prEN ISO 11781

Molecular biomarker analysis - General guidelines for single-laboratory validation of qualitative real-time PCR methods (ISO/DIS 11781:2023)

Publication date:   Nov 30, 2023

General information

45.99 Dispatch of FV draft to CCMC   Nov 25, 2024

CEN

CEN/TC 275 Food analysis - Horizontal methods

European Norm

67.050   General methods of tests and analysis for food products

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Scope

This document describes the performance characteristics and minimum performance criteria which should be taken into account when conducting a single-laboratory validation study for qualitative (binary) real-time polymerase chain reaction (PCR) methods applied for the detection of specific DNA sequences present in foods.

The protocol was developed for qualitative real-time PCR methods for the detection of DNA sequences derived from genetically modified foodstuffs. It is applicable also for single-laboratory validation of qualitative PCR methods used for analysis of other food materials, e.g. for species detection and identification.
The document does not cover the evaluation of the applicability and the practicability with respect to the specific scope of the PCR method.

Life cycle

PREVIOUSLY

PUBLISHED
CEN/TS 17329-1:2021

NOW

IN_DEVELOPMENT
prEN ISO 11781
45.99 Dispatch of FV draft to CCMC
Nov 25, 2024