Clinical biochemistryPub Date : 2025-12-01Epub Date: 2025-10-22DOI: 10.1016/j.clinbiochem.2025.111030
Yubin Lei , Anik Forest , Caroline Daneault , Ying Liu , Kostas Pantopoulos , Adisak Tantiworawit , Arintaya Phrommintikul , Siriporn Chattipakorn , Nipon Chattipakorn , Christine Des Rosiers , Gary Sweeney
{"title":"Correlation of plasma lipidomic profiles with cardiometabolic disease in transfusion-dependent thalassemia patients with six-month N-acetylcysteine intervention: A prospective cohort study","authors":"Yubin Lei , Anik Forest , Caroline Daneault , Ying Liu , Kostas Pantopoulos , Adisak Tantiworawit , Arintaya Phrommintikul , Siriporn Chattipakorn , Nipon Chattipakorn , Christine Des Rosiers , Gary Sweeney","doi":"10.1016/j.clinbiochem.2025.111030","DOIUrl":"10.1016/j.clinbiochem.2025.111030","url":null,"abstract":"<div><h3>Objectives</h3><div>Oxidative stress, driven by iron imbalance from recurrent blood transfusions, is a major contributor to cardiometabolic complications in transfusion-dependent thalassemia (TDT). N-acetylcysteine (NAC), a glutathione precursor, is a well-known antioxidant with cardioprotective effects achieved by mitigating the impact of oxidative stress on cell metabolism. Current study aimed to evaluate the effect of a six-month NAC intervention by focusing on previously reported changes in the plasma lipidome in TDT patients.</div><div>Design & Methods</div><div>A randomized cohort of 62 Thai TDT patients was divided into two groups: both received six months of cocktail therapy involving standardized blood transfusions and iron chelator therapy, with the intervention group additionally receiving 600 mg oral NAC daily and the control group receiving a placebo. Plasma lipidomic profiling was performed using mass spectrometry to assess 339 previously annotated lipid features significantly altered in TDT patients. Clinical parameters, including heart rate variability (HRV), were measured before and after the intervention.</div></div><div><h3>Results</h3><div>NAC treatment significantly altered 152 plasma lipid features (P < 0.03), 78 of which were also altered in the placebo group. Importantly, 29 lipid features (26 unique lipids) were restored toward healthy control levels following NAC treatment. Within this subset, circulating diacylglycerophosphocholines PC(14:0_20:4) and cholesteryl ester CE 18:3 positively correlated with HRV, a clinical marker markedly improved in NAC-treated patients.</div></div><div><h3>Conclusions</h3><div>Six-month oral NAC intervention modified the plasma lipidomic profile in TDT patients, partially restoring lipid species likely disrupted by chronic oxidative stress. The observed correlation between NAC-responsive lipids and improved HRV suggests a potential cardioprotective effect. These findings highlight the potential of NAC as an adjunctive therapy to mitigate cardiometabolic complications in TDT.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111030"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145358079","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical biochemistryPub Date : 2025-12-01Epub Date: 2025-10-10DOI: 10.1016/j.clinbiochem.2025.111028
Tiziana Zangardi , Sara Altinier , Monica Maria Mion , Michele Cennamo , Ada Aita , Silvia Bressan , Daniela Basso
{"title":"Myocardial damage in a 4-year old who ingested bisoprolol and hydrochlorothiazide – Incidental CK-BB highlighted other tissue toxicity","authors":"Tiziana Zangardi , Sara Altinier , Monica Maria Mion , Michele Cennamo , Ada Aita , Silvia Bressan , Daniela Basso","doi":"10.1016/j.clinbiochem.2025.111028","DOIUrl":"10.1016/j.clinbiochem.2025.111028","url":null,"abstract":"<div><h3>Introduction</h3><div>A 4-year-old girl accidentally ingested an unknown quantity of bisoprolol (2.5 mg)-hydrochlorothiazide (6.25 mg) pills. Initialy asymptomatic, laboratory testing revealed elevated concentrations of cardiac and skeletal muscle injury markers. This case provided insight into potential myocardial toxicity and bone remodeling effects of these antihypertensive medications following acute overdose ingestion.