Clinical biochemistry最新文献

{"title":"Greening the lab: Creation of a national playbook on environmental sustainability in lab medicine","authors":"Launny Lowden ,&nbsp;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":"2025-06-28","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}

{"title":"Comparison of laboratory results and pain perception in self-sampled capillary blood versus venous blood sampling: a systematic review and meta-analysis","authors":"Dominik Schröder ,&nbsp;Angelika Hafke ,&nbsp;Eva Hummers ,&nbsp;Christopher Schuchardt ,&nbsp;Christiane A. Müller ,&nbsp;Linda Hoffmeister ,&nbsp;Christine Happle ,&nbsp;Alexandra Dopfer-Jablonka ,&nbsp;Georg M.N. Behrens ,&nbsp;Julie Schanz ,&nbsp;Frank Müller","doi":"10.1016/j.clinbiochem.2025.110965","DOIUrl":"10.1016/j.clinbiochem.2025.110965","url":null,"abstract":"<div><div>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 (I² = 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.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"138 ","pages":"Article 110965"},"PeriodicalIF":2.5,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144522141","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}

{"title":"Long time monitoring of serum lithium results using patient median values show stable test results over a time period of more than 20 years","authors":"Anders Larsson,&nbsp;Johanna Helmersson-Karlqvist,&nbsp;Mathias Karlsson","doi":"10.1016/j.clinbiochem.2025.110964","DOIUrl":"10.1016/j.clinbiochem.2025.110964","url":null,"abstract":"<div><h3>Introduction and Objectives</h3><div>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.</div></div><div><h3>Materials and Methods</h3><div>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.</div></div><div><h3>Results</h3><div>Patient median and quartile values showed that lithium had a stable calibration between 2004 and 2024. The lithium results did not show seasonal variation.</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"138 ","pages":"Article 110964"},"PeriodicalIF":2.5,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144526568","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}

{"title":"Estimation formulas for ionized magnesium in critically ill children","authors":"Soichiro Tanimura ,&nbsp;Hiroki Kato ,&nbsp;Yurie Yamaga ,&nbsp;Tomohiro Wakabayashi ,&nbsp;Shiro Hinotsu ,&nbsp;Norihiko Tsuboi ,&nbsp;Shotaro Matsumoto ,&nbsp;Satoshi Nakagawa","doi":"10.1016/j.clinbiochem.2025.110962","DOIUrl":"10.1016/j.clinbiochem.2025.110962","url":null,"abstract":"<div><h3>Introduction</h3><div>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.</div></div><div><h3>Materials and methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusions</h3><div>We successfully developed an iMg estimation model using routinely measured clinical parameters.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"138 ","pages":"Article 110962"},"PeriodicalIF":2.5,"publicationDate":"2025-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144489721","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}

{"title":"The predictive value of ferroptosis marker SLC7A11 in the prognosis of advanced non-small cell lung cancer patients","authors":"Shiqiang Wang ,&nbsp;Xinlai Jin ,&nbsp;Xuefei Yang ,&nbsp;Zhidi Zhang","doi":"10.1016/j.clinbiochem.2025.110961","DOIUrl":"10.1016/j.clinbiochem.2025.110961","url":null,"abstract":"<div><h3>Objective</h3><div>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).</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"138 ","pages":"Article 110961"},"PeriodicalIF":2.5,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144481400","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}

{"title":"Optimization and validation of the Kairos amino acid Kit for plasma amino acid monitoring in inherited metabolic disorder patients","authors":"Kiara Theron ,&nbsp;Jeannette Gauthier ,&nbsp;Marijn Van Hulle ,&nbsp;Murray Potter","doi":"10.1016/j.clinbiochem.2025.110960","DOIUrl":"10.1016/j.clinbiochem.2025.110960","url":null,"abstract":"<div><h3>Purpose</h3><div>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 (&gt;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.</div></div><div><h3>Design and methods</h3><div>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.</div></div><div><h3>Results</h3><div>Clinical validation has been performed, indicating high reproducibility and clinical applicability. Linearity results demonstrated 42/45 amino acids with R² &gt; 0.975 over a linear range of at least 5–1000 µmol/L. Spiked plasma calibrators demonstrated high recovery with R² &gt; 0.971. Twenty-day precision testing demonstrated total coefficient of variation &lt; 15 % and sensitivity testing confirmed all analytes have limits of detection &lt; 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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"138 ","pages":"Article 110960"},"PeriodicalIF":2.5,"publicationDate":"2025-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144474108","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}

