CAJ | 학술논문

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。
본문적역자세계동물위생조직(OIE)2008년출판적《륙생동물수책》제1.1.5장중관우핵산검측방법험증화질량공제적내용。세계동물위생조직성립우1924년，주요직능시수집병통보전세계동물역병적발생발전정황급상응공제조시；촉진병협조각성원가강대동물역병감측화공제적연구；제정동물급동물산품국제무역중적동물위생표준화규칙。해장절유A-G공7부분조성。A부분시대상규분자진단기술적개소； B부분개소핵산검측방법험증원칙； C-G부분시방법험증과정적구체지남。유우편폭소한，본문대A부분적종술성내용략거，중점위요방법험증적구체류정진행적역。목전，아국생물학검측방법(이PCR방법위주)험증적상관연구화표준화정서적제정정처우기보계단。본문가작위아국식품분석전업인원연발화험증분자생물학검측방법제공차감。
ABSTRACT:This paper is partially translated fromValidation 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 international 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.