Training manual on GMO quantification : proper calibration and estimation of measurement uncertainty

The content of this manual is based on the training course that was organised on the premises of the European Commission, Joint Research Centre, Institute for Reference Materials and Measurements (Geel, BE) at the end of 2013. The training manual complements the training course that was intended to improve the quality of measurement results obtained when quantifying genetically modified organisms (GMO) in food and feed. Both, the training course and this manual, were developed in line with the current EU GMO legislation. The manual is addressed to laboratory managers and practitioners in analytical laboratories who perform GM quantification measurements and use reference materials for calibration, quality control and method validation including in-house verification. It is also intended for analysts who need to assess measurement uncertainties as required by (EC) No 1829/2003 [1], (EC) No 619/2011 [2] and ISO/IEC 17025:2005. This training document has been written by JRC-IRMM upon request of the European Union Reference Laboratory for Genetically Modified Food and Feed (EURL-GMFF) to further improve the reporting of National Reference Laboratories (NRLs) nominated under Regulation (EC) No 882/2004 [ ] and official GMO control laboratories within the EU. This manual is organised in four chapters covering the proper calibration of PCR methods, the estimation of measurement uncertainty, the establishment of metrological traceability of a measurement result and the way to prove the trueness of measurement results. The training manual is a didactic support of a previous guidance document that outlines issues related to the estimation of measurement uncertainty (MU) in the GMO sector [ ]. The training manual is also in line with the European technical guidance document for the flexible scope accreditation of laboratories quantifying GMOs, that is intended for laboratories that are acquiring or are holding a flexible scope of accreditation according to ISO/IEC 17025.