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OIE Collaborating Centres Reports Activities Activities in 2017 This report has been submitted : 2018-01-12 06:41:15 Title of collaborating centre: Diagnostic Test Validation Science in the Asia- Region Address of Collaborating Centre: CSIRO Australian Animal Health Laboratory (AAHL) 5 Portarlington Road Newcomb, Victoria 3219 AUSTRALIA Tel.: +61-3 5227 5255 Fax: +61-3 5227 5250 E-mail address: axel.colling@csiro.au Website: www.csiro.au/en/research/facilities/aahl Name of Director of Institute (Responsible Official): Dr Kurt Zuelke, Director Name (including Title and Position) of Head of the Collaborating Centre (formally OIE Contact Point): Veterinary Diagnostic Scientist Name of writer: OIE Collaborating Centres Reports Activities, 2017 1

Diagnostic Test Validation Science in the Asia- Region - CSIRO Newcomb ToR: To provide services to the OIE, in particular within the region, in the designated specialty, in support of the implementation of OIE policies and, where required, seek for collaboration with OIE Reference Laboratories ToR: To identify and maintain existing expertise, in particular within its region 1. Activities as a centre of research, expertise, standardisation and dissemination of techniques within the remit of the mandate given by the OIE Training, capacity building Title of activity Training in diagnostic test evaluation of OIE/MFAT SEACFMD project staff of four SEA countries in epidemiology. Three post conference workshops on epidemiology, microbiology and genomics at the 10th International Leptospirosis Society Meeting, 03-05 Dec 2017. Scope 4 week intensive course work on epidemiology and analysis of diagnostic test data of veterinarians from Myanmar (3), Laos PDR (3), Cambodia (2), Vietnam (2), 20Aug-16Sep 2017 36 participants from 14 countries trained in epidemiology, microbiological diagnostics and pathogen genomics incl. hands-on data analysis. Training course on the diagnosis of transboundary animal diseases. In collaboration with the International Atomic Energy Agency (IAEA), provision of a three day training workshop in Rabies antigen detection diagnostic and molecular characterization methods, incorporating phylogenetic analysis of Genotype 1 Rabies viruses. FAO Backstopping missions to participating Laboratories in Asia - 2017. Technical Support in country to laboratory personnel to strengthen laboratory diagnostic capacity and ensure implementation of a standardised protocol for diagnosis for priority animal diseases under accredited quality assurance system. The services will contribute to the reduced animal disease and associated human health risks, by enhancing capacity to implement and maintain national and regional approaches to animal disease prevention and control which will contribute to increased sustainable livestock production. Regional PT provision for FAO, OIE and OFFLU programs. To develop and distribute Proficiency Testing panels to assess and standardise the capability of national and regional laboratories in the to detect and characterise virus isolates of key targeted emergency animal health diseases. Zoonoses Title of activity Scope Diagnostic preparedness for emerging zoonotic avian influenza strains. In partnership with the OFFLU network AAHL receives AI isolates from the region and evaluates the performance of existing diagnostic tests, fine tuning tests where needed, validating new tests and preparing and distributing reagents regionally for surveillance and diagnosis. The OFFLU contribution to the WHO VCM process. AAHL networks with other AI reference centres to analyse isolates and data relating to isolates of H5 and H9 AI twice a year for consideration by the WHO in the selection of antigens to bank in preparedness for emergence of a human pandemic influenza of animal origin. 2 OIE Collaborating Centres Reports Activities, 2017