</div></div><div><h3>Materials and methods</h3><div>Upon admission, the patient underwent clinical and laboratory evaluations, which included electrocardiogram (ECG), echocardiography, blood gas analysis, and assessment of biochemical markers for cardiac injury (high sensitivity troponin [hs-TnI], N-terminal pro brain natriuretic peptide [NT-proBNP]) and bone turnover (parathyroid hormone [PTH], vitamin D, bone alkaline phosphatase [bALP], beta cross-laps [CTX]). Bisoprolol was measured in plasma and urine. Creatine kinase (CK) isoenzymes were performed on agarose gel electrophoresis. Activated charcoal was administered; fluids and electrolytes were closely monitored. Clinical and laboratory follow-up continued for two months.</div></div><div><h3>Results</h3><div>The child’s vital signs were stable, but a reduced heart rate (75 bpm) developed within 24 h. Elevated hs-TnI and NT-proBNP levels indicated myocardial stress, despite normal ECG and echocardiography findings. The CK-BB isoenzyme increased to 8 % of total CK by day 3. An increase of CTX along with decreased PTH and bALP, suggested thiazide-induced osteoclastic activation. Bisoprolol concentrations quickly decreased over 12 h. The patient was discharged in good condition after 36 h. All biomarkers normalized progressively during follow-up.</div></div><div><h3>Conclusions</h3><div>This case highlights subclinical myocardial toxicity and an unexpected bone remodeling after a pediatric overdose of bisoprolol-hydrochlorothiazide. CK-BB elevation, likely due to osteoclast activity, underscores the importance of monitoring skeletal biomarkers in thiazide exposures. Clinical recovery can occur before biochemical normalization, emphasizing the need for extended follow-up even in asymptomatic cases.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111028"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145273981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical biochemistryPub Date : 2025-12-01Epub Date: 2025-10-28DOI: 10.1016/j.clinbiochem.2025.111034
Elisa Buzzatti , Fabiana Esposito , Maria Morello , Vanessa Rossi , Maria Christina Cox , Ombretta Annibali , Enrico Santinelli , Maria Antonietta Irno-Consalvo , Giovangiacinto Paterno , Lucia Cardillo , Massimiliano Postorino , Adriano Venditti , Maria Ilaria Del Principe
{"title":"The contribution of IL-10 and IL-6 as potential biomarkers for detecting central nervous system involvement in non-Hodgkin lymphomas","authors":"Elisa Buzzatti , Fabiana Esposito , Maria Morello , Vanessa Rossi , Maria Christina Cox , Ombretta Annibali , Enrico Santinelli , Maria Antonietta Irno-Consalvo , Giovangiacinto Paterno , Lucia Cardillo , Massimiliano Postorino , Adriano Venditti , Maria Ilaria Del Principe","doi":"10.1016/j.clinbiochem.2025.111034","DOIUrl":"10.1016/j.clinbiochem.2025.111034","url":null,"abstract":"<div><h3>Introduction</h3><div>A significant clinical challenge in the management of hematologic malignancies is the occurrence of central nervous system (CNS) involvement. In non-Hodgkin lymphoma (NHL), it occurs in varying percentages depending on the subtype and identifying patients is crucial but challenging. Furthermore, a definitive gold standard for diagnosing leptomeningeal involvement is still lacking. Conventional cytology (CC) of cerebrospinal fluid (CSF) has high specificity but low sensitivity. Multiparametric flow cytometry offers superior sensitivity but is limited by CSF cellularity and the need for specialized expertise, a resource not available at every institution. CSF cytokine analysis is emerging as a promising diagnostic approach, with IL-6 and IL-10 showing potential as biomarkers.</div></div><div><h3>Objective</h3><div>This prospective study investigated the utility of dosing the aforementioned cytokine in serum and CSF samples for diagnosing CNS involvement in non-primary CNS lymphoma patients.