Scandinavian Journal of Clinical & Laboratory Investigation最新文献

In this study, we used manual microscopy as the gold standard, and compared the analytical and clinical performance of EH-2090 and UF-5000 to evaluate their application characteristics in daily clinical practice. Results show the EH-2090 has comparable analytical performance to Sysmex UF-5000. In clinical performance, the EH-2090 shows better counting accuracy for urine formed elements except bacteria. Besides, the EH-2090 could provide more accurate assessment especially in samples with yeast cells, crystals and dysmorphic red blood cells.

The screening test for early detection of α-thalassemia is essential in effective management and genetic counseling. The immunochromatographic (IC) strip test is widely used for α-thalassemia screening due to its simplicity and high sensitivity. This study explores the causes of false-positive IC strip results in subjects with HbF >5% who tested negative for common α⁰-thalassemia --^SEA, --^Thai and --^{Chiang Rai} type deletions. Fifty whole blood samples were tested using IC strips, and resulting positive samples were retested with washed red blood cells (RBCs) and plasma. Follow-up testing included molecular analysis to detect common hemoglobinopathies in washed RBCs, including α⁺-thalassemia -α^3.7 and -α^4.2 deletions, Hb Constant Spring (CS), Hb Quong Sze (QS) and Hb Westmead (WM), as well as antinuclear antibodies (ANAs) screening in plasma. Ten of 50 EDTA whole-blood samples tested positive using the IC strip test, with eight showing positivity in plasma and seven in washed RBCs. Among them, one plasma-positive sample was also positive for ANA, suggesting potential antibody interference. Of the seven RBC-positive samples, three had common hemoglobinopathies: two with the -α^3.7 deletion and one with Hb CS. The remaining four RBC-positive cases had no detectable mutations but were infants under three months of age. Since most false positives occur in infants under 8 months, caution is recommended when testing this age group. Additionally, washing red cells can help reduce antibody interference. Further molecular studies, such as Sanger sequencing, MLPA and NGS, should be initiated in cases without obvious causes.

Biochemical tests are crucial in acute patient care, and the validity of the results is important. We aimed to evaluate extreme results reported in a routine hospital laboratory and to review patient characteristics. This is a retrospective cohort study of extreme laboratory results reported at the Department of Clinical Biochemistry, Aalborg University Hospital, Denmark (2022-2024). For six common analytes (sodium, potassium, creatinine, calcium, phosphate, and magnesium), the most extreme low (n = 25) and high (n = 25) results were identified. Electronic health records of 284 unique patients were reviewed to determine pathophysiological causes, pre-analytical errors, clinical course, and 7-day survival. Among 5,794,014 biochemical test results, 300 extreme results (0.005%) were identified, with 261 (87.0%) being compatible with a pathophysiological cause, and 39 (13.0%) being caused by a pre-analytical error. For high results, renal failure was the predominant cause (54.1%), particularly affecting creatinine, phosphate, and potassium. For low results, low creatinine was caused by muscle atrophy, while for other analytes, the most common causes were malnutrition, alcoholism, sepsis, diarrhea/emesis, and diuretics. The 7-day survival was lower for patients with extremely high results (77.4%) compared to low (94.5%). In conclusion, in a routine hospital laboratory, extreme biochemical test results were often pathophysiological, with pre-analytical errors accounting for around 10% of the reported results. Survival was generally high and patients with extremely low results had higher survival compared to those with extremely high results. Results inform the laboratory's decision-making on the handling and release of extreme biochemical results.