Diagnostic Test Validation Science in the Asia- Region - CSIRO Newcomb Diagnosis, biotechnology and laboratory Title of activity Inter-laboratory comparison of n swine fever diagnostic platforms using laboratory and field samples from domestic pigs and East n wild pigs. Scope To assess serological and molecular tests for the detection of AFSV infection and compare their performance across laboratories at AAHL and ILRI. Rapid detection and epidemiology surveillance of n Swine Fever using oral fluid. A partnership with Kansas State University to compare the diagnostic performance of available ASFV RT-PCR and ELISAs, including commercial kits. Compare diagnostic performance as a function of the diagnostic specimen tested. The findings will guide sample selection under specific testing circumstances. Development and validation of a real-time PCR test for the detection and identification of Megalocytiviruses. This project has established a sensitive, pan-specific diagnostic test for the detection of both RSIV-like and ISKNV-like Megalocytiviruses. A non-infectious plasmid positive-control is also available and has been transferred to several laboratories within Australia as well as overseas. Diagnostic preparedness for circulating and emerging avian influenza strains from disease outbreaks and surveillance. Technical Support in country to laboratory personnel to strengthen laboratory diagnostic capacity and ensure implementation of a standardised protocol for diagnosis for priority animal diseases under accredited quality assurance system. The services will contribute to the reduced animal disease and associated human health risks, by enhancing capacity to implement and maintain national and regional approaches to animal disease prevention and control which will contribute to increased sustainable livestock production. Other (Name the category) Title of activity Scope Collaborative Centre for Diagnostic Test Validation Science. The CC is an international scientific consortium (AAHL, Uni Melbourne and EpiCentre at Massey University, NZ which combine expertise in diagnostics, epidemiology and modelling. The Centre s mission is to generate new knowledge and techniques that improve the use and interpretation of diagnostic tests used in human and animal health and to promote dissemination of that knowledge to the wider medical and veterinary communities." International networking in the validation and application of diagnostic tests for infectious diseases. Diagnostic test validation science for improved design and reporting of diagnostic accuracy studies (field and experimental) for OIE (World Organisation for Animal Health)-listed terrestrial and aquatic pathogens. Dr Ian Gardner (UPEI, Canada) visited AAHL 14-22 March 2017 as part of a CSIRO Mc Master fellowship program for visiting scientists. ELISA and Molecular Techniques in Animal Disease Diagnosis FAO/IAEA Animal Production and Health Laboratory, Animal Production and Health Laboratory, Agriculture and Biotechnology Laboratory, IAEA Laboratories. Research Coordination Project on the Early Detection of Transboundary Animal Diseases to Facilitate Prevention and Control through a Veterinary Diagnostic Laboratory Network (VETLAB Network). Validation of real-time polymerase chain reactions for the detection of WSSV in clinically diseased or sub-clinically infected prawns via the OIE template. Latent class models were identified and adopted to estimate performance characteristics of two TaqMan assays in two populations with different prevalences. ToR : To propose or develop methods and procedures that facilitate harmonisation OIE Collaborating Centres Reports Activities, 2017 3

Diagnostic Test Validation Science in the Asia- Region - CSIRO Newcomb of international standards and guidelines applicable to the designated specialty 2. Proposal or development of any procedure that will facilitate harmonisation of international regulations applicable to the surveillance and control of animal diseases, food safety or animal welfare Proposal title Scope/Content Applicable area Special Issue of OIE Scientific and Technical Review: Diagnostic Test Validation Co-ordination of a series of papers on test validation science for a special issue of the OIE Technical Review scheduled for 2020. Surveillance and control of animal diseases Food safety Animal welfare Special Issue in Preventive Veterinary Medicine Design, statistical analysis and reporting standards for test accuracy studies for infectious diseases in animals: progress, challenges and recommendations. Surveillance and control of animal diseases Food safety Animal welfare Special Issue in Journal of Veterinary Diagnostic Investigations Validation of diagnostic tests used in wildlife and use of Latent Class Analysis Surveillance and control of animal diseases Food safety Animal welfare OIE ad hoc Group on the OIE Manual of Diagnostic Tests for Aquatic Animals Review specific issues in the Aquatic Manual to improve consistency among chapters and improve the quality and completeness of information. Surveillance and control of animal diseases Food safety Animal welfare ToR: To establish and maintain a network with other OIE Collaborating Centres designated for the same specialty, and should the need arise, with Collaborating Centres in other disciplines ToR: To carry out and/or coordinate scientific and technical studies in collaboration with other centres, laboratories or organisations 3. Did your Collaborating Centre maintain a network with other OIE Collaborating Centres (CC), Reference Laboratories (RL), or organisations designated for the same specialty, to coordinate scientific and technical studies? Yes Name of OIE CC/RL/other organisation(s) Location Region of networking Centre Purpose 4 OIE Collaborating Centres Reports Activities, 2017

