SIST EN ISO 18330:2004

Milk and milk products - Guidelines for the standardized description of immunoassays or receptor assays for the detection of antimicrobial residues (ISO 18330:2003)

ISO 18330|IDF 188:2003 gives guidelines for the standardized description of immunoassays or receptor assays for the detection of antimicrobial residues in milk and milk products.
It is intended to provide a framework and basis for the evaluation/validation of tests based on the binding of an antimicrobial compound to its specific antibody or to other types of detecting molecules.
In addition to immunoassays [e.g. enzyme-immunoassay (EIA) and radio-immunoassay (RIA)], there are several quantitative, semi-quantitative and qualitative test formats based on the binding of antimicrobial compounds to microbial receptors or to receptor proteins. Enzymatic assays and particle-based assays based on receptor proteins are referred to as receptor assays in ISO 18330|IDF 188:2003.

Milch und Milchprodukte - Anleitung für die vereinheitlichte Beschreibung von Immunoassays oder Rezeptorassays zum Nachweis von Rückständen antimikrobiell wirksamer Stoffe (ISO 18330:2003)

Diese Internationale Norm gibt eine Anleitung für die vereinheitlichte Beschreibung vorläufiger Bestätigungstests zum Nachweis von Hemmstoffrückständen in Milch und Milchprodukten.
Die Internationale Norm zielt darauf ab, einen Rahmen und eine Grundlage für die Bewertung bzw. Validierung von Tests zu liefern, deren Grundlage die Bindung einer antimikrobiellen Verbindung an ihren spezifischen Antikörper oder an andere Typen von Nachweismolekülen ist.
Zusätzlich zu den Immunoassays [z. B. Enzym-Immunoassay (EIA) und Radio-Immunoassay (RIA)] gibt es auf der Grundlage der Bindung antimikrobieller Verbindungen an mikrobielle Rezeptoren oder an Rezeptorproteine mehrere quantitative, halbquantitative und qualitative Prüfverfahren. Enzymgebundene Essays und teilchengebundene Assays auf der Grundlage von Rezeptorproteinen werden in dieser Internationalen Norm als Rezeptorassays behandelt.

Laits et produits laitiers - Lignes directrices pour la description normalisée des essais immunologiques et des essais récepteur pour la détection des résidus antimicrobiens (ISO 18330:2003)

Mleko in mlečni proizvodi - Navodila za standardizirani opis za imuno analizo ali receptor analizo za detekcijo antimikrobnih ostankov (ISO 18330:2003

General Information

• Status: Published
• Publication Date: 30-Apr-2004
• ICS: 67.100.01 - Milk and milk products in general
• Technical Committee: KŽP - Agricultural food products
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-May-2004
• Due Date: 01-May-2004
• Completion Date: 01-May-2004
• Ref Project: EN ISO 18330:2003 - Milk and milk products - Guidelines for the standardized description of immunoassays or receptor assays for the detection of antimicrobial residues (ISO 18330:2003)

Relations

• Parent: SIST EN ISO 13969:2004 - Milk and milk products - Guidelines for a standardized description of microbial inhibitor tests (ISO 13969:2003)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Milch und Milchprodukte - Anleitung für die vereinheitlichte Beschreibung von Immunoassays oder Rezeptorassays zum Nachweis von Rückständen antimikrobiell wirksamer Stoffe (ISO 18330:2003)Laits et produits laitiers - Lignes directrices pour la description normalisée des essais immunologiques et des essais récepteur pour la détection des résidus antimicrobiens (ISO 18330:2003)Milk and milk products - Guidelines for the standardized description of immunoassays or receptor assays for the detection of antimicrobial residues (ISO 18330:2003)67.100.01VSORãQRMilk and milk products in generalICS:Ta slovenski standard je istoveten z:EN ISO 18330:2003SIST EN ISO 18330:2004en01-maj-2004SIST EN ISO 18330:2004SLOVENSKI
STANDARD



