《世界动物卫生组织传染病诊断PCR方法验证和质量控制指南》摘译

Translation from “Validation and Quality Control of Polymerase Chain Reaction Methods used for the Diagnosis of Infectious Disease” issued by OIE

中文关键词:  世界动物卫生组织  PCR  验证  指南

英文关键词:OIE  PCR  validation  guideline

中文摘要:

      本文摘译自世界动物卫生组织(OIE)2008年出版的《陆生动物手册》第1.1.5章中关于核酸检测方法验证和质量控制的内容。世界动物卫生组织成立于1924年, 主要职能是收集并通报全世界动物疫病的发生发展情况及相应控制措施; 促进并协调各成员加强对动物疫病监测和控制的研究; 制定动物及动物产品国际贸易中的动物卫生标准和规则。该章节由A-G共7部分组成。A部分是对常规分子诊断技术的介绍; B部分介绍核酸检测方法验证原则; C-G部分是方法验证过程的具体指南。由于篇幅所限, 本文对A部分的综述性内容略去, 重点围绕方法验证的具体流程进行摘译。目前, 我国生物学检测方法(以PCR方法为主)验证的相关研究和标准化程序的制定正处于起步阶段。本文可作为我国食品分析专业人员研发和验证分子生物学检测方法提供借鉴。

英文摘要:

      This paper is partially translated from Validation and Quality Control of Polymerase Chain Reaction Methods used for the Diagnosis of Infectious Disease (Chapter 1.1.5., OIE Terrestrial Manual 2008) and is focused on validation and quality control of nucleic acid detection method. World Organization for Animal Health (OIE) was established in 1924 with the main objectives as follows: Collect, analyse and disseminate veterinary scientific information, ensure transparency in the global animal disease situation, encourage in-ternational solidarity in the control of animal diseases, safeguard world trade by publishing health standards for international trade in animals and animal products. This chapter consists of 7 parts from A to G. part A is an introduction of molecular diagnostic techniques; part B focuses on principles of assay validation; part C to G provide details in validation process. Due to limited length of this paper, Part A is omitted. Currently, research on assay validation and standardization of molecular method in our country is still in early stages. The objective of this paper is to provide a reference for Chinese food analyst to develop and validate molecular methods.