ISO 18330:2003 ミルクおよび乳製品—抗菌残留物を検出するためのイムノアッセイまたは受容体アッセイの標準化された説明のガイドライン | ページ 2

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, 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.

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)

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.

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.

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

Bibliography