Clinical chemistry and laboratory medicine最新文献

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Simple steps to achieve harmonisation and standardisation of dried blood spot phenylalanine measurements and facilitate consistent management of patients with phenylketonuria.
IF 3.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-02-04 DOI: 10.1515/cclm-2024-1367
Rachel S Carling, Zoe Barclay, Nathan Cantley, Nana Ghansah, Sarah L Hogg, Alistair Horman, Stuart J Moat, Simon Cowen, Chris Hopley, Chloe Deaves, Emily Whyte
{"title":"Simple steps to achieve harmonisation and standardisation of dried blood spot phenylalanine measurements and facilitate consistent management of patients with phenylketonuria.","authors":"Rachel S Carling, Zoe Barclay, Nathan Cantley, Nana Ghansah, Sarah L Hogg, Alistair Horman, Stuart J Moat, Simon Cowen, Chris Hopley, Chloe Deaves, Emily Whyte","doi":"10.1515/cclm-2024-1367","DOIUrl":"https://doi.org/10.1515/cclm-2024-1367","url":null,"abstract":"<p><strong>Objectives: </strong>Management of phenylketonuria (PKU) relies upon life-long monitoring of phenylalanine (Phe) in dried blood spots (DBS), thus comparability of measurements is important. The lack of harmonisation and standardisation between laboratories, combined with the variable quality of patient-collected DBS specimens, are currently preventing this from being achieved. A traceable, matrix-matched Phe certified reference material, common methodology and means to ensure patient collected DBS specimens are of consistent quality would improve comparability between laboratories.</p><p><strong>Methods: </strong>Baseline inter-laboratory (n=15) variation of DBS Phe was determined by triplicate measurement of four DBS materials, on three days. Laboratories prepared and analysed these samples using their routine method of analysis. A sub-set of laboratories (n=5) repeated the process using a common sample preparation and instrument methodology (LC-MS/MS), and three different calibration approaches. Samples prepared on dried blood spot microsampling cards (DBS-MCs) from whole blood, value assigned for Phe concentration by National Measurement Laboratories (NML), were then analysed using the harmonised methodology.</p><p><strong>Results: </strong>Inter-laboratory co-efficient of variation (CV) differed with calibration approach; internal calibration 27.7 %; in-house aqueous calibration 4.7 %; centrally distributed aqueous calibration, 2.1 %. Inter-laboratory CV was reduced from 8.7 to 2.1 % by using common sample preparation and LC-MS/MS methodology. No significant difference was observed between consensus and assigned values for Phe in the four materials (p>0.05).</p><p><strong>Conclusions: </strong>This study demonstrates a simple approach to harmonising and standardising DBS Phe measurements, traceable to value assigned materials. Combined with the introduction of DBS-MCs to ensure specimen quality, clinical laboratories can achieve comparability of patient results over time.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143078608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Inclusion of pyridoxine dependent epilepsy in expanded newborn screening programs by tandem mass spectrometry: set up of first and second tier tests.
IF 3.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-02-04 DOI: 10.1515/cclm-2024-1230
Roberta Damiano, Maria Della Bona, Elena Procopio, Renzo Guerrini, Alessandra Bettiol, Giancarlo la Marca
{"title":"Inclusion of pyridoxine dependent epilepsy in expanded newborn screening programs by tandem mass spectrometry: set up of first and second tier tests.","authors":"Roberta Damiano, Maria Della Bona, Elena Procopio, Renzo Guerrini, Alessandra Bettiol, Giancarlo la Marca","doi":"10.1515/cclm-2024-1230","DOIUrl":"https://doi.org/10.1515/cclm-2024-1230","url":null,"abstract":"<p><strong>Objectives: </strong>Pyridoxine-dependent epilepsy (PDE) is a rare genetic disorder characterized by intractable neonatal seizures responsive to pyridoxine. Diagnosis relies on quantification of α-aminoadipic semialdehyde, piperideine-6-carboxylate and pipecolic acid in urine or plasma in patients with overt symptoms. We developed and validated simple and rapid first- and second-tier methods for two recently published biomarkers of PDE (2S,6S-/2S,6R-oxopropylpiperidine-2-carboxylic acid (2-OPP) and 6-oxopiperidine-2-carboxylic acid (6-oxoPIP)) in extended newborn screening (NBS) programs from neonatal dried blood spots (DBS).</p><p><strong>Methods: </strong>For the first-line test, DBS specimens were collected from 5,405 newborns who underwent routine NBS and analysed by FIA-MS/MS. For the second-tier test, samples were analysed by LC-MS/MS. The neonatal DBS from two patients with genetically confirmed PDE were also analysed.</p><p><strong>Results: </strong>The reference values for NBS resulted <0.34 μmol/L for 2-OPP and <4.51 μmol/L for 6-oxoPIP. In the second-tier test, limits of detection were 0.07 μmol/L and 0.14 μmol/L, whereas limits of quantification were 0.25 μmol/L and 0.48 μmol/L, respectively, for 2-OPP and for 6-oxoPIP. The tests provided good linearity, reproducibility, accuracy and precision, with acceptable matrix effect and carry-over, according to international validation criteria. The biomarkers in DBS were stable at room temperature, +4 °C and -20 °C for one month. When assessing these biomarkers in two patients with genetically confirmed PDE, the higher sensitivity of 2-OPP as compared to 6-oxoPIP in discriminating PDE emerged.</p><p><strong>Conclusions: </strong>The first-line and second-tier tests developed in this study highlight the potential for including PDE in the NBS panel, early diagnosis and prompt precision treatment initiation.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143122088","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Establishment of gender- and age-related reference intervals for serum uric acid in adults based on big data from Zhejiang Province in China.
