Guidance Document On Measurement Uncertainty For Gmo Testing Laboratories
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| Total Pages | : 41 |
| Release | : 2009 |
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| ISBN | : 9789279112287 |
This technical report outlines the technical issues related to the estimation of measurement uncertainty (MU) involved in the GMO sector. In particular it gives guidance to GMO testing laboratories how to estimate the analytical variability of quantitative analytical results obtained by real-time PCR. This guidance document has been written on request of the European Network of GMO Laboratories (ENGL) as a follow-up of a workshop on Measurement Uncertainty in the GMO sector organised by the Institute for Reference Materials and Measurements (IRMM), Geel, Belgium and held on 05.07.2005. It is recognised that in order to be able to judge if an analytical results exceeds a threshold; the MU must be estimated and reported together with the measurement result. Enforcement Authorities shall therefore estimate the MU associated with an analytical result and use it to decide whether an analytical result falls within the specification of food and feed control. The value obtained by subtracting the expanded uncertainty from the reported concentration is used to assess compliance. Only if this value is greater than the legal threshold, it is sure 'beyond reasonable doubt' that the sample concentration of the analyte is beyond what is permissible. Two selected approaches for the estimation of MU are presented in detail; references to alternative approaches are given. The first approach presented in detail is using data from collaborative trial in combination with in-house quality control data for the estimation of MU. Prerequisites for the use of such collaborative trial data are outlined. In case no suitable collaborative trial data are available, an alternative approach using data from within-laboratory samples for the estimation of MU is presented.
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| Release | : 2020 |
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| ISBN | : 9789276194323 |
This document provides guidance on how to estimate measurement uncertainty (MU) and supports the enforcement of EU food and feed labelling legislation in the GMO sector. Measurement uncertainty is a parameter which is always associated with the result of a measurement, and characterises the dispersion of values attributed to that result. This measurement uncertainty needs to be estimated when compliance is investigated. The first version of this guidance document was written on request of the European Network of GMO Laboratories (ENGL) as a follow-up to a workshop on MU in the GMO sector organised by the European Commission, Joint Research Centre and was published in 2007. It was updated in 2009. The current version takes into account current EU legislation, availability of certified reference materials (CRMs) and validated quantification methods and the need for control laboratories which carry out measurements for the enforcement of EU legislation to be accredited according to ISO/IEC 17025. This guidance document contributes towards a harmonised approach for how EU Member States check compliance of food and feed samples with EU legislation. Other documents, e.g. the flexible scope accreditation document refer to this document concerning aspects related to MU.
| Author | : S. Trapmann |
| Publisher | : |
| Total Pages | : 41 |
| Release | : 2007 |
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| ISBN | : 9789279055669 |
| Author | : Jana Žel |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 110 |
| Release | : 2011-10-26 |
| Genre | : Technology & Engineering |
| ISBN | : 1461413907 |
The detection of genetically modified organisms (GMOs) is becoming very complex, with new GMOs, approved and unapproved, constantly entering world markets. Traceability and labelling of GMOs is defined in regulations worldwide, demanding accurate and reliable testing to support the requirements of legislation. This Brief provides the current state-of-the-art on all key topics involved in GMO testing and is a source of detailed practical information for laboratories. Special focus is given to qualitative and quantitative real-time PCR analysis relevant to all areas where detection and identification rely on nucleic acid-based methods. The following topics, important for testing laboratories, are also discussed: organization of the laboratory, focusing on aspects of the quality system and methods for testing, validation and verification of methods, and measurement uncertainty. The Brief also discusses the new challenges of GMOs and novel modified organisms, using new technologies, and the possible solutions for GMO detection, including bioinformatics tools. Finally, legislation on GMOs and sources of information on GMOs are provided, which are relevant not only to testing laboratories, but to anyone interested in GMOs. The authors of this Brief have many years of experience in GMO testing, development of real-time PCR methods, implementation of quality system requirements, validations and verification of methods, and measurement uncertainty. The National Institute of Biology is a highly qualified research laboratory and a National Reference Laboratory, which also performs routine analyses of food, feed and seed. The Institute for Health and Consumer Protection of the European Union Joint Research Centre has extensive knowledge and experience of GMO detection. It hosts the European Union Reference Laboratory for GM Food and Feed in addition to chairing the European Network of GMO Laboratories.