There is limited evidence regarding the role of circulating neutrophil gelatinase-associated lipocalin (NGAL) in patients admitted with complications of cirrhosis. This prospective cohort study evaluated 161 adult patients hospitalized for acute decompensation (AD) of cirrhosis, with serum samples collected within 48 h of admission. The aim was to investigate the association between NGAL levels, acute kidney injury (AKI), and patient outcomes. Sixty patients presented with AKI at admission. Serum NGAL was independently associated with AKI (OR 1.019, 95% CI 1.012-1.027; p < 0.001), with levels increasing across AKI stages: no AKI (94.24 µg/L), stage 1 (179.20 µg/L), stage 2 (235.50 µg/L), and stage 3 (257.85 µg/L; p < 0.001). Hepatorenal syndrome (HRS) was associated with significantly higher NGAL compared to pre-renal AKI (259.70 vs. 179.30 µg/L; p = 0.002). NGAL predicted HRS with an AUROC of 0.837 (±0.064), with a negative predictive value of 94% for NGAL < 215.00 µg/L. It also predicted AKI reversibility, with an AUROC of 0.829 (±0.061) and a positive predictive value of 98% for NGAL < 242.00 µg/L. Furthermore, NGAL independently predicted 30-day mortality, with a survival probability of 90.8% for NGAL < 160 µg/L and 66.7% for NGAL ≥ 160 µg/L (p < 0.001). These findings support the clinical utility of circulating NGAL as a biomarker reflecting AKI phenotype and disease severity in patients acutely hospitalized for cirrhosis-related complications, with prognostic relevance.

Our aim was to determine the stability of complete blood count (CBC) parameters in low-volume tubes under different storage conditions. Thirty apparently healthy volunteers were included in the study. Two venous blood samples were taken into low-volume K2EDTA tubes from each individual. The samples were analyzed immediately, then one tube was stored at room temperature and the other under refrigerated conditions (+4 °C), and subsequent measurements were performed at 24, 48 and 72 h. The CBC was performed on the Sysmex XN-1000 analyzer. Stability of CBC parameters was assessed based on total allowable error (TEa) goals. White blood cells (WBCs), red blood cells (RBCs), hemoglobin (Hb), mean corpuscular hemoglobin (MCH), plateletcrit (PCT), neutrophils, lymphocytes and basophils were found stable throughout 72 h at both room temperature and +4 °C. In addition, hematocrit (Hct), mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCHC) and eosinophils remained stable for 72 h at +4 °C. The remaining parameters exhibited stability for less than 72 h under both temperature conditions. As a result, the stability of CBC parameters in low-volume tubes improves with storage under refrigerated conditions. However, not all parameters remain stable until 72 h, even under refrigerated conditions. For this reason, CBC analysis should be performed as fast as possible without delay.

This study investigated the prevalence of Thalassemia (Thal) gene in pregnant women in the Quanzhou area, China. And explored the clinical application value of Erythroferrone (ERFE) and Hepcidin in screening pregnant women with Thal complicated by Iron-deficiency anemia (IDA, defined as serum ferritin (SF) < 20 μg/L). From January 2020 to December 2022, the detection rate of Thal in suspected Thal populations was 35.9%, with 256 pregnant women having Thal, and 11.3% of them also had IDA. From April 2023 to September 2024, 50 pregnant women with simple IDA and 54 with Thal complicated by IDA were selected. Blood samples were collected to detect ERFE, Hepcidin, and other indicators. Binary logistic regression analysis showed that ERFE, Hepcidin, MCH, and SF had a significant impact on Thal screening. The combined detection of these four indicators had the highest AUC at 0.916 (sensitivity 92.0%, specificity 81.5%). The study concluded that pregnant women with Thal are at risk of developing IDA, and routine screening for Thal complicated by IDA is prone to miss cases. ERFE and Hepcidin have higher screening value than MCH and SF, and the combined detection of the four indicators provides high diagnostic efficacy in distinguishing simple IDA from Thal complicated by IDA.