IF 3.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-02-04 DOI: 10.1515/cclm-2024-1288
Dandan Chen, Yunxian Zhou, Lina Fan, Zheng Yang, Dagan Yang
{"title":"Establishment of gender- and age-related reference intervals for serum uric acid in adults based on big data from Zhejiang Province in China.","authors":"Dandan Chen, Yunxian Zhou, Lina Fan, Zheng Yang, Dagan Yang","doi":"10.1515/cclm-2024-1288","DOIUrl":"https://doi.org/10.1515/cclm-2024-1288","url":null,"abstract":"<p><strong>Objectives: </strong>This study utilized large-scale health examination data to explore gender- and age-specific reference intervals (RIs) for serum uric acid (UA) using indirect methods and assessed the consistency of different approaches.</p><p><strong>Methods: </strong>UA data were collected from a hospital in Zhejiang Province, China. The test set covered January 2019 to December 2023, with a validation set from January to June 2024. Various methods - EP28 nonparametric (EP28-NP), parametric (EP28-P), TMC, refineR, and Kosmic - were used to establish gender- and age-specific RIs. Continuous age-based RIs were derived using the Generalized Additive Model for Location Scale and Shape (GAMLSS). Validation rates were calculated for each method using the validation set.</p><p><strong>Results: </strong>Using EP28-NP as the benchmark, other methods showed similar UA RIs (bias ratios ≤0.375, except for one group), with Kosmic, refineR, and TMC yielding slightly higher values than EP28-NP and EP28-P. For males, UA RIs varied by age: 19-42 years (256-537 μmol/L), 43-66 years (235-513 μmol/L) and ≥67 years (214-515 μmol/L), with validation rates ranging from 94.05 to 96.50 %. Male continuous RIs declined from ages 20-79 and then gradually increased after age 80. For females, UA RIs were age-dependent: 19-48 years (169-374 μmol/L), 49-74 years (178-405 μmol/L), and ≥75 years (186-470 μmol/L), with validation rates ranging from 92.70 to 96.80 %. Female continuous RIs decreased from ages 20-48, then increased significantly from age 49 onward.</p><p><strong>Conclusions: </strong>Three indirect methods and two EP28 methods demonstrated good consistency in establishing UA RIs. Males had higher RIs than females, and RIs showed a non-linear correlation with age.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143078607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Prevalence and detection of citrate contamination in clinical laboratory.
