The Joint Committee for Traceability in Laboratory Medicine (JCTLM) database represents a valuable resource for implementing metrological traceability in laboratory medicine. Three main database users can be identified: (a) diagnostic (IVD) manufacturers, using the database information for meeting ISO 17511:2020 requirements, (b) laboratory professionals, for defining the quality of their test results, and (c) providers of higher-order certified reference materials (CRM) and reference measurement procedures (RMP), to be helped in improving the suitability of their products, if needed, and assistance with prioritizing their future efforts. In this report, we focus on the utility of the information provided (or still not provided) by the JCTLM database on this last category of users. Two types of information are discussed: (a) the use of listed CRMs as common calibrators intended to transfer trueness from the top of the calibration hierarchy to commercial IVD calibrators, and (b) the measurement uncertainty (MU) of CRM certified values and the reproducibility characteristics of RMP measurements, considering their impact on the MU of clinical samples, when compared to maximum allowable MU (MAU). The discussion output is a recommendation for suppliers to respond urgently to the need to provide higher-order references (CRMs and/or RMPs) for a number of key analytes that are currently lacking or do not yet fully meet quality criteria related to: (a) commutability assessment, (b) contribution to MAU fulfilment, and (c) demonstration of the extent of equivalence to an already listed higher-order reference.

To analyze the available evidence about the correlation between the presence of detectable amounts of clostebol metabolites in urine and the transdermal or transmucosal contact of clostebol.

Dried blood spot (DBS) specimen acceptance guidelines recommend rejecting specimens based on DBS size, often expressed as a diameter. Computer vision methods can estimate DBS size from images obtained from standalone equipment, smartphone cameras or existing laboratory instrumentation. However, no consensus definition of DBS diameter exists. We assessed how different DBS diameter definitions affect measurement and specimen rejection rates.

Diagnosing monoclonal gammopathy in chronic kidney disease (CKD) patients is challenging due to the complex interpretation of serum free light chain (FLC) levels. This study aimed to assess the FLC levels in a large cohort of Chinese CKD patients.

Laboratory medicine is faced with rapid developments in data exchange, secondary use of data and artificial intelligence. Safe exchange of laboratory data requires a suitable terminology standard. NPU, LOINC and SNOMED CT are increasingly used for this purpose, but none of these terminology standards can currently accommodate safe exchange across the full spectrum of conventional laboratory data. Furthermore, rapid technological advances in, amongst others, the 'omics' area will enforce a shift towards precision diagnostics. These emerging technologies demand an appropriate and future-proof terminology standard. Given the current and future challenges in laboratory terminologies, we here present a concept for digital metrology in laboratory medicine. Terminology standards used in laboratory medicine should be adjusted to the current state of science to allow safe data exchange and interpretation. Essential test information entails the full spectrum of pre-pre-analysis to post-post-analysis. Major improvements needed include sufficient coding detail for the molecular form of the measurand and information on metrological traceability. Furthermore, especially given the advances in precision diagnostics, it will become essential to indicate interrelationships between measurands. Herefore, integration with established taxonomies would allow improved identification of interrelationships between measurands and linkage with scientific information for multidisciplinary data science. Hence, laboratory data can further gain in specificity and value. The time has come to lay the basis for safe data exchange in the era of precision diagnostics, with a global focus. A consensus for digital metrology in laboratory medicine will be essential to move forward with health data exchange within Europe and beyond.

Traditional biomarkers used for sepsis diagnosis have limited sensitivity and specificity and, so far, are not recommended for sepsis diagnosis. We aimed to evaluate diagnostic accuracy of XN-9000 hematology analyzer derived cell population data (CPD) for sepsis.

Amongst the main perspectives when evaluating the results of medical studies are statistical significance (following formal statistical testing) and clinical significance. While statistical significance shows that a factor's observed effect on the study results is unlikely (for a given alpha) to be due to chance, effect size shows that the factor's effect is substantial enough to be clinically useful. The essence of statistical significance is "negative" - that the effect of a factor under study probably did not happen by chance. In contrast, effect size and clinical significance evaluate whether a clinically "positive" effect of a factor is effective and cost-effective. Medical diagnoses and treatments should never be based on the results of a single study. Results from numerous well-designed studies performed in different circumstances are needed, focusing on the magnitude of the effects observed and their relevance to the medical matters being studied rather than on the p-values. This paper discusses statistical inference and its relevance to clinical importance of quantitative testing in clinical laboratories. To achieve this, we first pose questions focusing on fundamental statistical concepts and their relationship to clinical significance. The paper also aims to provide examples of using the methodological approaches of superiority, equivalence, non-inferiority, and inferiority studies in clinical laboratories, which can be used in evidence-based decision-making processes for laboratory professionals.

Primary aldosteronism (PA) is a common cause of secondary hypertension. The aldosterone-to-renin ratio (ARR) is the current recommended biomarker for PA screening, but it has limitations. This study evaluates another ratio, the aldosterone-to-angiotensin II ratio (AAIIR), as an alternative screening tool for PA.

Recent advances in information technology have renewed interest in patient-based real-time quality control (PBRTQC) as an alternative to internal quality control (IQC). However, since regulations mandate IQC, PBRTQC can only be implemented as a separate system. The additional labor required for PBRTQC may hinder widespread adoption. Therefore, a more efficient system that integrates IQC with PBRTQC is needed for laboratories to implement the methods effectively.

This study aimed to investigate the prevalence of macroprolactinemia and the changes in hyperprolactinemia status over time among hyperprolactinemic patients in the Turkish population.

Macroprolactin (macro-PRL) mostly comprises a complex of PRL with IgG. The aim of this study was to clarify whether IgA-type macro-PRL exists and, if so, to elucidate the prevalence of and differences in laboratory data from IgG-type.

Urine albumin is a key biomarker utilized for diagnosis and monitoring progression of chronic kidney disease (CKD). These characteristics highlight the importance urine albumin serves in patient management. However, laboratory results are confounded by a lack of standardization where results may exceed 40 % difference between diagnostic platforms. This presents serious issues since current guideline clinical decision points are fixed values and misclassification may occur between laboratory methods. Therefore, standardization is needed for urine albumin measurements.

We determined the efficacy of a high sensitivity cardiac troponin I (hs-cTnI) assay for newly derived 0 h and 0/2-h rule-out concentrations for myocardial infarction and determined the safety of incremental changes at low concentrations.

The stability of plasma samples for basic coagulation tests, prothrombin time (PT) and activated partial thromboplastin time (aPTT), has been widely studied. Recently, the Clinical and Laboratory Standards Institute (CLSI) updated its recommendations, extending the acceptable time frame for aPTT. These guidelines are based on experimental studies, which define limits according to different maximum permissible error (MPE) criteria. This study compiles raw data from 43 studies published over the last 30 years to develop a consensus instability equation that describes degradation independently of specific study parameters.

The insulin-like growth factors (IGFs) regulate growth in humans. IGF-I and IGF binding protein (IGFBP)-3 are biomarkers in children with growth disorders. We investigate a targeted proteomics method for absolute quantitation of eight IGF protein family members in human serum, including the peptide hormones IGF-I and -II, and the six binding proteins IGFBP-2, -3, -4, -5, -6 and acid labile subunit (ALS).