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.
标题:《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
英文标题:Translation from “Validation and Quality Control of Polymerase Chain Reaction Methods used for the Diagnosis of Infectious Disease” issued by OIE