BS EN 15842-2010 食品.食物过敏源的探测.一般考虑和方法有效性.pdf

BS EN 15842:2010 ICS 67.050 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Foodstuffs Detection of food allergens General considerations and validation of methods icensed copy: Mr. Leeds BSOL User, The University of Leeds, Version correct as of 10/04/2010 21:40, (c) BSI This British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 February 2010 © BSI 2010 ISBN 978 0 580 63172 6 Amendments/corrigenda issued since publication DateComments BS EN 15842:2010 National foreword This British Standard is the UK implementation of EN 15842:2010. The UK participation in its preparation was entrusted to Technical Committee AW/-/3, Food analysis - Horizontal methods. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. icensed copy: Mr. Leeds BSOL User, The University of Leeds, Version correct as of 10/04/2010 21:40, (c) BSI BS EN 15842:2010 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN 15842 February 2010 ICS 67.050 English Version Foodstuffs - Detection of food allergens - General considerations and validation of methods Produits alimentaires - Détection des allergènes alimentaires - Considérations générales et validation des méthodes Lebensmittel - Nachweis von Lebensmittelallergenen - Allgemeine Betrachtungen und Validierung von Verfahren This European Standard was approved by CEN on 25 December 2009. 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 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 respons bility of a CEN member into its own language and notified to the CEN 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 15842:2010: E icensed copy: Mr. Leeds BSOL User, The University of Leeds, Version correct as of 10/04/2010 21:40, (c) BSI BS EN 15842:2010 EN 15842:2010 (E) 2 Contents Page Foreword 3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 General aspects for the use of reference materials in food allergen analysis . 12 4.1 Reference material 12 4.2 Reference method. 13 4.3 General requirements for production and storage of reference materials . 13 5 Guidance to the user for selection of methods . 14 5.1 General . 14 5.2 Immunoassay based methods 14 5.3 Molecular biology based methods 15 5.4 Chromatographic methods 15 6 Laboratory organisation 15 6.1 General . 15 6.2 Laboratory design. 15 7 Procedure 15 7.1 General . 15 7.2 Preparation of sample 16 7.3 Extraction 16 7.4 Preparation of calibration curves 16 7.5 Assay procedure . 16 7.6 Quality assurance requirements . 16 8 Interpretation and expression of the results . 16 8.1 General . 16 8.2 Quantitative analysis 16 8.3 Qualitative analysis 16 8.4 Provisions 17 8.5 Ambiguous results . 17 9 Test report . 17 Bibliography . 18 icensed copy: Mr. Leeds BSOL User, The University of Leeds, Version correct as of 10/04/2010 21:40, (c) BSI BS EN 15842:2010 EN 15842:2010 (E) 3 Foreword This document (EN 15842:2010) has been prepared by 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 2010, and conflicting national standards shall be withdrawn at the latest by August 2010. 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. 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. icensed copy: Mr. Leeds BSOL User, The University of Leeds, Version correct as of 10/04/2010 21:40, (c) BSI BS EN 15842:2010 EN 15842:2010 (E) 4 Introduction The main focus of this European Standard is on immunoassays, chromotographic and nucleic acid based methods for the determination of food allergens. However, because of the rapid developments in this area, other technologies may be considered. The search for food allergens is performed by means of the following successive (or simultaneous) steps. After sample collection, proteins, nucleic acids or other markers are extracted from the test portion. Extracted analytes can be further purified, simultaneously or after the extraction process. Afterwards, they are diluted (if necessary) and subjected to analytical procedures such as immunoassays (e.g. ELISA), nucleic acid based assays (e.g. PCR) or chromatographic (e.g. LC-MS). These steps are detailed in this document and in the following documents: EN 15633-1:2009, Foodstuffs Detection of food allergens by immunological methods Part 1: General considerations EN 15634-1:2009, Foodstuffs Detection of food allergens by molecular biological methods Part 1: General considerations icensed copy: Mr. Leeds BSOL User, The University of Leeds, Version correct as of 10/04/2010 21:40, (c) BSI BS EN 15842:2010 EN 15842:2010 (E) 5 1 Scope This European Standard specifies how to use the standards for immunoassays, nucleic based and chromatographic methods and their relationship in the analysis of food allergens; and contains general definitions, requirements and guidelines for laboratory set-up, method validation requirements, description of methods, and test reports. This document also specifies general guidelines for the requirements and use of reference materials for the determination of allergenic commodities in food products. The term “reference materials“ in this document includes certified reference materials as well as quality control materials. Currently only a limited number of reference materials for food allergen determination are available. As new materials become accepted and validated, they may be appended as an annex to this document. This document does not deal with sampling issues. It simply details processes involved from receipt of the laboratory sample to the end result. 