SIST EN ISO 18330:2004



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 18330September 2003ICS 67.100.01English versionMilk and milk products - Guidelines for the standardizeddescription of immunoassays or receptor assays for thedetection of antimicrobial residues (ISO 18330:2003)Laits et produits laitiers - Lignes directrices pour ladescription normalisée des essais immunologiques et desessais récepteur pour la détection des résidusantimicrobiens (ISO 18330:2003)Milch und Milchprodukte - Anleitung für die vereinheitlichteBeschreibung von Immunoassays oder Rezeptorassayszum Nachweis von Rückständen antimikrobiell wirksamerStoffe (ISO 18330:2003)This European Standard was approved by CEN on 7 August 2003.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the 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 translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and UnitedKingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2003 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 18330:2003 ESIST EN ISO 18330:2004



EN ISO 18330:2003 (E)2CORRECTED
2003-10-01ForewordThis document (EN ISO 18330:2003) has been prepared by Technical Committee ISO/TC 34"Agricultural food products" in collaboration with Technical Committee CEN/TC 302 "Milk andmilk products - Methods of sampling and analysis", the secretariat of which is held by NEN.This European Standard shall be given the status of a national standard, either by publication ofan identical text or by endorsement, at the latest by March 2004, and conflicting nationalstandards shall be withdrawn at the latest by March 2004.According to the CEN/CENELEC Internal Regulations, the national standards organizations ofthe following countries are bound to implement this European Standard: Austria, Belgium, CzechRepublic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland andthe United Kingdom.Endorsement noticeThe text of ISO 18330:2003 has been approved by CEN as EN ISO 18330:2003 without anymodifications.SIST EN ISO 18330:2004



Reference numbersISO 18330:2003(E)IDF 188:2003(E)© ISO and IDF 2003
INTERNATIONAL STANDARD ISO18330IDF188First edition2003-09-01Milk and milk products — Guidelines for the standardized description of immunoassays or receptor assays for the detection of antimicrobial residues Laits et produits laitiers — Lignes directrices pour la description normalisée des essais immunologiques et des essais récepteur pour la détection des résidus antimicrobiens
SIST EN ISO 18330:2004



ISO 18330:2003(E) IDF 188:2003(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. Neither the ISO Central Secretariat nor the IDF accepts any liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies and IDF national committees. In the unlikely event that a problem relating to it is found, please inform the ISO Central Secretariat at the address given below.
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ISO and IDF 2003 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO or IDF at the respective address below. ISO copyright office International Dairy Federation Case postale 56 • CH-1211 Geneva 20 Diamant Building • Boulevard Auguste Reyers 80 • B-1030 Brussels Tel.
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ii © ISO and IDF 2003 — All rights reserved
SIST EN ISO 18330:2004



ISO 18330:2003(E) IDF 188:2003(E) © ISO 2003 — All rights reserved iii 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 18330IDF 188 was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 5, Milk and milk products, and the International Dairy Federation (IDF), in collaboration with AOAC International. It is being published jointly by ISO and IDF and separately by AOAC International. SIST EN ISO 18330:2004



ISO 18330:2003(E) IDF 188:2003(E) iv © ISO 2003 — All rights reserved Foreword IDF (the International Dairy Federation) is a worldwide federation of the dairy sector with a National Committee in every member country. Every National Committee has the right to be represented on the IDF Standing Committees carrying out the technical work. IDF collaborates with ISO and AOAC International in the development of standard methods of analysis and sampling for milk and milk products. Draft International Standards adopted by the Action Teams and Standing Committees are circulated to the National Committees for voting. Publication as an International Standard requires approval by at least 50 % of the National Committees casting a vote. ISO 18830IDF 188 was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 5, Milk and milk products, and the International Dairy Federation (IDF), in collaboration with AOAC International. It is being published jointly by ISO and IDF and separately by AOAC International. All work was carried out by the Joint ISO/IDF/AOAC Action Team Antimicrobials and other veterinary medical residues, of the Standing Committee Analytical methods for additives and contaminants, under the aegis of its project leader, Mr E. Märtlbauer (DE)
SIST EN ISO 18330:2004



