scholarly journals Provisional standardization of hepcidin assays: creating a traceability chain with a primary reference material, candidate reference method and a commutable secondary reference material

2019 ◽  
Vol 57 (6) ◽  
pp. 864-872 ◽  
Author(s):  
Laura E. Diepeveen ◽  
Coby M.M. Laarakkers ◽  
Gustavo Martos ◽  
Marta E. Pawlak ◽  
Fatih F. Uğuz ◽  
...  
Keyword(s):  
Reference Material ◽  
Clinical Laboratory ◽  
Isotope Dilution Mass Spectrometry ◽  
Reference Method ◽  
Serum Samples ◽  
Traceability Chain ◽  
Long Term Stability ◽  
Purity Analysis ◽  
Primary Reference

Abstract Background Hepcidin concentrations measured by various methods differ considerably, complicating interpretation. Here, a previously identified plasma-based candidate secondary reference material (csRM) was modified into a serum-based two-leveled sRM. We validated its functionality to increase the equivalence between methods for international standardization. Methods We applied technical procedures developed by the International Consortium for Harmonization of Clinical Laboratory Results. The sRM, consisting of lyophilized serum with cryolyoprotectant, appeared commutable among nine different measurement procedures using 16 native human serum samples in a first round robin (RR1). Harmonization potential of the sRM was simulated in RR1 and evaluated in practice in RR2 among 11 measurement procedures using three native human plasma samples. Comprehensive purity analysis of a candidate primary RM (cpRM) was performed by state of the art procedures. The sRM was value assigned with an isotope dilution mass spectrometry-based candidate reference method calibrated using the certified pRM. Results The inter-assay CV without harmonization was 42.1% and 52.8% in RR1 and RR2, respectively. In RR1, simulation of harmonization with sRM resulted in an inter-assay CV of 11.0%, whereas in RR2 calibration with the material resulted in an inter-assay CV of 19.1%. Both the sRM and pRM passed international homogeneity criteria and showed long-term stability. We assigned values to the low (0.95±0.11 nmol/L) and middle concentration (3.75±0.17 nmol/L) calibrators of the sRM. Conclusions Standardization of hepcidin is possible with our sRM, which value is assigned by a pRM. We propose the implementation of this material as an international calibrator for hepcidin.

Multi-Center Calibration of the Second Reference Material for Thromboplastin, Rabbit, Plain, Coded CRM 149R

1991 ◽  
Vol 65 (03) ◽  
pp. 263-267 ◽  
Author(s):  
A M H P van den Besselaar ◽  
R M Bertina
Keyword(s):  
Reference Material ◽  
Standard Error ◽  
Standard Errors ◽  
Sensitivity Index ◽  
Long Term Stability ◽  
Significant Bias ◽  
The Mean ◽  
The Relationship ◽  
International Sensitivity Index

SummaryIn a collaborative trial of eleven laboratories which was performed mainly within the framework of the European Community Bureau of Reference (BCR), a second reference material for thromboplastin, rabbit, plain, was calibrated against its predecessor RBT/79. This second reference material (coded CRM 149R) has a mean International Sensitivity Index (ISI) of 1.343 with a standard error of the mean of 0.035. The standard error of the ISI was determined by combination of the standard errors of the ISI of RBT/79 and the slope of the calibration line in this trial.The BCR reference material for thromboplastin, human, plain (coded BCT/099) was also included in this trial for assessment of the long-term stability of the relationship with RBT/79. The results indicated that this relationship has not changed over a period of 8 years. The interlaboratory variation of the slope of the relationship between CRM 149R and RBT/79 was significantly lower than the variation of the slope of the relationship between BCT/099 and RBT/79. In addition to the manual technique, a semi-automatic coagulometer according to Schnitger & Gross was used to determine prothrombin times with CRM 149R. The mean ISI of CRM 149R was not affected by replacement of the manual technique by this particular coagulometer.Two lyophilized plasmas were included in this trial. The mean slope of relationship between RBT/79 and CRM 149R based on the two lyophilized plasmas was the same as the corresponding slope based on fresh plasmas. Tlowever, the mean slope of relationship between RBT/79 and BCT/099 based on the two lyophilized plasmas was 4.9% higher than the mean slope based on fresh plasmas. Thus, the use of these lyophilized plasmas induced a small but significant bias in the slope of relationship between these thromboplastins of different species.

