Clinical Biochemistry[JOURNAL]
Sun
200 papers
Metabolic score for insulin resistance (METS-IR) as a predictor of gestational diabetes: Findings from a prospective Iranian cohort study.
Rouholamin S, Razavi M, Pirjani R … +1 more , Rezaeinejad M
Clin Biochem · 2025 Oct · PMID 40716693 · Publisher ↗
BACKGROUND: Gestational diabetes mellitus (GDM) represents a significant metabolic challenge in pregnancy, with relevance for Middle Eastern populations showing high prevalence rates. The metabolic score for insulin resi...
BACKGROUND: Gestational diabetes mellitus (GDM) represents a significant metabolic challenge in pregnancy, with relevance for Middle Eastern populations showing high prevalence rates. The metabolic score for insulin resistance (METS-IR) has emerged as a potential early predictor, though its performance in Iranian populations remains underexplored. METHODS: In this prospective cohort study conducted at Arash Women's Hospital, Tehran (2020-2023), we enrolled 1,845 pregnant women during their first trimester (<12 weeks gestation). Participants underwent comprehensive metabolic evaluation including calculation of METS-IR. GDM diagnosis was established at 24-28 weeks using 75-g oral glucose tolerance test per American Diabetes Association criteria. We employed modified Poisson regression with robust variance estimation to assess associations, adjusting for key confounders identified through directed acyclic graphs. RESULTS: The study population demonstrated a GDM incidence of 19.78 % (365/1845). METS-IR showed strong predictive capacity with area under the ROC curve (AUC) of 0.82 (95 % CI: 0.79, 0.83). At the optimal cutoff of 2.36 (95 % CI: 2.30-2.41), sensitivity reached 72 % (95 % CI: 67, 76 %) and specificity 76 % (95 % CI: 74, 78 %). Adjusted risk ratios revealed a striking dose-response relationship across quartiles: Q2 = 4.21 (2.16, 8.23), Q3 = 8.85 (4.66, 16.78), and Q4 = 18.94 (10.16, 35.29) compared to the reference quartile. CONCLUSION: This study establishes METS-IR as a robust early predictor of GDM in Iranian women, demonstrating superior performance to conventional metabolic markers. The simple calculation and strong predictive validity suggest its potential for first-trimester risk stratification in clinical practice, particularly valuable in high-prevalence populations.
LRG and NGAL are potential diagnosis and disease activity biomarkers for inflammatory bowel disease.
Zhang D, Meng Y, Li D … +1 more , Zhu S
Clin Biochem · 2025 Oct · PMID 40706891 · Publisher ↗
BACKGROUND: Neutrophil gelatinase-associated lipocalin (NGAL) and serum leucine-rich α-2 glycoprotein (LRG) are reported as potential biomarkers in inflammatory bowel disease (IBD), but the difference in diagnostic effic...
BACKGROUND: Neutrophil gelatinase-associated lipocalin (NGAL) and serum leucine-rich α-2 glycoprotein (LRG) are reported as potential biomarkers in inflammatory bowel disease (IBD), but the difference in diagnostic efficacy has not been reported. We aimed to investigate the clinical value of NGAL and LRG in IBD diagnosis and disease assessment. METHODS: One hundred IBD patients, including 75 Crohn's disease (CD) and 25 ulcerative colitis, and 100 healthy controls were enrolled. The serum NGAL and LRG concentrations were quantified by enzyme linked immunosorbent assay. Receiver operating characteristic (ROC) curve analysis was used to evaluate their diagnostic performance. RESULTS: The serum concentrations of NGAL and LRG were significantly higher in IBD patients than in healthy controls (P < 0.001). Serum NGAL is significantly correlated with LRG (r = 0.574, P < 0.001). Serum LRG showed a better capacity to identify IBD with an area under the ROC curve (AUC) of 0.90 (sensitivity 89 %, specificity 78 %), compared to NGAL with an AUC of 0.84 (sensitivity 85 %, specificity 71 %). Additionally, serum NGAL and LRG were highly correlated with disease activity in CD patients (r = 0.865 and 0.878, P < 0.001), and gradually increased with disease activity severity (P < 0.05). CONCLUSION: Serum NGAL and LRG are potential diagnostic and disease activity biomarkers for IBD, which have good clinical application value.
Navigating an unexpected creatinine result during a pre-intravenous contrast renal function workup.
Narasimhan M, Smith K, Muthukumar A
Clin Biochem · 2025 Oct · PMID 40685062 · Publisher ↗
BACKGROUND: Increasing chronic disease incidence drives intravenous (IV) contrast-based diagnostic imaging. While IV procedure is largely safe, contrast-induced neuropathy risk in patients with predisposing factors deman...