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. EN ISO/IEC 17025, General requirement for the competence of testing and calibration laboratories (ISO/IEC 17025:2005) EN ISO 17511:2003, In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) ISO Guide 31, Reference materials Contents of certificates and labels ISO Guide 35, Reference materials General and statistical principles for certification 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 accepted reference value value that serves as an agreed-upon reference for comparison and which is derived as: theoretical or established value, based on scientific principles, an assigned value, based on experimental work of some national or international organization, consensus value, based on collaborative experimental work under the auspices of a scientific or engineering group ISO Guide 30:1992 3.2 accuracy closeness of agreement between a test result or measurement result and the true value icensed copy: Mr. Leeds BSOL User, The University of Leeds, Version correct as of 10/04/2010 21:40, (c) BSI BS EN 15842:2010 EN 15842:2010 (E) 6 NOTE 1 In practice, the accepted reference value is substituted for the true value. NOTE 2 The term “accuracy“, when applied to a set of test or measurement results, involves a combination of random components and a common systematic error or a bias component. NOTE 3 Accuracy refers to a combination of trueness and precision. ISO 3534-2:2006 3.3 applicability range quantity interval within which the analytical procedure has been demonstrated by collaborative trial or other appropriate validation to have a suitable level of precision and accuracy EN ISO 24276:2006 3.4 bias difference between the expectation of a test result or measurement result and a true value NOTE 1 Bias is the total systematic error as contrasted to random error. There may be one or more systematic error components contributing to the bias. A larger systematic difference from the accepted reference value is reflected by a larger bias value. NOTE 2 The bias of a measuring instrument is normally estimated by averaging the error of indication over an appropriate number of repeated measurements. The error of indication is the “indication of a measuring instrument minus a true value of the corresponding input quantity“. ISO 3534-2:2006 3.5 Certified Reference Material CRM reference material, accompanied by a certificate, one or more of whose property values are certified by a procedure which establishes its traceability to an accurate realisation of the unit in which the property values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level of confidence ISO Guide 30:1992 3.6 certified value for a CRM, value that appears in the certificate accompanying the material ISO Guide 30:1992 3.7 characterization for a reference material, determination of one or more physical, chemical, biological, or technological property values that are relevant to its intended end use ISO Guide 30:1992 3.8 collaborative study interlaboratory study interlaboratory study in which each laboratory uses a defined method of analysis to analyse identical portions of homogenous material to assess the performance characteristics obtained for the method of analysis icensed copy: Mr. Leeds BSOL User, The University of Leeds, Version correct as of 10/04/2010 21:40, (c) BSI BS EN 15842:2010 EN 15842:2010 (E) 7 NOTE Guidelines for performing collaborative trials are elaborated in ISO 5725-1 3 and in IUPAC harmonized protocol 1995 16. 3.9 commutability of a material closeness of agreement between the mathematical relationship of the measurement results obtained by two measurement procedures for a stated quantity in a given material, and the mathematical relationship obtained for the quantity in routine samples EN ISO 17511:2003 3.10 consensus value (of a given quantity) for a reference material, value of the quantity obtained by interlaboratory testing, or by agreement between appropriate bodies or experts ISO Guide 30:1992 3.11 fitness for purpose applicability degree to which data produced by a measurement process enables a user to make technically and administratively correct decisions for a stated purpose NOTE See 17. 3.12 homogeneity condition of being of uniform structure or composition with respect to one or more specified properties NOTE A reference material is said to be homogeneous with respect to a specified property if the property value, as determined by tests on samples of specified size, is found to lie within the specified uncertainty limits, the samples being taken either from different supply units (bottles, packages, etc.) or from a single supply unit. Adapted from ISO Guide 30:1992 3.13 laboratory sample sample as prepared for sending to the laboratory and intended for inspection or testing ISO 78-2:1999 3.14 limit of detection LOD minimum amount or concentration of the analyte in test sample which can be detected reliably but not necessarily quantified, as demonstrated by a collaborative trial or other appropriate validation 3.15 limit of detection for quantitative determinations amount of an analyte corresponding to the lowest measurement signal which with a closely defined confidence may be interpreted as indicating that the analyte is present in the sample, but without allowing exact quantification 3.16 limit of detection for qualitative determinations threshold concentration below which positive identification is unreliable according to the established requirements for reliability icensed copy: Mr. Leeds BSOL User, The University of Leeds, Version correct as of 10/04/2010 21:40, (c) BSI BS EN 15842:2010 EN 15842:2010 (E) 8 NOTE See 24. 3.17 limit of quantitation LOQ lowest concentration or amount of the analyte in a test sample which can be quantitatively determined with an acceptable level of precision and accuracy, as demonstrated by collaborative trail or other appropriate validation NOTE See 24. 3.18 limit of quantification limit of determination lowest amount of an analyte which can be determined quantitatively with a closely defined confidence NOTE See 24. 3.19 linearity ability to elicit test results that are directly, or by means of well defined, mathematical transformations, proportional to the concentration of analyte in samples within a given range NOTE See 15. 3.20 matrix all compounds in the sample with the analyte NOTE Each matrix has generally a common name which permits classification. EN ISO 21572:2004 3.21 outlier member of a set of values which is inconsistent with the other members of that set NOTE ISO 5725 specifies the statistical tests and the significance level used to identify outliers in trueness and precision experiments. ISO 5725-1:1994 3.22 practicability ease of operations, in terms of sample throughput and costs, to achieve the require