ISO/TS 16393:2019

Molecular biomarker analysis — Determination of the performance characteristics of qualitative measurement methods and validation of methods

Scope

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.