scholarly journals Multianalyte Conventional Reference Material (MacRM): A Useful Tool for Nationwide Standardization of Laboratory Measurements for Medical Care—A Model Study in Japan

2016 ◽  
Vol 62 (2) ◽  
pp. 392-406 ◽  
Author(s):  
Katsuyuki Shinohara ◽  
Naotaka Hamasaki ◽  
Yasushi Takagi ◽  
Yutaka Yatomi ◽  
Hiroshi Kikuchi ◽  
...  
Keyword(s):  
Reference Material ◽  
Reference Materials ◽  
Clinical Laboratory ◽  
Certified Reference Materials ◽  
Laboratory Measurements ◽  
Clinical Laboratories ◽  
Model Study ◽  
Low Concentrations ◽  
Target Values ◽  
Measurement Results

Abstract BACKGROUND The Japanese Committee for Clinical Laboratory Standards (JCCLS) has developed a multianalyte conventional reference material (MacRM) for nationwide standardization of laboratory measurements. METHODS To prepare the MacRM, pooled sera were obtained from healthy Japanese individuals. Target values of the pooled sera for 30 analytes were assigned on the basis of the measurement results of 45 certified clinical laboratories whose calibration was verified by measuring certified reference materials (CRMs) provided by the National Institute of Standards and Technology, the Institute for Reference Materials and Measurements, and JCCLS. Commutability of MacRM was assessed by comparison with results for 150 individual inpatients at Fukuoka University Chikushi Hospital. Survey samples were prepared by essentially the same method for MacRM but without target values. The survey samples were used to assess agreement among 165 laboratories that used various assay kits and platforms calibrated with the MacRM. RESULTS The commutability of MacRM was confirmed for 30 analytes with sera from 150 individual patients. The imprecision (CV) of measurements of survey samples (high and low concentrations) among the 165 laboratories was 0.4%–10.0%. Twenty-six of 30 analytes were within the goals for interinstitutional allowable bias. An aliquot of MacRM stored frozen at −80 °C remained stable for ≥4 years. CONCLUSIONS The MacRM was successfully applied as a calibrator to achieve nationwide standardization for 30 analytes measured by 165 laboratories that used various methods from different manufacturers.

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.

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

scholarly journals The problem of improving the quality of seriously issued certified reference materials of the composition of gas mixtures

2019 ◽  
Vol 15 (3) ◽  
pp. 5-13
Author(s):  
L. A. Konopelko ◽  
A. V. Kolobova ◽  
O. V. Fatina
Keyword(s):  
Reference Material ◽  
Reference Materials ◽  
Certified Reference Materials ◽  
Metrological Traceability ◽  
Gas Mixtures ◽  
Measuring Instruments ◽  
Expanded Uncertainty ◽  
Iso Guide 35 ◽  
The Russian Federation

Currently, in the Russian Federation, the metrological traceability of certified reference materials of the composition of gas mixtures in cylinders under pressure produced by manufacturers of certified reference materials is carried out in accordance with GOST 8.578-2014. Considering that certified reference materials of the composition of gas mixtures in cylinders under pressure are used for testing to approye the type of measuring instruments, verification, calibration, and graduation of gas-analytical measuring instruments used to control explosive gases and vapors, harmful components in the atmospheric air and the air of the working area, emissions from vehicles and enterprises, to control technological processes, the quality of hydrocarbon products, etc., the issue of ensuring the quality of seriously produced certified reference materials (about 100.000 cylinders with gas mixtures per year) is important. To ensure the quality of certified reference materials of gas mixtures in cylinders under pressure, mass-produced by manufacturers of certified reference materials, we offer the following actions:– manufacturers of certified reference materials’ passing of mandatory accreditation for compliance with the requirements of GOST ISO Guide 34–2014 and GOST ISO Guide 35–2015;– manufacturers of certified reference materials’ constant participation in the proficiency testing programs through interlaboratory tests;– actualizing and refining the existing set of standards defining the requirements for the entire life cycle of a certified reference material of a gas mixture in a cylinder under pressure;– improving the method of certification of a reference material by calculating the value of the expanded uncertainty of the reference material and the introducting a new coefficient «technological reserve».

Experience with Certified Reference Material Proficiency Testing for Quality Control of Wheat

1998 ◽  
Vol 6 (A) ◽  
pp. A53-A61
Author(s):  
Judit Budai ◽  
Judit Fükó
Keyword(s):  
Quality Control ◽  
Reference Material ◽  
Proficiency Testing ◽  
Reference Materials ◽  
Certified Reference Material ◽  
Certified Reference Materials ◽  
Long Term Stability ◽  
Determining Factors ◽  
Chemical Section

The Chemical Section of OMH1,2 embarked on the preparation of a series of wheat samples as Certified Reference Materials (CRMs) in 1992. The certification processes were carried out according to the recommendations of ISO. Since then we have developed a series of flour samples as well. The investigations of the long-term stability and the application of wheat and flour CRMs are continuous. Wheat is one of the most widely grown crops in Hungary and it is one of the major determining factors of the economy. Its uniform and objective qualification is of great importance. There are well-equipped laboratories available with sufficient experience but, as the proficiency testing regularly showed, certified samples need to be used to achieve exact and uniform measuring results.

scholarly journals Estimate of Uncertainty of Measurement from a Single-Laboratory Validation Study: Application to the Determination of Lead in Blood

