scholarly journals Evaluation of Homogeneity in Certified Reference Materials (CRM)

2019 ◽  
Author(s):  
Florbela A. Dias ◽  
Carlos J. Costa
Keyword(s):  
Reference Materials ◽  
Certified Reference Materials ◽  
Statistical Treatment ◽  
Gravimetric Method ◽  
Measurement Procedure ◽  
Gas Mixture ◽  
Special Focus ◽  
Clinical Tests ◽  
Homogeneity Study ◽  
International Standard

The production of Certified Reference Materials (CRM), according to the international standard ISO 17034:2016, has been playing an increasingly role in measurements and accreditation activities of entities/laboratories, with special focus on the field of chemical, biological and clinical tests and physical properties. The IPQ LGR is responsible for the production of various types of CRM, namely gas mixture standards of ethanol in nitrogen (C2H5OH/N2), by gravimetric method according to the international standard ISO 6142-1:2015, and certification by non-dispersive infrared spectroscopy (NDIR) in accordance with ISO 6143:2001. According to ISO 17034:2016, these mixtures have to be evaluated regarding the homogeneity, which is one of the fundamental requirements for the production of CRM. In this communication, the results of the homogeneity study of standards gas mixtures of ethanol in nitrogen are presented, according to a validated measurement procedure, in order to guarantee the traceability to SI units and also to meet the requirements of ISO 17034:2016. The statistical treatment of the data is presented through analysis of variance ANOVA.

scholarly journals Analysis Methods for Development of Standard Reference Material (SRM) Zircon Minerals Synthesis

2018 ◽  
Vol 18 (3) ◽  
pp. 448 ◽  
Author(s):  
Samin Samin ◽  
Susanna Tuning Sunanti
Keyword(s):  
Reference Material ◽  
Statistical Methods ◽  
Reference Materials ◽  
Certified Reference Materials ◽  
Synthesis Method ◽  
Gravimetric Method ◽  
Iso 13528 ◽  
Major Chemical ◽  
Characterization Test ◽  
Zircon Mineral

The synthesis method of in-house zircon minerals certified reference material (CRM) from Kalimantan (Tumbang Titi), and Bangka has been studied with statistical method of ISO 13528-2008 and ISO 35-2006. Zircon Minerals weighing of 10 kg, and it was dried at 90 °C for 2 × 6 h in a closed room, then crushed with a Ball-Mill up to passes 200 mesh, and homogenized in a homogenizer for 3 × 6 h. The water content in zircon minerals powder is tested by gravimetric method, whereas the homogeneity and stability assessed by statistical methods. Zircon mineral powders are distributed to seven accredited testing laboratory for testing the composition and content of the oxides with the validated analytical methods. Standardization and characterization of candidate zircon mineral certified reference materials are done by using XRD (X-Ray Diffraction) and used standard materials of JCRM R 502 from Japan. The test results of oxide concentrations from various laboratories processed with statistical methods. From the data by test laboratories obtained 40 bottles of the prototype in-house certified reference materials zircon mineral powders from Kalimantan and Bangka with a capacity of 100 g. Based on standardization and characterization test data obtained a major chemical compound on zircon minerals Kalimantan and Bangka similar to the standard that is ZrSiO4. This in-house CRM is traced to certified reference materials from Japan (JCRM-502).

scholarly journals Commutability Assessment of Candidate Reference Materials for Pancreatic α-Amylase

2018 ◽  
Vol 64 (8) ◽  
pp. 1193-1202 ◽  
Author(s):  
Liesbet Deprez ◽  
Brigitte Toussaint ◽  
Ingrid Zegers ◽  
Heinz Schimmel ◽  
Denis Grote-Koska ◽  
...  
Keyword(s):  
Human Serum ◽  
Reference Materials ◽  
Prediction Interval ◽  
Certified Reference Materials ◽  
Linear Regression Analysis ◽  
Measurement Procedure ◽  
Matrix Composition ◽  
Bias Analysis ◽  
The Matrix ◽  
Primary Reference

