OIE Reference Laboratory Reports Activities

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1 OIE Reference Laboratory Reports Activities Activities in 2017 This report has been submitted : :13:48 Name of disease (or topic) for which you are a designated OIE Reference Laboratory: Foot and mouth disease Address of laboratory: Yur'evets Vladimir RUSSIA Tel.: Fax: address: mail@arriah.ru Website: Name (including Title) of Head of Laboratory (Responsible Official): S.N. Fomina Head of Reference Laboratory for FMD diagnosis. Candidate of Science (Veterinary Medicine) A.V. Scherbakov Head of Reference Laboratory for Highly Dengerous Deasises.Candidate of Science (Biology) Name (including Title and Position) of OIE Reference Expert: V.M.Zakharov doctor of Science (Veterinary Medicine) 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 Liquid phase blocking indirect ELISA (LPB ELISA) yes Virus neutralization test yes Indirect ELISA (ELISA-NSP) yes Vaccine matching in VNT yes no 26 Direct diagnostic tests Nationally Internationally Virus isolation in cell culture yes Indirect double sandwich ELISA yes 40 7 CFT yes 32 no Real-time RT-PCR, 3D gene yes Real-time RT-PCR, 5 HTO gene yes RT-PCR, VP1 gene yes 5(O) 23 (22-O, 1-A) VP1 gene sequencing yes 5 18 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 2 OIE Reference Laboratory Reports Activities, 2017

3 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 Kit for detection of FMD antibodies in animal sera by ELISA LPB ELISA kits 41 kits 3 Africa Americas Asia and Pacific Europe Middle East Kit for FMDV antigen detection by ELISA Ag detection ELISA kits 14 kits 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? OIE Reference Laboratory Reports Activities,

4 Vaccine name Amount supplied nationally (ml, mg) (including for own use) Amount supplied to other countries (ml, mg) Name of recipient OIE Member Countries Sorbat, mono- and polyvalent FMD vaccine (based on the virus grown in BHK-21 cells) contract contract PAKISTAN orbat, mono- and polyvalent FMD vaccine (based on the virus grown in BHK-21 cells) contract contract SAUDI ARABIA orbat, mono- and polyvalent FMD vaccine (based on the virus grown in BHK-21 cells) contract contract KAZAKHSTAN Emulsion, mono- and polyvalent FMD vaccine (based on the virus grown in BHK-21 cells) contract contract KOREA (REP. OF) Emulsion, mono- and polyvalent FMD vaccine (based on the virus grown in BHK-21 cells) contract contract IRAQ 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.) Method used to determine concentration of foot-and-mouth disease virus 146Scomponent in virus-containing vaccine raw materials using real-time reverse transcription polymerase chain reaction Patent: Method used to determine concentration of foot-andmouth disease virus 146S-component in virus-containing vaccine raw materials using real-time reverse transcription polymerase chain reaction / D. A. Lozovoy, D. V. Mikhalishin, M. I. Doronin [et al.] ; FGBI ARRIAH ; Appl ; Published , Bul Introduced. from OIE Reference Laboratory Reports Activities, 2017

5 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 MONGOLIA April 12 no MONGOLIA Septemder 7 RUSSIA October 38 MONGOLIA December 5 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? OIE Reference Laboratory Reports Activities,

6 Title of the study Duration Purpose of the study Partners (Institutions) OIE Member Countries involved other than your country Immunity level assessment in animals vaccinated against FMD and identification of possible virus circulation in vaccination zones Improvement of Mongolian livestock animal health status in relation to highly dangerous diseases, including FMD National Central Veterinary Laboratory, Ulaan Baator MONGOLIA Agreement on Transboundary Trade and Mitigation of Transboundary Animal Disease Spread Risk between China, Mongolia and Russia t established Cooperation in case of dangerous animal disease emergency, including FMD PRC MoA Veterinary Bureau, Department of Veterinary and Animal Breeding of Mongolian Ministry of Food, Agriculture and Light Industry CHINA (PEOPLE'S REP. OF) ARMENIA AZERBAIJAN BELARUS KAZAKHSTAN KYRGYZSTAN TAJIKISTAN UZBEKISTAN Agreement on Transboundary Trade and Mitigation of Transboundary Animal Disease Spread Risk between China, Mongolia and Russia t established Cooperation in case of dangerous animal disease emergency, including FMD Agriculture and Light Industry MONGOLIA 6 OIE Reference Laboratory Reports Activities, 2017