BACKGROUND: Increasing chronic disease incidence drives intravenous (IV) contrast-based diagnostic imaging. While IV procedure is largely safe, contrast-induced neuropathy risk in patients with predisposing factors demand pre-IV renal assessment. Although common, point-of-care creatinine (POC) tests are prone to generating ambiguous results. This frequently result in time-consuming retests, rescheduled appointments, patient distress, and healthcare burdens. CASE PRESENTATION: A diabetic, hypertensive, and chronic kidney diseased Caucasian male, aged 61, presented for a scheduled intravenous contrast-enhanced computed tomography scan. His initial POC-based creatinine result of 1.20 mg/dL (106.1 μmol/L) narrowly exceeded the reference interval (0.67---1.17 mg/dL [59.2 - 103.5 μmol/L]). Given the patient's pre-existing conditions, laboratory-based creatinine test was performed to reassure his renal function. The new result was found to be 0.95 mg/dL (84 μmol/L), which fell within the normal reference interval. This substantial disparity of 0.25 mg/dL (22.1 μmol/L; 20.8 %) between creatinine tests while delaying the intravenous procedure prompted the clinicians to request an in-depth laboratory investigation. CONCLUSION: Comprehensive analysis using patient-centered metrics such as index of individuality, reference change value, and subject-based reference interval alleviated the concerns on his renal health and disparity in assay results (<0.3 mg/dL≡ <26.5 μmol/L) total allowable error limit), thus allowing intravenous contrast imaging.
Low serum thyroglobulin level in A 15-year-old girl with papillary thyroid cancer and multiple neck lymph nodes: a case report.
Barwari N, Sofronescu AG
Clin Biochem · 2025 Oct · PMID 40664292 · Publisher ↗
BACKGROUND: Papillary thyroid carcinoma (PTC) is the most common form of differentiated thyroid cancer. Serum thyroglobulin (Tg) is a key biomarker used in postoperative surveillance. However, discrepancies between Tg le...
BACKGROUND: Papillary thyroid carcinoma (PTC) is the most common form of differentiated thyroid cancer. Serum thyroglobulin (Tg) is a key biomarker used in postoperative surveillance. However, discrepancies between Tg levels and disease burden may occur, complicating clinical assessment. The report herein proposes to discuss such a case. CASE PRESENTATION: We present a case of a 15-year-old girl with a history of total thyroidectomy for PTC (age 13) who developed a new vascular neck mass. Sonographic and cytologic evidence confirmed metastasis. Serum Tg levels (evaluated using concurrent immunoassays and liquid chromatography - tandem mass spectrometry) were detectable, but not proportional to the extent of disease burden, while the fine-needle aspirate (FNA) Tg levels were markedly elevated, consistent with metastatic disease. DISCUSSION: This case illustrates a phenomenon in which the degree of Tg elevation in serum is not proportional to the extent of metastatic disease. We discuss the analytical and biological factors that can contribute to this discordance and highlight the importance of multimodal monitoring strategies. CONCLUSION: Clinicians should be aware that any detectable serum Tg in athyreotic patients indicates residual thyroid tissue or disease. However, this might not necessarily correlate well with the degree of metastatic disease. The integration of imaging, FNA cytology, and aspirate Tg measurement is essential for accurate disease assessment, particularly in cases with discordant laboratory findings.
DNA methylation levels are independently associated with prevalence of atherosclerotic cardiovascular disease in multifactorial chylomicronemia syndrome.
Guay SP, Paquette M, Taschereau A … +4 more , Desgagné V, Bouchard L, Bernard S, Baass A
Clin Biochem · 2025 Oct · PMID 40664291 · Publisher ↗
BACKGROUND: Multifactorial chylomicronemia syndrome (MCS) is a form of severe hypertriglyceridemia (sHTG) associated with increased risk of acute pancreatitis and atherosclerotic cardiovascular disease (ASCVD). We recent...
BACKGROUND: Multifactorial chylomicronemia syndrome (MCS) is a form of severe hypertriglyceridemia (sHTG) associated with increased risk of acute pancreatitis and atherosclerotic cardiovascular disease (ASCVD). We recently reported suggestive evidence that DNA methylation (DNAm) contribute to the sHTG phenotype in MCS. While few predictors of acute pancreatitis were previously identified in MCS, predictors of ASCVD in MCS remain mostly unknown. OBJECTIVE: To study the factors associated with previous history of ASCVD in MCS patients. METHODS: A total of 114 patients with MCS were included in this retrospective study. Prevalence of ASCVD was determined at the baseline visit and defined as any atherosclerotic event: angina, myocardial infarction, coronary angioplasty, coronary bypass surgery, claudication, peripheral angioplasty, peripheral arterial surgery, transient ischemic attack, stroke, carotid endarterectomy, and artery stenosis (>50 %). DNAm level at ABCG1 (cg06500161), CPT1A (cg00574958), and SREBF1 (cg11024682) candidate gene loci was quantified using pyrosequencing of bisulfite-treated DNA. RESULTS: Univariate analysis showed that age, ABCG1 and SREBF1 DNAm level, and the presence of obesity, hypertension, diabetes, and maximal TG level > 40 mmol/L were associated with previous history of ASCVD. Multivariate analysis showed that age (OR 1.11 [1.04-1.18], p = 0.0006), SREBF1 DNAm levels (OR 1.12 [1.03-1.24], p = 0.01), the presence of a maximal TG level > 40 mmol/L (OR 0.13 [0.02-0.90], p = 0.04), and obesity (OR 3.32 [1.00-11.19, p = 0.05] were independently associated with history of ASCVD and explained 44.8 % of the variability in the prevalence of ASCVD (p < 0.0001). CONCLUSION: This study shows that SREBF1 DNAm levels are independently associated with prevalence of ASCVD in MCS patients. It suggests that further studies of epivariations may contribute to better understand the clinical heterogeneity seen in MCS patients.