IF 3.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-02-03 DOI: 10.1515/cclm-2024-1389
Nathan Lorde, Rousseau Gama, Tejas Kalaria
{"title":"Prevalence and detection of citrate contamination in clinical laboratory.","authors":"Nathan Lorde, Rousseau Gama, Tejas Kalaria","doi":"10.1515/cclm-2024-1389","DOIUrl":"https://doi.org/10.1515/cclm-2024-1389","url":null,"abstract":"<p><strong>Objectives: </strong>To study the prevalence of trisodium citrate (Na<sub>3</sub>Citrate) contamination in hypernatraemic serum samples by direct measurement of citrate and to evaluate the performance of indirect markers for identification of Na<sub>3</sub>Citrate contamination.</p><p><strong>Methods: </strong>Serum citrate was measured in all hypernatraemic serum samples (sodium ≥148 mmol/L) over a three-month period. The performance of serum chloride, sodium-chloride gap, indirect ion selective electrode (ISE)-direct ISE sodium disparity and osmolar gap in identification of Na<sub>3</sub>Citrate contaminated samples was assessed against the 'gold-standard' direct citrate measurement.</p><p><strong>Results: </strong>In total, 27 Na<sub>3</sub>Citrate contaminated samples were identified based on serum citrate concentration ≥1.5 mmol/L. The prevalence of citrate contamination was 3.1 % of hypernatraemic samples (n=875) and 0.017 % of all samples received for urea and electrolyte analysis (n=153,404). Most contaminated samples were from patients receiving haemodialysis (59.3 %), and the rest from inpatients. Cut-offs to give 100 % sensitivity were chloride ≤105 nmol/L (specificity 93.4 %), sodium-chloride gap ≥47 mmol/L (specificity 95.3 %), indirect ISE-direct ISE sodium disparity ≥3 mmol/L (specificity 81.9 %), and osmolar gap ≥39 mOsm/kg (specificity 2.8 %).</p><p><strong>Conclusions: </strong>Trisodium citrate contamination is uncommon. Most contaminated samples were from patients receiving haemodialysis, likely because of contamination with citrate catheter locking solution. Screening with serum chloride or sodium-chloride gap can confidently exclude Na<sub>3</sub>Citrate contamination in over 90 % of hypernatraemic samples, and in nearly all samples with sodium ≥155 mmol/L if metabolic alkalosis has been excluded. In the remaining samples, Na<sub>3</sub>Citrate contamination can only be definitively confirmed or excluded by measurement of serum citrate. We propose algorithms to identify spurious hypernatraemia.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143074065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Tumor specific protein 70 targeted tumor cell isolation technology can improve the accuracy of cytopathological examination.
IF 3.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-02-03 DOI: 10.1515/cclm-2024-0878
Lixia Zhang, Yutong Zhou, Shuxian Yang, Qiong Zhu, Jian Xu, Yuan Mu, Chunrong Gu, Huanyu Ju, Rong Rong, Shiyang Pan
{"title":"Tumor specific protein 70 targeted tumor cell isolation technology can improve the accuracy of cytopathological examination.","authors":"Lixia Zhang, Yutong Zhou, Shuxian Yang, Qiong Zhu, Jian Xu, Yuan Mu, Chunrong Gu, Huanyu Ju, Rong Rong, Shiyang Pan","doi":"10.1515/cclm-2024-0878","DOIUrl":"https://doi.org/10.1515/cclm-2024-0878","url":null,"abstract":"<p><strong>Objectives: </strong>Although existing cytopathological examination is considered essential for the diagnosis of malignant serous effusions, its accuracy is pretty low. Tumor specific protein 70 (SP70), which is highly expressed on human tumor cell membrane, was identified in our previous study. This study aimed to explore whether SP70 targeted tumor cell isolation technology with immunomagnetic beads can improve the accuracy of cytopathological examination.</p><p><strong>Methods: </strong>Cytopathological analysis with SP70 targeted tumor cell isolation technology was used in this study. In total, 255 cases were enrolled. Serous effusions were analyzed by both existing cytopathological examination and the new cytopathological analysis concurrently.</p><p><strong>Results: </strong>The sensitivities of existing cytopathological examination and the new cytopathological analysis were 51.26 % and 85.43 %, respectively, while the specificities were 100 % for both. This new cytopathological analysis demonstrated a higher interobserver agreement with malignant diagnosis than the existing cytopathological examination (kappa coefficient: 0.720 vs<i>.</i> 0.316, p<0.001). In addition, it achieved superior diagnostic efficacy for malignancy differentiation compared to existing cytopathological examination (AUC: 0.927 vs<i>.</i> 0.756, p<0.001). The follow-up results showed that 74 malignant cases with final clinical diagnosis were positive only with the new cytopathological analysis. Among these cases, there were 58 negative and 16 atypical by the existing cytopathological examination. In these malignant cases, 74.3 % (55/74) had been confirmed to have serosa metastasis based on radiographic evidence, and 73.7 % (28/38) harbored tumor hotspot mutations.</p><p><strong>Conclusions: </strong>As illustrated in this work, cytopathological analysis with SP70 targeted tumor cell isolation technology can improve the accuracy of existing cytopathological examination prominently.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143074067","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluation of AUTION EYE AI-4510 flow cell morphology analyzer for counting particles in urine.
