Guide for Aquatic Animal Health Surveillance Primary authors: Flavio Corsin Aquaculture and Aquatic Animal Health Specialist Hanoi Vietnam Marios Georgiadis Lecturer of Epidemiology Faculty of Veterinary Medicine Aristotle University of Thessaloniki Greece K. Larry Hammell Professor, Dept of Health Management Director, AVC Centre for Aquatic Health Sciences Atlantic Veterinary College University of Prince Edward Island Canada Barry Hill Chief Advisor for Aquatic Animal Health Centre for Environment, Fisheries and Aquaculture Science United Kingdom Published by The World Organisation for Animal Health (OIE) All OIE (World Organisation for Animal Health) publications are protected by international copyright law. Extracts may be copied, reproduced, translated, adapted or published in journals, documents, books, electronic media and any other medium destined for the public, for information, educational or commercial purposes, provided prior written permission has been granted by the OIE. The designations and denominations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the OIE concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers and boundaries. The views expressed in signed articles are solely the responsibility of the authors. The mention of specifi c companies or products of manufacturers, whether or not these have been patented, does not imply that these have been endorsed or recommended by the OIE in preference to others of a similar nature that are not mentioned. © Copyright OIE (World Organisation for Animal Health) 12, rue de Prony, 75017 Paris, France Tel.: 33-(0)1 44 15 18 88 Fax: 33-(0)1 42 67 09 87 http://www.oie.int ISBN: 978-92-9044-767-2 Contents Acknowledgements vii Foreword ix Chapter 1 General introduction 1 Purposes of aquatic animal health surveillance 1 Surveillance versus surveys 2 Surveillance versus monitoring 2 Surveillance methodologies 3 Demonstrating the absence of disease or infection 3 Determining the occurrence or distribution of endemic disease or infection, including changes to their incidence or prevalence 4 Deciding which diseases to subject to surveillance 4 Chapter 2 Pathogen transmission in the aquatic environment 5 Transmission mechanisms 5 Routes of pathogen transmission among aquatic animals 5 Pathogen transmission in aquaculture 6 Transmission between farmed and wild aquatic animals 6 Chapter 3 Populations 8 The concept of populations 8 Host factors affecting population defi nitions 10 Epidemiological units 11 Zones and compartments 11 Clustering 13 Target population 14 Susceptibility of host species 14 Chapter 4 General design considerations 16 Types of surveillance system 16 Background information requirements 18 Prioritisation of resources 19 Sources of data 20 Case defi nition 20 Surveillance and denominator-based information 21 Chapter 5 Diagnostic tests 22 Diagnostic testing in aquatic animal health surveillance 22 Test sensitivity and specifi city 22 Predictive value of a test 23 Factors that affect test sensitivity and specifi city 24 Estimation of test sensitivity and specifi city 24 Serological tests 25 Testing using pooled samples 26 Observation of clinical signs and productivity as a diagnostic test 27 Testing in multiple laboratories 27 Use of molecular techniques for confi rmatory testing and diagnosis 27 Guide for Aquatic Animal Health Surveillance iii Contents Chapter 6 Sampling considerations for surveillance 29 General considerations 29 Sampling strategies 29 Non-probability sampling methods 30 Probability sampling 32 Clustering of disease and selection bias 33 Cluster and multi-stage sampling 33 Summary of valid sampling for disease and production 34 Sampling units 35 Sample size considerations 35 Chapter 7 Flow of information and tools/methods 38 Data and information fl ow 38 Registration of units 38 Collecting health data and information 38 Recording health data 40 Flow of information through the system 41 Reporting from laboratories 43 Chapter 8 Data management 44 General considerations 44 Diagnostic laboratory sources of data 45 Under-reporting of data in voluntary systems 45 Data validation 45 Detection of new diseases 45 Disease frequency estimation 46 Chapter 9 Statistical aspects 47 Expertise required 47 Quantifying uncertainty 47 Statistical inference 47 Statistical hypothesis testing 47 Errors in statistical hypothesis testing 47 The power of the statistical hypothesis test and sample size 48 Statistical estimation 48 Bayesian statistical inference 48 Assumptions 49 Surveillance to support claims of disease freedom 49 Design prevalence 49 Sensitivity and power of the surveillance system 50 Analysis of data 51 FreeCalc 51 Bayesfreecalc 54 Other data sources 55 Surveillance to describe disease occurrence 56 Estimating disease prevalence using imperfect diagnostic tests 57 WinPEPI 58 Temporal distribution of disease in a population 58 Surveillance for detection of new diseases 59 iv Guide for Aquatic Animal Health Surveillance Contents Chapter 10 Responsibilities and resources 60 Roles and responsibilities 60 Capacity building 62 Allocation of resources 63 Human resources 63 Infrastructure 64 Financial resources 64 Incentives 65 Chapter 11 Response to surveillance information 66 Information