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User support / Application Notes

The JRC is systematically developing additional supporting tools to satisfy the needs of reference material users. It provides dedicated training courses introducing the practice of uncertainty estimation and covering topics such as certified reference materials (CRMs) in calibration, proving laboratory proficiency using CRMs, correct handling of CRMs, identification of available CRMs and selection amongst them. The theoretical knowledge is applied in exercises which take about half of the total course time. These courses are targeted towards practitioners in the laboratory as well as to accreditation bodies.


Technical advice/Frequently Asked Questions

A helpdesk operated by the reference material distribution team of the JRC ( see 'contact us' on the top of the page) and a web-based collection of 'Frequently Asked Questions'  (on the top of the page) are available.


Application Notes

Application Notes are usually published in various languages are designed to help laboratory personnel with exploiting the full potential of certified reference materials. They describe general issues of use of CRMs or give detailed guidance for the use of a specific CRM.


ERM-Application Note 1: Comparison of a measurement result with the certified value (includes Excel-file for evaluation)

Click for summary and pdf-files
The approach compares the difference between the certified and measured values with its uncertainty, i.e. the combined uncertainty of certified and measured value. Guidance on how to determine the standard uncertainties of certified values as well as standard uncertainties of measurement results is given.
 Български  čeština  dansk  Deutsch  Ελληνικά  English
 español  eesti  suomi  français  hrvatski  magyar
 italiano  日本語  한국어  latviešu  lietuvių  Malti
 Nederlands  polski  português  română  slovenčina  slovenščina
 svenska  汉语     



Excel-file for the calculations

ERM Application Note 2: Using Reference Materials for Calibration

Click for summary and pdf-file
This note explains principles for the use of reference materials in analytical calibration, that is, calibration for the purpose of determining the response behaviour of analytical instruments. Issues addressed include the estimation and use of calibration uncertainty, and requirements on reference materials for calibration. ERM® are perfectly suited for this purpose, because they fulfil the stated requirements.

English

ERM-Application Note 3: Using Reference Materials to Establish Metrological Traceability

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This note describes the steps that need to be applied to chemical measurement methods to ensure traceability of the results. Reference materials are key to achieving traceability of measurement results. The ERM® range of certified reference materials are produce by three of Europe’s top metrology institutions. ERM® reference materials have stated traceabilities and provide a means of ensuring reliability and comparability of the results of chemical analysis.

 English  한국어


ERM-Application Note 4: Use of Certified Reference Materials for the Quantification of GMO in Food and Feed

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This application note provides guidance on the correct use of IRMM’s Reference Materials certified for their GM (genetically modified) mass fraction of a specific GM event. The details given below refer particularly to the use of the CRMs ERMBF410, ERM-BF411, ERM-BF412, ERM-BF413, ERM-BF414, ERMBF415, ERM-BF416, ERM-BF417, ERM-BF418 and ERM-BF423.
 Български  čeština  dansk  Deutsch  Ελληνικά  English
 español  eesti  suomi  français  hrvatski  magyar
 italiano  日本語  한국어  latviešu  lietuvių  Malti
 Nederlands  polski  português  română  slovenčina  slovenščina
 svenska  汉语     


ERM-Application Note 5: Use of Certified Reference Materials for the Quantification of GMO in DNA Copy Number Ratio

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This application note provides guidance on the correct use of European Reference Materials certified for their GM (genetically modified) copy number fraction of a specific GM event. The details given below refer particularly to the use of the CRMs ERM-BF413d and ERM-AD413 and the upcoming CRMs certified for copy number ratio.
 Български  čeština  dansk  Deutsch  Ελληνικά  English
 español  eesti  suomi  français  hrvatski  magyar
 italiano  日本語  한국어  latviešu  lietuvių  Malti
 Nederlands  polski  português  română  slovenčina  slovenščina
 svenska  汉语     