Development of a primary reference material of natural C-reactive protein: verification of its natural pentameric structure and certification by two isotope dilution mass spectrometry

2021 ◽  
Vol 13 (5) ◽  
pp. 626-635
Author(s):  
Jianyi Liu ◽  
Wen Zhu ◽  
Haofeng Sun ◽  
Dewei Song ◽  
Peng Xiao ◽  
...  
Keyword(s):  
Mass Spectrometry ◽  
Reference Material ◽  
Isotope Dilution ◽  
Isotope Dilution Mass Spectrometry ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Primary Reference

Development of a primary reference material of natural C-reactive protein: verification of its natural pentameric structure and certification by two isotope dilution mass spectrometry.

scholarly journals Development of a Water Matrix Certified Reference Material for Volatile Organic Compounds Analysis in Water

Molecules ◽  
2021 ◽  
Vol 26 (14) ◽  
pp. 4370
Author(s):  
Liping Fang ◽  
Linyan Huang ◽  
Gang Yang ◽  
Yang Jiang ◽  
Haiping Liu ◽  
...  
Keyword(s):  
Volatile Organic Compounds ◽  
Reference Material ◽  
Organic Compounds ◽  
Certified Reference Material ◽  
Pure Water ◽  
Term Stability ◽  
Long Term Stability ◽  
Water Matrix ◽  
Volatile Organic

Water matrix certified reference material (MCRM) of volatile organic compounds (VOCs) is used to provide quality assurance and quality control (QA/QC) during the analysis of VOCs in water. In this research, a water MCRM of 28 VOCs was developed using a “reconstitution” approach by adding VOCs spiking, methanol solution into pure water immediately prior to analysis. The VOCs spiking solution was prepared gravimetrically by dividing 28 VOCs into seven groups, then based on ISO Guide 35, using gas chromatography-mass spectrometry (GC-MS) to investigate the homogeneity and long-term stability. The studies of homogeneity and long-term stability indicated that the batch of VOCs spiking solution was homogeneous and stable at room temperature for at least 15 months. Moreover, the water MCRM of 28 VOCs was certified by a network of nine competent laboratories, and the certified values and expanded uncertainties of 28 VOCs ranged from 6.2 to 17 μg/L and 0.5 to 5.3 μg/L, respectively.

scholarly journals An updated protocol based on CLSI document C37 for preparation of off-the-clot serum from individual units for use alone or to prepare commutable pooled serum reference materials

2020 ◽  
Vol 58 (3) ◽  
pp. 368-374 ◽  
Author(s):  
Uliana Danilenko ◽  
Hubert W. Vesper ◽  
Gary L. Myers ◽  
Patric A. Clapshaw ◽  
Johanna E. Camara ◽  
...  
Keyword(s):  
Human Serum ◽  
Reference Materials ◽  
Frozen Storage ◽  
Metrological Traceability ◽  
Medical Laboratory ◽  
Serum Samples ◽  
Long Term Stability ◽  
Individual Human

AbstractManufacturers of in vitro diagnostic medical devices, clinical laboratories, research laboratories and calibration laboratories require commutable reference materials that can be used in the calibration hierarchies of medical laboratory measurement procedures used for human specimens to establish metrological traceability to higher order reference systems. Commutable materials are also useful in external quality assessment surveys. In order to achieve these goals, matrix-based reference materials with long-term stability, appropriate measurand concentrations and commutability with individual human specimens are required. The Clinical and Laboratory Standards Institute (CLSI) guideline C37-A (now archived) provided guidance to prepare commutable pooled serum reference materials for use in the calibration hierarchies of cholesterol measurement procedures. Experience using the C37-A guideline has identified a number of technical enhancements as well as applications to measurands other than cholesterol. This experience is incorporated into this updated protocol to ensure the procedure will continue to meet the needs of the medical laboratory. The updated protocol describes a procedure for preparing frozen human serum units or pools with minimal matrix alterations that are likely to be commutable with individual human serum samples. The protocol provides step-by-step guidance for the planning phase, collection of individual serum units, processing the units, qualifying the units for use in a pool and frozen storage of aliquots of pooled sera to manufacture frozen serum pools. Guidance on how to perform quality control of the final product and suggestions on documentation are also provided.

