Objectives: In this study, the first commercially available CE-certified test kit for the determination of ethyl glucuronide (EtG) in hair (EUREKA - Lab Division, Chiaravalle, Italy) known to us was evaluated. The aim was to assess the analytical performance of the assay with regard to clinical and forensic applications. The results provide a basis for evaluating the kit's suitability for routine laboratory use and for the objective assessment of long-term alcohol consumption in sensitive clinical and legal decision-making processes. Methods: 50 mg of ground hair is used for analysis. An isotopically labeled internal standard is added for later quantification. After extraction, 10 & micro;l aliquot of the resulting solution is injected into the LC-MS/MS system. The injection interval is 7.5 min. For the measurement an QTRAP 6500+ tandem mass spectrometer (AB Sciex, Darmstadt, Germany) and an Agilent UHPLC system (Waldbronn, Germany) were used. The method was validated according to the guidelines of the GTFCh directive. Results: The limit of detection of the commercial EtG test kit was 1.6 pg/mg hair. Intra-assay and inter-assay coefficients of variation were determined to be <9.2 %. Participation in interlaboratory proficiency tests was successful in all cases. A correlation of r=0.98 was observed between the commercial test kit and an established LC-MS/MS method. Conclusions: The commercial test kit is suitable for quantifying EtG in hair in order to estimate alcohol consumption or provide evidence of abstinence, in accordance with CTU criteria for participants undergoing driving aptitude assessments.
Objectives Measurement of ionized calcium is considered the gold standard for assessment of calcium status; however, it is not routinely available in many clinical laboratories. Total calcium measurement adjusted for serum albumin is therefore widely used, most commonly employing the Payne equation. Since adjusted calcium equations are influenced by analytical methods and population characteristics, locally derived equations may offer improved clinical accuracy.Methods This retrospective cross-sectional study included laboratory data from Dubai Health hospitals and ambulatory care centers between January and December 2023. Total plasma calcium and albumin were measured using NM-BAPTA (5-nitro-5 '-methyl-(1,2-bis(o-aminophenoxy) ethan-N,N,N ',N '-tetraacetic acid) and bromocresol green (BCG) methods, respectively, on the Roche Cobas c platform. After applying predefined exclusion criteria, 1,313 paired calcium-albumin results were analyzed. Deming regression was used to derive a locally applicable albumin-adjusted calcium equation. Agreement between the newly derived equation and Payne's equation was assessed using linear regression and Bland-Altman analysis.Results A total of 1,313 samples (906 females, 407 males) were included. Deming regression analysis demonstrated a slope of 0.553 and an intercept of 7.217 mg/dL between total calcium and albumin (lambda=3.68; slope 95 % CI 0.479-0.627). The locally derived equation was: A.Ca (mg/dL)=T.Ca + 0.553 & times; (4.22-albumin [g/dL]). Comparison with Payne's equation showed strong correlation (r=0.93), with Bland-Altman analysis demonstrating acceptable agreement. Use of the local equation reduced classification of hypocalcemia and increased identification of hypercalcemia compared with unadjusted total calcium.Conclusions A locally derived albumin-adjusted calcium equation demonstrated clinically meaningful differences from Payne's equation and improved classification of calcium status. Laboratories should establish method- and population-specific adjusted calcium equations to enhance clinical interpretation and decision-making.
Objectives Disulfidptosis is a recently defined form of regulated cell death driven by aberrant disulfide bonding in actin cytoskeleton proteins during glucose starvation and high cystine import. To our knowledge, its relevance in mantle cell lymphoma (MCL), a clinically heterogeneous B-cell malignancy, has not been examined.Methods Using publicly available microarray data (GSE93291; 123 MCL patients with overall survival, Affymetrix GPL570), we characterized 13 canonical disulfidptosis-related genes (DRGs). A six-gene LASSO-Cox score was constructed, evaluated by Kaplan-Meier analysis and time-dependent ROC, internally validated by bootstrap optimism correction, and tested for independence from a proliferation score in a multivariable model.Results Seven DRGs were individually prognostic; notably, SLC7A11, the cystine transporter central to disulfidptosis, was not (hazard ratio [HR] = 1.14; p=0.36), whereas cytoskeletal genes carried the signal. The six-gene score (SLC3A2, MYH9, MYH10, FLNB, MYL6, DSTN) separated two groups with markedly different survival (HR=4.28; 95 % CI=2.38-7.70; log-rank p=1.8 & times; 10-7). Discrimination held after bootstrap correction (apparent C-index, 0.76; corrected, 0.72). The score was uncorrelated with proliferation (r=0.14) and remained prognostic after adjustment (likelihood-ratio p=3.9 & times; 10-12).Conclusions To our knowledge, this is the first description of disulfidptosis-related gene expression in MCL, suggesting the prognostic signal is cytoskeletal rather than transporter-driven and distinct from proliferation. As no independent public MCL cohort with survival was available, external validation could not be performed and remains an essential next step.
Laboratory medicine has witnessed three generational paradigm shifts over the past 75 years - from manual work to early automation, from batch processing to patient-oriented selective analysis, and from human perianalytics to Total Laboratory Automation (TLA). Drawing on a personal trajectory spanning half a century of the discipline, this essay argues that a fourth generation, called "Laboratory 4.0", is not a distant utopia but an expected reality, just like the so-called "Industry 4.0," which is emerging in other areas of technological development. Three converging forces are driving this transformation: miniaturization (microfluidics, lab-on-a-chip platforms, and painless capillary sampling), decentralization (pervasive diagnostics available at any point and time without a central laboratory as intermediary), and artificial intelligence (from classical decision-support systems to generative large language models). A hybrid model is proposed in which incremental modernization within existing structures (until similar to 2035) gives way to genuine decentralization and democratization of diagnostic services (similar to 2035 to 2045), followed by a fundamental redefinition of the discipline's role in society from 2045 onwards. Underlying these technical developments is a new epistemic responsibility: as AI transforms raw data into medical knowledge autonomously, laboratory professionals must claim their irreplaceable role as the sole legally and professionally qualified institution responsible for translating laboratory data into medical insight. The future of laboratory medicine is not a swan song, it is an invitation to actively shape the laboratory 4.0.
Objectives To establish the first population-specific 95th percentile upper reference limit (URL) for N-terminal pro-B-type natriuretic peptide (NT-proBNP) in a health-associated Malaysian population using a retrospective direct approach with a posteriori selection. Methods Clinical laboratory data (n=3,113) from two university centres (January 2022-March 2025) were systematically screened following IFCC C-RIDL and CLSI EP28-A3c guidelines. Rigorous exclusion criteria; including a biochemical filter (>300 pg/mL), clinical history of cardiac or organ disease, interfering medications, and obesity (BMI >= 27.5 kg/m2), were applied to isolate a healthy cohort. Following outlier removal via the Horn-Tukey method, the 95th percentile URL was determined nonparametrically with 1,000 bootstrap samples for a final reference population of n=121. Results The derived 95th percentile URL was 138.8 pg/mL (95 % CI: 112.8-151.0 pg/mL). Age was significantly associated with higher NT-proBNP levels (p=0.004), while sex (p=0.066), race (p=0.462), and BMI (p=0.138) showed non-significant variations with small-to-negligible effect sizes. Internal validation confirmed the stability of the threshold with a 2.9 % exceedance rate. Conclusions This study establishes a Malaysian-specific NT-proBNP baseline of 138.8 pg/mL. While overlapping with international 125.0 pg/mL benchmarks, this locally derived URL provides a necessary foundation for enhancing diagnostic specificity and optimizing healthcare resources in primary care heart failure screening within the Malaysian context.