Diagnostic Test Validation Science in the Asia- Region - CSIRO Newcomb Faculty of Veterinary and Agricultural Sciences (FVAS),> The University of Melbourne, Parkville, Victoria 3010, Australia Melbourne, Australia Quantitative and spatial epidemiology, modelling of infectious diseases and analysis of complex datasets including the use and development of latent class models to validate diagnostics for a range of endemic pathogens. URL: http://fvas.unimelb.edu.au EpiCentre, Institute of Veterinary and Biomedical Sciences, Massey University, Palmerston North, New Zealand Research and training in veterinary epidemiology with expertise in the understanding and control of disease in animal populations, the transmission of disease from animals to humans, and hazards in food of animal origin. Private Bag 11-222, Palmerston North 4412, New Zealand, http://epicentre.massey.ac.nz VetBioNet A global network The project forms a network of facilities researching animal diseases (including diseases which can spread to humans) in secure facilities. It will develop new technologies for this which go considerably beyond the current state of the art as well as activities such as standardization of protocols and best practices as well as connecting with similar institutes outside. New tools will be developed for remote monitoring of the animals' health and welfare. Vetlab (IAEA) A global network Early Detection of Transboundary Animal Diseases to Facilitate Prevention and Control through a Veterinary Diagnostic Laboratory Network. 4. Did your Collaborating Centre maintain a network with other OIE Collaborating Centres, Reference laboratories, or organisations in other disciplines, to coordinate scientific and technical studies? Yes OIE Collaborating Centres Reports Activities, 2017 5

Diagnostic Test Validation Science in the Asia- Region - CSIRO Newcomb Name of OIE CC/RL/other organisation(s) Location Region of networking Centre Purpose Canada Excellence Research Chair - Aquatic Epidemiology Atlantic Veterinary College (3N), UPEI 550 University Ave. Charlottetown, Prince Edward Island, C1A 4P3 Prince Edward Island, Canada Aquatic epidemiology and validation of diagnostic tests for infectious diseases of aquatic animals. Friedrich Loeffler Institute(FLI) Insel Riems, Germany Diagnosis and epidemiology of zoonotic diseases, validation of Hendra ELISA. National Institute of Animal Health (NIAH), Japan Tsukuba, Ibaraki Prefecture, Japan Diagnosis and epidemiology of foot and mouth disease virus based on genome sequencing data. Ministry for Primary Industries, New Zealand Upper Hutt, New Zealand Diagnosis and epidemiology of Q fever and Mycobacterium bovis. The University of Queensland, School of Veterinary Science The University of Queensland, Gatton Campus, Australia Diagnosis and epidemiology of Q fever and Mycobacterium bovis. 6 OIE Collaborating Centres Reports Activities, 2017

Diagnostic Test Validation Science in the Asia- Region - CSIRO Newcomb Australian Rickettsial Reference Laboratory Barwon Health, Geelong, Australia Diagnosis and epidemiology of Q fever. Animal & Plant Health Agency (APHA), Central Veterinary Laboratory, UK Animal & Plant Health Agency (APHA), Central Veterinary Laboratory, Weybridge, New Haw, Addlestone, Surrey, UK Evaluation and improvement of serological diagnostic testing for bovine Tuberculosis in camelids OFFLU A global network Coordination of the science underpinning the management and control of influenza in animals. OIE Aquatic Animal Health Standards Commission A global network Collaboration to ensure the Aquatic Animal Health Code (the Aquatic Code) and Manual of Diagnostic Tests for Aquatic Animals (the Aquatic Manual) reflect current scientific information. OIE ad hoc Group on susceptibility of fish species to infection with OIE listed diseases A global network Coordination of the science underpinning the management and control of OIE-listed diseases of fish species. ToR: To place expert consultants at the disposal of the OIE. 5. Did your Collaborating Centre place expert consultants at the disposal of the OIE? Yes Name of expert Kind of consultancy Subject Chair electronic ad hoc group for Tilapia Lake Virus (TiLV) The OIE electronic ad hoc Group on tilapia lake virus (TiLV) will evaluate published and unpublished methods for detection of TiLV, describe the level of validation of each method and determine additional validation requirements, recommend any additional assays that may need to be developed and facilitate the sourcing and distribution of well-characterised positive control material for method evaluation, implementation and inter-laboratory comparability studies. (8 experts in total). OIE Collaborating Centres Reports Activities, 2017 7