7 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: 13 1.Foot-and-mouth disease spread in Mongolia/ A. V. Mischenko, V.A. Mischenko, P. Bolortuya [et al] // Veterinariya, P Funtikov A.A. Foot-and-mouth disease outbreaks in South Korea and their economic impacts/ А. А. Funtikov, S. R. Kremenchugskaya // Veterinary Science Today, P Effect of serum concentration in nutritional medium on BHK-21/2-17 and FMDV reproduction /M. A. Shevchenko, M. I. Doronin, N. D. Klyukina [et al] // Veterinary Science Today, P Examination of antibody immunity in animals vaccinated with emulsion FMD vaccines/ S.R. Kremenchugskaya, N.N. Lugovskaya, T.K. Mayorova, A.S. Sharypov // Veterinary Science Today, P Lozovoy D.A. Analysis of epidemic situation on highly dangerous and economically significant diseases in CIS states ( )/D. A. Lozovoy // Veterinary Science Today, P Lozovoy D.A. Preventive vaccination of animals essential part of FMD freedom maintenance in the country /D. A. Lozovoy // Veterinaria I Kormlenie, : Veterinary immunology key considerations: conference proceedings.-p Sharypov А.С. Effect of immunizing doses of sorbate and emulsion vaccines on antibody response formation in sheep/a. S. Sharypov, D.A. Lozovoy// Veterinaria I Kormlenie, : Veterinary immunology key considerations: conference proceedings.-p Zhiltsova M.V. Significance of systematic control of circulation of highly dangerous disease agents in wild migratory animal populations/m. V. Zhiltsova, V. M. Zakharov, V. P. Semakina// Veterinary Science Today, P Use of real time RT-PCR for determination of concentration of 146S component of О/Saudi Arabia and Asia-1/Shamir in intermediate vaccine product /D. A. Lozovoy, D. V. Mikhalishin, A. A. Shishkova [et al]// Veterinariya, P Method for determination of whole particle concentration of FMDV strain A/Kuti/2013 in vaccine raw material by reverse transcription polymerase chain reaction with fluorescence in situ hybridization/m. I. Doronin, N. N. Medvedeva, M. N. Gusyeva [et al]// Aktualnye voprosy vet. biologiyi, 2017, 2 (34).-P.19-24;URL: 11.Potency control of FGBI ARRIAH foot-and-mouth disease vaccines for absence of antibodies against nonstructural virus proteins/d. A. Lozovoy, D. V. Mikhalishin, V. A. Starikov [et al]// Veterinary Science Today, P Issues of clinical foot-and-mouth disease diagnosis in sheep and goats/a. V. Mischenko, V. A. Mischenko, V. N. Shevkoplyas [et al.] // Veterinariya selkhozzhivotnykh, P Phylogenetic analysis of FMDV isolates recovered in post-soviet states and Mongolia in 2016/A.M. Timina, N.G. Zinyakov, A.V. Scherbakov, D.A. Lozovoy// Veterinary Medicine Today, P.3-8 b) International conferences: 3 1.Vaccine for foot and mouth disease (FMD) specific prevention in farm animals. Review of preparations manufactured in FGBI "ARRIAH"/A.E. Metlin, D.A. Lozovoy, D.V. Mikhalishin, A.V. Borisov // BIT`s 1st Annual International Congress of Biotherapy BIT`s 9th Annual International Congress of Antibody BIT`s 9th Annual World Congress of Vaccine Beijing, China, P Karaulov A.K. Foot-and-mouth epidemic situation in Russian Federation/A. K. Karaulov, O. N. Petrova, S. A. Dudnikov// First West Eurasia FMD Epidemiology and Laboratory Networks Meeting, September 18-20, 2017, Tbilisi, Georgia. - Tbilisi, Georgia, С.URL: 3.Lozovoy D.A. CIS complex of joint measures for FMD prevention and control and its implementation in 2016/ D. OIE Reference Laboratory Reports Activities,

8 A. Lozovoy// Current issues of veterinary pathology and biotechnology in agro-industrial complex: Proceedings of the Research and Practical Conference devoted to 95th anniversary of RUE S.N. Vyshelessky Institute of Experimental Veterinary Medicine". -Minsk, P c) National conferences: 1 1.Development of method to determine concentration of foot-and-mouth disease virus 146S-componentof A/Turkey FMDV in vaccine raw materials using real-time reverse transcription polymerase chain reaction /M. I. Doronin, A. A. Shishkova, D. V. Mikhalishin, D.A. Lozovoy// Molecular diagnosis : All-Russia Research and Practical Conference with International Participation, Moscow, 2017: Proceedings. -Tambov, V. 2.-P d) Other: (Provide website address or link to appropriate information) 3 1.Lozovoy D.A. Implementation of CIS complex of joint measures for FMD prevention and control as a factor for epidemic safety of dairy and meat livestock industry/ D. A. Lozovoy // Proceedings of Educational Establishment Vitebsk State Academy of Veterinary Medicine. -Vitebsk, V. 53,N ed.1.-p Foot-and-mouth disease. Booklet/FGBI ARRIAH // BIO, P 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: 6 b) Seminars: 1 c) Hands-on training courses: 0 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 Korea (Rep.of) 4 a Mongolia 3 a Iraq 10 a Iran 3 a Singapore 3 a China 2 b ARRIAH, Russia 25 8 OIE Reference Laboratory Reports Activities, 2017

9 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) аттестат_лдц.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 30th Conference of the OIE Regional Commission for Asia, the Far East and Oceania vember 2017 Putrajaya, Malaysia participant - 12th Annual Meeting of FAO/OIE FMD Reference Laboratories vember, 2017 Pretoria, South Africa speaker Report on Activities of Regional FMD Reference Laboratory (FGBI ARRIAH) for 2017 OIE Reference Laboratory Reports Activities,

10 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. specify the tests for FMD and SVDV participant 64 laboratories FAO/OIE World Reference Laboratory for FMD (Pirbright, 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 Molecular epidemiology of FMD outbreaks Exchange genomic sequences of FMDV, accoding to Memorandum of understanding for OIE/FAO Network for FMD Reference Laboratories FMD WRL (Pirbright, 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? te: See Interlaboratory test comparisons in: Laboratory Proficiency Testing at: see point OIE Reference Laboratory Reports Activities, 2017

11 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,