Early kidney function decline may be associated with reduced filtration of middle-sized molecules, currently defined as selective glomerular hypofiltration syndrome (SGHS), and driven by the accumulation of atherosclerosis-promoting proteins. We aimed to investigate whether SGHS and other markers of kidney function are associated with subclinical atherosclerosis as evaluated by intima-media thickness (IMT) in the carotid arteries, and whether these associations differ by sex. Data from 2,902 individuals in the 'Malmö Diet Cancer Study', with a mean age of 56 years ± 6, none of whom had a prior diagnosis of cardiovascular disease or diabetes, were followed for 17 years (IQR 2). Kidney function was estimated using glomerular filtration equations based on cystatin C and creatinine (eGFRcys and eGFRcr). The ratio eGFRcys/eGFRcr was used to assess glomerular filtration capacity and eGFR slopes were calculated. Two indices of atherosclerosis were utilized: (1) IMT of a. carotis communis (IMT_CCA), (2) IMT of the far wall of the carotid bulb, both at baseline and follow-up (IMT_BULB). In women, the eGFRcys/eGFRcr ratio was associated with the annual progression of IMT_BULB. Additionally, the eGFRcys/eGFRcys ratio was associated with IMT_BULB values greater than 1.5 mm at follow-up. In men, only eGFRcys slope was predictive of being in the sex-specific 75^th percentile of IMT_CCA at follow-up; no such association was found in women. Overall, SGHS was associated with the progression of IMT_BULB, plaque presence, and greater IMT thickness at follow-up in women. In men, only a faster decline in eGFRcys was associated with plaque presence (IMT_BULB above 1.5 mm), independent of traditional cardiovascular risk factors.

Hematology laboratories routinely face analytical challenges despite automation and standardized workflows. While Six Sigma metrics are increasingly applied in clinical chemistry, their use in hematology remains limited due to variability in Total Allowable Error (TEa) standards and lack of integrated assessment tools. This study aims to evaluate analytical performance in hematology by combining sigma metrics with an innovative graphic decision tool to guide quality control (QC) planning. A retrospective study over was conducted in a tertiary hematology lab. Internal Quality Control (IQC) and External Quality Assurance Scheme (EQAS) data for five analytes-hemoglobin, WBC, RBC, hematocrit, and platelet count-were analyzed using the Six Sigma model. TEa values were selected using a hierarchical approach based on the 2014 Milan Consensus, prioritizing biological variation, CLIA, and RCPA guidelines. A novel graphic tool was used to visualize performance zones and inform QC strategies. Sigma metrics varied across parameters and TEa sources. Hemoglobin demonstrated excellent performance (σ > 6), while hematocrit and platelet count showed sigma <3 under strict TEa. Graphic tool stratification revealed actionable insights; application of TEa optimization reclassified low-performing tests, significantly improving QC efficiency. Subsequent QGI calculations identified the predominant source of error. This study introduces a first-time application of a graphic tool in hematology for sigma visualization and QC planning. The dual-framework approach enhances diagnostic accuracy and resource utilization, offering a practical, scalable model for laboratories seeking personalized, risk-based quality management.

Objective: To investigate chemiluminescence immunoassay (CLIA) in detecting anti-centromere antibodies (ACA) in primary biliary cholangitis (PBC) patients.

Methods: In this retrospective study, 165 patients diagnosed with PBC at Hangzhou Xixi Hospital between December 2020 and January 2023 were enrolled. ACA positivity was assessed using three methods: indirect immunofluorescence (IIF), line immunoassay (LIA), and CLIA. The agreement among the methods was evaluated using kappa statistics and correlation analysis. Logistic regression was used to assess the association between ACA positivity and portal hypertension. Receiver operating characteristic (ROC) curve analysis was performed to compare the predictive performance of CLIA and LIA for portal hypertension.

Results: Among the 165 PBC patients, 69 (41.8%), 68 (41.2%), and 66 (40.0%) were ACA-positive by IIF, LIA, and CLIA, respectively. CLIA showed excellent agreement with IIF (κ = 0.962) and LIA (κ = 0.975), and a strong correlation with LIA in quantitative detection (R = 0.893, p < 0.001). Logistic regression confirmed that ACA positivity was significantly associated with portal hypertension (OR = 2.726, 95% CI: 1.437-5.169, p = 0.002). CLIA demonstrated superior predictive performance over LIA for portal hypertension (AUC: 0.705 vs. 0.638, p = 0.001).

Conclusion: CLIA exhibits excellent concordance with conventional methods for detecting ACA and provides a broader linear range for quantitative assessment. ACA positivity was significantly associated with portal hypertension in PBC patients. The main advantage of CLIA lies in its precise quantification of ACA and prognostic value, highlighting its potential role in risk stratification and disease monitoring in PBC patients.