IF 3.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-01-29 DOI: 10.1515/cclm-2024-1163
Matthijs Oyaert, Timo Kouri, Eva Carton, Sigrid Deprez, Stijn Lambrecht, Marijn Speeckaert
{"title":"Evaluation of AUTION EYE AI-4510 flow cell morphology analyzer for counting particles in urine.","authors":"Matthijs Oyaert, Timo Kouri, Eva Carton, Sigrid Deprez, Stijn Lambrecht, Marijn Speeckaert","doi":"10.1515/cclm-2024-1163","DOIUrl":"https://doi.org/10.1515/cclm-2024-1163","url":null,"abstract":"<p><strong>Objectives: </strong>We evaluated the performance of a novel flow cell morphology analyzer AUTION EYE AI-4510 for counting particles in urine.</p><p><strong>Methods: </strong>Analytical performance was assessed according to the EFLM European Urinalysis Guideline 2023. Trueness was compared by analyzing 1.012 fresh urine samples with the AUTION EYE AI-4510 (ARKRAY, Inc., Kyoto, Japan) against phase-contrast visual microscopy. Poisson statistics were utilized in assessment of imprecision of particle counts both with quality control material and patient specimens.</p><p><strong>Results: </strong>Relative imprecision against theoretical Poisson imprecision, R(CV), was estimated to be 1.1 for red blood cells (RBC), 1.0 for white blood cells (WBC), 0.9 for squamous epithelial cells (SEC) and 1.1 for bacteria. The agreement with visual microscopy (Cohen's weighted kappa) was 0.93 for RBC, 0.95 for WBC, 0.90 for SEC, 0.79 for non-squamous epithelial cells (NSEC), 0.67 for combined casts, 0.90 for crystals and 0.88 for bacteria. No clinically significant bias was observed. Limits of quantitation at CV=30 % reached 4 × 10<sup>6</sup>/L for RBC and 5 × 10<sup>6</sup>/L for WBC. Differentiation of urinary crystals was improved as compared to previous data on digital cuvette imaging.</p><p><strong>Conclusions: </strong>The ARKRAY AUTION EYE AI-4510 provided a desirable imprecision, met the criteria for linearity, LoQ and carry-over, and showed an optimum comparison to visual microscopy for RBC, WBC, SEC and crystals as defined in the EFLM European Urinalysis Guideline 2023. The identification of kidney damage is recommended to be improved by using user-defined review rules. Performance of bacteria counting needs to be confirmed against urine bacterial cultures.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143051678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
From errors to excellence: the pre-analytical journey to improved quality in diagnostics. A scoping review.
IF 3.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-01-28 DOI: 10.1515/cclm-2024-1277
George K John, Emmanuel J Favaloro, Samantha Austin, Md Zahidul Islam, Abishek B Santhakumar
{"title":"From errors to excellence: the pre-analytical journey to improved quality in diagnostics. A scoping review.","authors":"George K John, Emmanuel J Favaloro, Samantha Austin, Md Zahidul Islam, Abishek B Santhakumar","doi":"10.1515/cclm-2024-1277","DOIUrl":"https://doi.org/10.1515/cclm-2024-1277","url":null,"abstract":"<p><p>This scoping review focuses on the evolution of pre-analytical errors (PAEs) in medical laboratories, a critical area with significant implications for patient care, healthcare costs, hospital length of stay, and operational efficiency. The Covidence Review tool was used to formulate the keywords, and then a comprehensive literature search was performed using several databases, importing the search results directly into Covidence (n=379). Title, abstract screening, duplicate removal, and full-text screening were done. The retrieved studies (n=232) were scanned for eligibility (n=228) and included in the review (n=83), and the results were summarised in a PRISMA flow chart. The review highlights the role of healthcare professionals in preventing PAEs in specimen collection and processing, as well as analyses. The review also discusses the use and advancements of artificial intelligence (AI) and machine learning in reducing PAEs and identifies inadequacies in standard definitions, measurement units, and education strategies. It demonstrates the need for further research to ensure model validation, address the regulatory validation of Risk Probability Indexation (RPI) models and consider regulatory, safety, and privacy concerns. The review suggests that comprehensive studies on the effectiveness of AI and software platforms in real-world settings and their implementation in healthcare are lacking, presenting opportunities for further research to advance patient care and improve the management of PAEs.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Computer simulation approaches to evaluate the interaction between analytical performance characteristics and clinical (mis)classification: a complementary tool for setting indirect outcome-based analytical performance specifications.