Concentration dependent impact of hemolysis on lipase result: Does it clinically matter?
Zhou JR, Kunst A, Raizman JE … +9 more , Brun M, Butorin Y, Elian FA, de Koning L, Logan S, Seiden-Long I, Paul H, Venner AA, Tsui AKY
Clin Biochem · 2025 Oct · PMID 40619076 · Publisher ↗
BACKGROUND: The hemolysis index (HI) interference threshold for the Roche lipase assay was recently decreased in the package insert from 1000 (10 g/L hemoglobin) to 100 (1 g/L hemoglobin), but limited data was provided t...
BACKGROUND: The hemolysis index (HI) interference threshold for the Roche lipase assay was recently decreased in the package insert from 1000 (10 g/L hemoglobin) to 100 (1 g/L hemoglobin), but limited data was provided to support the change. A decrease in the threshold could increase re-collection rates, disrupt laboratory workflow and change result interpretation. We performed interference studies to verify the new manufacturer HI claim at clinically relevant lipase concentrations. METHODS: Five lipase concentrations in lithium heparin plasma (36-227 U/L; n = 3-5) were spiked with hemolysates of varying hemoglobin concentrations (0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12 g/L). Lipase concentrations and HI were measured on the Roche Cobas c503 analyzer in triplicate and singleton, respectively, and means and standard deviations of replicates were calculated. Interference was quantified as the absolute and percent differences from the 0 g/L control, then compared against several published total allowable error (TEa) thresholds. RESULTS: At 1 g/L hemoglobin, the HI was 95 ± 4 and yielded a 0.4-1.0 % difference from baseline across all lipase concentrations. Depending on the TEa criteria used, the lowest lipase concentration group (38 ± 2 U/L) either exhibited significantly (p < 0.05) elevated results starting at 3 g/L hemoglobin (HI = 289 ± 18) or no difference up to 12 g/L hemoglobin (HI = 1171 ± 22). All observed differences were within TEa limits for other lipase concentrations. CONCLUSION: Hemolysis affected lipase results in a concentration-dependent manner with an analytically significant impact only at lipase concentrations <40 U/L. This study stresses the importance of verifying new manufacturer claims and the value of assessing clinical change impact.
Implementation and validation of an intelligent auto-verification system in a coagulation testing automatic line.
Liu C, Huang X, Ling L … +3 more , Meng Q, Liao J, Zhou J
Clin Biochem · 2025 Oct · PMID 40617279 · Publisher ↗
OBJECTIVE: To evaluate the implementation and optimization of a fully automated coagulation testing system integrating dual-coagulation-autoline and auto-verification protocols in a high-throughput laboratory, aiming to...
OBJECTIVE: To evaluate the implementation and optimization of a fully automated coagulation testing system integrating dual-coagulation-autoline and auto-verification protocols in a high-throughput laboratory, aiming to enhance operational efficiency, standardization, and clinical utility. METHODS: A dual-coagulation-autoline system was deployed, each line equipped with four automated coagulation analyzers. Pre-implementation quality assessments evaluated centrifuge performance, open/closed-cap sampling, robotic arm effects, and sample stability. Auto-verification rules were optimized using several guidelines and validated with 18,373 samples. Key metrics included pass rate, sensitivity, specificity, and turnaround time (TAT). RESULTS: All centrifuged specimens met platelet-poor plasma criteria (platelet count <10 × 10/L). No significant differences (P > 0.05) were observed between open/closed-cap sampling, robotic arm handling, or room-temperature storage (≤4h). The dual-coagulation-autoline system reduced outpatient and inpatient TAT by 16.78 % (from 49.77 min to 41.42 min) and 33.06 % (from 110.3 min to 73.83 min), respectively, while sample volume increased by 7.9 % (from 74,902 to 80,869). Optimized auto-verification rules achieved a 62.48 % pass rate (11,479/18,373), 100 % sensitivity, 93.50 % specificity, and 0 % false negatives, outperforming initial benchmarks. Auto-verification reduced outpatient and inpatient TAT by 8.29 % (from 41.42 min to 38.25 min) and 16.21 % (from 73.83 min to 63.53 min), respectively, while sample volume increased by 2.8 % (from 80,869 to 83,126). DISCUSSION: The integration of dual-coagulation-autoline and refined auto-verification significantly improved TAT, reduced manual errors, and standardized workflows in a high-volume setting. Personalized system optimization, including dynamic testing allocation and real-time tracking, enhanced clinical efficiency. The validated auto-verification framework demonstrated robust generalizability for large-scale laboratories. The successful application and personalized setting of our laboratory can provide experience for other laboratories.