ERM-Application Note 6: Use of ERM certificates and materials

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This application note describes some practical aspects associated with handling and use of certified reference materials (CRMs) in laboratories. The various values provided on a certificate, re-use of materials, applying a moisture correction and interpretation of the traceability statement are also explained.
 Български  čeština  dansk  Deutsch  Ελληνικά  English
 español  eesti  suomi  français  hrvatski  magyar
 italiano  日本語  한국어  latviešu  lietuvių  Malti
 Nederlands  polski  português  română  slovenčina  slovenščina
 svenska  汉语     


Application Note IRMM-351: Use of IRMM-351

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This note describes the use of IRMM-351 for checking the correctness of presence/absence tests and method validation.
 Български  čeština  dansk  Deutsch  Ελληνικά  English
 español  eesti  suomi  français  hrvatski  magyar
 italiano  日本語  한국어  latviešu  lietuvių  Malti
 Nederlands  polski  português  română  slovenčina  slovenščina
 svenska  汉语     


Application Note IRMM-352: Use of IRMM-352

Click for summary and pdf-files

This note describes the use of IRMM-352 for checking the correctness of presence/absence tests and method validation.
 Български  čeština  dansk  Deutsch  Ελληνικά  English
 español  eesti  suomi  français  hrvatski  magyar
 italiano  日本語  한국어  latviešu  lietuvių  Malti
 Nederlands  polski  português  română  slovenčina  slovenščina
 svenska  汉语     

Application Note ERM-DA483/IFCC: Use of ERM-DA483/IFCC

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This note describes the use of ERM-DA483 for calibration of immunoassay-based in-vitro diagnostic devices.

English



Guidance documents 

The JRC also developed guidance documents on the use of reference material in the specific areas of GMO and genetic testing.

Training Manual on GMO Quantification: Proper Calibration and Estimation of Measurement Uncertainty

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This manual covers proper calibration of PCR methods, estimation of measurement uncertainty, traceability of a measurement result and the way to prove the trueness of an analytical result. The manual supports the work of the JRC-hosted European Union Reference Laboratory for Genetically Modified Food and Feed (EURL-GMFF) with the ultimate aim of further improving the reporting of National Reference Laboratories (NRLs) and official GMO control laboratories within the EU.

English

Guidance on the estimation of measurement uncertainty for GMO testing laboratories

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A guidance document on the estimation of measurement uncertainty has been compiled on request of the European Network of GMO Laboratories (ENGL) and as a follow-up of a workshop on measurement uncertainty in the GMO sector, organised by JRC in July 2005. It outlines the technical issues related to the estimation of measurement uncertainty involved in the GMO sector. In particular it gives guidance to GMO testing laboratories on how to estimate the analytical variability of quantitative analytical results obtained by real-time PCR. Two selected approaches for the estimation of measurement uncertainty are presented in detail; references to alternative approaches are given.

English

Guidance document on flexible scope accreditation for GMO measurements

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The aim of this guidance document is to ensure harmonised flexible scope accreditation within Europe, according to ISO/IEC 17025:2005 related to quantitative testing of genetically modified organisms (GMOs). Considering that polymerase chain reaction (PCR) is the method of choice in the European Union (EU) for the identification and quantification of GMOs, this document refers exclusively to quantitative real-time PCR (qPCR) and GM events authorised in the EU. A validated quantification method is published by the European Union Reference Laboratory for Genetically Modified Food and Feed (EURL-GMFF) for each of the authorised events as laid down in Regulation (EC) N° 1829/2003. This document is applicable to methods for GM events which were previously authorised in the EU or which are in the authorisation process, provided that the method validation has been completed and that a certified reference material (CRM) is available as requested in the low level presence (LLP) regulation for feed. This guidance document is intended for laboratories that are acquiring or holding a flexible scope of accreditation according to ISO/IEC 17025, and aims to provide information for assessors involved in the accreditation process of these laboratories. It therefore addresses primarily laboratory managers and assessors for ISO/IEC 17025. It has been written by the members of the Task Force (TF) Flexible scope accreditation, which has been initiated by European Commission, Joint Research Centre (Geel, BE) and which reported to the European Network of GMO Laboratories (ENGL). It passed an extensive commenting phase involving the ENGL. The 2nd version of this document published in 2014 has been approved by the European co-operation for Accreditation (EA) in September 2013 as an EA guidance document..