</div></div><div><h3>Methods</h3><div>CSF samples were analyzed using CC and IL-6/IL-10 assays. IL-6 and IL-10 levels were then compared between CC-positive (CC + ) and CC-negative (CC–) patients.</div></div><div><h3>Results</h3><div>The study cohort included 27 patients, with a median age of 71 years. Six patients (22.2 %) were CC + . In CSF, statistically significant differences were observed for both IL-6 (p = 0.02) and IL-10 (p = 0.04) levels between CC + and CC– patients, with higher levels in CC + patients. Elevated CSF IL-6 and IL-10 levels were also associated with elevated LDH, advanced disease stage, and elevated CSF protein.</div></div><div><h3>Conclusions</h3><div>This study suggests that CSF IL-6 and IL-10 are potential, widely available biomarkers for early detection of CNS involvement in NHL, offering a complement to traditional cytological analysis in clinical laboratories.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"140 ","pages":"Article 111034"},"PeriodicalIF":2.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145408395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical biochemistryPub Date : 2025-10-01Epub Date: 2025-08-21DOI: 10.1016/j.clinbiochem.2025.110995
Simmi Patel , Octavia M. Peck Palmer , Chanda B. Lay , Kathleen Mulvey , Michael R. Shurin , Sarah E. Wheeler
{"title":"Defining a clinically relevant thyroglobulin antibody interference threshold for high-sensitivity thyroglobulin immunoassays: a single institution case study","authors":"Simmi Patel , Octavia M. Peck Palmer , Chanda B. Lay , Kathleen Mulvey , Michael R. Shurin , Sarah E. Wheeler","doi":"10.1016/j.clinbiochem.2025.110995","DOIUrl":"10.1016/j.clinbiochem.2025.110995","url":null,"abstract":"<div><h3>Background</h3><div>The interpretation of serum thyroglobulin (Tg) levels in differentiated thyroid cancer is complicated by interference from thyroglobulin antibodies (TgAb) and there is no standardized threshold to determine interference. Following implementation of a new instrument, we observed increased TgAb-positive samples which reflex to alternate send-out Tg methods with reduced analytic sensitivity but which are more robust to TgAb interference. This resulted in fewer patients having detectable Tg for monitoring, longer turnaround times, and higher costs. We hypothesized that the TgAb assay limit of detection (LOD) was lower than the clinically meaningful interference threshold.</div></div><div><h3>Methods</h3><div>We analyzed 119 serum specimens with an electrochemiluminescent TgAb immunoassay (ECLIA-TgAb) ≥ 10 IU/mL, comparing TgAb measurements by radioimmunoassay (RIA-TgAb) and Tg levels measured via immunometric assay (IMA-Tg) and RIA (RIA-Tg; reference method), and clinical adjudication of discrepant samples.</div></div><div><h3>Results</h3><div>Of ECLIA-TgAb specimens above the LOD (10 IU/mL), 30 % were positive by RIA-TgAb. Increasing the ECLIA-TgAb threshold to 20 IU/mL improved concordance to 90 %. A 20 IU/mL threshold optimized qualitative agreement between IMA-Tg and RIA-Tg (95 %). Retrospective chart review of patient diagnosis and treatment indicated that there would be no change in patient management with the revised threshold.</div></div><div><h3>Conclusions</h3><div>We found that an ECLIA-TgAb threshold of 20 IU/mL allowed more patients to be followed by the high sensitivity IMA-Tg method with no change to clinical decision-making, reducing send-out testing by 66 %. This approach offers an accessible and practical strategy for individual laboratories to define clinically appropriate TgAb thresholds to maximize the samples eligible for highly sensitive Tg measurement.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110995"},"PeriodicalIF":2.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144888763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical biochemistryPub Date : 2025-10-01Epub Date: 2025-07-13DOI: 10.1016/j.clinbiochem.2025.110978
Simon-Pierre Guay , Martine Paquette , Amélie Taschereau , Véronique Desgagné , Luigi Bouchard , Sophie Bernard , Alexis Baass
