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  • ISO
    ISO 11781:2025 Molecular biomarker analysis - Requirements and guidance for single-laboratory validation of qualitative real-time polymerase chain reaction (PCR) methods
    Edition: 2025
    $344.69
    / user per year

Content Description

This document specifies minimum requirements and minimum performance criteria for conducting a single-laboratory validation study for qualitative (binary) real-time polymerase chain reaction (PCR) methods applied to the detection of specific DNA sequences present in foods.

The document is applicable to any single-laboratory validation of a qualitative real-time PCR method used for the detection of specific DNA sequences in food and food products (e.g. for the detection of genetically modified foodstuffs and for species determination, including species known to produce allergenic proteins).

The document does not apply to single laboratory validation of qualitative microbiological real-time PCR methods.

The document does not apply to the evaluation of applicability and practicability with respect to the specific scope of the PCR method.



About ISO

ISO, the International Organization for Standardization, brings global experts together to agree on the best way of doing things – for anything from making a product to managing a process. As one of the oldest non-governmental international organizations, ISO has enabled trade and cooperation between people and companies all over the world since 1946. The International Standards published by ISO serve to make lives easier, safer and better.

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