Standards Manage Your Business
We Manage Your Standards
Standards Manage Your Business
We Manage Your Standards
Molecular biomarker analysis — Determination of the performance characteristics of qualitative measurement methods and validation of methods
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.
Currently Viewing
Expand Your Knowledge and Unlock Your Learning Potential - Your One-Stop Source for Information!
© Copyright 2024 BSB Edge Private Limited.
