The Certification of the Mass Fractions of Tristearin in Blends of Pure Tristearin and Triolein Representing the Solid Fat Content - IRMM 805 (Set of 12 Primary Standards)

This report describes the preparation and certification of IRMM 805. This reference material is comprised of a set of 12 tristearin/triolein blends (primary triglyceride samples) for the solid fat content (SFC) determination by low-resolution nuclear magnetic resonance spectrometry (LR NMR). The preparation and processing of the materials, stability studies and a characterisation study (by interlaboratory comparison) are described hereafter and the results are discussed. Uncertainties were estimated in compliance with the Guide to the Expression of Uncertainty in Measurement (GUM) and include uncertainties due to gravimetric sample preparation, purity and possible instability.JRC.D.2-Standards for Innovation and sustainable Developmen

Certification of a reference material of Campylobacter coli and jejuni (CNET068 and CNET112) agarose plugs for PFGE: IRMM-313

This report describes the production of IRMM-313, a Campylobacter coli and jenuni gDNA material certified for the size of the DNA fragments obtained by enzymatic restriction and Pulsed Field Gel Electrophoresis (PFGE). The material was produced following ISO Guide 34:2009. The CRM was produced from cultures of Campylobacter coli CNET068 and jejuni CNET112 which were pooled and processed into agarose plugs suited for PFGE. The bacterial cells were lysed as to release the gDNA within the plug. Between unit-homogeneity and stability during dispatch and storage were assessed in accordance with ISO Guide 35:2006. The material was characterised by an intercomparison among laboratories of demonstrated competence and complying to ISO/IEC 17025. Technically invalid results were removed but no outlier was eliminated on statistical grounds only. The certified values were obtained by PFGE. Uncertainties of the certified values were calculated in compliance with the Guide to the Expression of Uncertainty in Measurement (GUM). The material is intended for quality control and assessment of method performance. As any reference material, it can also be used for control charts or validation studies. The CRM is available in plastic screw cap vials containing 1 plug suspended in Tris EDTA buffer solution. The minimum amount of sample recommended to be used is ½ plug.JRC.D.2-Standards for Innovation and sustainable Developmen

Certification of a Reference Material with Enterococcus Faecalis (CIP 106877) at a Target Level of 1000 Colony Forming Units per Material Sphere, IRMM-355

This report describes the certification of a reference material (IRMM-355) of Enterococcus faecalis. Certified Reference Materials (CRMs) for microbiological analysis are indispensible tools for development and validation of detection methods and for the implementation and support of internal and external quality control in the area of microbiological analysis. The content of each vial of IRMM-355 is one material sphere containing Enterococcus faecalis. The homogeneity and stability (at -20 °C and -70 °C) of the batch was assessed by counting colony forming units (cfu) per material sphere on horse blood agar (BA) and Slanetz and Bartley agar (SB agar). The material is stable when stored at a maximum temperature of -20 °C for up to 18 months. The batch was characterised by six laboratories to establish a certified value of cfu per material sphere on BA and SB agar. The certified value for BA is 890 cfu with an expanded uncertainty of 135. The certified value for SB agar is 823 cfu with an expanded uncertainty of 126. In both cases, a coverage factor k = 2 is used, corresponding to a level of confidence of about 95 %. The identity of the bacteria was confirmed by DNA sequence analysis of the coding region for the Enterococcus faecalis endocarditis antigen (efaA).JRC.D.2-Reference material

Certification of the Amount-of-Substance Fraction of HbA1c versus the Sum of all Hb Isoforms forming the glycated or non-glycated N-terminal Hexapeptide of the -Chain on Haemoglobin isolated from whole Blood, IRMM/IFCC-466

This report describes the preparation, homogeneity, stability and certification studies of HbA1c (IRMM/IFCC-466) from human blood. HbA1c is defined as the beta-N-(1-deoxyfructos-1-yl) haemoglobin. the amount-of-substance fraction of HbA1c in IRMM/IFCC-466 is 934 mmol/mol ± 22 mmol/mol (expressed as mmol HbA1c per mol HbA1c plus HbA0). The intended use of this certified reference material is the calibration of the IFCC reference measurement procedure and other analogous methods based on the quantification of the N-terminal hexapeptide including the stable glycation.JRC.D.2-Reference material