Abstract BACKGROUND Measurement standardization of the catalytic concentration of α-amylase in serum is based on 3 pillars: the primary reference measurement procedure (PRMP), reference laboratories, and suitable certified reference materials (CRMs). Commutability is a prerequisite when using a CRM for calibration and trueness control of routine methods or for value transfer from the PRMP to end-user calibrators of routine methods through a calibration hierarchy. METHODS We performed a commutability study with 30 serum pools and 5 candidate reference materials (RMs) for pancreatic α-amylase using an automated version of the PRMP and 5 different routine methods. Four candidate RMs had an artificial matrix, each with a different composition, and 1 candidate RM was based on human serum. Data were analyzed according to a linear regression analysis with prediction interval as described in the Clinical and Laboratory Standards Institute guideline EP30-A and a difference in bias analysis as described in the recommendations of the IFCC Working Group on Commutability. RESULTS The commutability profile of the 4 candidate RMs with an artificial matrix was variable. Only 1 candidate RM, with human serum albumin in the matrix, showed a good profile like that of the candidate RM based on serum. The comparison of both commutability assessment approaches indicated some differences because of inconclusive results for the difference in bias approach, suggesting a large uncertainty on the commutability assessment. CONCLUSIONS A CRM for pancreatic amylase in an artificial matrix can be commutable for routine methods using the same substrate as the PRMP, but the matrix composition is crucial.

Development of reference materials with the composition of propyl and isopropyl alcohol solutions

2020 ◽  
pp. 66-72
Author(s):  
Irina A. Piterskikh ◽  
Svetlana V. Vikhrova ◽  
Nina G. Kovaleva ◽  
Tatyana O. Barynskaya
Keyword(s):  
Reference Materials ◽  
Measurement Errors ◽  
Isopropyl Alcohol ◽  
Certified Reference Materials ◽  
Toxic Substances ◽  
Biological Objects ◽  
Margin Of Error ◽  
Measurement Results ◽  
And Control ◽  
Characteristic Mass

Certified reference materials (CRM) composed of propyl (11383-2019) and isopropyl (11384-2019) alcohols solutions were created for validation of measurement procedures and control of measurement errors of measurement results of mass concentrations of toxic substances (alcohol) in biological objects (urine, blood) and water. Two ways of establishing the value of the certified characteristic – mass consentration of propanol-1 or propanol-2 have been studied. The results obtained by the preparation procedure and comparison with the standard are the same within the margin of error.

PROGRESS ON THE DEVELOPMENT OF CERTIFIED REFERENCE MATERIALS FOR Aβ1-42

2017 ◽  
Vol 13 (7) ◽  
pp. P1512
Author(s):  
Sébastien Boulo ◽  
Julia Kuhlmann ◽  
Andreas Leinenbach ◽  
Tobias Bittner ◽  
Leentje Demeyer ◽  
...  
Keyword(s):  
Reference Materials ◽  
Certified Reference Materials

scholarly journals Development and certification of a reference material for zearalenone in maize germ oil

2021 ◽  
Author(s):  
Juliane Riedel ◽  
Sebastian Recknagel ◽  
Diana Sassenroth ◽  
Tatjana Mauch ◽  
Sabine Buttler ◽  
...  
Keyword(s):  
Reference Material ◽  
Reference Materials ◽  
Mass Fraction ◽  
High Performance ◽  
Certified Reference Materials ◽  
Maximum Level ◽  
Whole Process ◽  
Commission Regulation ◽  
Maize Oil ◽  
Maize Germ

AbstractZearalenone (ZEN), an estrogenic mycotoxin produced by several species of Fusarium fungi, is a common contaminant of cereal-based food worldwide. Due to frequent occurrences associated with high levels of ZEN, maize oil is a particular source of exposure. Although a European maximum level for ZEN in maize oil exists according to Commission Regulation (EC) No. 1126/2007 along with a newly developed international standard method for analysis, certified reference materials (CRM) are still not available. To overcome this lack, the first CRM for the determination of ZEN in contaminated maize germ oil (ERM®-BC715) was developed in the frame of a European Reference Materials (ERM®) project according to the requirements of ISO Guide 35. The whole process of CRM development including preparation, homogeneity and stability studies, and value assignment is presented. The assignment of the certified mass fraction was based upon an in-house study using high-performance liquid chromatography isotope dilution tandem mass spectrometry. Simultaneously, to support the in-house certification study, an interlaboratory comparison study was conducted with 13 expert laboratories using different analytical methods. The certified mass fraction and expanded uncertainty (k = 2) of ERM®-BC715 (362 ± 22) μg kg−1 ZEN are traceable to the SI. This reference material is intended for analytical quality control and contributes to the improvement of consumer protection and food safety. Graphical abstract

Sign in / Sign up

Export Citation Format

Share Document