Wright P, Zhou E M
National Center for Foreign Animal Disease, Canadian Food Inspection Agency, Winnipeg, Man.
Vet Immunol Immunopathol. 1999 Dec 15;72(1-2):243-8. doi: 10.1016/s0165-2427(99)00138-5.
Trade in animals and animal products has reached global proportions and so too has the threat of infectious diseases of veterinary importance. The Manual of Standards for Diagnostic Tests and Vaccines, published by the Office International des Epizooties (OIE), contains chapters on infectious diseases that may cause various degrees of socio-economic, public health, and/or zoo-sanitary consequence. These chapters cover the major diseases of cattle, sheep, goats, horses, pigs, poultry, lagomorphs and bees. A number of factors are considered when qualifying animals and animal products for international trade including epidemiological, clinical and testing parameters. Of particular note and relevance is a strong international movement to standardize the test methods and reference reagents in order to promote harmonization of testing and facilitation of trade. There is message here that is directed to those of us involved in the development and application of test methods for infectious disease diagnosis. Serological test methods have been and still remain the mainstay of diagnostic methods prescribed for trade. More than ever, there is a need to observe and apply international guidelines for the development and validation of serological test methods. There is also a need to develop international standard reagents for use in the calibration of test methods and the production of national and working standards. In the future, veterinary diagnostic testing laboratories involved in trade may also require a form of international accreditation unique to their specialty. This presentation describes the current developments in international standardization of test methods and reference reagents.
动物及动物产品贸易已达到全球规模，具有兽医重要性的传染病威胁亦是如此。国际兽疫局（OIE）出版的《诊断检测与疫苗标准手册》包含了关于可能造成不同程度社会经济、公共卫生和（或）兽医卫生后果的传染病的章节。这些章节涵盖了牛、羊、山羊、马、猪、家禽、兔形目动物和蜜蜂的主要疾病。在对用于国际贸易的动物及动物产品进行鉴定时，会考虑诸多因素，包括流行病学、临床和检测参数。尤其值得注意且相关的是，目前有一股强大的国际趋势，即规范检测方法和参考试剂，以促进检测的协调统一并便利贸易。这里传达给我们这些参与传染病诊断检测方法开发与应用的人的信息是，血清学检测方法一直是且仍然是贸易规定诊断方法的支柱。现在比以往任何时候都更需要遵守并应用血清学检测方法开发与验证的国际准则。还需要开发国际标准试剂，用于检测方法的校准以及国家标准和工作标准的生产。未来，参与贸易的兽医诊断检测实验室可能还需要一种针对其专业的国际认可形式。本报告介绍了检测方法和参考试剂国际标准化的当前进展。
