ISO 21572:2019 食品—分子バイオマーカー分析—タンパク質の検出と定量化のための免疫化学的方法 | ページ 2

Foreword

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This document was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 16, Horizontal methods for molecular biomarker analysis.

This third edition cancels and replaces the second edition (ISO 21572:2013), which has been technically revised. The main changes compared with the previous edition are as follows:

• the title has been changed to specify that the document is focused on immunochemical protein detection methods;
• an introduction has been added;
• terms, definitions and references have been updated;
• the text has been modified to improve the document’s applicability to general protein analysis applications.

Introduction

Analytical techniques based on highly specific immunochemical-binding interactions have become key tools for analysing many different chemical and macromolecular analytes, including proteins. Methods utilizing these techniques are widely accepted in the scientific and regulatory communities. Immunochemical assay methods are most commonly used to detect (presence or absence) and/or quantify specific protein analytes such as allergenic proteins, disease marker proteins or newly expressed proteins in biotech crops.

Prior to analysis, samples generally need to be ground or processed in a manner that facilitates extraction of the analyte from the sample matrix. An important step in analytical method development is therefore the selection of a suitable extraction buffer that does not interfere with the analytical method performance and that ensures an appropriate level of analyte stability during the analytical process.

The immunochemical assay process generally incorporates at least two steps:

• binding or capturing the analyte of interest present in samples with an antibody targeted specifically to the analyte;
• detection of the antibody-analyte complex using a technique that signals the specific interaction.

Once an analytical method has been developed and optimized, it should be validated to demonstrate that its performance is reliable and suitable for the intended use and to characterize the method limitations. This involves performing several experiments with real samples to evaluate parameters such as accuracy, precision, sensitivity, selectivity and the detection or quantification limits. Validation also allows for the establishment of method performance criteria, against which routine analytical performance can be compared to ensure that acceptable analytical results are consistently reported.

This document provides a set of general procedures and analytical considerations for using immunochemical techniques to analyse target proteins. It discusses aspects of sample processing, extraction, assay set-up, interpretation and reporting of results, and relevant assay performance parameters. Two annexes are included containing example procedures that can be followed when analysing a protein of interest (POI) in a variety of background matrices using methods based on enzyme-linked immunosorbent assays (ELISAs) and lateral flow devices (LFDs).

1 Scope

This document specifies performance criteria for immunochemical methods for the detection and/or quantification of a specific protein or protein(s) of interest [POI(s)] in a specified matrix.

The methods discussed are applicable to the analysis of proteins from a variety of sample types. Some uses for these methods include, but are not limited to, analysing proteins involved in crop and food production, food processing, food marketing, food safety, biotechnology or disease indexing.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 16577 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

Bibliography