During the 71st General Session of the World Animal Health Organisation (OIE) in May 2003, its International Committee adopted Resolution No. XXIX. This Resolution endorses the principle of validation and certification of diagnostic assays (test methods) for infectious animal diseases by the OIE and gives a mandate to the Director General of the OIE to set up the specific standard procedures for validation and certification of diagnostic assays. In 2005, the OIE has published a standard operation procedure for validation and certification of diagnostic assays on its website and invites assay developers to submit a standard application form which includes all relevant information for assessing the quality of a diagnostic assay by an appropriate panel of reviewers. The structure of this application form is based on a draft OIE assay validation template, which was drawn up at the 2nd FAO/IAEA-OIE Consultants Meeting on “OIE Guidelines for Validation and Certification of Diagnostic Assays for Animal Infectious Diseases” (9-12 December 2001, Vienna, Austria).
During the "International Meeting on the Design and Analyses of Diagnostic Test Evaluation Studies” hosted by the Society for Veterinary Epidemiology and Preventive Medicine in 2005, the “OIE assay validation template” was reviewed by a group of professionals with different backgrounds (test development, test application, test marketing, regulatory business, epidemiology, and statistics). The conclusions, comments and recommendations regarding the “OIE assay validation template” and the criteria to be used for reviewing validation dossiers, were summarised in a report provided to the OIE. The following priorities were suggested to further support the international standardisation of test validation.
To further discuss these priorities in a multi-disciplinary environment the “Second International Meeting on the Design and Analyses of Diagnostic Test Evaluation Studies” will be hosted by the Veterinary and Agrochemical Research Centre in Brussels, Belgium, 20-22 June 2006. This second meeting has three objectives.
The first objective is to discuss and disseminate quantitative methodology on diagnostic test evaluation and validation. Limited resources and the lack of a "gold standard" are typical constraints of evaluation studies and the possibilities to deal with these constraints differ from case to case. Experts and selected scientists will present methods for obtaining the analytical and diagnostic characteristics of a test. Topics on the analytical characteristics and quality assurance of a test, and topics on the diagnostic characteristics of a test in absence of a gold standard will be addressed in parallel sessions to allow a knowledge transfer to a wide range of professionals with different backgrounds.
The second objective is to optimise and harmonise guidelines on diagnostic test validation where required. The underlying principles of the diagnostic process are well established in each of the disciplines such as microbiology, laboratory science, statistics and epidemiology. However, since these disciplines approach the issue of test characteristics from different angles and use a different terminology, it may appear like they pursue different quality goals. Still, they all want to provide information on the uncertainty of a diagnostic test result. The further application of the ‘OIE assay validation template’ will be presented and discussed during the meeting. The feasibility, practicability and efficiency of all procedures will be considered and a comparison with the ISO 17025 and other guidelines will be made. Particular guidelines on the use of no-gold standard methods for estimation of the diagnostic sensitivity and specificity will be discussed. All this will be accomplished through a panel discussion in which relevant questions are posed and discussed. In conjunction with the panel discussion, the audience will be broken up into smaller groups when deemed necessary to address specific issues.
The third objective is to disseminate the outcomes of the meeting to a general audience of potential users of these methods. Needs and knowledge gaps will be identified. Therefore, the conclusions, comments and recommendations of the meeting will be summarised in a report that will be provided to the OIE and other authorities involved.
The meeting welcomes professionals involved in the development, evaluation, quality assurance, and routine use of diagnostic tests to participate in the discussions.