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OIE Reference Laboratory Reports Activities Activities in 2016 This report has been submitted : 2017-01-03 16:37:22 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 1151 E-mail address: Thomas.Mueller@fli.de Website: www.fli.bund.de 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, 2016 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 623 154 FAVN - 17 ELISA 540 294 Direct diagnostic tests Nationally Internationally FAT 791 17 RTCIT 101 17 RT-PCR 329 31 Vaccine titration 2 30 Sequencing 80 30 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, 2016

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 / RTCIT / RT-PCR provide - 4 ml 1 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? Name of the new test or diagnostic method or vaccine developed Description and References (Publication, website, etc.) HighSpeed rabies RT-qPCR Schlottau et al. 2017. Development of molecular point-of-care methods for swift and easy rabies diagnostics. PLos NTD (submitted) Isothermal recombinase polymerase amplification Schlottau et al. 2017. Development of molecular point-of-care methods for swift and easy rabies diagnostics. PLos NTD (submitted) ToR 4: To provide diagnostic testing facilities, and, where appropriate, scientific OIE Reference Laboratory Reports Activities, 2016 3

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 UNITED STATES OF AMERICA 07.01.2016 1 - UNITED STATES OF AMERICA 09.03.2016 2 UNITED STATES OF AMERICA 01.04.2016 1 UNITED STATES OF AMERICA 09.05.2016 1 UNITED STATES OF AMERICA 20.05.2016 1 UNITED STATES OF AMERICA 17.06.2016 1 UNITED STATES OF AMERICA 29.07.2016 1 UNITED STATES OF AMERICA 22.07.2016 4 UNITED STATES OF AMERICA 23.09.2016 1 UNITED STATES OF AMERICA 23.09.2016 1 UNITED STATES OF AMERICA 07.10.2016 1 UNITED STATES OF AMERICA 26.10.2016 1 UNITED STATES OF AMERICA 13.12.2016 1 9. Did your laboratory provide expert advice in technical consultancies on the request of an OIE Member Country? 4 OIE Reference Laboratory Reports Activities, 2016

Name of the OIE Member Country receiving a technical consultancy Purpose How the advice was provided NAMIBIA OIE/German Project Technical Support for Namibia in Eliminating Rabies in Dogs Interims Report: Epidemiological Analysis of the Rabies Situation 2011-2015 in Namibia Interims Report: Molecular Epidemiological Analysis of the Rabies Situation in Namibia ISRAEL Application of the Kimron Veterinary Institute for Designation as an OIE-RL for Rabies laboratory training & on-site consultation 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? OIE Reference Laboratory Reports Activities, 2016 5

Title of the study Duration Purpose of the study Partners (Institutions) OIE Member Countries involved other than your country Development of the Blueprint for Rabies Surveillance" Provision of OIE/WHO standards and expert opinion on rabies surveillance in an online blueprint format Partners for Rabies Prevention / GARC SOUTH AFRICA 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, Lindholm, UNITED KINGDOM Dog rabies elimination in Namibia Provision of OIE/WHO standards, expert opinion and technical support on dog rabies elimination in northern communal areas in Namibia OIE; Ministry of Agriculture, Water & Forestry, Namibia NAMIBIA Experimental studies to control kudu rabies 2 years Development of rabies vaccination strategies for kudus Agra Limited, Namibia; Ministry of Agriculture, Water & Forestry, Namibia NAMIBIA OIE Laboratory Twinning project German-Turkey 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 Pathogenicity of Lagos bat virus in its reservoir host University of Ghana; APHA Weybridge, UK; University of Cambridge, UK; Erasmus University, Rotterdam, The Netherlands UNITED KINGDOM Epidemiology of Bokeloh Bat Lyssavirus (BBLV) Molecular characterization and pathogenesis of recent BBLVs in Natter s Bats Institute Pasteur, Paris FRANCE Deep sequencing of vaccine induced rabies cases in the frame of ORV of foxes Genetic diversity of heterogeneous lyssavirus populations ANSES Malzeville; National Veterinary Institutes SLOVENIA 6 OIE Reference Laboratory Reports Activities, 2016