| Author | : Salah E. O. Mahgoub |
| Publisher | : CRC Press |
| Total Pages | : 288 |
| Release | : 2019-01-15 |
| Genre | : Health & Fitness |
| ISBN | : 135171385X |
An increasing number of genetically modified organisms (GMOs) continues to be produced every day. In response to the concerns raised by the development of GMOs and their incorporation in foods and feed, guidelines and regulations to govern and control the use of GMOs and their products have been enacted. These regulations necessitated the design of methods to detect and analyse the presence of GMOs or their products in agriculture produce, food and feed production chains. Design of techniques and instruments that would detect, identify, and quantify GM ingredients in food and feed will help inspection authorities to relay reliable information to consumers who might be concerned about the presence of GM ingredients. Information generated by detection of GMOs in food and feed would be helpful for setting regulations that govern the use of GM components as well as for labeling purposes. Qualitative detection methods of GM-DNA sequences in foods and feeds have evolved fast during the past few years. There is continuous need for the development of more advanced multi-detection systems and for periodic updates of the databases related to these systems. Testing and Analysis of GMO-containing Foods and Feed presents updates and comprehensive views on the various methods and techniques in use today for the detection, identification and quantification of GMOs in foods and feed. The eleven book chapters cover recent developments on sample preparation techniques, immunoassays methods and the PCR technique used in GMO analysis, the use of biosensors in relation to GMO analysis, the application of nucleic acid microarrays for the detection of GMOs, validation and standardization methods for GMO testing, in addition to the type of reference material and reference methods used in GMO testing and analysis. Some of the ISO standards designed for identifying and detecting the presence of GM material in foods are also presented in the book.
| Author | : Institute for Health and Consumer Protection |
| Publisher | : |
| Total Pages | : 23 |
| Release | : 2011 |
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| ISBN | : 9789279199257 |
In the EU, method validation is an essential part of the process that regulates the introduction of new GMOs as food and/or feed into the market. When the inter-laboratory validation study is completed, the method is ready to be implemented in routine testing laboratories. When implementing the new method, the laboratory has to verify that the method can be used for its intended purpose (method verification). The scope of this document is to provide guidance on how to carry out the method verification. Despite the fact that several guidelines on method verification have been published, no specific guidelines are available for GMO detection. The aim of this guidance document is to harmonise the in-house verification of inter-laboratory validated methods for the qualitative and quantitative detection of GMOs, including element-, construct-, and event-specific methods. Considering that the Polymerase Chain Reaction (PCR) is the method of choice in the EU for the identification and quantification of GMOs, this document refers exclusively to real time PCR. However, if novel methods are subsequently developed that fulfill legal requirements, then this document will be amended accordingly.
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| Total Pages | : 30 |
| Release | : 2017 |
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In the EU, method validation is an essential part of the process that regulates the introduction of new GMOs as food and/or feed into the market. When the inter-laboratory validation study is completed, the method is ready to be implemented in routine testing laboratories. When implementing the new method, the laboratory has to verify that the method can be used for its intended purpose (method verification). The scope of this document is to provide guidance on how to carry out the method verification of inter-laboratory validated methods for the qualitative and quantitative detection of GMOs. Considering that the Polymerase Chain Reaction (PCR) is the method of choice in the EU for the identification and quantification of GMOs, this document refers exclusively to real time PCR. However, if novel methods are subsequently developed that fulfil legal requirements, then this document will be amended accordingly.
