标准编号：ISO/TS 16393:2019
中文名称：分子生物标志物分析 定性测量方法性能特征的测定和方法的验证
英文名称：Molecular biomarker analysis — Determination of the performance characteristics of qualitative measurement methods and validation of methods
发布日期：2019-02
标准范围
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.
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