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: 6 Marston, D.A., Ellis, R.J., Wise, E.L., Aréchiga-Ceballos, N, Freuling, C.M., Banyard, A.C., McElhinney, L.M., de Lamballerie, X., Müller, T., Fooks, A.R., Echevarríad, J.E. 2016 Complete Genomic Sequence of LleidaBat Lyssavirus. Genome Announcements 5 (2) e01427-16. Wasniewski M, I. Almeida, A. Baur, T. Bedekovic, D. Boncea, L. Bothelho Chaves, D. David, P. De Benedictis, M. Dobrostana, P. Giraud, P. Hostnik, I. Jaceviciene, S. Kenklies, M. König, K. Mähar, M. Mojzis, S. Moore, S. Mrenoski, T. Müller, E. Ngoepe, M. Nishimura, T. kireki, N. Pejovic, M. Smreczak, B. Strandbygaard, E. Wodak and F. Cliquet. First international collaborative study to evaluate rabies antibody detection method for use in monitoring the effectiveness of oral vaccination programmes in fox and raccoon dog in Europe. Journal of Virological Methods 238 (2016) 77 85. Schuster, I., Mertens, M., Köllner, B., Korytář, T., Keller, M., Hammerschmidt, B., Müller, T., Tordo, N., Marianneau, P., Mroz, C., Rissmann, M., Stroh, E., Dähnert, L., Hammerschmidt, F., Ulrich, R.G., Groschup, M.H. 2016. A competitive ELISA for species-independent detection of Crimean-Congo hemorrhagic fever virus specific antibodies. Antiviral Res. 2016 Sep 10;134:161-166. doi: 10.1016/j.antiviral.2016.09.004. Hanke, D., Freuling, C.M., Fischer, S., Hueffer, K., Hundertmark, K., Nadin-Davis, S., Marston, D., Fooks, A.R., Bøtner, A., Mettenleiter, T.C., Beer, M., Rasmussen, T. B., Müller, T., Höper, D. 2016. Spatio-temporal analysis of the genetic diversity of arctic rabies viruses and their reservoir hosts in Greenland. PLoS Negl Trop Dis. 2016 Jul 26;10(7):e0004779. doi: 10.1371/journal.pntd.0004779. lden, T., Pfaff, F., Nemitz, S., Freuling, C.F., Höper, D., Müller. T., Finke, S. 2015. Reverse genetics in high throughput: rapid generation of complete negative strand RNA virus cdna clones and recombinant viruses thereof. Sci Rep. 2016 Apr 5;6:23887. doi: 10.1038/srep23887. Eggerbauer, E., DeBenedictis, P., Hoffmann, B., Mettenleiter, T.C., Schlottau, K., Ngoepe, E.C., Sabeta, C.T., Freuling, C.M., Müller, T. 2016. Evaluation of six commercially available rapid immunochromatographic tests for the diagnosis of rabies in brain material. PLoS Negl Trop Dis. 2016 Jun 23;10(6):e0004776. doi: 10.1371/journal.pntd.0004776. b) International conferences: 7 Annual Meeting of the Provincial Rabies Laboratories, 15-17 March 2016, Adana, Turkey Berlin Symposium on Species Barriers in Emerging Viral Diseases, 31 March -1 April 2016, Berlin, Germany Partners for Rabies Prevention meeting 2016, 10-12 May 2016, Wolfsberg, Switzerland Annual Meeting of the National Reference Laboratories for Rabies, 15-17 June 2016, Strasbourg, France USDA Middle East Regional Gap Analysis Workshop on Emerging Animal Diseases in the Middle East Region, 26-28, 2016, Amman, Jordan 27th Conference of the OIE Regional Commission for Europe, 19-23 September 2016, Lisbon, Portugal OIE Reference Laboratory Reports Activities, 2016 7

OIE-German-Namibian Meeting on Dog Rabies Elimination, 12 October 2016, Ondangwa, Namibia c) National conferences: 3 35. Arbeits- und Fortbildungsveranstaltung der DVG-Fachgruppe AVID (Arbeitskreis Veterinärmedizinische Infektionsdiagnostik), 12-14 September 2016, Kloster Banz, Germany Öffentlicher Themenabend Kann ich durch mein Tier krank werden? Tollwut und andere Zoonosen, 29 September 2016, Jena, Germany Verbreitung und Vorkommen der Fledermaustollwut Was wissen wir?, 06 December 2016, Buckow, Germany 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? a) Technical visits: 1 b) Seminars: 0 c) Hands-on training courses: 2 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 Israel 1 c Israel 2 c Namibia 6 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? 8 OIE Reference Laboratory Reports Activities, 2016

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? (See Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Chapter 1.1.4) 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 27th Conference of the OIE Regional Commission for Europe 19-23 September 2016 Lisbon Speaker Technical Item I (with questionnaire): Control and elimination of rabies in Europe: challenges and strategies for a rabies-free 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? OIE Reference Laboratory Reports Activities, 2016 9

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 OIE-RL ANSES Nancy, France (organising Lab) Rabies serology proficiency testing (FAVN) particpant >80 OIE-RL ANSES Nancy, France (organising Lab) Rabies serology proficiency testing (RFFIT, modified RFFIT, FAVN) participant >6 OIE-RL ANSES Nancy, France; OIE-RL Nepean, Canada; OIE-RL FLI Germany (participating OIE-RL LAbs) USDA Wildlife Services, USA (organising Lab) 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), Nepean, Canada; OIE-RL, Animal and Plant Health Agency (APHA), UK Virus-host interaction of phylogroup II lyssaviruses Pathogenicity of Lagos bat virus in its reservoir host OIE-RL AHPA Weybridge, UK Deep sequencing of vaccine induced rabies cases in the frame of ORV of foxes Genetic diversity of heterogeneous lyssavirus populations OIE-RL ANSES Nancy, France 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? 10 OIE Reference Laboratory Reports Activities, 2016

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 FAT/RTCIT/RT-PCR proficiency test for RABV, EBLV-1, EBLV-2 22 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? 25. Additional comments regarding your report: OIE Reference Laboratory Reports Activities, 2016 11