Commutability assessment of NIST SRM 3666 albumin and creatinine in frozen human urine among routine clinical laboratory measurement procedures.

Many new techniques for ensuring traceable temperature measurements at the point of use are being developed and some are approaching maturity. The aim of this study is to examine the formalism associated with traceability to the SI kelvin for these practical techniques, as well as to identify areas of research which should be a priority. First, the status quo of thermodynamic temperature realization and dissemination is summarized. Then the state of the art of two main types of thermometry which can potentially provide in situ traceability is discussed. These are self-validating thermometers which make use of the phase change of materials, and practical primary thermometers, examples of which are given in order of decreasing commercial readiness: relative primary radiometry, acoustic gas thermometry (AGT), Johnson noise thermometry (JNT) and Doppler broadening thermometry (DBT). It is shown that relative primary thermometry is, in general, much more likely to become a day-to-day practical reality than absolute primary thermometry, and that this has a significant bearing on what the formalism might look like regarding metrological traceability and demonstrations of equivalence. This article is part of the Theo Murphy meeting issue 'The redefined kelvin: progress and prospects'.

Nowadays, we are facing major changes in the landscape of test harmonization through metrological traceability approach, all expected to promote equivalence of reported laboratory results. However, having traceability tools in place does not automatically mean that metrological traceability is correctly implemented. As concepts that are poorly implemented do not produce expected benefits, it is time to move from just discussing the effectiveness of traceability theory to how correctly implement it and effectively monitor its effects. In particular, considering the implementation outcomes, there is still a limited knowledge about the actual harmonization status of laboratory test results. We need to increase the information about the expected outcome by assessing result uniformity across different invitro diagnostic medical devices (IVD-MDs) through an approach providing an ongoing robust evidence of standardization effectiveness. External Quality Assessment (EQA) programs have an irreplaceable role in this IVD traceability surveillance providing that they fulfill specific requirements. i.e.,the use of commutable materials with target values assigned by reference measurement procedure (RMP) or strictly controlled procedures, if RMP does not exist, and with validation of results in relation to fit-for-purpose analytical performance specifications. If adequately designed, EQA programs can create evidence about intrinsic standardization status and equivalence of the examined IVD-MDs, serving as management tool for the medical laboratory and IVD manufacturers, and forcing them to investigate and eventually fix the identified problems. In this way, major stumbling blocks opposing the correct implementation of metrological traceability and the obtaining of harmonized laboratory results can be identified and removed.

The commutability of thyroid-stimulating hormone international reference preparations plays an important role in metrological traceability.

Proficiency test for gamma-emitting radionuclides in seawater: A case study from South Korea.

Development of high-purity pyrethrins certified reference material.

IFCC primary reference procedure for the measurement of catalytic activity concentrations of enzymes at 37°C. Part 10: Reference procedure for the measurement of catalytic concentration of pancreatic α-amylase.

The invisible bridge: how harmonization closes the gap between impossible standardization and clinical necessity.

With global shipping accelerating its transition toward low-carbon development, establishing a scientific and operable carbon monitoring system has become essential. Existing mechanisms such as the EU MRV and IMO DCS are shaping a shift from voluntary cooperation to rule-based competition. For China, a major shipping nation, simply adopting international frameworks cannot accommodate its diverse fleet, complex operations, and uneven digitalization. This study reviews key monitoring technologies—including BDN-based methods, tank level measurement, flowmeters, and direct CO2 monitoring—and assesses their applicability within China. It further proposes an implementation pathway featuring multi-source data integration, digital governance, metrological traceability, differentiated monitoring strategies, and linkage with national carbon markets. The findings provide a framework to support accurate carbon accounting, regulatory compliance, and the sector’s green transition.

The production of certified reference material (CRM) in stable powdered milk matrix is important to ensure metrological traceability and quality management in the validation of methods and routine laboratory analyzes to ensure the quality of this product. Thus, the objective of the present study was to evaluate the short-term stability of the candidate batch for certified reference material in skimmed milk powder matrix. The work was conducted through a classic study according to the recommendations of ISO Guide 35. The parameters of moisture, lipids and total titratable acidity were evaluated during 21 days of storage. The material was stored at three different temperatures (2-8 °C, 25 °C and 40 °C). The data obtained in the stability study were evaluated through simple linear regression analysis and verified against the criteria established by ISO Guide 35. It was verified that the batch of material produced remained stable for determinations of lipids, moisture and titratable acidity for 28 days at temperatures from 2 to 8 °C, 25 °C and 40 °C.

