标准摘要
[中文适用范围]： 本文件规定了定性实时聚合酶链反应（PCR）方法在食品中外源DNA序列检测的最低要求和最低性能标准。这些方法适用于任何单个实验室对定性实时PCR方法进行验证，用于检测食品及加工品中外源DNA序列（如转基因食品、过敏原蛋白来源物种等）。本文件不适用于单实验室对定性微生物学实时PCR方法的验证。本文件不适用于评估PCR方法在其特定应用范围内的适用性和实用性。 [外文原描述]： This document specifies minimum requirements and minimum performance criteria for conducting a single-laboratory validation study for qualitative (binary) real-time polymerase chain reaction (PCR) methods applied to the detection of specific DNA sequences present in foods. The document is applicable to any single-laboratory validation of a qualitative real-time PCR method used for the detection of specific DNA sequences in food and food products (e.g. for the detection of genetically modified foodstuffs and for species determination, including species known to produce allergenic proteins). The document does not apply to single laboratory validation of qualitative microbiological real-time PCR methods. The document does not apply to the evaluation of applicability and practicability with respect to the specific scope of the PCR method.
英文名称Molecular biomarker analysis — Requirements and guidance for single-laboratory validation of qualitative real-time polymerase chain reaction (PCR) methods