{"title":"Primer part 2 - implementing a laboratory quality improvement project","authors":"Mary Kathryn Bohn ,&nbsp;Roy Augustin ,&nbsp;Lucas B. Chartier ,&nbsp;Luke Devine ,&nbsp;Samik Doshi ,&nbsp;Leanne Ginty ,&nbsp;Elliot Lass ,&nbsp;Felix Leung ,&nbsp;William Mundle ,&nbsp;Graeme Nimmo ,&nbsp;Alyson Sandy ,&nbsp;Kelly Shillington ,&nbsp;Amanda Simon ,&nbsp;Amanda Steiman ,&nbsp;Ahmed Taher ,&nbsp;Cindy Tang Friesner ,&nbsp;Cristina Zanchetta ,&nbsp;Jennifer Taher","doi":"10.1016/j.clinbiochem.2025.110959","DOIUrl":"10.1016/j.clinbiochem.2025.110959","url":null,"abstract":"<div><div>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.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"138 ","pages":"Article 110959"},"PeriodicalIF":2.5,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144368001","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}

{"title":"Impact of lot-to-lot variation in absolute neutrophil count measured by a point-of-care device in patients receiving clozapine treatment","authors":"Mary Kathryn Bohn ,&nbsp;Blaine Elliott ,&nbsp;Paul M Yip","doi":"10.1016/j.clinbiochem.2025.110957","DOIUrl":"10.1016/j.clinbiochem.2025.110957","url":null,"abstract":"<div><h3>Background</h3><div>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™).</div></div><div><h3>Methods</h3><div>Retrospective patient data were extracted over a 13-month period. Results were classified for treatment safety per vendor as green (≥2.0 × 10⁹/L), yellow (1.5–1.9 × 10⁹/L), or red (&lt;1.5 × 10⁹/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.</div></div><div><h3>Results</h3><div>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 × 10⁹/L). The lot with the largest bias demonstrated the highest red alert rate and repeat rate in real-time patient data.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"138 ","pages":"Article 110957"},"PeriodicalIF":2.5,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144330037","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}

{"title":"Less is more: minimum sample volume for the free phenytoin assay on the Roche Cobas c503 analyzer","authors":"Ka Keung Chan,&nbsp;Sharlene Butler,&nbsp;Y.Victoria Zhang","doi":"10.1016/j.clinbiochem.2025.110958","DOIUrl":"10.1016/j.clinbiochem.2025.110958","url":null,"abstract":"","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"138 ","pages":"Article 110958"},"PeriodicalIF":2.5,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144306438","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}

{"title":"Impact of age on cardiac troponin concentration among healthy individuals","authors":"Rasmus Bo Hasselbalch ,&nbsp;Nina Strandkjær ,&nbsp;Jonas Kristensen ,&nbsp;Nicoline Jørgensen ,&nbsp;Thilde Olivia Kock ,&nbsp;Theis Lange ,&nbsp;Sisse Rye Ostrowski ,&nbsp;Janna Nissen ,&nbsp;Margit Hørup Larsen ,&nbsp;Ole Birger Vesterager Pedersen ,&nbsp;Mustafa Vakur Bor ,&nbsp;Shoaib Afzal ,&nbsp;Pia Rørbæk Kamstrup ,&nbsp;Morten Dahl ,&nbsp;Linda Hilsted ,&nbsp;Line Rode ,&nbsp;Niklas Rye Jørgensen ,&nbsp;Christian Torp-Pedersen ,&nbsp;Henning Bundgaard ,&nbsp;Kasper Karmark Iversen","doi":"10.1016/j.clinbiochem.2025.110956","DOIUrl":"10.1016/j.clinbiochem.2025.110956","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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 &lt; 0.001). Only the 99th percentile of hs-cTnT was significantly associated with age (0.42 ng/L increase/year, p &lt; 0.001); for participants &gt;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: &lt;50 years 6.5 ng/L (90 % CI 5.0–26.9 ng/L) vs &gt;70 years 17.3 ng/L (90 % CI 9.7–33.2 ng/L).</div></div><div><h3>Conclusions</h3><div>Age was associated with increased cTn concentrations for all assays. The correlation was strongest for hs-cTnT, where the 99th percentile for participants &gt;70 years was more than double compared to those &lt;50 years, with over 20 % exceeding the manufacturer’s 99th percentile.</div></div><div><h3>Registration</h3><div>URL: <span><span>https://www.clinicaltrials.gov</span><svg><path></path></svg></span>; Unique identifier: NCT05336435.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"138 ","pages":"Article 110956"},"PeriodicalIF":2.5,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144270842","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}