Exploring the diagnostic potential of serum 5'tRF-Lys as a novel gastric cancer biomarker.
Chu X, Li X, Li Y … +4 more , Zhang Y, Gu X, Shen X, Ju S
Clin Biochem · 2025 Aug · PMID 40617278 · Publisher ↗
OBJECTIVES: Gastric cancer (GC) is a global health challenge due to its asymptomatic early stages, low sensitivity of traditional serum biomarkers, and the invasiveness of endoscopy, resulting in delayed diagnosis and po...
OBJECTIVES: Gastric cancer (GC) is a global health challenge due to its asymptomatic early stages, low sensitivity of traditional serum biomarkers, and the invasiveness of endoscopy, resulting in delayed diagnosis and poor prognosis. The expression levels of tRNA-derived small RNAs (tsRNAs) significantly influence the emergence and development of malignancies. This study focused on the potential of tsRNAs as serum biomarkers for diagnosing GC. METHODS: Quantitative real-time PCR was used to measure 5'tRF-Lys expression levels, validated by agarose gel electrophoresis and Sanger sequencing. Kaplan-Meier survival curves assessed the association between 5'tRF-Lys expression levels and patient outcomes, while receiver operating characteristic (ROC) curves evaluated diagnostic accuracy. ROC curves showed that 5'tRF-Lys outperformed traditional serum biomarkers, and combining these markers can enhance diagnostic accuracy. RESULTS: The expression level of 5'tRF-Lys effectively differentiated GC patients from gastritis patients and healthy subjects. 5'tRF-Lys expression is negatively correlated with the T stage, lymph node metastasis, tumor-node-metastasis stage, neuro/vascular invasion, and positively correlated with tumor differentiation. Patients with low serum 5'tRF-Lys had a lower survival rate. CONCLUSIONS: 5'tRF-Lys shows promise as a sensitive and specific biomarker for GC, including early-stage detection and survival prognosis, offering potential clinical applications.
Clinical features and capillary zone electrophoresis analysis of 10 patients with extremely elevated serum IgG4 levels.
Lu Q, Jia Z
Clin Biochem · 2025 Aug · PMID 40614891 · Publisher ↗
INTRODUCTION AND AIMS: Immunoglobulin G4-related disease (IgG4-RD) is an immune-mediated condition often marked by elevated serum IgG4 levels and diverse clinical presentations, making diagnosis challenging, especially i...
INTRODUCTION AND AIMS: Immunoglobulin G4-related disease (IgG4-RD) is an immune-mediated condition often marked by elevated serum IgG4 levels and diverse clinical presentations, making diagnosis challenging, especially in patients without visible signs. This study aimed to summarize the characteristics of capillary zone electrophoresis (CZE) changes caused by high serum concentrations of immunoglobulin G4 (IgG4), provide experience and data for clinical practice, and identify patients with suspected IgG4-related disease (IgG4-RD) through the details of CZE changes. MATERIALS AND METHODS: Ten patients with extremely elevated serum IgG4 levels were enrolled in this study. The clinical characteristics of these 10 patients were summarized, and the characteristics of CZE were analyzed. RESULTS: All 10 patients were men aged 32-82 years; of them, five had an obvious mass or lymph node enlargement on the body surface, while the remaining five patients had kidney lesions, enlarged lymph nodes in the mediastinum, and pancreatic tail occupation. The IgG4 values of the 10 patients were 15.3-80.6 g/L, 7.61-40.10 times higher than the upper limit of the reference range. The IgG levels were elevated in all cases, whereas the immunoglobulin A (IgA) and immunoglobulin M (IgM) levels were normal. The beta2 peak in CZE disappeared in all 10 cases. Instead, a broad basal bulge appeared where beta2 and gamma were connected and fused with the gamma region. With increasing IgG4 concentrations, the peak value of the bulge in this region increased. CONCLUSION: The presence of a beta-gamma bridge in CZE, excluding the increases in IgA and IgM, indicates the presence of high serum IgG4 concentrations.
Greening the lab: Creation of a national playbook on environmental sustainability in lab medicine.
Lowden L, Henderson C
Clin Biochem · 2025 Oct · PMID 40588181 · Publisher ↗
INTRODUCTION: Climate change is the greatest threat to the health of future generations, yet the healthcare system is a significant contributor to environmental degradation. Clinical laboratories drive much of this impac...
