Diagnostic tests

WOAH Standards, guidelines and recommendations

Terrestrial Manual

Aquatic Manual

WOAH Procedure for registration of diagnostic kits

WOAH-approved International Standard Sera

Diagnostic tests are essential tools for confirming the health status of animals and identifying pathogens. They enable the early detection, management and control of animal diseases including zoonosis and facilitate the safe trade in animals and animal products.

WOAH works actively on veterinary products, including diagnostic tests, and has developed a coherent strategy for its activities in this area.

The WOAH standards, guidelines and recommendations applying to diagnostic tests are published in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (Terrestrial Manual) and in the Manual of Diagnostic Tests for Aquatic Animals (Aquatic Manual). There is also the WOAH Quality Standard and Guidelines for Veterinary Laboratories, which provides a specific interpretation of the generally stated requirements of ISO/IEC 17025 for veterinary laboratories, as well as guidelines, which are practical texts that complement these Manuals.

In the introductory chapters of both Manuals, topics such as the collection, shipment and storage of diagnostic specimens, the quality management in veterinary laboratories, or the principles of validation of diagnostic tests are addressed.

For all WOAH listed diseases as well as several other diseases of importance, the two Manuals specify and detail the internationally agreed upon diagnostic test methods.

These standards, guidelines and recommendations are regularly updated to take account of the latest scientific findings and technological developments.

In complement to these two Manuals, WOAH launched in 2005 a procedure for the registration of diagnostic kits to provide its Member Countries with a list of diagnostic kits certified by WOAH as fit for specific purpose(s).

WOAH’s work is guided by the Biological Standards Commission and the Aquatic Animal Health Commission in their respective areas of competence and supported by several Reference Laboratories and Collaborating Centres. WOAH-approved International Standard Sera have been developed by Reference Laboratories for certain diseases.