ISO 18330:2003(E) IDF 188:2003(E) © ISO 2003 — All rights reserved v Introduction Because of the method of detection, the tests described in this International Standard may have limitations so that they cannot be used for quantification. For example, receptor assays have group-specific detection and not chemical-specific detection. Consequently, positive results cannot be subject to quantitation without knowledge of the identity of the specific contaminant. Moreover, assays based on a visual evaluation of colour development may not measure the degree of colour and thus may not provide a quantitative value. Within an integrated system for antimicrobial residue detection, immunoassays and receptor assays may be used as primary-screening methods (e.g. for screening of compounds which can not be detected at regulatory levels by microbiological inhibition assays). These methods may also be used as post-screening methods for preliminary identification and quantification of compounds in samples with a positive result in a microbiological inhibition assay. Depending on whether a certain test complies with the specifications given, immunoassays and receptor assays may be used for routine quality control, especially if the absence/presence of a certain compound in concentrations exceeding a certain level [e.g. maximum residue limit (MRL)] has to be determined. Substances which are not approved or for which no MRLs have been fixed, may require specific consideration. For legal purposes in many countries, positive results obtained by immunoassays or receptor assays require confirmation by an accepted physico-chemical method.
SIST EN ISO 18330:2004



SIST EN ISO 18330:2004



INTERNATIONAL STANDARD ISO 18330:2003(E)IDF 188:2003(E) © ISO and IDF 2003 — All rights reserved 1 Milk and milk products — Guidelines for the standardized description of immunoassays or receptor assays for the detection of antimicrobial residues 1 Scope This International Standard gives guidelines for the standardized description of immunoassays or receptor assays for the detection of antimicrobial residues in milk and milk products.
It is intended to provide a framework and basis for the evaluation/validation of tests based on the binding of an antimicrobial compound to its specific antibody or to other types of detecting molecules.
In addition to immunoassays [e.g. enzyme-immunoassay (EIA) and radio-immunoassay (RIA)], there are several quantitative, semi-quantitative and qualitative test formats based on the binding of antimicrobial compounds to microbial receptors or to receptor proteins. Enzymatic assays and particle-based assays based on receptor proteins are referred to as receptor assays in this International Standard. 2 Normative references The following referenced documents are indispensable for the application 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. ISO 13969, Milk and milk products — Guidance for a standardized description of microbial inhibitor tests 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 false positives percentage of positive results when testing negative samples 3.2 false negatives percentage of negative results at the claimed detection level(s) 3.3 specificity extent to which the presence of substances with chemical structures similar to that of the target analyte will result in a positive result (cross-reaction) 3.4 limit of detection for qualitative tests concentration level at which a defined percentage of samples is detected, e.g. 95 % together with the respective confidence level. SIST EN ISO 18330:2004



ISO 18330:2003(E) IDF 188:2003(E) 2 © ISO and IDF 2003 — All rights reserved 3.5 limit of detection for quantitative tests concentration level which gives a final result that is statistically different from that of negative milk 4 Information needed from the developer/manufacturer 4.1 Methodology The developer or manufacturer of the test should provide information regarding methodology by mentioning the following: a) description of the method (e.g. sample preparation and test performance); b) principle of the method (e.g. competitive direct enzyme-immunoassay); c) evaluation of test results (e.g. visual or instrumental reading, criteria for positive or negative result); d) capacity (e.g. sample throughput); e) special requirements for sampling, preservation and testing; f) procedure for the purpose of quality assurance, including the use of positive/negative control samples; g) field of application concerning
=the intended test use [e.g. screening for milk quality payment or for regulatory purposes (detection of banned substances)], =the substrate or matrix (e.g. raw tanker bulk milk or heat-treated milk), and =the limitations with respect to sample composition (e.g. cell count and bacteriological quality). 4.2 Test kit reagents
The following information should be given regarding test kit reagents. a) In the case of immunoassays: 1) type of antibodies (e.g. monoclonal or polyclonal, sheep, rabbit or egg); 2) type of antigen used in the test (e.g. antigen-enzyme conjugate, solid-phase antigen); 3) type of marker for signal production (e.g. enzyme: peroxidase, alkaline phosphatase; radiochemical: H3, C14, I125; inert bead: colour latex bead, gold); 4) type of enzyme substrate and type of substance used for transformation of enzyme activity to measured signal (e.g. hydrogen peroxide/tetramethylbenzidine), if applicable. b) In the case of microbial receptor assays: 1) type of label (e.g. radioactive isotope), 2) amount of radioactivity and safety requirements, and 3) type of receptor (e.g. non-viable microbial cells or antibody). SIST EN ISO 18330:2004



