Developing standards for diagnostic tests

Diagnostic tests are essential tools in veterinary medicine. By enabling the early detection of animal diseases, including zoonoses, they play a vital role in effective disease surveillance, management, and control. These tests are also fundamental to safe international trade in animals and animal products, as they help prevent transboundary disease spread, and ensure compliance with international health standards. 

Implementing a global strategy for diagnostic tests 

WOAH sets international standards, guidelines, and recommendations to ensure the accuracy, consistency, and reliability of diagnostic tests. These standards are published in two cornerstone references: the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals and the Manual of Diagnostic Tests for Aquatic Animals.

Both manuals offer detailed guidance on critical aspects such as specimen collection, their storage and shipment, quality management in veterinary laboratories, and the scientific principles behind test validation. They also define internationally agreed diagnostic test methods for all WOAH-listed diseases and other major animal health threats. Upgraded regularly, the manuals reflect the latest scientific findings and technological innovations. 

This work is overseen by WOAH’s Biological Standards Commission and Aquatic Animal Health Commission, with critical contributions from the global network of Reference Laboratories and Collaborating Centres. To further promote global harmonisation and test calibration, international standards are also developed and validated through these Reference Laboratories. 

Approving reference reagents 

WOAH also develops specific guidelines for the preparation, validation, and distribution of approved reference reagents used in the diagnosis of infectious animal diseases. 
Reference materials provided by WOAH Reference Centres, whether for pathogen detection or serological assays, can receive formal WOAH recognition if they meet stringent criteria. These include demonstrated fitness-for-purpose, safety, homogeneity, stability, traceable origin, intended use, and expected performance. Recognition also requires the official approval of the reagent as a WOAH reference standard. All approved reagents and related documentation are made publicly accessible online. 

To support transparency and facilitate access, WOAH maintains a regularly updated list of approved international standard reagents, complete with contact details for each responsible Reference Laboratory. This system ensures global consistency in diagnostic testing and supports reliable, harmonised disease detection worldwide. 

Producing a registry of recognised diagnostic kits 

WOAH has established a standardised procedure for validating diagnostic kits used to detect infectious animal diseases. This rigorous process strengthens the overall quality of diagnostic kits, promotes their appropriate use, and fosters global confidence in their reliability.  

To ensure full transparency, WOAH maintains an online Register of diagnostic kits, which  indicates the validation status of each submitted kit. This resource enables Members to easily identify manufacturers offering test kits that meet WOAH’s validation and certification standards. 

NOTICE: After more than 20 years, in consultation with the Director General, the endorsement of the relevant Specialist Commissions and having informed both WOAH’s Council and the World Assembly of Delegates during the 91st General Session (May 26-30, 2024), please be informed that WOAH’s Diagnostic Register activities have been suspended until May 2026. This means:

Please also be informed that WOAH will still consider exceptional cases linked to an emergency animal health situation upon request by our Members.

• There will be no review or validation of new applications;
• All validated and approved kits will maintain their certification;
• No renewal processing will be engaged, even if they reach the five-year due date;
• There will be no review of any potential appeal procedure.

This decision will enable WOAH’s Secretariat to optimise the use of the limited resources allocated to the Register, to focus on exploring mechanisms that could be implemented for facilitating regulatory harmonisation of diagnostic kits, as well as the value of setting minimum criteria needed for reliable registration of diagnostic kits, facilitating accessibility to Members, regardless of their regulatory capacity, streamlining kit recognition procedures and aligning WOAH Reference Centres with registration of diagnostic kits.

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