Scandinavian Journal of Clinical & Laboratory Investigation最新文献

Monocyte distribution width (MDW) is a promising biomarker for early sepsis detection, but its use in Asian populations has been limited due to the lack of region-specific reference intervals (RIs). This study aimed to establish the first MDW RI for healthy Chinese adults using EDTA-K₂ anticoagulant, strictly following CLSI EP28-A3C guidelines. A total of 262 samples from healthy Chinese blood donors were analyzed using a Beckman Coulter DxH 900 analyzer. Statistical methods included Shapiro-Wilk tests for normality, t-tests, ANOVA for group differences, and Spearman correlation analysis, with RIs calculated using parametric, non-parametric, and robust methods. The parametric RI limits were determined to be 14.48 (90% CI 14.16-14.80) and 21.56 (90% CI 21.24-21.88), closely aligning with results from the robust method (14.41-21.55) and non-parametric method (14.70-21.52). Our findings are consistent with Spanish data obtained using EDTA-K₂ anticoagulant but differ from Italian data that used EDTA-K₃, highlighting the potential impact of anticoagulant type on MDW values. This RI is unaffected by gender or age, providing a critical diagnostic tool for early sepsis detection in Chinese clinical practice and emphasizing the need for further studies to investigate anticoagulant influences for global standardization.

Kidney dysfunction is a significant complication of allogeneic hematopoietic cell transplantation (alloHCT). Standard serum creatinine (sCr) testing is imperfect due to latency from the event causing damage to sCr increase. The purpose of this study was to evaluate the role of kidney damage biomarkers in the field of alloHCT. Seventy adult alloHCT candidates from 2 centers were recruited. 34 patients constituted pilot cohort and 36 - validation cohort. In pilot cohort serum and urine samples obtained at baseline and 7 timepoints were tested using ELISA assays for LFABP-1, KIM-1, NAG, uromodulin, TIMP-2 and IGFBP-7. Urine concentrations were corrected to urine creatinine concentration (uCr). Results were analyzed as predictors of acute kidney injury (AKI) within 100 days from alloHCT using receiver operating curve (ROC). LFABP-1, KIM-1, uromodulin, NAG and TIMP-2 performed significant predictive value for AKI. The best results were obtained for LFABP-1 and NAG and these biomarkers were tested in validation cohort where the results were borderline significant. Given the heterogeneity of the studied population, calculations for the whole group were performed: ROC for day +7/baseline ratio of urinary LFABP-1 and NAG in predicting AKI within 100 days from alloHCT was 0.673 and 0.678 respectively (p < 0.05). ROC for baseline urinary LFABP-1 in predicting early AKI was 0.721 (p < 0.05). Findings from our study confirm that patients undergoing alloHCT frequently experience subclinical kidney damage. However, due to the multifactorial nature of renal insults and preexisting kidney impairment, the predictive value of studied biomarkers in this population is limited.

Aim: This study was carried out to estimate sigma values of two HbA1c analysers and compare laboratory's quality control (QC) procedure with a patient risk based statistical quality control (SQC) strategy.

Materials and methods: Internal quality control (IQC) and External quality control (EQC) results are downloaded from the laboratory data for different six-months' period when each analyser was used in the laboratory. Mean percent coefficient of variation (CV) and bias values of study period were calculated. Sigma values for each system were calculated. QC constellation program was used for risk-based QC parameters calculation and severity of harm level for HbA1c was taken as 'serious'.

Results: Sigma values for Capillarys 3 Tera analyser (Captera) were 3.83 and for Premier Hb9210 analyser (Premier) were 2.95. Using ±2 standard deviation (SD) as control limits; on Captera with a run size of 110 samples, probability of false rejection rate (Pfr) was 8.89%, expected maximum unreliable patient results (Max E(Nuf)) was 0.78 and on Premier analyser with a run size of 800 samples Pfr was 8.89% and Max E(Nuf) was 40.73. Effective statistical quality control strategies for both systems with acceptable Pfr and affordable Max E(Nuf) are provided in the study.

