标准摘要
[中文适用范围]： 本文件规定了环介导等温扩增（LAMP）在检测食品链中微生物及相关遗传标记（如抗菌素耐药性基因、毒力基因）的开发和应用的通用要求，并提供了指南。本文件适用于所有LAMP方法、平台以及来自食品链和实验室的样品。本文件不适用于LAMP用于定量检测。LAMP方法作为替代方法或参考方法的验证和确认不在本文件范围内。微生物方法的验证和确认在ISO 16140系列和ISO 17468中有详细描述。包括LAMP在内的等温方法用于分子生物标志物分析的通用要求在ISO 22942-1中给出，聚合酶链式反应（PCR）检测和定量食品链中微生物的通用要求和定义在ISO 22174中给出。本文件是为食品链中的微生物制定的，适用于：——供人类食用的产品；——动物饲料产品；——食品和饲料生产及处理区域的环境样品；——上述项目的初级生产阶段样品。 [外文原描述]： This document specifies the general requirements and provides guidance for the development and application of loop-mediated isothermal amplification (LAMP) to detect microorganisms and associated genetic markers (e.g. antimicrobial resistance genes, virulence genes) in the food chain. This document is applicable to all LAMP methods, platforms, and items from the food chain and laboratories. This document does not apply to the use of LAMP for quantification. Validation and verification of LAMP methods as either alternative or reference methods are not covered in this document. Both validation and verification of microbiological methods are described in detail in the ISO 16140 series and ISO 17468. General requirements for isothermal methods including LAMP for molecular biomarker analysis are given in ISO 22942-1, and general requirements and definitions for polymerase chain reaction (PCR) for the detection and quantification of microorganisms in the food chain are given in ISO 22174. This document has been established for microorganisms in the food chain and is applicable to: — products intended for human consumption; — products for feeding animals; — environmental samples in the area of food and feed production and handling; — samples from the primary production stage for the above items.
英文名称Microbiology of the food chain — Loop-mediated isothermal amplification (LAMP) for the detection of microorganisms and associated genetic markers — General requirements and definitions