2004 ◽  
Vol 50 (8) ◽  
pp. 1396-1405 ◽  
Author(s):  
Marina Patriarca ◽  
Marco Castelli ◽  
Federica Corsetti ◽  
Antonio Menditto
Keyword(s):  
Reference Materials ◽  
Certified Reference Materials ◽  
Electrothermal Atomic Absorption Spectrometry ◽  
Absorption Spectrometry ◽  
Environmental Pollutant ◽  
The European Union ◽  
Lead In Blood ◽  
Method Performance ◽  
Target Values

Abstract Background: Lead is an environmental pollutant, and human exposure is assessed by monitoring lead concentrations in blood. Because the main source of environmental exposure has been the use of leaded gasoline, its phase-out has led to decreased lead concentrations in the general population. Therefore, validated analytical methods for the determination of lower lead concentrations in blood (<150 μg/L) are needed. In addition, new ISO standards require that laboratories determine and specify the uncertainty of their results. Methods: We validated a method to determine lead in blood at concentrations up to 150 μg/L by electrothermal atomic absorption spectrometry with Zeeman background correction according to EURACHEM guidelines. Blood samples were diluted (1:1 by volume) with 2 mL/L Triton X-100. NH4H2PO4 (5 g/L) and Mg(NO3)2 (0.5 g/L) were used as modifiers. Matrix-matched standards were used for calibration. Results: We determined the limits of detection (3.1 μg/L) and quantification (9.4 μg/L). Repeatability and intermediate imprecision within the range 35–150 μg/L were <5.5% and <6.0%, respectively. We assessed trueness by use of certified reference materials, by recovery tests, and by comparison with target values of other reference materials (candidate external quality assessment samples). The expanded uncertainty ranged from 20% to 16% (with a confidence level of 95%) depending on concentration. Conclusions: This study provides a working example of the estimate of uncertainty from method performance data according to the EURACHEM/CITAC guidelines. The estimated uncertainty is compatible with quality specifications for the analysis of lead in blood adopted in the US and the European Union.

scholarly journals Global certified-reference-material- or reference-material-scaled nutrient gridded dataset GND13

2020 ◽  
Vol 12 (1) ◽  
pp. 487-499 ◽  
Author(s):  
Michio Aoyama
Keyword(s):  
Reference Material ◽  
Reference Materials ◽  
Certified Reference Materials ◽  
Global Ocean ◽  
Nutrient Concentrations ◽  
Correction Factors ◽  
Data Product ◽  
Gridded Dataset ◽  
Nutrient Analyses ◽  
Better Than

Abstract. A global nutrient gridded dataset that might be the basis for studies of more accurate spatial distributions of nutrients in the global ocean was created and named GND13. During 30 cruises, reference materials of nutrients in seawater or their equivalents were used at all stations, and high-precision measurements were made. The precision of the nutrient analyses was better than 0.2 %. Data were collected from the hydrographic cruises in the JASMTEC R/V Mirai cruises, JMA cruise, CARINA, PACIFICA, and WGHC datasets from which nutrient data were available. Analyses were conducted at 243 crossover stations. Cruises that used certified reference materials or reference materials (CRMs/RMs) for seawater nutrient concentration measurements were used as a reference of an unbroken chain of comparison to determine correction factors which made nutrient concentrations obtained by other cruises SI traceable. Dissolved oxygen was secondarily quality-controlled using the same methodology as was used to create the nutrient gridded data product, but, lacking a traceable standard, the resulting oxygen data product is not SI traceable. Finally, a dataset of nitrate, phosphate, and silicate concentrations was created at latitude and longitude intervals of 0.5∘ and on 136 isobaric surfaces to depths of 6500 m as an SI-traceable dataset. This dataset has already been published at: https://doi.org/10.17596/0000001 (Aoyama, 2017).

Certified Reference Materials and Metrological Traceability for Mycotoxin Analysis

2019 ◽  
Vol 102 (6) ◽  
pp. 1695-1707
Author(s):  
Zhen Guo ◽  
Xianjiang Li ◽  
Hongmei Li
Keyword(s):  
Reference Materials ◽  
Certified Reference Materials ◽  
Mutual Recognition ◽  
Metrological Traceability ◽  
International Standards ◽  
Great Effort ◽  
Legal Metrology ◽  
International Laboratory Accreditation Cooperation ◽  
Weights And Measures ◽  
Measurement Results

Abstract In the past decade, with the signing of the joint declaration by the International Bureau of Weights and Measures (BIPM), the International Organisation of Legal Metrology, the International Laboratory Accreditation Cooperation, and the International Organization for Standardization, and the issuing of new international standards such as ISO/IEC 17025 and ISO 13528, metrological traceability has become more and more important for the mutual recognition of measurement results. It is found that the important factors for ensuring the accuracy of results are not only relevant to calibrants but also to the analysis procedure. This paper focuses on the analysis of key factors that affect measurement results, such as analytical methods, reference materials (RMs), and proficiency testing of mycotoxins. The Capacity Building and Knowledge Transfer Programme for mycotoxins, led by the BIPM, which aims to establish a global measurement system traced to the Système International d’Unités (SI), is well illustrated. Furthermore, this paper suggests to stakeholders that great effort is needed to promote the effective use of certified RM resources that are traced to the SI and globally recognized by the International Committee for Weights and Measures to finally realize “one measurement, global recognition.”

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