D12009.PDF

WORLD ORGANISATION FOR ANIMAL HEALTH
MANUAL OF DIAGNOSTIC TESTS AND VACCINES
FOR TERRESTRIAL ANIMALS
(mammals, birds and bees)
Seventh Edition
Volume 2
2012

This Terrestrial Manual has been edited by the
OIE Biological Standards Commission and adopted by
the World Assembly of Delegates 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: www.oie.int).
OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals
Seventh Edition, 2012
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
Third Edition, 1996
Fourth Edition, 2000
Fifth Edition, 2004
Sixth Edition, 2008
Seventh Edition: ISBN 978-92-9044-878-5
Volume 2: ISBN 978-92-9044-880-8
© Copyright
World Organisation for Animal Health (OIE), 2012
12, rue de Prony, 75017 Paris, FRANCE
Telephone: [phone]
Fax: [phone]
Electronic mail: [email protected]
http://www.oie.int
All World Organisation for Animal Health (OIE) 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.

OIE Terrestrial Manual 2012 iii
FOREWORD
The Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (Terrestrial Manual) aims to
prevent and control animal diseases, including zoonoses, to contribute to the improvement of
animal health services world-wide and to allow safe international trade in animals and animal
products. The principal target readership is laboratories carrying out veterinary diagnostic tests and
surveillance, along with vaccine manufacturers and users, and regulatory authorities in Member
Countries. The main objective is to provide internationally agreed diagnostic laboratory methods
and requirements for the production and control of relevant vaccines and other biological products.
This ambitious task has required the cooperation of highly renowned animal health specialists from
many OIE Member Countries. The OIE, the World Organisation for Animal Health, received the
mandate from its Member Countries to undertake this task on a global level. The main activities of
the organisation, which was established in 1924, and in 2012 comprised 178 Member Countries,
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 seventh edition includes over 50 updated chapters and guidelines (including a new
guideline on the application of biotechnology to the development of veterinary vaccines, and the
addition of epizootic haemorrhagic disease to the relevant chapter). This edition has a slightly
different structure from former editions: Part 1 contains ten introductory chapters that set general
standards for the management of veterinary diagnostic laboratories and vaccine production
facilities; Part 2 comprises chapters on OIE listed diseases and other diseases of importance to
international trade; Part 3 comprises four guidelines that have been developed on topics such as
biotechnology and antimicrobial susceptibility testing that are intended to give a brief introduction to
their subjects (they are to be regarded as background information rather than strict standards); and
Part 4 is the list of OIE Reference Centres at the time of publication (the list of OIE Reference
Centres is updated by the World Assembly of Delegates (of OIE Member Countries) each year; the
revised list is available on the OIE Web site).
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 World Assembly of national Delegates. Manuscripts were
requested from specialists (usually the OIE designated experts at OIE Reference Laboratories) in
each of the diseases or the other topics covered. Occasionally, an ad hoc Group of experts was
convened tasked with updating or developing a chapter. 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, elected every 3 years by the World Assembly, and the

Foreword
iv OIE Terrestrial Manual 2012
Consultant Technical Editor took all the resulting comments into consideration, often referring back
to the contributors for further help, before finalising the chapters. The final text has the approval of
the World Assembly.
A procedure for the official recognition of commercialised diagnostic tests, under the authority of the
Assembly, 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 World
Assembly is sought. All information on the submission of applications can be found on the OIE Web
site.
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 World Assembly, so readers are advised to check there for the
latest information. This new version of the Terrestrial Manual is published in English and Spanish.
Doctor Bernard Vallat Professor Vincenzo Caporale
Director General, OIE President, OIE Biological Standards Commission
September 2012 September 2012

OIE Terrestrial Manual 2012 v
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. Vincenzo Caporale, Dr Beverly
Schmitt, Dr Mehdi El Harrak, Dr Paul Townsend, Dr Alejandro Schudel and Dr Hualan Chen
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. 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,
Prof. Steven Edwards, 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 Karin Schwabenbauer
President of the OIE World Assembly
September 2012