ISO 21570-2005 PDF

Full title and description

Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Quantitative nucleic acid based methods. This International Standard provides a framework of quantitative nucleic-acid-based methods (principally PCR) for the detection and quantification of genetically modified organisms (GMOs) and derived products in food and related matrices.

Abstract

ISO 21570:2005 sets out general requirements, minimum performance criteria and guidelines to ensure comparable, accurate and reproducible quantitative results when using nucleic-acid-based methods to determine the relative content of GMO-derived DNA. It is established principally for food matrices but is also applicable to feed, plant and other matrices; the standard addresses assay specificity, calibration, controls, validation and reporting to support inter-laboratory comparability.

General information

• Status: Published; version reviewed/confirmed in a systematic review and retained as current by the ISO maintenance process.
• Publication date: November 2005 (Edition 1, published 2005-11).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 67.050 — General methods of tests and analysis for food products.
• Edition / version: Edition 1 (2005). Technical corrigendum published 2006; Amendment 1 published 2013.
• Number of pages: 103 pages (main document).

Key bibliographic and status details as published by ISO.

Scope

ISO 21570:2005 defines the overall framework and general requirements for quantitative nucleic-acid-based methods used to detect and quantify GMO-derived DNA in foodstuffs and related matrices. It covers principles for specific amplification of target DNA sequences, approaches for calibration and quantification (relative quantification), performance criteria, method validation, and requirements for controls and reporting so that results are comparable and reproducible across laboratories.

Key topics and requirements

• Framework for quantitative PCR-based detection and relative quantification of GMO DNA.
• Requirements for assay specificity, sensitivity and limit of quantification.
• Calibration approaches and use of appropriate reference materials and controls.
• Method validation criteria and performance characteristics to demonstrate reproducibility and accuracy.
• Quality assurance, documentation and recommended reporting formats for quantitative results.
• Procedures for technical corrigenda and later amendments (standard has an amendment published in 2013 to clarify/update requirements).

Amendment and corrigendum work have been issued to clarify and extend the original requirements.

Typical use and users

Clinical and food-testing laboratories, government food safety and regulatory agencies, accreditation bodies, contract testing organizations, producers of PCR test kits and assay developers, and research laboratories involved in GMO detection and quantification typically use this standard to develop, validate and report quantitative nucleic-acid-based methods for food and feed testing.

Related standards

ISO 21570:2005 is part of a family of ISO documents on nucleic-acid-based methods for GMOs and is closely linked with ISO 21569 (qualitative nucleic-acid-based methods) and ISO 21571 (nucleic-acid extraction). Additional technical specifications describe procedures for submission or addition of methods to these standards. Regional/adopted versions (EN ISO) and corrections/amendments have been published to harmonize practice.

Keywords

GMO, genetically modified organism, foodstuffs, quantitative PCR, nucleic acid methods, method validation, reference material, calibration, limit of quantification, ISO 21570.

FAQ

Q: What is this standard?

A: ISO 21570:2005 is an International Standard that provides a framework and minimum requirements for quantitative nucleic-acid-based (mainly PCR) methods for detection and quantification of GMO-derived DNA in foodstuffs and related matrices.

Q: What does it cover?

A: It covers assay design principles, performance criteria (sensitivity, specificity, limit of quantification), calibration and reference material use, validation and quality-control measures, and reporting to ensure comparable and reproducible quantitative results across laboratories.

Q: Who typically uses it?

A: Food and feed testing laboratories, regulatory agencies, accreditation bodies, assay and kit manufacturers, and research groups involved in GMO analysis use the standard to develop and validate quantitative molecular methods.

Q: Is it current or superseded?

A: The 2005 edition remains the published edition; a technical corrigendum (2006) and Amendment 1 (2013) have been issued to update and clarify parts of the text. The standard has been maintained under ISO’s review cycle and was confirmed in systematic reviews. Users should check for any more recent amendments or newer parts in the ISO 2156x family before implementation.

Q: Is it part of a series?

A: Yes — ISO 21570 is part of a series of ISO documents addressing nucleic-acid-based detection of GMOs, including ISO 21569 (qualitative methods) and ISO 21571 (nucleic acid extraction), plus associated technical specifications and method annexation procedures.

Q: What are the key keywords?

A: GMO, quantitative PCR, nucleic acid, foodstuffs, method validation, calibration, reference material, limit of quantification, ISO 21570.