Diagnostic Test Validation Science in the Asia- Region - CSIRO Newcomb Chair of ad hoc group for registration of diagnostic kit (FMD ELISA) The OIE ad hoc group evaluates the submission of an OIE validation dossier for a non-structural antibody ELISA kit for the detection of FMD infected livestock (3 experts in total). Dr Wilna Vosloo Meeting participate OIE sub-committee for FMD in South East China - Coordination for the review of FMD threats, preparedness and diagnostic capabilities. Dr Mark Crane Invited participant/chair OIE ad hoc Group on Susceptibility of Fish Species to Infection with OIE Listed Diseases. Dr Sam McCullough, Dr Debbie Eagles, Dr Kim Halpin, Dr Nick Moody Invited participants Regional Meeting for OIE Reference Centres for the Dr John Allen,, Dr Jianning Wang, Dr Anthony Keyburn Invited participants Various meetings and consultations as part for the OIE Twinning Project a partnership to enhance and deliver emerging infectious diseases (EID) preparedness in the ASEAN region. Dr Nick Moody Invited participant OIE Aquatic Animal Health Standards Commission meeting. Dr Nick Moody Invited participant OIE ad hoc Group on the OIE Manual of Diagnostic Tests for Aquatic Animals. Dr Wilna Vosloo Invited participant OIE FMD ad hoc group meeting. Dr Wilna Vosloo Invited participant OIE/FAO lab network for FMD reference laboratories. Dr John Allen and Gemma Carlile Invited participant 2017 Regional Animal Health Laboratory Technical Advisory group (lab- TAG) Meeting - Regional coordination for technical advice to the member countries on strategic planning and laboratory capacity building activities related to emerging, re-emerging and priority animal diseases of the region. Bangkok, Thailand. Dr Frank Wong Invited participant (FAO lead) Regional consultation to contribute to the development of pilot bioinformatics training modules that align with a regional strategy for bioinformatics to support existing prevention and control strategies on emerging pandemic threats from animal and zoonotic diseases within the Asia- region. Dr Frank Wong Invited participant OFFLU Swine Influenza Virus Group Meeting Agreement Early Detection of Transboundary Animal Diseases to Facilitate Prevention and Control through a Veterinary Diagnostic Laboratory Network, Joint FAO/IAEA Programme of Nuclear Techniques in Food and Agriculture, Vienna, Austria, 4 17 August 2017. Invited presenter Series of seminars about OIE's principles and methods for diagnostic test validation, Brazil, Jan 2017. 8 OIE Collaborating Centres Reports Activities, 2017

Diagnostic Test Validation Science in the Asia- Region - CSIRO Newcomb Agreement Holder participant Second Research Coordination Meeting on Early Detection of Transboundary Animal Diseases to Facilitate Prevention and Control through a Veterinary Diagnostic Laboratory Network, Joint FAO/IAEA Programme of Nuclear Techniques in Food and Agriculture, Vienna, Austria, 17 Aug 2017. Invited participant IV International Conference for Animal Health and Prevention (ENISAP), Cuiaba, Brazil, 9 Sept - 9 Oct 2017. ToR: To provide, within the designated specialty, scientific and technical training to personnel from OIE Member Countries 6. Did your Collaborating Centre provide scientific and technical training, within the remit of the mandate given by the OIE, to personnel from OIE Member Countries? Yes a) Technical visits: 3 b) Seminars: 3 c) Hands-on training courses: 6 d) Internships (>1 month): 0 Type of technical training provided (a, b, c or d) Content Country of origin of the expert(s) provided with training No. participants from the corresponding country B OIE s principles and methods for diagnostic test validation.university of Juiz de Fora, Minas Gerais, Brazil, 23 January 2017 Brazil 15 B OIE s principles and methods for diagnostic test validation.ministry of Agriculture, Brasilia, Brazil, 26 January 2017. Brazil 35 B OIE s principles and methods for diagnostic test validation. Federal University of Rio de Janeiro, Brazil, 30 January 2017. Brazil 40 A Technical visit (study tour) by Professor Nathalie Cunha, Departamento de Saúde Coletiva Veterinária e Saúde Pública, Universidade Federal Fluminense, Brazil (Sept 2017): validation of diagnostic tests for CAE and rabies risk mapping. Brazil 1 C Validity in Observational Studies, Epi in the Vineyard 2017, Tanunda, South Australia (April 2017), with Professor Ian Dohoo (University of Prince Edward Island, Canada): quantitative bias adjustment of study outcomes incorporating bias due to imperfect test results. Australia 15 C Program for Proficiency Testing (PT) training/workshop Indonesia 24 OIE Collaborating Centres Reports Activities, 2017 9