INTRODUCTION: Climate change is the greatest threat to the health of future generations, yet the healthcare system is a significant contributor to environmental degradation. Clinical laboratories drive much of this impact due to the high volume of testing, reliance on consumables, and energy requirements of modern labs. Labs are also vulnerable to the effects of climate change. Reducing environmental impacts and improving climate change resilience can lead to cost savings, enhanced staff engagement, and better patient care. METHODS: Limited guidance is available for medical laboratories seeking to improve environmental sustainability. Through review of existing literature, consultation with experts, and collaboration with experienced labs, a CASCADES playbook has been developed to offer evidence-based direction for implementing high-quality, low-carbon lab practices. RESULTS: The Integrating Environmental Sustainability into Clinical Laboratories playbook captures a snapshot of the current state of environmental considerations in lab medicine as they start to become formalized. Recommendations regarding appropriate testing, energy use, reducing greenhouse gas emissions, managing waste, and reducing water use are put forward, as well as suggestions concerning green chemistry and procurement. Tools and resources for implementation are provided. Labs are encouraged to be a voice for change, advancing a culture of sustainability within their institutions. CONCLUSIONS: Incorporating sustainable principles into lab operations, testing algorithms, and climate-resilient laboratory design will allow the continued practice of lab medicine in a manner that considers planetary health an equal priority to individual patient health. There is a new vision for medicine: quality care must include protection of the patient's climate, providing care in the here and now while enabling care in the future.
Comparison of laboratory results and pain perception in self-sampled capillary blood versus venous blood sampling: a systematic review and meta-analysis.
Schröder D, Hafke A, Hummers E … +8 more , Schuchardt C, Müller CA, Hoffmeister L, Happle C, Dopfer-Jablonka A, Behrens GMN, Schanz J, Müller F
Clin Biochem · 2025 Aug · PMID 40582631 · Publisher ↗
Blood sampling is an essential part of medical diagnostics and treatment. Recent advances in capillary blood self-collection (BSC) devices offer promising alternatives to traditional venipuncture. However, the concordanc...
Blood sampling is an essential part of medical diagnostics and treatment. Recent advances in capillary blood self-collection (BSC) devices offer promising alternatives to traditional venipuncture. However, the concordance between laboratory results from self-collected capillary samples and the gold standard venous collection requires systematic evaluation before clinical implementation. We conducted a systematic review and meta-analysis comparing laboratory results and pain perception between self-collected capillary and venous blood samples. From 1,436 identified studies, 26 met the inclusion criteria. The overall correlation between capillary BSC and venous samples was strong (r = 0.89, 95 % CI: 0.86-0.92) with high heterogeneity (I = 94.2 %). For dichotomous outcomes, concordance was excellent (0.99, 95 % CI: 0.98-1.00). Capillary BSC was associated with significantly lower pain scores than venipuncture (SMD = -0.65, 95 % CI = -0.96; -0.35), with upper arm devices having lower pain scores compared to fingerprick methods. Despite methodological heterogeneity, capillary BSC shows strong agreement with venous sampling for most lab parameters and reduces patient discomfort. It appears especially promising for chronic disease monitoring, patients with difficult venous access, and resource-limited settings. Future studies should standardize collection protocols, assess clinical outcomes, and analyze cost-effectiveness. Although no included study showed improved disease management or cost benefits, broader BSC use may enhance healthcare accessibility while maintaining diagnostic accuracy.
Long time monitoring of serum lithium results using patient median values show stable test results over a time period of more than 20 years.
Larsson A, Helmersson-Karlqvist J, Karlsson M
Clin Biochem · 2025 Aug · PMID 40581313 · Publisher ↗
INTRODUCTION AND OBJECTIVES: Internal and external quality assurance materials often rely on highly processed matrices, which can compromise their commutability. As a result, they may not fully reflect the behavior of ac...
INTRODUCTION AND OBJECTIVES: Internal and external quality assurance materials often rely on highly processed matrices, which can compromise their commutability. As a result, they may not fully reflect the behavior of actual patient samples across different analytical systems. Monitoring laboratory methods using patient median values provides a complementary tool for identifying and correcting systematic errors that could otherwise impact diagnostic accuracy. The aim of the present study was to evaluate the utility of median patient lithium results in monitoring method performance over time. MATERIALS AND METHODS: Patient lithium results from 2004 to 2024 were analyzed (n = 64848) to assess long-term trends and seasonal variation. Lithium measurements were initially performed using an Abbott Architect instrument and were later transferred to a Roche Cobas Pro platform. RESULTS: Patient median and quartile values showed that lithium had a stable calibration between 2004 and 2024. The lithium results did not show seasonal variation. CONCLUSIONS: Monitoring lithium tests using patient medians, and quartiles offers a robust and clinically relevant addition to traditional internal and external quality controls for method monitoring.
Estimation formulas for ionized magnesium in critically ill children.
Tanimura S, Kato H, Yamaga Y … +5 more , Wakabayashi T, Hinotsu S, Tsuboi N, Matsumoto S, Nakagawa S
Clin Biochem · 2025 Aug · PMID 40578473 · Publisher ↗
INTRODUCTION: Clinically, ionized magnesium (iMg) measurement requires specialized equipment, leading many healthcare providers to rely on total magnesium (tMg) as a surrogate marker. However, accurately assessing magnes...