This study presents an improved approach for evaluating measurement uncertainty and ensuring metrological traceability in vibrometer calibration systems. The proposed method enhances the implementation of ISO 16063-21 and GUM guidelines by integrating a detailed uncertainty budget with frequency-dependent correction factors. The calibration experiments were performed in the range of 10-1000 Hz using a reference comparison technique. The expanded uncertainty of the developed system was estimated as U k = 2 = (1.7-2.1) %, depending on frequency and environmental stability. The novelty of the proposed approach lies in the refined identification of dominant uncertainty components – including reference sensor calibration, vibration table stability, and signal processing repeatability – with quantitative contribution analysis. The obtained results confirm the method’s capability to improve traceability and reproducibility in national and industrial calibration laboratories. The study provides a practical framework for enhancing accuracy, comparability, and long-term reliability of vibration measurement systems.

ABSTRACTRationaleIn January 2024, the IAEA experts meeting endorsed both δ13C scales that are currently used within the scientific community: the Vienna Peedee belemnite (VPDB) δ13C scale defined by NBS 19 with a value of +1.95‰ exactly, and the VPDB‐LSVEC scale defined by NBS 19 and the lithium carbonate LSVEC with a value of −46.60‰ exactly. Following the discovery of the instability of the LSVEC material, several expert laboratories independently proposed replacement reference materials (RMs). This study compares these calcium carbonate RMs IAEA‐610, ‐611, ‐612, and USGS44 at the highest level of the metrological traceability chain and recommends values that enable users to realize the VPDB and VPDB‐LSVEC scales.MethodsThe phosphoric acid reaction that is required to evolve CO2 from calcium carbonate RMs for isotope analyses is scrutinized by comparing the results of the different apparatuses used in the three participating laboratories. All three laboratories use high‐precision dual‐inlet isotope ratio mass spectrometers and assess the individual instrument offsets in terms of their effects on interlaboratory comparability of samples.ResultsThe reported values for IAEA‐610, ‐611, ‐612, and USGS44 on the δ13CVPDB scale are −9.114 ± 0.011‰, −30.815 ± 0.011‰, −36.739 ± 0.020‰, and −42.073 ± 0.015‰, respectively. Within their measurement uncertainty they are identical to previously published values. Finally, we provide values on the δ13CVPDB and δ13CVPDB‐LSVEC scales for some RMs that are routinely used in elemental analysis–isotope ratio mass spectrometry.

Activity standardization and determination of nuclear decay data of 212Pb at LNE-LNHB and first measurements in the SIR at BIPM.

Global Metrological Traceability at Different Measurement Levels: Practical Aspects [Measurement Methodology

Abstract Laboratory findings provide essential information for assessing the state of health. Two concepts for the classification and evaluation of the findings are central: reference intervals (RI) and clinical decision limits (CDL), which also include therapeutic target limits. The IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) with the Committee for Reference Intervals (C-RIDL) and the working group on the Global Reference Interval Database (TF-GRID) presented concepts and their sustainability with a focus on reference limits at EuroMedLab Brussels 2025. Sustainability for RIs and CDLs represents a new concept that has prerequisites like a data infrastructure and a quality and information framework. Not all of these prerequisites have been fully characterized yet, but the essential aspects are addressed in this article. Standardization with metrological traceability or, where not otherwise possible, harmonization forms the basis for sustainability of RIs and CDLs. Sustainable RIs and CDLs enhance the use and value of electronic patient records and help to establish cumulative reports.

In the context of the Brazilian heavy-haul railway industry, framing metrology not as a mere constraint but as a catalyst for innovation hinges first on embedding metrological traceability into all measurement systems used for infrastructure monitoring, rolling-stock maintenance, and material integrity. According to the Joint Committee for Guides in Metrology’s (JCGM) definition, metrological traceability means that a measurement result can be related to a reference through an unbroken chain of calibrations, each contributing to the measurement uncertainty. This paper aims to characterize and assess the concept of metrology as a sine qua non input to innovation, emphasizing its pivotal role in shaping technological competitiveness and industrial upgrading. In particular, it examines how the integration of robust metrological systems—comprising traceability, calibration, and uncertainty management—acts not merely as a compliance mechanism but as an enabler of sustained innovation within export-oriented manufacturing production and the railway equipment industry in Brazil.

