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1、 Reference number ISO 24276:2006(E) ISO 2006 INTERNATIONAL STANDARD ISO 24276 First edition 2006-02-01 Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products General requirements and definitions Produits alimentaires Mthodes danalyse pour la dtection
2、des organismes gntiquement modifis et des produits drivs Exigences gnrales et dfinitions Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 21:40:17 MDTNo reproduction or networking
3、 permitted without license from IHS -,-,- ISO 24276:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes 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
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6、m the Central Secretariat at the address given below. ISO 2006 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 ei
7、ther ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2006 All rights reserved Copyright Internatio
8、nal Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 21:40:17 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 24276:2006(E) ISO 2006 All rights reserved iii Contents Page Fo
9、reword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 1 3.1 General definitions . 1 3.2 Terms relative to extraction and purification of DNA . 5 3.3 Terms referring to DNA amplification and PCR. 5 3.4 Definitions referring to DNA and PCR controls. 5 3.5 Terms relati
10、ve to reference materials. 7 3.6 Terms relative to quantitation . 7 3.7 Terms relative to GMOs . 7 4 Application to the relevant International Standards. 7 4.1 General. 7 4.2 Guidance for the user on the selection of methods 8 4.3 Performance characteristics . 9 5 General laboratory and procedural r
11、equirements. 10 5.1 General. 10 5.2 Use of controls 10 5.3 Laboratory organization. 12 6 Interpretation and expression of results 13 6.1 General. 13 6.2 Interpretation of controls. 13 6.3 Expression of a negative result. 14 6.4 Expression of a positive result 14 6.5 Expression of ambiguous results.
12、14 6.6 Quality assurance requirements. 15 7 Test report . 15 Bibliography. 16 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 21:40:17 MDTNo reproduction or networking permitted
13、without license from IHS -,-,- ISO 24276:2006(E) iv ISO 2006 All rights reserved 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
14、 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 collaborate
15、s 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
16、. 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
17、 document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 24276 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 275, Food analysis Horizontal methods, in collaboration with Technical
18、 Committee ISO/TC 34, Food products, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/
19、2007 21:40:17 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 24276:2006(E) ISO 2006 All rights reserved v Introduction The purpose of such an analysis is to identify and quantify genetic elements or proteins common to genetically modified organisms (GMOs) and their der
20、ived products in a given matrix. The main focus of this International Standard is polymerase chain reaction (PCR) based methodologies. However, because of the rapid rate of technological change in this area, other technologies may be considered in the future. The search for ingredients of geneticall
21、y modified origin is performed by means of the following successive (or simultaneous) steps. After sample collection, nucleic acids or proteins are extracted from the test portion. Extracted analytes can be further purified, simultaneously or after the extraction process. Afterwards, they are quanti
22、fied (if necessary), diluted (if necessary) and subjected to analytical procedures, such as PCR or Enzyme-Linked Immunosorbent Assay (ELISA). These steps are detailed in this International Standard and in the following documents: EN/TS 21568, Foodstuffs Methods of analysis for the detection of genet
23、ically modified organisms and derived products Sampling strategies ISO 21569, Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products Qualitative nucleic acid based methods ISO 21570, Foodstuffs Methods of analysis for the detection of genetically modi
24、fied organisms and derived products Quantitative nucleic acid based methods ISO 21571, Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products Nucleic acid extraction ISO 21572, Foodstuffs Methods for the detection of genetically modified organisms and
25、 derived products Protein based methods Specific information pertaining to protein detection methods is found in ISO 21572. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 21:40:
26、17 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 21:40:17 MDTNo reproduction or networking permitted w
27、ithout license from IHS -,-,- INTERNATIONAL STANDARD ISO 24276:2006(E) ISO 2006 All rights reserved 1 Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products General requirements and definitions 1 Scope This International Standard specifies how to use
28、the standards for sampling strategies (EN/TS 21568), nucleic acid extraction (ISO 21571), qualitative nucleic acid analysis (ISO 21569), quantitative nucleic acid analysis (ISO 21570) and protein-based methods (ISO 21572), and explains their relationship in the analysis of genetically modified organ
29、isms in foodstuffs. It contains general definitions, requirements and guidelines for laboratory set-up, method validation requirements, description of methods and test reports. It has been established for food matrices, but could also be applied to other matrices (e.g. seeds, feed and plant samples