Certification of the Mass Fractions of Vitamins in Whole Milk Powder - Certified Reference Material ERM®-BD600

This report describes the production of the reference material ERM-BD600, a whole milk powder certified for the mass fractions of water- and fat-soluble vitamins. All the required steps during the production were conducted according to ISO Guides 34 and 35 [1,2] to ensure the high quality of the final product, including matrix material processing, homogeneity and stability studies and value assignment. The matrix material, a spray dried whole milk powder, was packed into sachets containing approximately 100 g of powder, and stored at -30 ºC. Dedicated studies confirmed the homogeneity and stability of the vitamins in the milk powder under the conditions evaluated. The characterisation of the material, organised and coordinated by IRMM, was done by an inter-laboratory comparison. The certified and indicative values were obtained as the unweighted mean of the laboratory means of the accepted sets of results for each analyte, and the expanded uncertainty associated (k = 2) includes contributions from the homogeneity, the long term stability and the characterisation of the material.JRC.D.2-Reference material

Guidance Document on the Use of Reference Materials in Genetic Testing

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 Organization for Standardization (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 and constitutes a deliverable of th NoE EuroGentest.JRC.D.2-Reference material

The Certification of the Mass Fraction of Oxytetracycline in Partially Skimmed Milk - Certified Reference Materials ERM®-BB492 and ERM®-BB493

This report describes the preparation of two milk powder matrix reference materials (ERM-BB492 and ERM-BB493) and the certification of their content (mass fraction) of oxytetracycline. The preparation and processing of the material, homogeneity and stability studies, and the characterisation are described hereafter and the results are discussed. Uncertainties were estimated in compliance with ISO Guide 98-3, Guide to the Expression of Uncertainty in Measurement (GUM) [1]. For ERM-BB492, the uncertainty contains contributions from possible heterogeneity, instability, characterisation, and purity of the common calibrant.JRC.DG.D.2-Reference material

The Certification of the Mass Fraction of Chloramphenicol in Pork Meat - Certified Reference Material ERM®-BB130

This report describes the preparation of the pork meat matrix reference material ERM-BB130 and the certification of the content (mass fraction) of chloramphenicol. The preparation and processing of the material, homogeneity and stability studies, and the characterisation are described hereafter and the results are discussed. Uncertainties were calculated in compliance with ISO Guide 98-3, Guide to the Expression of Uncertainty in Measurement (GUM) [1] and include uncertainties due to possible heterogeneity, instability, and characterisation.JRC.DG.D.2-Reference material

The Certification of the Mass Fractions of Stilbenes in Bovine Urine - Certified Reference Materials ERM®-BB386 and ERM®-BB389

This report describes the preparation of the pork meat matrix reference materials ERM BB386 and ERM-BB389 and the certification of the content (mass fraction) of three stilbenes. The preparation and processing of the material, homogeneity and stability studies, and the characterisation are described hereafter and the results are discussed. Uncertainties were calculated in compliance with the ISO/IEC Guide 98-3 Guide to the Expression of Uncertainty in Measurement (GUM) [1] and include uncertainties due to possible heterogeneity, instability, and characterisation.JRC.D.2-Standards for Innovation and sustainable Developmen

The Certification of the Mass Fractions of Proximates and Essential Elements in Rye Flour and Wheat Flour -- Certified Reference Materials ERM®-BC381 and ERM®-BC382

This report describes the preparation of the rye flour matrix reference materials ERM®BC381 and ERM®-BC382, respectively, and the certification of the contents (mass fractions) of four proximates and four essential elements. All results are expressed as a mass fraction on a dry mass basis. The preparation and processing of the materials, homogeneity studies, stability studies and characterisation are described hereafter and the results are discussed. Uncertainties were calculated in compliance with Guide to the expression of Uncertainty in Measurement (GUM) and include uncertainties due to possible heterogeneity, instability and from characterisation.JRC.DDG.D.2-Reference material