Scandinavian Journal of Clinical & Laboratory Investigation最新文献

Pneumatic tube systems (PTS) are routinely used in many hospitals for transporting collected body fluid samples and to reduce turnaround time. However, their use for transport of CSF is not widespread, in part due to ambiguous or non-existing data regarding possible impact on sample stability caused by PTS. This study investigates the effect of PTS transport on cell counts in CSF as well as on haemolysis. No statistical differences were observed on cell count for erythrocytes, leukocytes, lymphocytes, neutrophils, or monocytes as well as on haemolysis measured as absorbance at 415 nm. Therefore, it should be possible to use a PTS to transport CSF for these analyses.

Introduction: Treatment with infliximab (IFX) and adalimumab (ADL) are used in a range of inflammatory diseases. Measurement of drug levels is warranted, but can be challenged by turn-around-times at the laboratories. Consequently, point-of-care testing (POCT) technology is becoming increasingly relevant. We evaluated the precision and comparability of results obtained with ProciseDx (Biosynex) when used in outpatient gastroenterology clinics monitoring IFX and ADL.

Materials and methods: In this prospective multi-center study, capillary and venous blood samples were collected by trained nurses from patients with inflammatory bowel disease on maintenance therapy with either IFX or ADL. Fourteen different nurses performed blood sampling and IFX measurements using ProciseDx on 64 patients, while 11 different nurses performed ADL measurements on 48 patients. Venous samples were sent to the laboratory for routine testing using Promonitor ELISA kit on a Triturus (Grifols).

Results: Across all patients and all sites, a variation of 18.9% and 11.4% was observed for IFX and ADL measurements, respectively. Peak variance was in the 5-10 mg/L IFX concentration range, while peak variance for ADL measurements was above 12 mg/L. Compared to the routine ELISA, the r-value was 0.82 for IFX with a mean total deviation of 2.10 mg/L (27.1%). For ADL, the r-value was 0.91 with a mean total deviation of 2.93 mg/L (39.7%).

Conclusion: We find the efficacy and accuracy of the ProciseDx acceptable, but when performed by non-laboratory personnel, the differences to routine measurements are considerable and could have a clinical impact. Clinical implementation would at least require reevaluation of the therapeutic intervals.

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.

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.

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.

Serum antinuclear antibodies (ANAs) facilitate the diagnosis and evaluation of patients with many systemic autoimmune conditions. However, there are no systematic reports concerning differences in Guillain-Barré syndrome (GBS) and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Therefore, we assessed the differences in serum ANAs in GBS and CIDP patients and control subjects in a Chinese cohort. A retrospective enrollment of 417 patients was conducted for this study, consisting of 158 clinically confirmed GBS patients, 115 CIDP patients, and 144 non-GBS and CIDP inpatients as a control group. The measurement of serum ANAs, including autoantibodies against the Ro52 protein (anti-Ro52 antibody), anti-Sjogren's-syndrome-related antigen A antibodies (anti-SSA), anti-mitochondrial antibody M2 (AMA-M2), etc., was performed on all enrolled patients. Additionally, erythrocyte sedimentation rate (ESR), anti-streptolysin O (ASO), and C-reactive protein (CRP) values were also assessed. The results revealed significantly higher positive rates of Anti-Ro52 antibody, AMA-M2, and Anti-SSA antibody in the GBS group compared to the CIDP and control groups (adjusted p < 0.001). In the GBS group, Anti-Ro52 and AMA-M2 antibody positivity was moderate to severe, while anti-SSA antibody positivity was mild. In the GBS group, the most common finding for a serum ANAs burden score was 3 (58, 36.71%), which was higher than the CIDP group where a score of 1 was the most common finding (14, 12.17%). Anti-Ro52 antibodies, anti-SSA antibodies, and AMA-M2 were closely associated with GBS. Differential positivity of serum ANAs in GBS and CIDP patients was proposed to provide a reference for clinical diagnosis and treatment methods.

This study aims to propose and evaluate a modified version of the One-Sample Kolmogorov-Smirnov (K-S) test that addresses its current limitations in large sample groups, with the goal of improving its accuracy and reliability in assessing normality assumptions in medical research data. In addition to the classical K-S test, a logarithmic modification was applied to reduce the impact of sample size. This modification replaces the sample size in the test calculation with a logarithmic formula (ln n²) to prevent z-values from becoming excessively small in large samples. Statistical analyses were conducted using Microsoft 365/Excel, SPSS 21.0 and STATA/MP18 with a geometric approach employed to assess data normality using the Geometric Approach to Normality Testing. The study analyzed real-world laboratory data obtained from the complete blood count (CBC) results of 122,310 adult patients (aged ≥18 years) who were treated at Cerrahpaşa Medical Faculty Hospital throughout 2022. The modified K-S test with the proposed logarithmic modification (ln n²) reduced the tendency to reject normality solely due to large sample size. The modified test was able to confirm that some hematological parameters did indeed fit normal distribution models, while discriminating those that did not. In particular, analysis of the data set trimmed by 0.5% showed further improvement in test performance. Consequently, the proposed modification is shown to provide a more sensitive method for assessing the assumption of normal distribution in large data sets. The method can be easily integrated into existing statistical software, making it accessible for routine use in large-scale data analysis.