Diagnostic Test Validation Science in the Asia- Region - CSIRO Newcomb C Technical training diagnosis of transboundary diseases Vietnam 20 C Technical training Histopathology and EM for the purpose of enhancing capability in the investigation on new and emerging diseases Thailand 2 C Technical training molecular detection of Megalocytivirus Thailand 2 C Technical support and training on AFDL diagnostic tests Chile 24 A Technical advice provided at the Regional Technical Workshop on the Prevention and Control of Animal Brucellosis and Tuberculosis in Asia Thailand 45 A Technical advice for the control of AI in Asia Japan 64 ToR: To organise and participate in scientific meetings and other activities on behalf of the OIE 7. Did your Collaborating Centre organise or participate in the organisation of scientific meetings on behalf of the OIE? Yes National/International Title of event Co-organiser Date (mm/yy) Location No. Participants International 10th International Leptospirosis Society Meeting, 27 Nov - 01 Dec 2017 Cord Heuer, Jackie Benschop 11/17 Palmerston North 196 ToR: To collect, process, analyse, publish and disseminate data and information relevant to the designated specialty 8. Publication and dissemination of any information within the remit of the mandate given by the OIE that may be useful to Member Countries of the OIE a) Articles published in peer-reviewed journals: 3 1. Rahmadane I., Certoma A.F., Peck G.R., Fitria Yul, Payne J.,Colling A., Shiell B.J., Beddome G., Wilson S., Yu M., Morrissy C., Michalski W.P., Bingham J., Gardner I.A., Allen J.D.- Development and validation of an immunoperoxidase antigen detection test for improved diagnosis of rabies in Indonesia. PLOS Neglected Tropical Diseases https://doi.org/10.1371/journal.pntd.0006079 November 13, 2017 2. Roeber, F., Hassan, E.B., Skuce, P., Morrison, A., Claerebout, E., Casaert, S., Homer, D.R., Firestone, S., Stevenson, M., Smith, L., 2017. An automated, multiplex-tandem PCR platform for the diagnosis of gastrointestinal nematode infections in cattle: An Australian-an validation study. Vet Parasitol 239, 62-75. 3. Shaw, T., Kudnig, S., Firestone, S.M., 2017. Diagnostic accuracy of pre-treatment biopsy for grading cutaneous 10 OIE Collaborating Centres Reports Activities, 2017

Diagnostic Test Validation Science in the Asia- Region - CSIRO Newcomb mast cell tumours in dogs. Vet. Comp. Oncol. b) International conferences: 3 1. Colling, Axel. 2nd FAO/IAEA Coordinated Research Project Meeting: Early Detection of Transboundary Animal Diseases (TADs) to Facilitate Prevention and Control through a Veterinary Diagnostic Laboratory Network (VETLAB Network), 7-11 August 2017, IAEA Headquarters, Vienna, Austria. 2. Colling, Axel. Cases of Glanders in Mato Grosso: Serological tests and diagnosis. In: IV International Conference for Animal Health and Prevention (ENISAP), 3-6 October 2017, Cuiaba, Brazil. 3. Firestone, Simon. Evaluation of Foot and Mouth Disease Outbreak Transmission Models. In: Global FMD Research Alliance Scientific Meeting, 25-27 October, 2017, Incheon, South Korea. c) National conferences: 1 1. Newberry, Kim; Colling Axel. User beware: is your diagnostic test fit for its intended purpose? In: Australian Association of Veterinary Laboratory Diagnosticians (AAVLD), 23-24 November 2017, Sydney. d) Other (Provide website address or link to appropriate information): 3 Webpage for OIE Collaborative Centre for Test Validation Science South : http://fvas.unimelb.edu.au/research/research-centres/oie-dx/contact Webpage for epidemiology teaching tools, including Beta buster, sample size estimator and other tools for diagnostic test evaluation studies. http://fvas.unimelb.edu.au/research/research-areas/veterinary-epidemiology-melbourne/resources epir statistical library for the R statistical package, including functions for epidemiological calculations such as those required for or diagnostic test evaluation studies: https://cran.r-project.org/web/packages/epir/index.html OIE Collaborating Centres Reports Activities, 2017 11