Conclusion: HbA1c is a key parameter in diabetes management and accurate methods are required for an efficient clinical use.

Phototherapy is the most commonly used treatment for indirect (unconjugated) hyperbilirubinemia (IHB) in newborns. This study aims to determine the impact of IHB and phototherapy on oxidative stress balance by thiol-disulfide homeostasis and ischemia-modified albümin (IMA). This prospective study included 107 hospitalised newborns with IHB who received phototherapy and 55 controls. Neonates aged 0-28 days with a gestational age above 35 weeks were included in the patient group. Oxidative stress parameters were assessed in the control group as well as before and after phototherapy in the patient group. Sex, gestational age, and birth weight were similar between IHB group and control groups (p > 0.05). Native thiol and total thiol levels were significantly higher in the IHB group compared to controls (p < 0.05). After phototherapy, native thiol, total thiol, and Index 3 values were significantly reduced (p < 0.05), while disulfide levels, disulfide/native thiol ratio, disulfide/total thiol ratio, and IMA values significantly increased (p < 0.05). Oxidative stress via thiol-disulphide homeostasis is increasing in patients hospitalised due to IHB and receiving phototherapy. Our findings suggest that both IHB and phototherapy contribute to oxidative stress imbalance. Phototherapy should be used based on clinical indications and for the minimum needed duration.

Background and aims: The Triglyceride/HDL-Cholesterol (TG/HDL-C) ratio is a recognized biomarker for cardiovascular risk, linked to atherogenic dyslipidemia and insulin resistance. Recent evidence also implicates molecules like trimethylamine N-oxide (TMAO), CD36, and CD38 in metabolic inflammation and atherosclerosis. This study investigated the relationship between TMAO, CD36, and CD38 in individuals with a high TG/HDL-C ratio.

Methods: A total of 82 volunteer individuals with no known cardiac disease were enrolled in the study (41 dyslipidemic individuals and 41 healthy controls). Serum TMAO levels from participants were quantitatively measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS). The surface expression levels of CD36 and CD38 on the monocyte population were assessed by flow cytometry. The plasma atherogenic index (PAI) was calculated using the log(TG/HDL-C) formula to assess the atherogenic risk status.

Results: The TG/HDL-C ratio, TMAO level, and CD38 expressions were significantly higher in the dyslipidemia group compared to the control group (p < 0.05). Additionally, low-density lipoprotein cholesterol levels and HOMA-IR scores were higher in dyslipidemic individuals. According to the PAI assessment, the entire dyslipidemia group was in the high cardiovascular risk category. The TG/HDL-C ratio showed a positive correlation with TMAO and CD38 levels.

Conclusion: The positive relationship between the TG/HDL-C ratio and TMAO and CD38 levels suggests that these parameters could be evaluated together to reflect cardiovascular risk. However, given the cross-sectional design of the study, these findings indicate associations rather than causal relationships, and metabolic and inflammatory markers may reflect early stages of subclinical atherosclerosis in individuals without known cardiovascular disease.

Aim: Neuron-specific enolase (NSE) is an acknowledged biomarker for prognosticating neurological outcome after cardiac arrest, with elevated concentrations associated with poor outcome. This study assesses and compares the prognostic performance of NSE measured in serum and plasma for 1-year all-cause mortality among patients resuscitated from out-of-hospital cardiac arrest (OHCA).

Methods: This investigation is based on post hoc analyses of the Blood Pressure and Oxygenation Targets After Out-of-Hospital Cardiac Arrest (BOX) trial, performed in patients remaining comatose after resuscitation. NSE was measured 48 h after admission using three distinct methods; 1) Serum-NSE measured in fresh serum samples, 2) frozen-plasma-NSE, measured in freeze-thaw EDTA-plasma from stored biobank samples, and 3) in a subset of the samples also as frozen-serum-NSE, measured in freeze-thaw serum from stored biobank samples.