30、from the environment). 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
31、 5725-1, Accuracy (trueness and precision) of measurement methods and results Part 1: General principles and definitions 3 Terms and definitions For the purpose of this document, the terms and definitions given in ISO 5725-1 concerning validation, those in Reference 1 and the following apply. 3.1 Ge
32、neral definitions 3.1.1 target taxon taxon to which the genetically modified organism belongs NOTE In this context, taxon usually means species but it could be of lower or higher taxonomic rank. 3.1.2 laboratory sample sample as prepared for sending to the laboratory and intended for inspection or t
33、esting ISO 7002:1986 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 21:40:17 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 24276:2006(E) 2 ISO 20
34、06 All rights reserved 3.1.3 test sample test portion sample, as prepared for testing or analysis, the whole quantity being used for analyte extraction at one time 3.1.4 specificity property of a method to respond exclusively to the characteristic or analyte under investigation 3.1.5 sensitivity cha
35、nge in the response divided by the corresponding change in the concentration of a standard (calibration) curve NOTE This is the slope of the analytical calibration curve. 3.1.6 limit of detection LOD minimum amount or concentration of the analyte in a test sample which can be detected reliably but n
36、ot necessarily quantified, as demonstrated by a collaborative trial or other appropriate validation NOTE See Reference 2 for collaborative trial and Reference 3 for validation. 3.1.7 limit of quantitation LOQ analytical procedure lowest concentration or amount of the analyte in a test sample which c
37、an be quantitatively determined with an acceptable level of precision and accuracy, as demonstrated by a collaborative trial or other appropriate validation NOTE See Reference 2 for collaborative trial and Reference 3 for validation. 3.1.8 accuracy closeness of agreement between a test result and th
38、e accepted reference value 3.1.9 trueness closeness of agreement between the average value obtained from a large series of test results and an accepted reference value NOTE The measure of trueness is usually expressed in terms of bias. Trueness has been referred to as “accuracy of the mean”. 3.1.10
39、precision closeness of agreement between independent test results obtained under stipulated conditions NOTE 1 Precision depends only on the distribution of random errors and does not relate to the true value or to the specified value. NOTE 2 The measure of precision usually is expressed in terms of
40、imprecision and computed as a standard deviation of the test results. Lower precision is reflected by a larger standard deviation. NOTE 3 “Independent test results” means results obtained in a manner not influenced by any previous result on the same or similar test object. Quantitative measures of p
41、recision depend critically on the stipulated conditions. Repeatability and reproducibility conditions are particular sets of extreme conditions. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resa
42、le, 04/18/2007 21:40:17 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 24276:2006(E) ISO 2006 All rights reserved 3 3.1.11 repeatability precision under repeatability conditions 3.1.12 reproducibility precision under reproducibility conditions 3.1.13 repeatability cond
43、itions conditions where independent test results are obtained with the same method on identical test items in the same laboratory by the same operator using the same equipment within short intervals of time 3.1.14 reproducibility conditions conditions where test results are obtained with the same me
44、thod on identical test items in different laboratories with different operators using different equipment NOTE When different methods give test results that do not differ significantly, or when different methods are permitted by the design of the experiment (as in a proficiency study or a material-c
45、ertification study for the establishment of a consensus value of a reference material), the term “reproducibility” may be applied to the resulting parameters. The conditions must be explicitly stated. 3.1.15 repeatability standard deviation standard deviation of test results obtained under repeatabi
46、lity conditions NOTE Repeatability standard deviation is a measure of the dispersion of the distribution of test results under repeatability conditions. Similarly “repeatability variance” and “repeatability coefficient of variation” could be defined and used as measures of the dispersion of test res
47、ults under repeatability conditions. 3.1.16 reproducibility standard deviation the standard deviation of test results obtained under reproducibility conditions NOTE Reproducibility standard deviation is a measure of the dispersion of the distribution of test results under repeatability conditions. S
48、imilarly “reproducibility variance” and “reproducibility coefficient of variation” could be defined and used as measures of the dispersion of test results under reproducibility conditions. 3.1.17 repeatability limit value less than or equal to which the absolute difference between two test results obtained under repeatability conditions may be expected to be with a probability of 95 % NOTE 1 The symbol used is r. NOTE 2 When examining two sing