[F14.3.2.1. Scope U.K.
The scope applies to bioanalytical methods based on immuno-recognition or receptor binding (such as ELISA, dip-sticks, lateral flow devices, immuno-sensors) and physicochemical methods based on chromatography or direct detection by mass spectrometry (e.g. ambient MS). Other methods (e.g. thin layer chromatography) are not excluded provided the signals generated relate directly to the mycotoxins of interest and allow that the principle described hereunder is applicable.
The specific requirements apply to methods of which the result of the measurement is a numerical value, for example a (relative) response from a dip-stick reader, a signal from LC-MS, etc., and that normal statistics apply.
The requirements do not apply to methods that do not give numerical values (e.g. only a line that is present or absent), which require different validation approaches. Specific requirements for these methods are provided in point 4.3.3.
This document describes procedures for the validation of screening methods by means of an inter-laboratory validation, the verification of the performance of a method validated by means of an inter-laboratory exercise and the single-laboratory validation of a screening method.]
Textual Amendments