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用于家畜疾病诊断和监测的检测试剂盒验证的相关方面:生产者和最终用户的责任。

Aspects of kit validation for tests used for the diagnosis and surveillance of livestock diseases: producer and end-user responsibilities.

作者信息

Crowther J R, Unger H, Viljoen G J

机构信息

Animal Production and Health Section, Joint Food and Agriculture Organization/International Atomic Energy Agency, Division of Nuclear Techniques in Food and Agriculture, Wagramer Strasse 5, A1400 Vienna, Austria.

出版信息

Rev Sci Tech. 2006 Dec;25(3):913-35.

Abstract

The Joint Food and Agriculture Organization/International Atomic Energy Agency (IAEA) Division of Nuclear Techniques in Food and Agriculture, based at the IAEA in Vienna, Austria, has extensive experience in helping to develop and validate assays and has provided strong support in developing World Organisation for Animal Health (OIE) norms. This paper will focus on enzyme-linked immunosorbent assay and polymerase chain reaction as the major technologies exploited in diagnosis and surveillance. Problems involving the terminology and factors in kit production, supply and validation are examined, in particular emphasising the importance of robustness and ruggedness of tests. The authors discuss the responsibilities of the various stakeholders (producers, distributors, users, and national/international organisations) in achieving quality controlled data to solve diagnostic and surveillance problems. The roles of internal quality control (internal proficiency testing) and external quality assurance (external proficiency testing) as well as aids to solving problems with kits are examined.

摘要

设在奥地利维也纳国际原子能机构的联合国粮食及农业组织/国际原子能机构(粮农组织/原子能机构)粮食和农业核技术司,在协助开发和验证检测方法方面拥有丰富经验,并在制定世界动物卫生组织(OIE)规范方面提供了大力支持。本文将重点介绍酶联免疫吸附测定和聚合酶链反应,这是诊断和监测中使用的主要技术。文中探讨了试剂盒生产、供应和验证中涉及的术语和因素问题,特别强调了检测的稳健性和耐用性的重要性。作者讨论了各利益相关方(生产商、经销商、用户以及国家/国际组织)在获取质量可控数据以解决诊断和监测问题方面的责任。文中还探讨了内部质量控制(内部能力验证)和外部质量保证(外部能力验证)的作用以及解决试剂盒问题的辅助手段。

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