The paper presents the results of a comprehensive quality control of the input substances used in the production of the veterinary drug “Devivit Selen”. Four key components were involved in the study: vitamin E (tocopherol acetate) and selenium (in the form of sodium selenite), benzyl alcohol and water for injection. The aim of the work was to experimentally substantiate the physicochemical quality indicators of these substances in accordance with the requirements of the State Pharmacopoeia of Ukraine. The control was carried out in the laboratory for quality control, safety and registration of veterinary medicines and feed additives of LLC “DEVIE”. The results obtained confirmed the compliance of all the studied substances with the established pharmacopoeial standards. It was determined that the quality of each component significantly affects the stability, effectiveness and safety of the drug. In particular, the purity of water for injection and benzyl alcohol ensures the sterility of the dosage form, while the concentration of vitamin E and selenium determines the antioxidant activity and therapeutic effect of the drug. The control methods used were based on the principles of validation, metrological traceability and compliance with GMP requirements. The analysis confirmed the high quality of each substance, which allows to guarantee the stability of the drug throughout the entire shelf life. The results of the study are of practical importance for increasing the efficiency of internal quality control at pharmaceutical enterprises. They can be used in the educational process for training veterinary and pharmaceutical specialists. The work demonstrates the importance of integrating modern analytical methods into the GMP system for improving the production of veterinary drugs. A comprehensive approach to the control of input materials is the key to high quality and safety of finished dosage forms.

The article presents a comprehensive analysis of the harmonization of national standards of Ukraine with international requirements regarding the quality and safety of food additives. The role of food additives in food production processes is considered, including their function in stabilizing structure, organoleptic properties, and extending product shelf life. The current regulatory framework of Ukraine, which governs the use of food additives, including national standards (DSTU), technical regulations, and sanitary norms, is analyzed, and discrepancies with international requirements of Codex Alimentarius, EU Regulations No. 1333/2008 and No. 231/2012, as well as ISO 22000 and ISO/IEC 17025 standards, are identified. Special attention is given to the metrological support of food additive control, including the determination of analytical method accuracy, verification of method reliability, and adherence to the principle of measurement traceability. The absence of unified methodological approaches and the limited availability of certified reference materials complicate comparability of results between laboratories and the integration of Ukrainian control procedures into international practice. Classification and labeling of food additives are analyzed, revealing inconsistencies between national terminology and the European “E-code” system and EFSA risk assessment principles. The practical implementation of harmonized standards faces challenges such as the lack of a unified approach to additive classification, insufficient number of accredited laboratories with confirmed metrological traceability, fragmented control methods, limited availability of reference materials, and low integration of information systems. The main directions of harmonization are identified, including updating additive classification according to EU Regulation No. 1333/2008, creating an integrated database of control methods, accrediting laboratories under ISO/IEC 17025, and developing interagency cooperation for a coordinated policy on food additive regulation. The article summarizes regulatory, metrological, analytical, and managerial aspects of harmonization, which determine mechanisms for ensuring measurement uniformity and reliability of food additive control results.

Data spaces are digital realms of data and information shared between stakeholders and peer groups. They underpin several developments in sectors ranging from the automotive industry, through social sciences, to governmental networks. Digital traceability of information in data spaces is needed to validate statements about metadata, data quality, and data features. In many cases, this also directly translates to metrological traceability of measurements to the SI. The concept and development of Digital Product Passports bring these traceability aspects together to form a tool for a digital quality infrastructure. This paper outlines the general principles of digital metrological traceability based on digital certificates, a digital international system of units, and Digital Product Passports.

Presented is a series of narrative reviews that summarize published information regarding the effect or potential effect of interfering substances on the accuracy of continuous glucose monitoring (CGM) devices. Whilst drawing together what is currently known regarding this topic, the future direction in this field and clinical implications posed by polypharmacy on CGM performance are considered. This fourth and final in this series of articles reviews the following topics: the benefits and drawbacks of conducting interfering substance studies in vitro versus in vivo; the balance between the cost and complexity of undertaking in vitro or in vivo studies to screen for potential interferences versus the clinical relevance of the findings; clinical factors influencing interferent behavior on CGM performance (pharmacokinetics and polypharmacy considerations); the need for standardization, including consideration of the metrological traceability of CGM readings, establishment of CGM analytical performance metrics and standardized CGM assessment procedures for measuring interferents.