INTRODUCTION: Clinically, ionized magnesium (iMg) measurement requires specialized equipment, leading many healthcare providers to rely on total magnesium (tMg) as a surrogate marker. However, accurately assessing magnesium homeostasis necessitates precise iMg measurement. Given this challenge, we conducted a study to develop predictive formulas for estimating iMg levels based on molecules involved in acid-base regulation. MATERIALS AND METHODS: This exploratory study was conducted prospectively with pediatric patients under 18 years of age admitted to the pediatric intensive care unit in a tertiary children's hospital in Japan between July and August 2024. We measured serum iMg levels using the Stat Profile Prime analyzer from Nova Biomedical. Concurrent blood samples were collected for ion analysis following the Stewart approach. Multiple regression analysis was utilized to develop an equation for estimating iMg levels. The accuracy of the developed equations was further assessed using Bland-Altman analysis and weighted κ coefficients. RESULTS: A total of 200 samples were analyzed. Spearman's rank correlation coefficient between iMg and tMg concentrations was 0.915, indicating a strong and statistically significant association in the simple regression analysis (β = 0.275, 95 % confidence interval 0.271-0.278). Three predictive equations were developed using multivariate analysis. These models were tested on another 86 additional samples. Bland-Altman analysis demonstrated minimal error between measured and estimated values, with κ coefficients indicating high concordance. CONCLUSIONS: We successfully developed an iMg estimation model using routinely measured clinical parameters.
The predictive value of ferroptosis marker SLC7A11 in the prognosis of advanced non-small cell lung cancer patients.
Wang S, Jin X, Yang X … +1 more , Zhang Z
Clin Biochem · 2025 Aug · PMID 40562295 · Publisher ↗
OBJECTIVE: This study aimed to evaluate the prognostic value of serum solute carrier family 7 member 11 (SLC7A11), a key regulator of ferroptosis, in patients with advanced non-small cell lung cancer (NSCLC). METHODS: A...
OBJECTIVE: This study aimed to evaluate the prognostic value of serum solute carrier family 7 member 11 (SLC7A11), a key regulator of ferroptosis, in patients with advanced non-small cell lung cancer (NSCLC). METHODS: A prospective observational study was conducted on 142 patients diagnosed with stage IIIB or IV NSCLC. Serum SLC7A11 levels, along with traditional tumor markers including carcinoembryonic antigen (CEA), cytokeratin 19 fragment (CYFRA 21-1), cancer antigen 125 (CA125), and cancer antigen 15-3 (CA15-3), were measured using enzyme-linked immunosorbent assay (ELISA). Patients were followed for one year, and demographic, clinical, and survival data were collected. The required sample size was calculated a priori using standard statistical methods. Statistical analyses, including receiver operator characteristic (ROC) curve analysis with bootstrap internal validation and Kaplan-Meier survival curves, were performed to assess the predictive value of SLC7A11. RESULTS: The non-survivors group (n = 91) exhibited significantly higher serum SLC7A11 levels compared to the survivors group (n = 51). Pearson correlation analysis indicated a positive correlation between serum SLC7A11 and serum CYFRA 21-1 levels. ROC analysis demonstrated that SLC7A11, particularly when combined with CYFRA 21-1, had significant predictive value for poor prognosis. Kaplan-Meier analysis revealed that patients with lower SLC7A11 levels had significantly longer overall survival. Multivariate logistic regression identified SLC7A11 and CYFRA 21-1 as independent risk factors for poor prognosis. CONCLUSION: Serum SLC7A11 was a promising prognostic biomarker for advanced NSCLC, with elevated levels strongly associated with poor one-year survival outcomes. The combination of SLC7A11 with traditional markers enhanced predictive accuracy, offering potential for improved risk stratification and personalized treatment strategies in advanced NSCLC patients.
Impact of lot-to-lot variation in absolute neutrophil count measured by a point-of-care device in patients receiving clozapine treatment.
Bohn MK, Elliott B, Yip PM
Clin Biochem · 2025 Aug · PMID 40553697 · Publisher ↗
BACKGROUND: Clozapine is indicated for patients with schizophrenia who are refractory to standard antipsychotic treatment. Due to risk of severe neutropenia, routine monitoring of absolute neutrophil count (ANC) is requi...
