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OIE Reference Laboratory Reports Activities Activities in 2015 This report has been submitted : 2016-01-07 14:15:05 Name of disease (or topic) for which you are a designated OIE Reference Laboratory: Rabies Address of laboratory: Südufer 10 D-17493 Greifswald - Insel Riems GERMANY Tel.: +49-38351 7 1659 / 1 Fax: +49-38351 7 1524 E-mail address: Thomas.Mueller@fli.bund.de Website: https://www.fli.de/en/home/ Name (including Title) of Head of Laboratory (Responsible Official): Dr. Thomas Müller Name (including Title and Position) of OIE Reference Expert: Dr. Thomas Müller Which of the following defines your laboratory? Check all that apply: Governmental Research OIE Reference Laboratory Reports Activities, 2015 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 RFFIT 79 1006 FAVN 1 14 Direct diagnostic tests Nationally Internationally FAT 1066 130 RTCIT 229 62 Realtime PCR 5 380 Vaccine virus titration 8 20 Sequencing 15 35 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, 2015

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 Lyssaviruses FAT, drit, RTCIT Produced / provided 50 ml 4 ml 2 Africa Americas 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? 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? OIE Reference Laboratory Reports Activities, 2015 3

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) Development of the Blueprint for Rabies Surveillance" ongoing Provision of OIE/WHO, and expert opinion as well as expertise on rabies surveillance in an online blueprint format Members of the Partners for Rabies Prevention and GARC Arctic rabies in Greenland 3 years Elucidation of Arctic rabies phylogeny in Greenland Canadian Food Inspection Agency (CFIA), University of Alaska, USA Animal and Plant Health Agency (APHA), UK University of Liverpool, UK National Veterinary Institute, Denmark, Dog rabies elimination in Namibia 3 years Provision of OIE/WHO, and expert opinion as well as technical support on dog rabies elimination in northern communal areas in Namibia OIE, Ministry of Agriculture, Water & Forestry, Namibia University of Pretoria, RSA Experimental studies to control rabies kudus 2 years Development of rabies vaccination strategies for kudus Agra Limited, Namibia Ministry of Agriculture, Water & Forestry, Namibia Dvelopment of a direct rapid immunohistochemical test for rabies diagnosis 3 years alternative test for FAT St. Ross University ANSES Nancy AHPA Weybridge Canadian Food Inspection Agency Onderstepoort Veterinary Institute OIE Laboratory Twinning project German-Turkey ongoing Laboratory and epidemiological capacity building on rabies according to OIE standards ETLIK Veterinary Research and Control Institute, Ankara, Turkey Virus-host interaction of phylogroup II lyssaviruses ongoing Pathogenicity of Lagos bat virus in its reservoir host University of Ghana AHPA Weybridge University of Cambridge, UK Evaluation of commercial rapid immunochromatographic tests for the diagnosis of rabies 2 years Comparisson of the sensitivity & specificity of rapid rabies diagnostic test Onderstepoort Veterinary Institute 4 OIE Reference Laboratory Reports Activities, 2015