{"title":"DNA methylation levels are independently associated with prevalence of atherosclerotic cardiovascular disease in multifactorial chylomicronemia syndrome","authors":"Simon-Pierre Guay , Martine Paquette , Amélie Taschereau , Véronique Desgagné , Luigi Bouchard , Sophie Bernard , Alexis Baass","doi":"10.1016/j.clinbiochem.2025.110978","DOIUrl":"10.1016/j.clinbiochem.2025.110978","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Objective</h3><div>To study the factors associated with previous history of ASCVD in MCS patients.</div></div><div><h3>Methods</h3><div>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 <em>ABCG1</em> (cg06500161), <em>CPT1A</em> (cg00574958), and <em>SREBF1</em> (cg11024682) candidate gene loci was quantified using pyrosequencing of bisulfite-treated DNA.</div></div><div><h3>Results</h3><div>Univariate analysis showed that age, <em>ABCG1</em> and <em>SREBF1</em> 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), <em>SREBF1</em> 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 (<em>p</em> < 0.0001).</div></div><div><h3>Conclusion</h3><div>This study shows that <em>SREBF1</em> 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.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110978"},"PeriodicalIF":2.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144632509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical biochemistryPub Date : 2025-10-01Epub Date: 2025-06-28DOI: 10.1016/j.clinbiochem.2025.110963
Launny Lowden , Christine Henderson
{"title":"Greening the lab: Creation of a national playbook on environmental sustainability in lab medicine","authors":"Launny Lowden , Christine Henderson","doi":"10.1016/j.clinbiochem.2025.110963","DOIUrl":"10.1016/j.clinbiochem.2025.110963","url":null,"abstract":"<div><h3>Introduction</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>The <em>Integrating Environmental Sustainability into Clinical Laboratories</em> 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.</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110963"},"PeriodicalIF":2.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144526567","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical biochemistryPub Date : 2025-10-01Epub Date: 2025-07-05DOI: 10.1016/j.clinbiochem.2025.110968
Janet R. Zhou , Andrea Kunst , Joshua E. Raizman , Miranda Brun , Yury Butorin , Fahed A. Elian , Lawrence de Koning , Samantha Logan , Isolde Seiden-Long , Heather Paul , Allison A. Venner , Albert K.Y. Tsui
{"title":"Concentration dependent impact of hemolysis on lipase result: Does it clinically matter?","authors":"Janet R. Zhou , Andrea Kunst , Joshua E. Raizman , Miranda Brun , Yury Butorin , Fahed A. Elian , Lawrence de Koning , Samantha Logan , Isolde Seiden-Long , Heather Paul , Allison A. Venner , Albert K.Y. Tsui","doi":"10.1016/j.clinbiochem.2025.110968","DOIUrl":"10.1016/j.clinbiochem.2025.110968","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110968"},"PeriodicalIF":2.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144571934","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical biochemistryPub Date : 2025-10-01Epub Date: 2025-07-03DOI: 10.1016/j.clinbiochem.2025.110969
Chaonan Liu , Xunbei Huang , Liqin Ling, Qiang Meng, Juan Liao, Jing Zhou
{"title":"Implementation and validation of an intelligent auto-verification system in a coagulation testing automatic line","authors":"Chaonan Liu , Xunbei Huang , Liqin Ling, Qiang Meng, Juan Liao, Jing Zhou","doi":"10.1016/j.clinbiochem.2025.110969","DOIUrl":"10.1016/j.clinbiochem.2025.110969","url":null,"abstract":"<div><h3>Objective</h3><div>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.</div></div><div><h3>Methods</h3><div>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).</div></div><div><h3>Results</h3><div>All centrifuged specimens met platelet-poor plasma criteria (platelet count <10 × 10<sup>9</sup>/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).</div></div><div><h3>Discussion</h3><div>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.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110969"},"PeriodicalIF":2.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144567148","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical biochemistryPub Date : 2025-10-01Epub Date: 2025-07-22DOI: 10.1016/j.clinbiochem.2025.110981
