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: 2 Fabrizio De Massis, Annamaria Conte, Giuliano Garofolo, Cesare Cammà, Carla Ippoliti, Luca Candeloro, Massimo Ancora, Paolo Calistri. Genetic characterization of Brucella melitensis and Brucella abortus geographical clusters in Italy. Veterinaria Italiana. In press Ancora M., Garofolo G., 2014. MLST e MLVA-16 come strumenti di epidemiologia molecolare per la brucellosi in Italia, Large Animal Review supplement 1 n. 4 - August 2014. b) International conferences: 5 Garofolo G., Sacchini F., Ancora M., Travaglini D., Ekateriniadou L., Petridou E., Banai M., Tittarelli M. 2014 Multiple-locus variable-number tandem repeat analysis (MLVA) of Brucella melitensis strains isolated in Italy, Greece and Israel. International Research Conference Brucellosis 2014 Including the 67th Annual Brucellosis Research Meeting 9-12 September 2014 Berlin Sacchini F., Bonfini B., Chiarenza G., Conte A., Gargano V., Paci V., Salini R., Travaglini D., Vesco G., Villari S., Zilli K., Tittarelli M. 2014 False positive reactions to serological tests for brucellosis: analysis of antibody response to Escherichia coli O157:H7 and Yersinia enterocolitica O:9 in experimentally immunised sheep. International Research Conference Brucellosis 2014 Including the 67th Annual Brucellosis Research Meeting 9-12 September 2014 Berlin De Massis F., Zilli K., Ancora M., Di Donato G., Scacchia M., Di Giannatale E. 2014 Update about typing of Brucella field strains isolated from livestock and wildlife populations in Italy,2007-2012. International Research Conference Brucellosis 2014 Including the 67th Annual Brucellosis Research Meeting 9-12 September 2014 Berlin Garofolo G., Foster J.T., Drees K., Platone I., Zilli K., Ancora M., De Massis F., Scacchia M., Di Giannatale E. 2014 Insights into the genetic lineages and current spreadof B. abortus and B. melitensis in Italy. International Research Conference Brucellosis 2014 Including the 67th Annual Brucellosis Research Meeting 9-12 September 2014 Berlin F. De Massis, M. Ancora, M. Atzeni, S. Rolesu, E. Bandino, M. L. Danzetta, K. Zilli, E. Di Giannatale. Multilocus Variable Number of Tandem Repeats Analysis (MLVA) as an epidemiological tool to trace-back the re-emergence of Brucella melitensis biovar 1 in Italy. International Research Conference Brucellosis 2014 Including the 67th Annual Brucellosis Research Meeting 9-12 September 2014 Berlin c) National conferences: 1 Villari S., Vesco G., Chiarenza G., Gargano V., Bonfini B., Luciani M., Travaglini D., Ciarelli A., Paci V., Orsini G., Tittarelli M., Sacchini F. 2014 Cross-reattività nei test sierologici per brucellosi: valutazione della risposta immunitaria verso Escherichia coli O157:H7 e Yersinia enterocolitica O:9. Simposio di Immunologia Veterinaria Firenze, 28 maggio 2014 d) Other: (Provide website address or link to appropriate information) 0 ToR 7: To provide scientific and technical training for personnel from OIE Member OIE Reference Laboratory Reports Activities, 2014 5
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? a) Technical visits: 1 b) Seminars: 0 c) Hands-on training courses: 7 d) Internships (>1 month): 0 Type of technical training provided (a, b, c or d) Country of origin of the expert(s) provided with training. participants from the corresponding country a Kazakhstan 4 c Zimbabwe 6 c Kazakhstan 8 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 17025 Certificate scan (PDF, JPG, PNG format) Certificate_of_accreditation_ISO_17025_IZSAM-1.pdf 16. Is your laboratory accredited by an international accreditation body? 6 OIE Reference Laboratory Reports Activities, 2014
Test for which your laboratory is accredited Complement Fixation test (CFT) RBT c-elisa FPA PCR-RFLP (identification) Bacterial isolation Accreditation body 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) 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 10/2014 Seoul, Korea - - 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? OIE Reference Laboratory Reports Activities, 2014 7
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? Purpose of the proficiency tests: 1 Role of your Reference Laboratory (organiser/ participant). participants Participating OIE Ref. Labs/ organising OIE Ref. Lab. To assess performance of serological tests: RBT, CFT and i- ELISA organiser/participant 78 an and OIE Reference Laboratory for Brucellosis - SENASA To assess Laboratory performancances on Brucella isolatioan and identification from animal matrix organiser/participant 16 Italian Laboratories To assess Laboratory performancances on Brucella isolatioan and identification from food matrix organiser/participant 13 Italian Laboratories 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 ANIHWA:Brucellosis in wildlife and domestic animals: development of a direct diagnostic method and assessment of genetic diversity of Brucella melitensis and Brucella suis biovar 2 strains in the EU To develop new methods for epidemiological study Italy and France EMIDA:Brucella melitensis: byotiping and differential diagnostic To develop new antigen for serological tests Italy and Israel 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 8 OIE Reference Laboratory Reports Activities, 2014
OIE Reference Laboratories for the same disease? Brucellosis (Brucella melitensis) - Massimo Scacchia - italy te: See Interlaboratory test comparisons in: Laboratory Proficiency Testing at: http://www.oie.int/en/our-scientific-expertise/reference-laboratories/proficiency-testing see point 1.3 Purpose for inter-laboratory test comparisons 1. participating laboratories Region(s) of participating OIE Member Countries To assess Laboratory performancances on serological diagnosis of Brucellosis 6 Asia and Pacific 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) Revision of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals Teramo - Italy Revision of chapter on Brucellosis of Manual of diagnostic tests and Vaccines OIE Procedure -Scientific Assessment Teramo - Italy ELISA Kits for Brucella sp. 25. Additional comments regarding your report: OIE Reference Laboratory Reports Activities, 2014 9