EN ISO 21572:2019

Foodstuffs - Molecular biomarker analysis - Immunochemical methods for the detection and quantification of proteins (ISO 21572:2019)

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.

Lebensmittel - Untersuchung auf molekulare Biomarker - Immunochemische Verfahren zum Nachweis und zur Quantifizierung von Proteinen (ISO 21572:2019)

Dieses Dokument legt allgemeine Leistungskriterien für immunochemische Verfahren zum Nachweis und/oder zur quantitativen Bestimmung eines spezifischen Proteins oder von mehreren Proteinen von Interesse (en: protein(s) of interest, POI) in einer spezifischen Matrix fest.
Die hier besprochenen Verfahren sind für die Untersuchung von Proteinen in einer Vielzahl von Probentypen anwendbar. Einige dieser Verfahren dienen zur Untersuchung von Proteinen, die beim Anbau von Feldfrüchten, bei der Herstellung, Verarbeitung, Vermarktung und Sicherheit von Lebensmitteln, in der Biotechnik oder zur Krankheitsbestimmung relevant sind, sind aber nicht darauf beschränkt.

Produits alimentaires - Analyse des biomarqueurs moléculaires - Méthodes immunochimiques pour la détection et la quantification des protéines (ISO 21572:2019)

Le présent document énonce des critères de performances pour les méthodes immunochimiques de détection et/ou de quantification d'une protéine spécifique ou de protéine(s) d'intérêt (POI) dans une matrice donnée.
Les méthodes décrites sont applicables à l'analyse de protéines provenant de divers types d'échantillons. Certaines utilisations de ces méthodes comprennent, entre autres, l'analyse des protéines impliquées dans la production végétale et agroalimentaire, la transformation des aliments, la commercialisation des produits alimentaires, la sécurité des aliments, les biotechnologies ou l'indexation des maladies.

Živila - Analiza molekulskih biomarkerjev - Imunokemijske metode za odkrivanje prisotnosti in kvantifikacijo beljakovin (ISO 21572:2019)

Ta standard določa merila uspešnosti imunokemijskih metod za odkrivanje in/ali kvantifikacijo specifičnih zadevnih beljakovin ali (POI) v določeni matrici. Obravnavane metode so uporabne za analizo beljakovin iz različnih vrst vzorcev. Nekatere uporabe teh metod med drugim vključujejo analizo beljakovin, vključenih v pridelavo pridelkov in hrane, predelavo hrane, trženje hrane, varnost hrane, biotehnologijo ali indeksiranje bolezni.

General Information

• Status: Published
• Publication Date: 29-Oct-2019
• Withdrawal Date: 29-Apr-2020
• ICS: 67.050 - General methods of tests and analysis for food products
• Technical Committee: CEN/TC 275 - Food analysis - Horizontal methods
• Drafting Committee: CEN/TC 275/WG 11 - Genetically modified foodstuffs
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 30-Oct-2019
• Completion Date: 30-Oct-2019
• Ref Project: SIST EN ISO 21572:2020 - Foodstuffs - Molecular biomarker analysis - Immunochemical methods for the detection and quantification of proteins (ISO 21572:2019)

Relations

• Replaces: EN ISO 21572:2013 - Foodstuffs - Molecular biomarker analysis - Protein-based methods (ISO 21572:2013)
• Effective Date: 01-Aug-2018

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2020
Nadomešča:
SIST EN ISO 21572:2013
Živila - Analiza molekulskih biomarkerjev - Imunokemijske metode za odkrivanje
prisotnosti in kvantifikacijo beljakovin (ISO 21572:2019)
Foodstuffs - Molecular biomarker analysis - Immunochemical methods for the detection
and quantification of proteins (ISO 21572:2019)
Lebensmittel - Untersuchung auf molekulare Biomarker - Proteinverfahren (ISO
21572:2019)
Produits alimentaires - Analyse des biomarqueurs moléculaires - Méthodes
immunochimiques pour la détection et la quantification des protéines (ISO 21572:2019)
Ta slovenski standard je istoveten z: EN ISO 21572:2019
ICS:
67.050 Splošne preskusne in General methods of tests and
analizne metode za živilske analysis for food products
proizvode
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 21572
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2019
EUROPÄISCHE NORM
ICS 67.050 Supersedes EN ISO 21572:2013
English Version
Foodstuffs - Molecular biomarker analysis -
Immunochemical methods for the detection and
quantification of proteins (ISO 21572:2019)
Produits alimentaires - Analyse des biomarqueurs Lebensmittel - Untersuchung auf molekulare
moléculaires - Méthodes immunochimiques pour la Biomarker - Proteinverfahren (ISO 21572:2019)
détection et la quantification des protéines (ISO
21572:2019)
This European Standard was approved by CEN on 30 September 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21572:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 21572:2019) has been prepared by Technical Committee ISO/TC 34 "Food
products" in collaboration with Technical Committee CEN/TC 275 “Food analysis - Horizontal methods”
the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2020, and conflicting national standards shall be
withdrawn at the latest by April 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 21572:2013.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 21572:2019 has been approved by CEN as EN ISO 21572:2019 without any modification.

INTERNATIONAL ISO
STANDARD 21572
Third edition
2019-10
Foodstuffs — Molecular biomarker
analysis — Immunochemical methods
for the detection and quantification of
proteins
Produits alimentaire — Analyse des biomarqueurs moléculaires —
Méthodes immunochimiques pour la détection et la quantification des
protéines
Reference number
ISO 21572:2019(E)
©
ISO 2019
ISO 21572:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 21572:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 1
5 Reagents . 2
6 Laboratory equipment . 2
7 Sampling . 2
8 Procedure. 2
8.1 General . 2
8.2 Preparation of sample solution . 2
8.3 Extraction . 3
8.4 Preparation of calibration curves, positive controls, and reference materials . 3
8.5 Assay procedure . 3
9 Interpretation and expression of results . 3
9.1 General . 3
9.2 Quantitative and semi-quantitative analysis . 4
9.3 Qualitative analysis . 4
10 Specific parameters that can influence results . 4
10.1 General . 4
10.2 Special considerations . 5
10.2.1 Selectivity . 5
10.2.2 Extraction efficiency . 5
10.2.3 Matrix effects. 5
10.2.4 Assay applicability . 5
10.2.5 Hook effect . 5
10.2.6 Parallelism/linearity . 5
10.2.7 Limits of detection . 6
10.2.8 Limits of quantification . 6
11 Confirming method . 6
12 Test report . 6
Annex A (informative) Detection of a protein by ELISA . 8
Annex B (informative) Detection of a protein or proteins by lateral flow devices .19
Bibliography .26
ISO 21572:2019(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for th
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