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WORLD ORGANISATION FOR ANIMAL HEALTH

WORLD ORGANISATION FOR ANIMAL HEALTH . MANUAL OF DIAGNOSTIC TESTS AND VACCINES. FOR TERRESTRIAL ANIMALS. (mammals, birds and bees). Sixth Edition Volume 2. 2008. This Terrestrial Manual has been edited by the OIE Biological Standards Commission and adopted by the International Committee of the OIE. Reference to commercial kits does not mean their endorsement by the OIE. All commercial kits should be validated; tests on the OIE register have already met this condition (the register can be consulted at: ). OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals Sixth Edition, 2008. Manual of Recommended Diagnostic Techniques and Requirements for Biological Products: Volume I, 1989; Volume II, 1990; Volume III, 1991. Manual of Standards for Diagnostic Tests and Vaccines: Second Edition, 1992.

How to use this Terrestrial Manual iv OIE Terrestrial Manual 2008 The Terrestrial Manual continues to expand and to extend its range of topics covered. It is our sincere hope that it will grow in usefulness to veterinary diagnosticians and vaccine manufacturers in all the OIE Member Countries.

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Transcription of WORLD ORGANISATION FOR ANIMAL HEALTH

1 WORLD ORGANISATION FOR ANIMAL HEALTH . MANUAL OF DIAGNOSTIC TESTS AND VACCINES. FOR TERRESTRIAL ANIMALS. (mammals, birds and bees). Sixth Edition Volume 2. 2008. This Terrestrial Manual has been edited by the OIE Biological Standards Commission and adopted by the International Committee of the OIE. Reference to commercial kits does not mean their endorsement by the OIE. All commercial kits should be validated; tests on the OIE register have already met this condition (the register can be consulted at: ). OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals Sixth Edition, 2008. Manual of Recommended Diagnostic Techniques and Requirements for Biological Products: Volume I, 1989; Volume II, 1990; Volume III, 1991. Manual of Standards for Diagnostic Tests and Vaccines: Second Edition, 1992.

2 Third Edition, 1996. Fourth Edition, 2000. Fifth Edition, 2004. ISBN 978-92-9044-718-4. Copyright OFFICE INTERNATIONAL DES EPIZOOTIES, 2008. 12, rue de Prony, 75017 Paris, FRANCE. Telephone: 33-(0)1 44 15 18 88. Fax: 33-(0)1 42 67 09 87. Electronic mail: 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.

3 FOREWORD. The Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (Terrestrial Manual) aims to facilitate international trade in animals and ANIMAL products and to contribute to the improvement of ANIMAL HEALTH services WORLD -wide. The principal target readership is laboratories carrying out veterinary diagnostic tests and surveillance, plus vaccine manufacturers and regulatory authorities in Member Countries. The objective is to provide internationally agreed diagnostic laboratory methods and requirements for the production and control of vaccines and other biological products. This ambitious task has required the cooperation of highly renowned ANIMAL HEALTH specialists from many countries. The OIE, the WORLD ORGANISATION for ANIMAL HEALTH , is clearly the most appropriate ORGANISATION to undertake this task on a global level.

4 The main activities of the ORGANISATION , which was established in 1924 and in 2008 comprised 172 Member Countries and Territories, are as follows: 1. To ensure transparency in the global ANIMAL disease and zoonosis situation. 2. To collect, analyse and disseminate scientific veterinary information on ANIMAL disease control methods. 3. To provide expertise and encourage international solidarity in the control of ANIMAL diseases. 4. Within its mandate under the WTO ( WORLD Trade Organization) Agreement on Sanitary and Phytosanitary Measures (SPS Agreement), to safeguard WORLD trade by publishing HEALTH standards for international trade in animals and ANIMAL products. 5. To improve the legal framework and resources of national veterinary Services. 6. To provide a better guarantee of the safety of food of ANIMAL origin and to promote ANIMAL welfare through a science-based approach.