BACKGROUND: Clozapine is indicated for patients with schizophrenia who are refractory to standard antipsychotic treatment. Due to risk of severe neutropenia, routine monitoring of absolute neutrophil count (ANC) is required. Image-based point-of-care devices for ANC measurement in capillary blood present an opportunity to reduce treatment barriers. The objective of this study was to evaluate the impact of lot-to-lot variation on ANC results using a point-of-care device (CSAN® Pronto™). METHODS: Retrospective patient data were extracted over a 13-month period. Results were classified for treatment safety per vendor as green (≥2.0 × 10/L), yellow (1.5-1.9 × 10/L), or red (<1.5 × 10/L). Distribution of ANC results, flagging rates, and rate and concordance of repeated results were determined. Patient comparisons between a laboratory analyzer (Sysmex XN-10) and Pronto were completed for ANC and WBC for each lot using linear regression and Bland-Altman statistics. RESULTS: 522 patient results across four lots were reviewed. Percentage of results classified as yellow or red varied with lot (yellow: 4.4-10.1 %, red: 2.2-7.8 %). Results for 31 patients were repeated and a reclassification rate of 65 % was observed. Patient comparisons between Pronto and laboratory analyzer for ANC and WBC demonstrated good correlation (Pearson R: ≥0.970). A negative bias was observed for ANC relative to the laboratory that varied with lot (-0.80 to -0.53 × 10/L). The lot with the largest bias demonstrated the highest red alert rate and repeat rate in real-time patient data. CONCLUSION: Our study combines patient-level data with method comparisons to highlight the impact of lot variation on results with potential consequences, including increased rates of repeated blood sampling. While point-of-care devices may facilitate lowering barriers for clozapine use, provider education and additional quality metrics are needed to inform testing.
Optimization and validation of the Kairos amino acid Kit for plasma amino acid monitoring in inherited metabolic disorder patients.
Theron K, Gauthier J, Hulle MV … +1 more , Potter M
Clin Biochem · 2025 Aug · PMID 40550459 · Publisher ↗
PURPOSE: Genetic disorders affecting amino acid metabolism are a significant subset of inherited metabolic disorders (IMDs). Plasma amino acid (PAA) analysis is used for the diagnosis and monitoring of these disorders in...
PURPOSE: Genetic disorders affecting amino acid metabolism are a significant subset of inherited metabolic disorders (IMDs). Plasma amino acid (PAA) analysis is used for the diagnosis and monitoring of these disorders in order to avoid development of severe symptoms. However, PAA assays are often lengthy in analysis time (>2h/sample) and some methods lack specificity and sensitivity. This project offers a novel solution through the optimization and clinical validation of the Kairos Amino Acid Kit by Waters Corp. DESIGN AND METHODS: Using liquid chromatography with tandem mass spectrometry and 6-aminoquinolyl-N-hydroxysuccinimidyl carbamate derivatization, amino acid quantification has been achieved for 45 amino acids in 15 min of chromatography time per sample. The method utilizes reversed-phase chromatography via a high-strength silica C18 column. The optimized column chemistry enables strong hydrophobic retention, resolving all isobaric amino acids for individual mass-spectrometer quantification. Method validation protocols include linearity, sensitivity, precision, and bias. RESULTS: Clinical validation has been performed, indicating high reproducibility and clinical applicability. Linearity results demonstrated 42/45 amino acids with R > 0.975 over a linear range of at least 5-1000 µmol/L. Spiked plasma calibrators demonstrated high recovery with R > 0.971. Twenty-day precision testing demonstrated total coefficient of variation < 15 % and sensitivity testing confirmed all analytes have limits of detection < 5 µmol/L, indicating high analytical sensitivity and precision. Method comparison to Waters' MassTrak Kit demonstrates acceptable bias and supports a future study to update reference intervals. CONCLUSION: The clinical validation of the Kairos Amino Acid Kit for plasma amino acid monitoring highlights the potential of this novel method to enhance amino acid quantification in clinical laboratories for IMD management.
Primer part 2 - implementing a laboratory quality improvement project.
Bohn MK, Augustin R, Chartier LB … +15 more , Devine L, Doshi S, Ginty L, Lass E, Leung F, Mundle W, Nimmo G, Sandy A, Shillington K, Simon A, Steiman A, Taher A, Friesner CT, Zanchetta C, Taher J
Clin Biochem · 2025 Aug · PMID 40544985 · Publisher ↗
The quality improvement (QI) paradigm is a continual approach to systematic improvement that focuses on patient outcomes and safety. This framework should be applied to laboratory driven quality efforts across the total...
The quality improvement (QI) paradigm is a continual approach to systematic improvement that focuses on patient outcomes and safety. This framework should be applied to laboratory driven quality efforts across the total testing process. However, there is minimal guidance and few resources on how to prepare, implement, and evaluate a QI initiative from a clinical laboratory perspective. Relative to other disciplines in healthcare, the quality gaps and types of errors and challenges in laboratory medicine are quite unique. This presents a major gap and barrier for clinical laboratorians to drive QI projects. This article is the second in a three-part primer series that aims to bridge this knowledge gap and act as a guide for clinical laboratories to execute and sustain QI initiatives. In the first article, an approach to preparing a QI project was outlined, including problem identification, root cause analysis, and SMART aim establishment. A clinical vignette of a real QI initiative related to serum protein electrophoresis (SPEP) utilization at our institution was introduced. The second part of this primer series focuses on the implementation of a QI initiative. Throughout, we introduce fundamental concepts related to change concepts and ideas, hierarchy of effectiveness, family of measures, and implementation cycles. Theoretical concepts are applied to the clinical vignette where we continue to follow the progress of a real SPEP utilization initiative.