IF 3.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-01-28 DOI: 10.1515/cclm-2024-1195
Hikmet Can Çubukçu
{"title":"Computer simulation approaches to evaluate the interaction between analytical performance characteristics and clinical (mis)classification: a complementary tool for setting indirect outcome-based analytical performance specifications.","authors":"Hikmet Can Çubukçu","doi":"10.1515/cclm-2024-1195","DOIUrl":"https://doi.org/10.1515/cclm-2024-1195","url":null,"abstract":"<p><p>Simulation-based approaches for setting indirect outcome-based analytical performance specifications (APS) predominantly involve test repetition through analytical reruns or resampling. These methodologies assess the agreement between original and simulated measurement results, determining the APS corresponding to pre-established performance thresholds. For APS related to imprecision and bias, both analytical performance characteristics (APCs) are typically considered in simulations, whereas for APS regarding measurement uncertainty, bias is excluded in alignment with traceability standards. This paper introduces the \"APS Simulator,\" a novel tool designed to complement the existing APS Calculator by simulating APS under various scenarios involving imprecision, bias, and measurement uncertainty. The APS Simulator facilitates simulations using distinct analytical rerun and resampling models, enabling laboratory professionals to explore a wide range of performance levels for their specific needs. While the APS Simulator provides valuable insights, significant challenges remain in the broader application of indirect outcome-based APS. These include incorporating sources of diagnostic uncertainty, setting appropriate thresholds for performance metrics, validating clinical decision limits, and accounting for population data characteristics. Addressing these limitations will be essential to enhancing the standardization and robustness of APS determination. The source code and desktop application for the APS Simulator are freely available at https://github.com/hikmetc/APS_Simulator, providing a user-friendly platform for researchers and clinicians to further explore these methodologies.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143051674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Biological variation of cardiac biomarkers in athletes during an entire sport season.
IF 3.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-01-28 DOI: 10.1515/cclm-2024-1203
Blanca Beumer Prieto, Isabel Moreno-Parro, Berta Sufrate-Vergara, Blanca Fabre-Estremera, Antonio Buño Soto, Pilar Fernández-Calle, Jorge Díaz-Garzón Marco
{"title":"Biological variation of cardiac biomarkers in athletes during an entire sport season.","authors":"Blanca Beumer Prieto, Isabel Moreno-Parro, Berta Sufrate-Vergara, Blanca Fabre-Estremera, Antonio Buño Soto, Pilar Fernández-Calle, Jorge Díaz-Garzón Marco","doi":"10.1515/cclm-2024-1203","DOIUrl":"https://doi.org/10.1515/cclm-2024-1203","url":null,"abstract":"<p><strong>Objectives: </strong>Cardiac biomarkers are useful for the diagnostic and prognostic assessment of myocardial injury (MI) and heart failure. By measuring specific proteins released into the bloodstream during heart stress or damage, these biomarkers help clinicians detect the presence and extent of heart injury and tailor appropriate treatment plans. This study aims to provide robust biological variation (BV) data for cardiac biomarkers in athletes, specifically focusing on those applied to detect or exclude MI, such as myoglobin, creatine kinase-myocardial band (CK-MB) and cardiac troponins (cTn), and those related to heart failure and cardiac dysfunction, brain natriuretic peptide (BNP) and N-terminal brain natriuretic pro-peptide (NT-proBNP).</p><p><strong>Methods: </strong>Thirty athletes participated, providing monthly fasting blood samples over 11 months. Samples were analyzed using chemiluminescent immunoassays and statistical analyses were conducted using the classical ANOVA method, a linear mixed model and a Bayesian approach.</p><p><strong>Results: </strong>The study observed significant gender differences in biomarker concentrations, with higher BNP and NT-proBNP in females and higher myoglobin and CK-MB in males. Physical activity within 24 h before sampling notably affected CK-MB, myoglobin, and hs-cTnI variability. The BV estimates demonstrated high individuality for most biomarkers, suggesting their potential for personalized monitoring. The study also revealed substantial heterogeneity for NT-proBNP and BNP within the population.</p><p><strong>Conclusions: </strong>These findings underscore the importance of considering gender-specific reference intervals and the impact of recent physical activity when interpreting cardiac biomarkers in athletes. The study delivers new BV estimates for CK-MB and myoglobin while emphasizing the need for tailored clinical assessments in athlete populations.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045418","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The journey to pre-analytical quality.
IF 3.8 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-01-28 DOI: 10.1515/cclm-2025-0057
Mario Plebani
{"title":"The journey to pre-analytical quality.","authors":"Mario Plebani","doi":"10.1515/cclm-2025-0057","DOIUrl":"https://doi.org/10.1515/cclm-2025-0057","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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