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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. 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.

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 rhinotracheitis (avian metapneumovirus), 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. 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. 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.

OIE Terrestrial Manual 2008

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OIE Biological Standards Commission January 2008 iv OIE Terrestrial Manual 2008 .Foreword The Terrestrial Manual continues to expand and to extend its range of topics covered. The Terrestrial Manual is published in English. OIE Professor Steven Edwards President. Doctor Bernard Vallat Director General. so readers are advised to check there for the latest information. French and Spanish. It is our sincere hope that it will grow in usefulness to veterinary diagnosticians and vaccine manufacturers in all the OIE Member Countries. 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. A new paper edition of the Terrestrial Manual is published every 4 years.

The Members of the OIE Standards Commission. as Scientific Editor. Steven Edwards. Dr James E. The contributors listed on pages xxii to xxxv who contributed their invaluable time and expertise to write the chapters. Pearson. These were essential in making the Terrestrial Manual internationally acceptable. for editing all the contributions so as to finalise this edition of the Terrestrial Manual. who gave his encouragement and support to the project of preparing the new edition of this Terrestrial Manual. with the Consultant Technical Editor. Prof. Dr Mehdi El Harrak and Dr Santanu K. for their assistance. organised this complex project and made major contributions to the quality of the text. Dr Barry O’Neill President of the OIE International Committee January 2008 OIE Terrestrial Manual 2008 v . Ms Sara Linnane who. Consultant Technical Editor of the Terrestrial Manual. Dr Adama Diallo and Dr Peter Wright. Those OIE Member Countries that submitted comments on the draft chapters that were circulated to them. The expert advisers to the Biological Standards Commission’s meeting. the OIE Reference Laboratory experts and other reviewers who also gave their time and expertise to scrutinising the chapters. Members of both the OIE Scientific and Technical Department and the Publications Department. Director General of the OIE from 2001 to the present.ACKNOWLEDGEMENTS I am most grateful to the many people whose combined efforts have gone into the preparation of this Terrestrial Manual. Dr Beverly Schmitt. Bandhopadhyay who were responsible for commissioning chapters and. In particular. Dr Anatoly Golovko. I would like to express my thanks to: Dr Bernard Vallat. but also in collating and incorporating Member Country comments. who contributed hugely to editing and harmonising the contents.

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...............1...........CONTENTS VOLUME 1 Introduction (How to use this Terrestrial Manual)... Chapter 2....... Chapter 1.... Chapter 1........................................ Chapter 1..........1.......15....10............1.............................................1........................ OIE Terrestrial Manual 2008 ix xi xv xvii xxii 3 15 27 34 46 56 66 90 105 115 120 135 145 158 175 190 217 231 240 251 265 276 292 304 323 334 344 352 vii ..6....... Chapter 2................................................................................ Glossary of terms................ Japanese encephalitis............1............9........................8... Contributors........... Chapter 2...........1................ Chapter 1...............................5........1.......................................................................................9............................................1...................................................... Rift Valley fever..............8....... Chapter 2.............5................ Chapter 2........................................1....7...................................................................... New World screwworm (Cochliomyia hominivorax) and Old World screwworm (Chrysomya bezziana)....1........ Biosafety and biosecurity in the veterinary microbiology laboratory and animal facilities..............................………………… The role of official bodies in the international regulation of veterinary biologicals.........3.......... Trichinellosis........................................... Chapter 1..................................... Chapter 2....................... Chapter 1........ Chapter 1......14...........11.... PART 2 OIE LISTED DISEASES AND OTHER DISEASES OF IMPORTANCE TO INTERNATIONAL TRADE SECTION 2. Quality management in veterinary testing laboratories........ MULTIPLE SPECIES Chapter 2....................10......1...................................3....1..... Common abbreviations used in this Terrestrial Manual............. Guidelines for international standards for vaccine banks…………......13....................... Principles of veterinary vaccine production...................................... PART 1 GENERAL INFORMATION SECTION 1........... Echinococcosis/hydatidosis......2...17.............. Q fever...... Chapter 1................ Leishmaniosis...... Principles of validation of diagnostic assays for infectious diseases................. Chapter 2......................................................................... Biotechnology in the diagnosis of infectious diseases and vaccine development. Chapter 1.........................................................1...... Tests for sterility and freedom from contamination of biological materials....................................................................................................... Chapter 2......... Collection and shipment of diagnostic specimens. INTRODUCTORY CHAPTERS Chapter 1...........1......................1.............................................................. Chapter 2........................... Leptospirosis............. Heartwater.......... Chapter 2...........................................................1......4...................................12................................................................1.. Chapter 2............................................................... Rabies................ Bluetongue.........................11........................... Chapter 2........1...............1........4..............1..... Chapter 1....2..................... Trypanosoma evansi infections (including surra)….......... Validation and quality control of polymerase chain reaction methods used for the diagnosis of infectious diseases......................................7..... List of tests for International trade.............1..............................16.......1................1...............................................................1....1................... Laboratory methodologies for bacterial antimicrobial susceptibility testing………................................................... Anthrax...................1.......................... Rinderpest....................1........1............................. Chapter 2...............1........... Chapter 2............6....................................1.. Chapter 2.. Foot and mouth disease............................... Paratuberculosis (Johne’s disease)......1.........................................1.............. Chapter 2...... Aujeszky’s disease...................

