本文件规定了基于等温聚合酶链反应（isoPCR）的核酸分析方法的开发、验证和使用的一般标准。它为特定的isoPCR技术提供了额外的信息和指导。 本文件适用于需要扩增特定生物分子靶序列的食品、饲料、植物基质及其繁殖体、植物病原体和动物。

This document specifies general criteria for development, validation and use of nucleic acid analytical methods based on the isothermal polymerase chain reaction (isoPCR). It provides additional information and guidance for specific isoPCR technologies. This document is applicable to food, feed, plant matrices and their propagules, plant pathogens, and animals in which amplification of a specific biomolecular target sequence is required.