dissemination 66 International reporting 66 Eradication 66 Zoning 67 Evidence collection and outbreak investigations 67 Research 67 Aquatic animal health management practices 68 Modifi cations to the surveillance system 68 Health certifi cation and quarantine 69 Diagnostics 69 Contingency plans 69 Risk analysis 70 Policy and legal frameworks 70 Chapter 12 Monitoring and evaluation 71 Flexibility of surveillance 71 Sensitivity and specifi city of surveillance programmes 71 Component testing 72 Timeliness 73 Cost effi ciency 73 Ability for external audit and verifi cation 74 Chapter 13 Special design considerations for surveillance of wild, ornamental and sessile aquatic organisms 75 Wild populations 75 Ornamental aquatic animals 76 Sessile organisms 77 Chapter 14 Improving evidence to support the design and performance of surveillance systems 79 Evidence-based policy decisions 79 Considerations for assessment 79 Coordination, responsibilities and funding 80 Confl ict with end-users 80 Appendices 81 1 Establishing a passive surveillance system 82 2 One-stage structured survey (farm certifi cation) 90 3 Two-stage structured survey (national freedom) 94 4 Spatial sampling and the use of tests with imperfect specifi city 98 5 Example record sheet for aquatic animal health offi cers 101 6 Example formats of pond level information records (partial ‘pond book’) 103 Guide for Aquatic Animal Health Surveillance v Contents References and further reading 107 Software 108 Index 109 Notes 115 vi Guide for Aquatic Animal Health Surveillance Acknowledgements The OIE gratefully acknowledges the work of the members of the OIE ad hoc Group on Aquatic Animal Health Surveillance in the preparation of this Guide. The principal authors are Dr Flavio Corsin, Dr Marios Georgiadis, Dr K. Larry Hammell and Dr Barry Hill. In addition, thanks are due to Drs A. Cameron, J. Jarp and E. Peeler for their work in preparing the OIE Manual of Diagnostic Tests for Aquatic Animals, parts of which appear in this Guide, and to Drs C. V. Mohan, A. H. McVicar and E. Peeler for their work peer reviewing the manuscript. Finally, the OIE appreciates the technical and secretarial support of Drs Gillian Mylrea and Nathanaelle Donay (OIE Headquarters) in the preparation of this Guide. Guide for Aquatic Animal Health Surveillance vii Foreword For over 40 years the mandate of the World Organisation for Animal Health (OIE) has included aquatic animals. Mindful of its role as a reference standard-setting organisation of the World Trade Organization (WTO), the OIE constantly encourages Members to meet their obligations regarding their OIE Membership and the implementation of OIE standards in line with the WTO Agreement on the Application of Sanitary and Phytosanitary Standards (the SPS Agreement). The ability of veterinary services or other competent authorities to substantiate their reports of the animal health situation in their territory by conducting sound surveillance programmes is essential to safeguard trade in animals and animal products. This Guide has been prepared for the OIE by an expert ad hoc Group on Surveillance for Aquatic Animal Health, which I appointed on the recommendation of the OIE Aquatic Animal Health Standards Commission. The members of this group (Dr Flavio Corsin, Dr Marios Georgiadis, Dr K. Larry Hammell and Dr Barry Hill) are world-renowned experts on the subjects treated in the Guide. The purpose of this Guide is to provide information and guidance on the design and evaluation of surveillance systems for aquatic animal diseases. The diseases are principally, but not exclusively, those listed in the OIE Aquatic Animal Health Code (Aquatic Code). This detailed guidance supports implementation of the surveillance standards set out in the Aquatic Code and will be invaluable to OIE Members, and others, in implementing effi cient surveillance systems for obtaining information on the situation and occurrence of aquatic animal diseases, including evidence to support self-declaration of freedom from a particular disease. This will also enable veterinary and other competent authorities to better comply with the OIE Aquatic Code standards, including obligations for disease reporting, early detection and rapid response to adverse events, and thereby reduce the risk of spread of aquatic animal diseases through national, regional and global trade in live aquatic animals and their products. The emphasis throughout this Guide is on surveillance for diseases and pathogens of farmed aquatic animals, but many of the concepts and approaches apply equally to wild populations. However, while some guidance is given on disease surveillance in wild aquatic animal populations, extensive guidance for this specialised subject is beyond the scope of this fi rst edition of this Guide. The topic of wild aquatic animal disease surveillance may be considered for inclusion in future revisions, depending on feedback from OIE Members. I would like to thank the experts from the ad hoc Group who generously contributed their time and their extensive knowledge in preparing this excellent Guide. Dr Bernard Vallat Director General OIE Guide for Aquatic Animal Health Surveillance ix
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