............ Duck virus hepatitis.....2........2....................................... Infectious bursal disease (Gumboro disease)............................3..14.................................... Avian mycoplasmosis (Mycoplasma gallisepticum............................ SECTION 2...................... European foulbrood of honey bees....................................................... Newcastle disease..............18...... American foulbrood of honey bees...........3....3...............................3.. Chapter 2............................................3................................ Vesicular stomatitis......5............................................. Chapter 2....7. Chapter 2..........................................15..............................................). Chapter 2.... Chapter 2...........................3..................1.......6... Fowl cholera……………………................... Chapter 2........3...... Turkey rhinotracheitis (avian metapneumovirus).. Small hive beetle infestation (Aethina tumida).................2........... Chapter 2.... Chapter 2................................... Chapter 2................................................................................2.............................1....................12....................3..4....................................1....................................3.......................... Chapter 2...... Chapter 2.............................................. Chapter 2...............................................2.... Fowl typhoid and Pullorum disease........................................ Varroosis of honey bees........ Chapter 2...................................………...3...4.............................................11.......................2.. Chapter 2.. Chapter 2.................... Avian chlamydiosis. Chapter 2.....................2.........................3........................................................3...........................20........................... M................ APIDAE Chapter 2..................................3.. Fowl pox.... Acarapisosis of honey bees................................. Avian tuberculosis...........13..................... Chapter 2............. Chapter 2................................................................ Chapter 2..............10..... Marek’s disease...........1..8..7...........3...... Chapter 2...................... West Nile fever...................19.....Contents Chapter 2.. Tularemia....... AVES Chapter 2......................................... Chapter 2......... Tropilaelaps infestation of honey bees (Tropilaelaps spp............................3..............2......6...... Chapter 2......................2................................2...........5.........................9. Avian influenza..…………………………... SECTION 2............................ Avian infectious laryngotracheitis....... Avian infectious bronchitis....... Nosemosis of honey bees................................................................ Introductory note on bee diseases........3..............................3.................................. Duck virus enteritis.............1....................................................... synoviae)....2............................. viii 361 367 377 387 388 395 405 410 415 419 424 431 443 456 465 482 497 507 515 524 531 538 549 566 576 590 OIE Terrestrial Manual 2008 ...................................................................

OIE listed diseases are transmissible diseases that have the potential for very serious and rapid spread. There are often other tests described in the chapters. Prescribed tests are those that are required by the Terrestrial Animal Health Code for the testing of animals before they are moved internationally.9. There is an alphabetical index of the diseases at the end of Volume 2. which may also be of some practical value in local situations or which may still be under development. The diseases are in alphabetical order. The contributors of all the chapters are listed on pages xxii–xxxv. and Part C (where appropriate) with the requirements for vaccines or in vivo diagnostic biologicals. it is not always necessary to follow these when there are scientifically justifiable reasons for using alternative approaches. Part A gives a general introduction to the disease. Bibliographic references that provide further information are listed at the end of each chapter. but the final responsibility for the content of the Terrestrial Manual lies with the International Committee of the OIE. These chapters are intended to give a brief introduction to their subjects. but these chapters cover several species and thus give a broader description. Some additional diseases that may also be of importance to trade but that do not have a chapter in the Terrestrial Code are also included in Section 2. The information concerning production and control of vaccines or diagnostics is given as an example. and can also be used in the import/export of animals after bilateral agreement. OIE Terrestrial Manual 2008 ix . The main part of the Terrestrial Manual (Part 2) covers standards for diagnostic tests and vaccines for the diseases listed in the OIE Terrestrial Animal Health Code. the beginning of this Terrestrial Manual. In the Terrestrial Manual these tests are printed in blue. • Format of chapters Each disease chapter includes a summary intended to provide information for veterinary officials and other readers who need a general overview of the tests and vaccines available for the disease. They are to be regarded as background information rather than standards. irrespective of national borders. At present it is not possible to have prescribed tests for every listed disease.9 are included in some individual species sections. subdivided by animal host species. This is followed by a text giving greater detail for laboratory workers. contains eleven introductory chapters that deal with a variety of general subjects of interest to veterinary laboratory diagnosticians. They have particularly serious socio-economic or public health consequences and are of major importance in the international trade of animals and animal products. Part B deals with laboratory diagnosis of the disease. Four of the diseases in Section 2. ‘Alternative tests’ are those that are suitable for the diagnosis of disease within a local setting. In each disease chapter. • Explanation of the tests described and of the table on pages xi–xiv The table on pages xi–xiv lists diagnostic tests in two categories: ‘prescribed’ and ‘alternative’.INTRODUCTION (How to use this Terrestrial Manual) • Arrangement of the Terrestrial Manual Part 1.

The list of OIE Reference Laboratories will be updated by the International Committee of the OIE each year. In some cases standard strains of micro-organisms or reference reagents (e.g. antigens) can also be obtained from the reference laboratories. They are able to provide advice to other laboratories on methodology. These laboratories have been designated by the OIE as centres of excellence with expertise in their particular field. The revised list is available on the OIE Web site. antisera.Introduction (How to use this Terrestrial Manual) • List of OIE Reference Laboratories A list of OIE Reference Laboratories is given in Part 3 of this Terrestrial Manual. * * * x OIE Terrestrial Manual 2008 .