EN ISO 21572:2013

Foodstuffs - Molecular biomarker analysis - Protein-based methods (ISO 21572:2013)

ISO 21572:2013 provides general guidelines and performance criteria for methods for the detection and/or quantification of specific proteins or protein(s) of interest [POI(s)] in a specified matrix.
These general guidelines address existing antibody based methods. Methods other than those described in Annex A or Annex B can also detect the POI. The same criteria as outlined in ISO 21572:2013 apply generally.

Lebensmittel - Untersuchung von molekularen Biomarkern - Proteinverfahren (ISO 21572:2013)

Diese Internationale Norm legt allgemeine Leitlinien und Leistungskriterien für Verfahren zum Nachweis und/oder zur quantitativen Bestimmung von spezifischen Proteinen oder interessierenden Proteinen [(POI)s] in einer spezifischen Matrix fest.
Diese allgemeinen Leitlinien befassen sich mit vorhandenen auf Antikörpern basierenden Verfahren. Auch andere Verfahren als die im Anhang A oder Anhang B aufgeführten können POIs nachweisen. Die in dieser Norm umrissenen Kriterien werden allgemein angewendet.
WARNUNG — Alle im Testkit vorliegenden bzw. vom Reagenzienhersteller gelieferten Anleitungen oder grundlegenden Laborsicherheitsanweisungen müssen befolgt werden. Die Sicherheits¬datenblätter müssen gelesen und umgesetzt werden.

Produits alimentaires - Analyse des biomarqueurs moléculaires - Méthodes basées sur les protéines (ISO 21572:2013)

L'ISO 21572:2013 énonce des lignes directrices et des critères de performances généraux pour les méthodes de détection et/ou de quantification de protéines spécifiques ou de protéine(s) d'intérêt [POI] dans une matrice donnée.
Ces lignes directrices générales concernent les méthodes basées sur des anticorps existants. Il existe d'autres méthodes que celles décrites en Annexe A ou B susceptibles de détecter des POI. Les mêmes critères que ceux répertoriés dans l'ISO 21572:2013 sont applicables de façon générale.

Živila - Analiza molekulskih biomarkerjev - Metode na osnovi proteinov (ISO 21572:2013)

Ta mednarodni standard zagotavlja splošne smernice in merila učinkovitosti za metode za odkrivanje in/ali kvantifikacijo posameznih zadevnih proteinov ali proteina(-ov) (POI) v določeni matrici. Te splošne smernice obravnavajo obstoječe metode na osnovi protiteles. Za odkrivanje zadevnih proteinov se lahko uporabljajo tudi metode, ki niso opisane v dodatku A ali B. Na splošno se uporabljajo merila iz tega mednarodnega standarda.

General Information

• Status: Withdrawn
• Publication Date: 12-Feb-2013
• Withdrawal Date: 29-Oct-2019
• ICS: 07.100.30 - Food microbiology
• ICS: 67.050 - General methods of tests and analysis for food products
• ICS: 67.060 - Cereals, pulses and derived products
• Technical Committee: CEN/TC 275 - Food analysis - Horizontal methods
• Drafting Committee: CEN/TC 275/WG 11 - Genetically modified foodstuffs
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 30-Oct-2019
• Ref Project: SIST EN ISO 21572:2013 - Foodstuffs - Molecular biomarker analysis - Protein-based methods (ISO 21572:2013)

Relations

• Replaces: EN ISO 21572:2004 - Foodstuffs - Methods for the detection of genetically modified organisms and derived products - Protein based methods (ISO 21572:2004)
• Effective Date: 08-Jun-2022
• Replaces: EN ISO 21572:2004/AC:2005 - Foodstuffs - Methods for the detection of genetically modified organisms and derived products - Protein based methods (ISO 21572:2004)
• Effective Date: 20-Feb-2013
• Replaced By: EN ISO 21572:2019 - Foodstuffs - Molecular biomarker analysis - Immunochemical methods for the detection and quantification of proteins (ISO 21572:2019)
• Effective Date: 01-Aug-2018