5 The Terrestrial Manual, covering infectious and parasitic diseases of mammals, birds and bees, was first published in 1989. Each successive edition has extended and updated the information provided. This sixth edition includes new chapters on Guidelines for international standards for vaccine banks, Turkey rhinopneumonitis, Small hive beetle infestation (Aethina tumida) and camelpox, and Mycoplasma synoviae has been added to the chapter on Avian mycoplasmosis (previously the chapter focused on Mycoplasma gallisepticum. As a companion volume to the Terrestrial ANIMAL HEALTH Code, the Terrestrial Manual sets laboratory standards for all OIE listed diseases as well as several other diseases of global importance. In particular it specifies (in blue font) those Prescribed Tests that are recommended for use in HEALTH screening for international trade or movement of animals.)

6 The Terrestrial Manual has become widely adopted as a key reference book for veterinary laboratories around the WORLD . Aquatic ANIMAL diseases are included in a separate Aquatic Manual. The task of commissioning chapters and compiling the Terrestrial Manual was assigned to the OIE. Biological Standards Commission by the International Committee of the OIE (General Assembly of national Delegates of Member Countries and Territories). Manuscripts were requested from specialists in each of the diseases or the other topics covered. After initial scrutiny by the Consultant Technical Editor, the chapters were sent to scientific reviewers and to experts at OIE. Reference Laboratories. They were also circulated to all OIE Member Countries for review and comment.

7 The Biological Standards Commission and the Consultant Technical Editor took all the resulting comments into consideration, often referring back to the authors for further help, before finalising the chapters. The final text has the approval of the International Committee of the OIE. A procedure for the official recognition of commercialised diagnostic tests, under the authority of the International Committee, was finalised in September 2004. Data are submitted using a validation template that was developed by the Biological Standards Commission. Submissions are evaluated by appointed experts, who advise the Biological Standards Commission before the final opinion of the OIE International Committee is sought. All information on the submission of applications can be found on the OIE Web site.

8 OIE Terrestrial Manual 2008 iii How to use this Terrestrial Manual The Terrestrial Manual continues to expand and to extend its range of topics covered. It is our sincere hope that it will grow in usefulness to veterinary diagnosticians and vaccine manufacturers in all the OIE Member Countries. A new paper edition of the Terrestrial Manual is published every 4 years. It is important to note that annual updates to the Terrestrial Manual will be published on the OIE website once approved by the International Committee, so readers are advised to check there for the latest information. The Terrestrial Manual is published in English, French and Spanish. Doctor Bernard Vallat Professor Steven Edwards Director General, OIE President, OIE Biological Standards Commission January 2008.

9 Iv OIE Terrestrial Manual 2008. ACKNOWLEDGEMENTS. I am most grateful to the many people whose combined efforts have gone into the preparation of this Terrestrial Manual. In particular, I would like to express my thanks to: Dr Bernard Vallat, Director General of the OIE from 2001 to the present, who gave his encouragement and support to the project of preparing the new edition of this Terrestrial Manual, The Members of the OIE Standards Commission, Prof. Steven Edwards, Dr Beverly Schmitt, Dr Anatoly Golovko, Dr Mehdi El Harrak and Dr Santanu K. Bandhopadhyay who were responsible for commissioning chapters and, with the Consultant Technical Editor, for editing all the contributions so as to finalise this edition of the Terrestrial Manual, The contributors listed on pages xxii to xxxv who contributed their invaluable time and expertise to write the chapters, The expert advisers to the Biological Standards Commission's meeting, Dr Adama Diallo and Dr Peter Wright, the OIE Reference Laboratory experts and other reviewers who also gave their time and expertise to scrutinising the chapters, Those OIE Member Countries that submitted comments on the draft chapters that were circulated to them.

10 These were essential in making the Terrestrial Manual internationally acceptable, Ms Sara Linnane who, as Scientific Editor, organised this complex project and made major contributions to the quality of the text, Dr James E. Pearson, Consultant Technical Editor of the Terrestrial Manual, who contributed hugely to editing and harmonising the contents, but also in collating and incorporating Member Country comments, Members of both the OIE Scientific and Technical Department and the Publications Department, for their assistance. Dr Barry O'Neill President of the OIE International Committee January 2008. OIE Terrestrial Manual 2008 v CONTENTS. VOLUME 2. Introduction (How to use this Terrestrial Manual).. ix List of tests for International xi Common abbreviations used in this Terrestrial xv Glossary of xvii xxii PART 2 OIE LISTED DISEASES AND OTHER DISEASES OF IMPORTANCE TO.


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