Results: A total of 381 comatose OHCA patients were included, with an overall one-year mortality of 33.1%. Serum-NSE concentrations were significantly higher than frozen-plasma-NSE, with median concentrations of 21.2 µg/L (IQR: 15.7-45.5) versus 19.1 µg/L (IQR: 11.2-39.6), p < 0.001, respectively. Notably, the difference between serum-NSE and frozen-plasma-NSE increased with higher NSE concentrations. The mean difference was 65.8 µg/L with 95% limits of agreement of +/- 125.75 µg/L among patients with NSE > 60 µg/L. For predicting 1-year all-cause mortality, the AUROC for serum-NSE was 0.93 and 0.83 for frozen-plasma-NSE with a significant difference in AUROC of 0.10 (CI: 0.06; 0.14), p < 0.001. In a sub-group analysis (n = 67), there was no significant difference when comparing AUROC between serum-NSE and frozen-serum-NSE (difference of 0.03 [CI: -0.04; 0.09], p = 0.44). However, within this sub-group, frozen-serum-NSE performed better than frozen-plasma-NSE with an AUROC difference of 0.08 (CI: -0.15; -0.01), p = 0.02.

Conclusions: Serum-NSE had greater accuracy in predicting 1-year mortality than frozen-plasma-NSE.

The aim of this study was to establish reference intervals (RIs) for prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (APTT) in the Turkish pediatric population using the Cobas t511 analyzer. This retrospective study included preoperative laboratory results from 1065 healthy pediatric patients (aged 0-18 years) who underwent minor elective surgeries. RIs were established following Clinical and Laboratory Standards Institute (CLSI) guidelines and were summarized as 2.5th-97.5th percentile reference limits using nonparametric approach. The overall median (95% RI) values were 9.0 s [8.1-10.5] for PT, 1.02 [0.93-1.17] for INR, and 29.7 s [24.3-35.2] for APTT. Statistically significant differences were observed in PT, INR and APTT across age groups (p < 0.001). Accordingly, data were stratified into 18 age partitions, and reported for each group. In conclusion, our study provides pediatric-specific RIs for PT, INR and APTT using the Cobas t511 analyzer in a Turkish cohort. These age-stratified intervals can improve the interpretation of coagulation tests in clinical practice and contribute to more accurate pediatric diagnostics.

Background: Repeat testing in emergency clinical chemistry is common, often triggered by critical values, delta checks, or instrument flags. However, its clinical utility is uncertain, and unnecessary repeats may delay reporting and waste resources.

Objective: To assess the necessity of repeat testing by applying three analytical criteria: laboratory-specific observed total allowable error (TEa_Obs), CLIA-based TEa (TEa_CLIA), and reference change values (RCV) to the same cohort.

Methods: In this retrospective study, we analyzed 18,736 repeated result pairs across 23 analytes retrieved from the laboratory information system (LIS) of a tertiary-care emergency laboratory (Jan 2022 to Jun 2025). Each pair was classified as necessary or unnecessary under TEa_Obs, TEa_CLIA, and RCV; agreement between criteria was assessed using Cohen's kappa (κ). Necessary versus unnecessary TAT was compared within each criterion.

Results: TEa_Obs classified 86.2% (16,143/18,736) of repeats as unnecessary, versus 93.7% (17,564/18,736) by TEa_CLIA and 96.7% (18,119/18,736) by RCV. Agreement was generally low to moderate, with κ ranging from <0.2 (e.g. creatinine, CRP, bilirubins) to >0.8 (magnesium). Necessary repeats were associated with longer TAT, although the statistical significance of these differences varied by criterion.

Conclusions: Criterion selection is not neutral; it changes both clinical interpretation and operational outcomes. Rule-driven workflows that combine TEa_Obs, TEa_CLIA, and RCV within LIS-based auto verification may reduce unnecessary repeats, stabilize turnaround times, and optimize resource use without compromising patient safety.