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2013
1DGRPHãþD
SIST EN ISO 21572:2004
SIST EN ISO 21572:2004/AC:2005
Živila - Analiza molekulskih biomarkerjev - Metode na osnovi proteinov (ISO
21572:2013)
Foodstuffs - Molecular biomarker analysis - Protein-based methods (ISO 21572:2013)
Lebensmittel - Untersuchung von molekularen Biomarkern - Proteinverfahren (ISO
21572:2013)
Produits alimentaires - Analyse des biomarqueurs moléculaires - Méthodes basées sur
les protéines (ISO 21572:2013)
Ta slovenski standard je istoveten z: EN ISO 21572:2013
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.

EUROPEAN STANDARD
EN ISO 21572
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2013
ICS 67.050 Supersedes EN ISO 21572:2004
English Version
Foodstuffs - Molecular biomarker analysis - Protein-based
methods (ISO 21572:2013)
Produits alimentaires - Analyse des biomarqueurs Lebensmittel - Untersuchung von molekularen Biomarkern -
moléculaires - Méthodes basées sur les protéines (ISO Proteinverfahren (ISO 21572:2013)
21572:2013)
This European Standard was approved by CEN on 12 January 2013.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21572:2013: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Foreword
This document (EN ISO 21572:2013) 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 August 2013, and conflicting national standards shall be withdrawn at
the latest by August 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 21572:2004.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 21572:2013 has been approved by CEN as EN ISO 21572:2013 without any modification.

INTERNATIONAL ISO
STANDARD 21572
Second edition
2013-02-01
Foodstuffs — Molecular biomarker
analysis — Protein-based methods
Produits alimentaires — Analyse des biomarqueurs moléculaires —
Méthodes basées sur les protéines
Reference number
ISO 21572:2013(E)
©
ISO 2013
ISO 21572:2013(E)
© ISO 2013
All rights reserved. Unless otherwise specified, 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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Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
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Published in Switzerland
ii © ISO 2013 – All rights reserved

ISO 21572:2013(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General . 1
3.2 Terms relating to antibodies . 2
3.3 Terms relating to techniques . 2
3.4 Terms relating to control . 3
3.5 Terms relating to validation . 3
4 Principle . 6
5 Reagents . 6
6 Laboratory equipment . 6
7 Sampling . 6
8 Procedure. 7
8.1 General . 7
8.2 Preparation of sample solution . 7
8.3 Extraction . 7
8.4 Preparation of calibration curves, positive controls and reference materials . 7
8.5 Assay procedure . 7
9 Interpretation and expression of results . 8
9.1 General . 8
9.2 Quantitative and semiquantitative analysis . 8
9.3 Qualitative analysis . 8
10 Specific parameters which may influence results . 8
10.1 General . 8
10.2 Special considerations . 9
10.3 Assay applicability . 9
11 Confirmation method .10
12 Test report .10
Annex A (informative) Detection of a protein by ELISA .12
Annex B (informative) Detection of protein(s) by lateral flow devices .22
Bibliography .29
ISO 21572:2013(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
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.
ISO 21572 was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 16,
Horizontal methods for molecular biomarker analysis.
This second edition cancels and replaces the first edition (ISO 21572:2004), which has been technically
revised. It also incorporates the Technical Corrigendum ISO 21572:2004/Cor. 1:2005.
iv © ISO 2013 – All rights reserved

INTERNATIONAL STANDARD ISO 21572:2013(E)
Foodstuffs — Molecular biomarker analysis — Protein-
based methods
WARNING — Follow all instructions provided by the kit/reagent manufacturers and other standard
laboratory safety procedures. Read and implement the material safety data sheets (MSDS).
1 Scope
This International Standard provides general guidelines and performance criteria for methods for the
detection and/or quantification of specific proteins or protein(s) of interest [POI(s)] in a specified matrix.
These general guidelines address existing antibody based methods. Methods other than those described
in Annex A or Annex B can also detect the POI. The same criteria as outlined
...