English

Guidance document on the use of reference materials in genetic testing

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The aim of this guidance document is to provide a short and user-friendly support to genetic testing laboratories. It is based on internationally harmonised basic concepts and terminology for quality assurance and control (QA/QC). Relevant terms of the International Organisation for Standardisation (ISO) and the International Vocabulary of Metrology (VIM) are explained and references to other expert texts are provided. The document includes discussion and clarification of several often misunderstood issues. It takes into account the current scientific knowledge and the existing technological capabilities. This document may be revised, when appropriate, to take into account progress in science and technology.

English




Useful links

Much information on reference materials is available on the internet. There are not only lists or searchable catalogues of available reference materials, but also several documents on the selection and use of reference materials. This page gives an overview over available databases and documents, but does not claim to be exhaustive. These websites are not updated with the same frequency. In case of specific CRMs, we therefore recommend checking the website of the producer for availability and additional information.

International Reference Material databases

Several databases exist that compile information from a multitude of reference material producers.
Click for links
  • COMAR: Most comprehensive database worldwide containing approximately 10 000 CRMs. Quality is controlled via the COMAR Secretariat.

  • Database of the AOAC Technical Division for Reference Materials. Registration required to searching for Reference Materials. Address:  tdrmdb.aoac.org

  • VIRM (Virtual Institute for Reference Materials)
    Database of the Virtual Institute for Reference Materials. Registration required to searching for Reference Materials.

  • GeoReM (Geological and Environmental Reference Materials)
    Database of reference materials and isotopic standards of geochemical and mineralogical interest. It contains about 2200 different materials.


  • Matrix reference materials from Metrology Institutes and designated institutes of the CIPM Mutual Recognition Arrangement

    National Metrology Institutes and their designated institutes which have signed the Comité International des Poids et Mesures - Mutual Recognition Arrangement (CIPM-MRA) aim at providing measurement tools at highest standard for disseminating metrological traceability. Several of these signatories also produce certified reference materials.
    Click for links
  • International Atomic Energy Agency (IAEA), UN

  • Bundesanstalt für Materialforschung und – Prüfung (BAM), DE

  • National Metrology Institute of Japan (NMIJ), JP

  • National Research Council of Canada (NRCC), CA

  • National Sharing Platform for Reference Materials (CNRM), CN:
    Address "ncrm.org.cn/Web/Home/EnglishIndex"

  • Instituto Nacional de Metrologia, Normalização e Qualidade Industrial (INMETRO), BR : Address "inmetro.gov.br/metcientifica/mat_ref_cert.asp"

  • Korea Research Institute of Standards and Science, KR.
    Address: "www.kriss.re.kr/eng/rnd/rnd03_2.html"

  • Centro Nacional de Metrología (CENAM), MX

  • National Institute of Standards and Technology (NIST), US



  • Guides for the selection and use of reference materials

    National Metrology Institutes and their designated institutes which have signed the Comité International des Poids et Mesures - Mutual Recognition Arrangement (CIPM-MRA) aim at providing measurement tools at highest standard for disseminating metrological traceability. Several of these signatories also produce certified reference materials.

    Click for links
  • ISO Guide 33:Uses of certified reference materials

  • The APLMF to The selection and use of certified reference materials for legal metrological control in food safety amp; agricultural products
    Author: Asia-Pacific Legal Metrology Forum (APMLF)

  • The Use of Reference Materials: A Tutorial (2001)
    Geostandards and Geoanalytical Research, Volume 25, pp. 7-22,
    Author: J. S. Kane

  • EA-4/14: Selection and Use of Reference Materials (2003)
    Author: This document was prepared by the European Co-operation for accreditation (EA), the European Federation of National Associations of Measurement, Testing and Analytical Laboratories (Eurolab) and Eurachem, a network of organisations in Europe having the objective of establishing a system for the international traceability of chemical measurements and the promotion of good quality practices.
    Address: "european-accreditation.org/publication/ea-4-14-inf-rev00-february-2003-rev"




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