The World Animal Health Organization (OIE) divides immunological based diagnostics, such as antibody and antigen detection tests for infectious animal diseases (including zoonotic diseases), into recommended and standard assays. The application of these tests for different epidemiological purposes, e.g. declaration of historical freedom or proof of freedom after a disease outbreak or disease surveillance on healthy populations fulfil important regulatory requirements for international trade of animals and animal commodities in a highly competitive global market.
New tests that are to be included in the OIE Manual of Diagnostic Tests and Vaccines have to undergo a rigorous benchmarking assessment. This assessment includes a statement about the assay’s purpose, e.g. screening or confirmatory test, analytical and diagnostic sensitivity and specificity, cut-off, repeatability and reproducibility. New diagnostic tests must be validated according to the core parameters provided in chapter 1.1.6 Principles and Methods of Validation of Diagnostic Assays for Infectious Diseases.
Chapter 1.1.6 is supported by a range of supporting chapters that deal with fundamentally different assays such as antibody, antigen and nucleic acid detection tests, along with other validation-related topics such as measurement uncertainty, statistical approaches, selection and use of reference samples and panels, e.g. for proficiency testing, principles and methods for the validation of diagnostic tests for infectious diseases applicable to wildlife species, and comparability of tests after changes.
AAHL’s modern one-house approach bridges the gap between early research, including selection and development of quality reagents and test development and subsequent validation, application, certification and registration leading to an accelerated process and final product. Experiences with OIE methods and principles are presented and discussed.