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: 8 Höper, D., Freuling, C., Müller, T., Hanke, D., von Messling, V., Duchow, K., Beer, M., Mettenleiter; T.C. 2015. High definition viral vaccine strain identity and stability testing using full-genome population data the next generation of vaccine quality control. Vaccine Oct 26;33(43):5829-37. doi: 10.1016/j.vaccine.2015.08.091. Müller, T.F., Schröder, R., Wysocki, P., Mettenleiter, T.C., Freuling, C.M. 2015.Spatio-temporal Use of Oral Rabies Vaccines in Fox Rabies Elimination Programmes in Europe. PLoS Negl Trop Dis. Aug 17;9(8):e0003953. doi: 10.1371/journal.pntd.0003953. Freuling, C.M., Binger, T., Beer, M., Adu-Sarkodie, Y., Schatz, J., Fischer, M., Hanke, D., Hoffmann, B., Höper, D., Mettenleiter, T.C., Oppong, S.K., Drosten, C., Müller, T. 2015. Lagos bat virus transmission in an Eidolon helvum bat colony, Ghana. Virus Res. Virus Research 210 (2015) 42 45. doi: 10.1016/j.virusres.2015.07.009. Eckardt, M., C. Freuling, T. Müller, and T. Selhorst. 2015. Spatio-temporal analysis of fox rabies incidences in Germany 2005-2006. Geospat Health. 3;10(1):313. Horton, D.L., L.M. McElhinney, C. Freuling, D.A. Marston, H. Goharrriz, E. Wise, N. wotny, T. Müller, and A.R. Fooks. 2015. Complex epidemiology of rabies in a culturally diverse region: phylogeography of Rabies virus in the Middle East. PLoS Negl Trop Dis. 2015 Mar 26;9(3):e0003569. doi: 10.1371/journal.pntd.0003569. Ross, S., B. Wolters, B. Hoffmann, L. Geue, S. Viazov, N. Grüner, M. Roggendorf, and T. Müller. 2015. Instructive even after a decade: Complete results of initial virologicaldiagnostics and re-evaluation of molecular data in the German rabiesvirus outbreak caused by transplantations. J Med Micro boil, Oct;305(7):636-43. doi: 10.1016/j.ijmm.2015.08.013. Hampson, K., L. Coudeville, T. Lembo, M. Burton Sambo, A. Kieffer, M. Attlan, J. Barrat, J. Blanton, D. Briggs, S. Cleaveland, P. Costa, C. Freuling, E. Hiby, L. Knopf, F. Leanes, A. Metlin, M.E. Miranda, T. Müller, L. Nel, S. Recuenco, C. Rupprecht, C. Schumacher, L. Taylor, M. Vigilato, J. Zinstaag, and J. Dushoff J. 2015. Estimating the Global Burden of Endemic Canine Rabies. PLoS Negl Trop Dis. Apr 16;9(4):e0003709. doi: 10.1371/journal.pntd.0003709 Hampson, K., L. Coudeville, T. Lembo, M. Burton Sambo, A. Kieffer, M. Attlan, J. Barrat, J. Blanton, D. Briggs, S. Cleaveland, P. Costa, C. Freuling, E. Hiby, L. Knopf, F. Leanes, A. Metlin, M.E. Miranda, T. Müller, L. Nel, S. Recuenco, C. Rupprecht, C. Schumacher, L. Taylor, M. Vigilato, J. Zinstaag, and J. Dushoff J. 2015. Correction: Estimating the global burden of endemic canine rabies. PLoS Negl Trop Dis. May 11;9(5):e0003786. doi: 10.1371/journal.pntd.0003786 b) International conferences: 8 3rd International One Health Congress, Amsterdam, The Netherlands, 15-18 March 2015 Annual Meeting of the Partners for Rabies Prevention, Wolfsberg, Switzerland, 5-7 May 2015 1st Pan-African Rabies Control Network Meeting, Gauteng, South Africa, 9 11 June 2015 The International Conference on Emerging Infectious Diseases (ICEID), Atlanta, USA, 24-26 August 2015 OIE Reference Laboratory Reports Activities, 2015 5

XXVI. International Conference Rabies in the Americas, Fort Collins, USA, 4-8 October 2015 WHO Meeting on Human and Dog Rabies Vaccine and Immunoglobulins, Geneva, Switzerland, 12-13 October 2015 Technical Meeting of the WHO Collaborating Centres on Rabies, Geneva, Switzerland, 9 December 2015 OIE/WHO Conference on Global Elimination of Dog-Mediated Human Rabies -The Time Is w, Geneva, Switzerland, 9-11 December 2015 c) National conferences: 2 DVG Conference on Animal Disease Control, Berlin, 27-28 May 2015 Lower Saxony Symposium on Animal Health, Oldenburg, 25-26 June 2015 d) Other: (Provide website address or link to appropriate information) 2 http://www.who-rabies-bulletin.org/ www.fli.bund.de 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 17025 Certificate scan (PDF, JPG, PNG format) Akkreditierungsurkunde_FLI_Riems-Jena-2015.pdf 16. Is your laboratory accredited by an international accreditation body? 17. Does your laboratory maintain a biorisk management system for the pathogen and the disease concerned? 6 OIE Reference Laboratory Reports Activities, 2015

(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 OIE/WHO Conference on Global Elimination of Human Dog-Mediated Rabies 12/15 Geneva speaker PROGRESS IN RABIES ELIMINATION IN EUROPE 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? Purpose of the proficiency tests: 1 Role of your Reference Laboratory (organiser/ participant). participants Participating OIE Ref. Labs/ organising OIE Ref. Lab. FAT/RTCIT/RT-PCR proficiency test participant 50 ANSES Nancy (organising Lab.) Rabies serology proficiency testing participant > 80 ANSES Nancy (organising Lab.) OIE Reference Laboratory Reports Activities, 2015 7

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 Arctic rabies in Greenland Elucidation of Arctic rabies phylogeny in Greenland OIE-RL, Canadian Food Inspection Agency (CFIA), OIE-RL, Animal and Plant Health Agency (APHA), UK Development of a direct rapid immunohistochemical test for rabies diagnosis alternative test for FAT OIE-RL ANSES Nancy OIE-RL AHPA Weybridge OIE-RL Canadian Food Inspection Agency OIE-RL Onderstepoort Veterinary Institute Virus-host interaction of phylogroup II lyssaviruses Pathogenicity of Lagos bat virus in its reservoir host OIE-RL AHPA Weybridge Evaluation of commercial rapid immunochromatographic tests for the diagnosis of rabies Comparison of the sensitivity & specificity of rapid rabies diagnostic test OIE-RL Onderstepoort Veterinary Institute 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? 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 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? 8 OIE Reference Laboratory Reports Activities, 2015

25. Additional comments regarding your report: Rabies - Thomas Müller - germany OIE Reference Laboratory Reports Activities, 2015 9