本文件规定了产生二元结果的方法，并用于测定食品或食品产品（包括粮食作物种子）中是否存在分子生物标记物。这些方法通常用于被测物预计在检测限（LOD）下以极少量和浓度存在的情况。 方法根据检测概率（POD）和POD的精度进行验证。他们不依赖假阳性/假阴性结果的概念，也不依赖LOD的概念。然而，可以对经典LOD的精度进行推断。 本文件描述了方法验证的范围。附件提供了不同的统计模型，可根据分析方法、数据结构和统计经验加以考虑。 本文件不适用于通过比较响应值与切割值来做出检测决策的定量方法- 使用定量方法的偏差值，通过对响应进行定量统计来验证这些方法。本文件也不适用于微生物测试方法、淀粉、精油或定量方法。

This document specifies methods that yield a binary result and are used for the determination in food or food products (including seeds of food crops) of the presence of molecular biomarkers. These methods are typically used where the measurand is expected to be present in very small amounts and concentrations at the limit of detection (LOD). Methods are validated in terms of the probability of detection (POD) and of the precision of the POD. They do not rely on the concept of false positive/false-negative results, or the concept of LOD. However, inferences about the precision of the classical LOD can be made. This document describes the extent of method validation. The annexes provide different statistical models that can be considered depending on the analytical method, structure of data and statistical experience. This document does not apply to quantitative methods that are used to make a detection decision by comparing the value of a response to a cut-off value using a quantitative method, where the methods are validated by using quantitative statistics on the responses. This document also does not apply to microbiological test methods, starch, essential oils or quantitative methods.