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国际兽疫局实验室质量评估指南、抗体检测国际参考标准及实验室能力验证指南。

Guidelines of the Office International des Epizooties for laboratory quality evaluation, for international reference standards for antibody assays and for laboratory proficiency testing.

出版信息

Rev Sci Tech. 1998 Aug;17(2):600-31.

PMID:9713900
Abstract

Three guidelines, adopted by the International Committee of the Office International des Epizooties (OIE), have been combined for publication in a single document. The Guidelines for evaluating laboratory quality (adopted in 1995) form part of the OIE Guidelines for evaluating Veterinary Services. General requirements for equipment, staffing and management of laboratories are outlined. The guidelines for international reference standards for antibody assays (adopted in 1998) provide general rules governing the preparation of immune sera by OIE Reference Laboratories. A data sheet should accompany each preparation dispatched from the laboratory, and details are given of the information to be contained in the data sheet. The guidelines are to be used in conjunction with the OIE Manual of standards for diagnostic tests and vaccines. Guidelines on the proficiency of laboratory testing (adopted in 1996) describe how the operation of a laboratory can be assessed by inter-laboratory testing, and by voluntary participation in an accreditation (quality assurance) audit, operated by an independent authority. Criteria for assessing serological testing are provided.

摘要

国际兽疫局(OIE)国际委员会通过的三项准则已合并在一份文件中发布。《实验室质量评估准则》(1995年通过)是OIE《兽医服务评估准则》的一部分。概述了实验室设备、人员配备和管理的一般要求。《抗体检测国际参考标准准则》(1998年通过)规定了OIE参考实验室制备免疫血清的一般规则。从实验室发出的每份制剂都应附有一份数据表,并给出了数据表应包含信息的详细内容。这些准则应与OIE《诊断试验和疫苗标准手册》一起使用。《实验室检测能力准则》(1996年通过)描述了如何通过实验室间检测以及自愿参与由独立机构进行的认可(质量保证)审核来评估实验室的运作情况。提供了评估血清学检测的标准。

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