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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Foreword

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

Director General, OIE

Professor Steven Edwards

President, OIE Biological Standards Commission
January 2008

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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 Commissions 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. 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 ONeill
President of the OIE International Committee

January 2008

OIE Terrestrial Manual 2008

CONTENTS
VOLUME 1
Introduction (How to use this Terrestrial Manual).....................................................
List of tests for International trade............................................................................
Common abbreviations used in this Terrestrial Manual............................................
Glossary of terms......................................................................................................
Contributors..............................................................................................................

PART 1

GENERAL INFORMATION

SECTION 1.1.

INTRODUCTORY CHAPTERS

Chapter 1.1.1.
Chapter 1.1.2.

Collection and shipment of diagnostic specimens....................................................

Biosafety and biosecurity in the veterinary microbiology laboratory
and animal facilities..................................................................................................
Quality management in veterinary testing laboratories.............................................
Principles of validation of diagnostic assays for infectious diseases........................
Validation and quality control of polymerase chain reaction methods
used for the diagnosis of infectious diseases...........................................................
Laboratory methodologies for bacterial antimicrobial susceptibility testing.
Biotechnology in the diagnosis of infectious diseases and vaccine development....
Principles of veterinary vaccine production...............................................................
Tests for sterility and freedom from contamination of biological materials...............
Guidelines for international standards for vaccine banks..
The role of official bodies in the international regulation of veterinary biologicals....

Chapter 1.1.3.
Chapter 1.1.4.
Chapter 1.1.5.
Chapter 1.1.6.
Chapter 1.1.7.
Chapter 1.1.8.
Chapter 1.1.9.
Chapter 1.1.10.
Chapter 1.1.11.

PART 2

OIE LISTED DISEASES AND OTHER DISEASES OF IMPORTANCE TO

INTERNATIONAL TRADE

SECTION 2.1.

MULTIPLE SPECIES

Chapter 2.1.1.
Chapter 2.1.2.
Chapter 2.1.3.
Chapter 2.1.4.
Chapter 2.1.5.
Chapter 2.1.6.
Chapter 2.1.7.
Chapter 2.1.8.
Chapter 2.1.9.
Chapter 2.1.10.

Anthrax......................................................................................................................
Aujeszkys disease....................................................................................................
Bluetongue................................................................................................................
Echinococcosis/hydatidosis......................................................................................
Foot and mouth disease...........................................................................................
Heartwater................................................................................................................
Japanese encephalitis..............................................................................................
Leishmaniosis...........................................................................................................
Leptospirosis.............................................................................................................
New World screwworm (Cochliomyia hominivorax) and
Old World screwworm (Chrysomya bezziana).........................................................
Paratuberculosis (Johnes disease)..........................................................................
Q fever......................................................................................................................
Rabies.......................................................................................................................
Rift Valley fever.........................................................................................................
Rinderpest.................................................................................................................
Trichinellosis.............................................................................................................
Trypanosoma evansi infections (including surra)..................................................

Chapter 2.1.11.
Chapter 2.1.12.
Chapter 2.1.13.
Chapter 2.1.14.
Chapter 2.1.15.
Chapter 2.1.16.
Chapter 2.1.17.

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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

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Contents

Chapter 2.1.18.
Chapter 2.1.19.
Chapter 2.1.20.

Tularemia..................................................................................................................
Vesicular stomatitis...................................................................................................
West Nile fever.........................................................................................................

SECTION 2.2.

APIDAE

Chapter 2.2.1.
Chapter 2.2.2.
Chapter 2.2.3.
Chapter 2.2.4.
Chapter 2.2.5.
Chapter 2.2.6.
Chapter 2.2.7.

Introductory note on bee diseases............................................................................

Acarapisosis of honey bees......................................................................................
American foulbrood of honey bees...........................................................................
European foulbrood of honey bees...........................................................................
Nosemosis of honey bees.........................................................................................
Small hive beetle infestation (Aethina tumida)..........................................................
Tropilaelaps infestation of honey bees (Tropilaelaps spp.)......................................
Varroosis of honey bees...........................................................................................

SECTION 2.2.

AVES

Chapter 2.3.1.
Chapter 2.3.2.
Chapter 2.3.3.
Chapter 2.3.4.
Chapter 2.3.5.
Chapter 2.3.6.
Chapter 2.3.7.
Chapter 2.3.8.
Chapter 2.3.9.
Chapter 2.3.10.
Chapter 2.3.11.
Chapter 2.3.12.
Chapter 2.3.13.
Chapter 2.3.14.
Chapter 2.3.15.

Avian chlamydiosis...................................................................................................
Avian infectious bronchitis........................................................................................
Avian infectious laryngotracheitis..............................................................................
Avian influenza..........................................................................................................
Avian mycoplasmosis (Mycoplasma gallisepticum, M. synoviae).............................
Avian tuberculosis.....................................................................................................
Duck virus enteritis....................................................................................................
Duck virus hepatitis...................................................................................................
Fowl cholera.................................................................................
Fowl pox....................................................................................................................
Fowl typhoid and Pullorum disease..........................................................................
Infectious bursal disease (Gumboro disease)..........................................................
Mareks disease........................................................................................................
Newcastle disease....................................................................................................
Turkey rhinotracheitis (avian metapneumovirus)...

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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

INTRODUCTION
(How to use this Terrestrial Manual)

Arrangement of the Terrestrial Manual

Part 1, the beginning of this Terrestrial Manual, contains eleven introductory chapters that deal with
a variety of general subjects of interest to veterinary laboratory diagnosticians. These chapters are
intended to give a brief introduction to their subjects. They are to be regarded as background
information rather than standards.
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 diseases are in alphabetical
order, subdivided by animal host species. OIE listed diseases are transmissible diseases that have
the potential for very serious and rapid spread, irrespective of national borders. They have
particularly serious socio-economic or public health consequences and are of major importance in
the international trade of animals and animal products.
Four of the diseases in Section 2.9 are included in some individual species sections, 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 2.9.
The contributors of all the chapters are listed on pages xxiixxxv, but the final responsibility for the
content of the Terrestrial Manual lies with the International Committee of the OIE.
There is an alphabetical index of the diseases at the end of Volume 2.

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.
This is followed by a text giving greater detail for laboratory workers. In each disease chapter,
Part A gives a general introduction to the disease, Part B deals with laboratory diagnosis of the
disease, and Part C (where appropriate) with the requirements for vaccines or in vivo diagnostic
biologicals. The information concerning production and control of vaccines or diagnostics is given
as an example; it is not always necessary to follow these when there are scientifically justifiable
reasons for using alternative approaches. Bibliographic references that provide further information
are listed at the end of each chapter.

Explanation of the tests described and of the table on pages xixiv

The table on pages xixiv lists diagnostic tests in two categories: prescribed and alternative.
Prescribed tests are those that are required by the Terrestrial Animal Health Code for the testing of
animals before they are moved internationally. In the Terrestrial Manual these tests are printed in
blue. At present it is not possible to have prescribed tests for every listed disease. Alternative tests
are those that are suitable for the diagnosis of disease within a local setting, and can also be used
in the import/export of animals after bilateral agreement. There are often other tests described in
the chapters, which may also be of some practical value in local situations or which may still be
under development.

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

*
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OIE Terrestrial Manual 2008