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 The importance of cylinder passivation chemistry for preparation and long-term stability of multicomponent monoterpene primary reference materials

2018 ◽  
Author(s):  
Nicholas D. C. Allen ◽  
David R. Worton ◽  
Paul J. Brewer ◽  
Céline Pascale ◽  
Bernhard Niederhauser
Keyword(s):  
Reference Materials ◽  
Chemical Reactivity ◽  
International System ◽  
High Chemical ◽  
Term Stability ◽  
Long Term Stability ◽  
System Of Units ◽  
Primary Reference ◽  
High Chemical Reactivity

Abstract. Monoterpenes play an important role in atmospheric chemistry due to their large anthropogenic and biogenic emission sources and high chemical reactivity. As a consequence, measurements are required to assess how changes in emissions of monoterpenes impact air quality. Accurate and comparable measurements of monoterpenes in indoor and outdoor environments require gaseous primary reference materials (PRMs) that are traceable to the international system of units (SI). PRMs of monoterpenes are challenging to produce due to the high chemical reactivity and low vapour pressures of monoterpenes and also their propensity to convert into other compounds, including other terpenes. In this paper, the long-term stability of gravimetrically prepared static monoterpene PRMs produced in differently passivated cylinders, including sampling canisters, was assessed. We demonstrate that static PRMs of multiple monoterpenes can be prepared and used as a suitable long-term standard. For the first time the effect of cylinder pressure and decanting from one cylinder to another on the chemical composition and amount fraction of monoterpenes was also studied. Gravimetrically prepared PRMs of limonene in high pressure cylinders were compared to a novel portable dynamic reference gas generator based on dilution of pure limonene vapour emitted from a permeation tube.

PKP-008 Long term stability of trastuzumab in serum samples: Abstract PKP-008 Table 1

2016 ◽  
Vol 23 (Suppl 1) ◽  
pp. A181.2-A182
Author(s):  
J González García ◽  
F Gutiérrez Nicolás ◽  
GJ Nazco Casariego ◽  
MM Viña Romero ◽  
R Ramos Díaz ◽  
...  
Keyword(s):  
Serum Samples ◽  
Term Stability ◽  
Long Term Stability

Do we measure bilirubin correctly anno 2005?

2005 ◽  
Vol 43 (5) ◽  
Author(s):  
Joke J. Apperloo ◽  
Fedde van der Graaf ◽  
Volkher Scharnhorst ◽  
Huib L. Vader
Keyword(s):  
Reference Material ◽  
Human Serum ◽  
Reference Materials ◽  
Standard Reference Material ◽  
Total Bilirubin ◽  
Reference Method ◽  
Serum Samples ◽  
Suitable Material ◽  
Good Agreement

AbstractWe observed 30% discrepancy between liquid chemistry and dry chemistry analysers for the determination of total bilirubin in human adult serum samples, which were consistent with a 20% overestimation and 10% underestimation relative to a Jendrassik-Grof reference method, respectively. In contrast, standard reference material SRM916, which was recently recommended as being the most suitable material for attaining interlaboratory agreement, shows very good agreement on both types of analysers, as well as close to 100% recovery with respect to the reference method. We show that the liquid vs. dry bilirubin discrepancies seem to originate in the presence of either conjugated or δ-bilirubin. Our observations make it clear that good interlaboratory (or inter-analyser) agreement between bilirubin reference materials does not guarantee the same for bilirubin concentrations in human serum samples.

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