ISO 18330:2003(E) IDF 188:2003(E) © ISO and IDF 2003 — All rights reserved 3 c) In the case of receptor protein assays: 1) type of receptor protein used (e.g. enzyme-receptor conjugate), 2) type of reagent competing for receptor protein binding sites (e.g. analyte-enzyme conjugate, solid-phase analyte), 3) type of enzyme substrate and type of substance used for transformation of enzyme activity to measured signal, and 4) enzymatic reaction(s) used to produce signal. 4.3 Additional chemicals not necessarily included in the test kit The following should be mentioned regarding additional chemicals not necessarily included in the test kit: a) purity and quality of chemicals required; b) composition and preparation of solutions; c) storage conditions and stability of solutions; d) water quality required. 4.4 Operating requirements The following information should be given regarding operating requirements: a) requirements for user experience and training; b) requirements for laboratory equipment: 1) microtitre plate reader,
2) fluorometer, scintillation counter, computer hard- and software,
3) incubators and precision pipettes; c) requirements for safety (e.g. for handling and disposal of radioactive waste); d) requirements for quality control by developer/manufacturer and/or user. 4.5 Test specifications The following information should be given regarding test definitions: a) false positives: see 3.1; b) false negatives: see 3.2; c) specificity: see 3.3; d) limit of detection: see 3.4 and 3.5 respectively; e) precision: figures for repeatability and reproducibility obtained from the results of collaborative studies, if carried out and available. SIST EN ISO 18330:2004



ISO 18330:2003(E) IDF 188:2003(E) 4 © ISO and IDF 2003 — All rights reserved 4.6 Documentation The following information should be given regarding documentation: a) user manual, including a trouble-shooting guide; b) suppliers of instruments, reagents, standards, technical services and customer support; c) status of official recognition in specified countries (if available); d) availability of reference material; e) availability of internationally recognized and/or validated references from ISO, IDF and AOAC International or others;
f) availability of, for example, literature and practical experiences. 5 Evaluation of the attributes of the enzyme-immuno or receptor assay 5.1 Prerequisites (see ISO 13969) 5.1.1 Milk free from antimicrobials (“negative milk”) The cows from which milk is collected in order to serve as “negative milk” shall meet the following requirements. If, however, a test is applied for milk of an animal species other than cows, the requirements with respect to the status of that animal should be adjusted accordingly. a) The clinical and sub-clinical health status shall be good, with special emphasis on udder health (less than 150 000 somatic cells per millilitre). b) The treatment or feeding with antimicrobial substances shall be prohibited for at least 8 weeks before milk collection. In the case of dry cow treatment, the milk shall not be collected earlier than 60 days after calving provided the dry cow period was at least 4 weeks. c) The cows shall be mid-lactation: more than 60 days and less than 200 days after calving, producing more than 5 kg milk per day. d) The milking of at least five to seven cows shall be combined to overcome individual variations in milk composition. e) The total viable count shall be less than 104 colony-forming units (CFU) per millilitre before the preservation process (deep-freezing, lyophilisation). The possible presence of b-lactamase-producing microorganisms shall be kept in mind in the case of b-lactam antibiotic testing. 5.1.2 Test substances The test substances which are used in the testing procedure should be obtained from a recognized developer/manufacturer, preferably with an analytical certificate with a guaranteed specification. The concentration required should be calculated based on the free acid or base forms of the drug corrected for purity. Special considerations should be given to substances with stability/potency problems. Unless otherwise stated, it is preferable that the evaluation of detection limits (5.2.2) should be undertaken using those antimicrobials and/or concentrations that the developer/manufacturer claims the test will detect. SIST EN ISO 18330:2004



ISO 18330:2003(E) IDF 188:2003(E) © ISO and IDF 2003 — All rights reserved 5 5.1.3 Solvents If special solvents or other chemicals are required to dissolve the substances, it should have been ensured that these solvents or chemica
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