This book, together with ISO/IEC 17025:1999, General requirements for the competence of testing and calibration laboratories, which it interprets, and the OIE Manual of Standards for Diagnostic Tests and Vaccines, provide information useful for laboratories conducting tests to enable the international movement of animals.
The extensive glossary, with precise definitions of assay parameters, will ease communication between scientists working in the laboratories of various countries, who may be accustomed to different terminology.
The OIE Standard for Management and Technical Requirements for Laboratories Conducting Tests for Infectious Diseases follows the format familiar to laboratory personnel who conform to ISO/IEC 17025. It describes the management and technical requirements, including items such as document control, corrective actions, records, internal audits, personnel, equipment and reports, to name a few. Workers in veterinary laboratories who have been audited to ISO/IEC 17025:1999 or expect to be audited to ISO/IEC 17025:2005 will appreciate the further clarification of the requirements, as they pertain to veterinary laboratories, for items such as test methods. In ISO/IEC 17025, the emphasis is on selection of appropriate test methods to meet the client’s needs. In this standard for veterinary laboratories, the emphasis is on the selection of appropriate test methods that are widely accepted by scientists and regulators. Client agreement is required, of course, and testing laboratories must inform the client of the test method chosen and the reasons for the choice.
OIE Guide 1
Validation of Diagnostic Assays for Infectious Diseases describes validation as a multi-stage process. Scientists can use this information to decide how far to proceed with validation, based on a new test’s performance at each stage. Validation of test methods is described in the context of animal disease diagnostics and the calculation of various estimates of assay performance is explained.
OIE Guide 2
International Reference Standards for Antibody Assays describes the preparation, approval, and use of standards. Essential for standardizing tests within and between laboratories, these reference standards are also useful for verifying that tests are performed correctly and for trouble-shooting problems that may occur while conducting tests.
OIE Guide 3
Laboratory Proficiency Testing provides guidance for the evaluation of veterinary laboratories. This is key to fostering trust in the test results reported by a laboratory or country, when importing or exporting animals. Proficiency testing may be used to evaluate a technician, a test method, or a laboratory.
OIE Guides 1, 2, and 3 provide invaluable information for the harmonization of testing between laboratories, which is crucial for those carrying out tests for international movement of animals.
Laboratories that are already certified to ISO/IEC 17025 will have arrived at a workable interpretation of the ISO standard on their own and may find that this publication does not offer much additional information. This book will be particularly useful to veterinary laboratories that wish to implement a quality system and obtain ISO certification. Veterinarians collecting specimens to submit to such laboratories will benefit from reading this publication.