| Author | : Saverio Mannino |
| Publisher | : Springer Nature |
| Total Pages | : 170 |
| Release | : 2022-11-22 |
| Genre | : Technology & Engineering |
| ISBN | : 3031117247 |
This useful and extensive set of guidelines is designed to assist food control laboratories in gaining accreditation from an internationally recognized external body, providing all of the necessary information and practices in an easy-to-read, step-by-step fashion. Authored by an experienced consultant for laboratory accreditation in many different countries, with this text food control lab owners now have all of the up-to-date information they need to gain accreditation in a single source. Guidelines for Laboratory Quality Managers covers the essentials for quality management in the food control laboratory, from testing processes to current quality management systems. The ISO standards for accreditation are extensively explored, including managerial requirements, organizational aspects, complaint handling procedures, internal audits, and sampling. An entire section is dedicated to the implementation of managerial and technical requirements from quality control to program monitoring and evaluation. Analysis selection, preparation, and validation is covered extensively, and an entire section is dedicated to basic statistics from data presentation to distribution. Each section comes with helpful tips for lab managers plus definitions and terms. Comprehensive, easy-to-use and up-to-date, Guidelines for Laboratory Quality Managers is the guide for accreditation for food control laboratories.
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| Total Pages | : 0 |
| Release | : 2023 |
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| ISBN | : 9789268017456 |
The document "Definition of Minimum Performance Requirements for analytical methods of GMO testing" (ENGL 2015) is a guidance developed by the ENGL and the EU Reference Laboratory for Genetically Modified Food and Feed (EURL GMFF). It supports the development and validation of methods for GMO analysis submitted in the frame of applications for EU market authorisation of GMO products, as well as those to be used in the official control of food and feed. The guidance document provides definitions and requirements to assess the performance of the methods developed for the detection and quantification of GMOs based on real-time PCR. More recently, technologies like digital PCR were successfully applied in various fields for the quantification of nucleic acid molecules, including GMOs. Moreover, GM animals and products developed by means of so-called new genomic techniques (Broothaerts et al. 2021) are being released on the market and present additional challenges from the analytical viewpoint. Therefore, ENGL experts have extended the original method performance parameters for guiding users in the development and validation of digital PCR methods for GMO analysis. While the developments in the fields of GM animals and new genomic techniques are still evolving, in addition to the Minimum Performance Requirements guidelines also specific recommendations for methods for the detection and quantification of organisms with short genomic alterations and of GM animals are provided. Given that developments in the fields of GM animals and new genomic techniques are ongoing, these recommendations may be further elaborated in the future.
| Author | : Malcolm Burns |
| Publisher | : Royal Society of Chemistry |
| Total Pages | : 251 |
| Release | : 2019-10-14 |
| Genre | : Technology & Engineering |
| ISBN | : 1788018974 |
The food supply chain needs to reassure consumers and businesses about the safety and standards of food. Global estimates of the cost of food fraud to economies run into billions of dollars hence a huge surge in interest in food authenticity and means of detecting and preventing food fraud and food crime. Approaches targeting DNA markers have assumed a pre-eminence. This book is the most comprehensive and timely collection of material from those working at the forefront of DNA techniques applied to food authenticity. Addressing the new field of analytical molecular biology as it combines the quality assurance rigour of analytical chemistry with DNA techniques, it introduces the science behind DNA as a target analyte, its extraction, amplification, detection and quantitation as applied to the detection of food fraud and food crime. Making the link with traditional forensic DNA profiling and describing emerging and cutting-edge techniques such as next generation sequencing, this book presents real-world case studies from a wide perspective including from analytical service providers, industry, enforcement agencies and academics. It will appeal to food testing laboratories worldwide, who are just starting to use these techniques and students of molecular biology, food science and food integrity. Food policy professionals and regulatory organisations who will be using these techniques to back up legislation and regulation will find the text invaluable. Those in the food industry in regulatory and technical roles will want to have this book on their desks.