Dongdan Zhang , Yue Meng , Dan Li , Shaomei Zhu
{"title":"LRG and NGAL are potential diagnosis and disease activity biomarkers for inflammatory bowel disease","authors":"Dongdan Zhang , Yue Meng , Dan Li , Shaomei Zhu","doi":"10.1016/j.clinbiochem.2025.110981","DOIUrl":"10.1016/j.clinbiochem.2025.110981","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>The serum concentrations of NGAL and LRG were significantly higher in IBD patients than in healthy controls (<em>P</em> < 0.001). Serum NGAL is significantly correlated with LRG (r = 0.574, <em>P</em> < 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, <em>P</em> < 0.001), and gradually increased with disease activity severity (<em>P</em> < 0.05).</div></div><div><h3>Conclusion</h3><div>Serum NGAL and LRG are potential diagnostic and disease activity biomarkers for IBD, which have good clinical application value.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110981"},"PeriodicalIF":2.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144706544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clinical biochemistryPub Date : 2025-10-01Epub Date: 2025-08-09DOI: 10.1016/j.clinbiochem.2025.110989
Ziyue Jiang , Shouxia Li , Li Yang , Xuedong Song , Xiaofang Zhang , Lili Guo , Jia Guo , Haili Zhang , Dingli Chen
{"title":"Diagnostic value of serum TSI levels in Graves’ disease and direct comparison of diagnostic performance with TRAb: A systematic review and meta-analysis","authors":"Ziyue Jiang , Shouxia Li , Li Yang , Xuedong Song , Xiaofang Zhang , Lili Guo , Jia Guo , Haili Zhang , Dingli Chen","doi":"10.1016/j.clinbiochem.2025.110989","DOIUrl":"10.1016/j.clinbiochem.2025.110989","url":null,"abstract":"<div><div>This study aimed to systematically assess the diagnostic value of thyroid-stimulating immunoglobulin on the Siemens Immulite platform (the TSI assay) and to conduct a direct comparison with thyrotropin receptor antibodies on the Roche cobas platform (the TRAb assay) for the diagnosis of Graves’ disease (GD). We performed systematic literature searches across multiple databases. Following strict screening, we identified 20 eligible clinical studies that evaluated the diagnostic value of the TSI assay, either alone or in comparison with the TRAb assay. Using random-effects models, we calculated pooled estimates of sensitivity (SEN), specificity (SPE), positive likelihood ratio (PLR), negative likelihood ratio (NLR), and diagnostic odds ratio (DOR). Diagnostic accuracy was further evaluated through summary receiver operating characteristic curve analysis. The findings revealed that the TSI assay demonstrated excellent diagnostic accuracy, with pooled SEN of 0.933 (95 % CI: 0.924 − 0.941), SPE of 0.961 (95 % CI: 0.956 − 0.964), PLR of 24.078 (95 % CI: 16.727 − 34.659), NLR of 0.036 (95 % CI: 0.020 − 0.066), and DOR of 778.29 (95 % CI: 343.45 − 1763.67), supported by an area under the curve (AUC) of 0.9919. In direct comparison to the TRAb assay, the TSI assay showed slightly better SEN (0.967 vs. 0.889), DOR (1310.03 vs. 692.73), and NLR (0.023 vs. 0.046), comparable SPE (0.964 vs. 0.959) and PLR (29.954 vs. 30.066), and higher AUC (0.9963 vs. 0.9899). These results conclusively demonstrate that the TSI assay shows high sensitivity and specificity in the diagnosis of GD, exceeding or at least comparable to TRAb, making it a valuable tool for clinical diagnosis.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"139 ","pages":"Article 110989"},"PeriodicalIF":2.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144810234","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}