Less is more: minimum sample volume for the free phenytoin assay on the Roche Cobas c503 analyzer.
Chan KK, Butler S, Zhang YV
Clin Biochem · 2025 Aug · PMID 40532871 · Publisher ↗
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Impact of age on cardiac troponin concentration among healthy individuals.
Hasselbalch RB, Strandkjær N, Kristensen J … +17 more , Jørgensen N, Kock TO, Lange T, Ostrowski SR, Nissen J, Larsen MH, Vesterager Pedersen OB, Bor MV, Afzal S, Kamstrup PR, Dahl M, Hilsted L, Rode L, Jørgensen NR, Torp-Pedersen C, Bundgaard H, Iversen KK
Clin Biochem · 2025 Aug · PMID 40513714 · Publisher ↗
BACKGROUND: The 99th percentile of cardiac troponin (cTn) among healthy individuals is the diagnostic cutoff for myocardial infarction. This study investigates the effect of age on the 99th percentile of cTn among health...
BACKGROUND: The 99th percentile of cardiac troponin (cTn) among healthy individuals is the diagnostic cutoff for myocardial infarction. This study investigates the effect of age on the 99th percentile of cTn among healthy individuals. METHODS: We sampled healthy Danish blood donors, screened using hemoglobin A1c, N-terminal pro-brain natriuretic peptide, and creatinine. The cTn assays investigated were Siemens Atellica and Dimension Vista hs-cTnI, Abbott hs-cTnI, Vitros hs-cTnI, and Roche hs-cTnT. The 99th percentiles were calculated using the non-parametric method and modeled using quantile regressions adjusted for sex and creatinine concentration. RESULTS: We included 2287 participants, excluding 118 due to a history of heart disease, insufficient plasma, or biomarker screening, leaving 2169 participants with a median age of 58 years (IQR 49-69 years), and 1152 (53 %) were female. Concentrations increased with age for all assays (p < 0.001). Only the 99th percentile of hs-cTnT was significantly associated with age (0.42 ng/L increase/year, p < 0.001); for participants >70 years, the 99th percentile was 36.8 ng/L (90 % CI 33.8-40.7 ng/L), with 22.2 % above the manufacturer's 99th percentile. The difference in the 99th percentile between age groups was less clear for cTnI, except for the Vitros assay: <50 years 6.5 ng/L (90 % CI 5.0-26.9 ng/L) vs >70 years 17.3 ng/L (90 % CI 9.7-33.2 ng/L). CONCLUSIONS: Age was associated with increased cTn concentrations for all assays. The correlation was strongest for hs-cTnT, where the 99th percentile for participants >70 years was more than double compared to those <50 years, with over 20 % exceeding the manufacturer's 99th percentile. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT05336435.
Multi-institution comparison of whole blood potassium hemolysis rates.
Farnsworth C, Yang J, Maynard R … +1 more , Stieglitz HM
Clin Biochem · 2025 Aug · PMID 40480412 · Publisher ↗
INTRODUCTION: Hemolysis causes falsely elevated potassium results and if undetected, can lead to misidentification of hypokalemia or hyperkalemia causing delayed or inappropriate treatment. The prevalence of hemolysis in...
INTRODUCTION: Hemolysis causes falsely elevated potassium results and if undetected, can lead to misidentification of hypokalemia or hyperkalemia causing delayed or inappropriate treatment. The prevalence of hemolysis in whole blood samples submitted for potassium or blood gas analysis remains unknown due to historical limitations in blood gas analyzer hemolysis detection. This study aimed to compare hemolysis rates in whole blood potassium samples measured by blood gas analyzers at four different academic medical centers. Further, we compared rates among differing blood sources and hospital settings, and potassium results among different hemolysis flags. MATERIALS AND METHODS: Potassium results and hemolysis flags measured on the GEM Premier 7000 at four different academic medical centers were compiled for six months at each location. RESULTS: A total of 37,944 samples with hemolysis flags were obtained from four academic medical centers with an overall hemolysis rate of 10.0 % (hemolysis flags corresponding to > 50 mg/dL plasma free hemoglobin). Hemolysis rates varied by institution ranging from 9.2-14.6 %. Hemolysis rates were similar between arterial (8.6 %) and venous (10.6 %) samples but were substantially higher for capillary (17.7 %) samples. Samples collected in the emergency department showed greater hemolysis rates (17 %) compared to those samples originating in intensive care units (8.1 %) and all other (10.2 %) departments. CONCLUSIONS: This study demonstrates high hemolysis rates for whole blood potassium samples measured by blood gas analyzers, particularly for the emergency department setting and capillary specimens. This study demonstrates the importance of hemolysis detection for improving laboratory quality and patient safety.
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