Clinical chemistry and laboratory medicine最新文献

{"title":"An isotope dilution-liquid chromatography-tandem mass spectrometry-based candidate reference measurement procedure for the quantification of cortisol in human serum and plasma.","authors":"Myriam Ott, Neeraj Singh, Friederike Bauland, Daniel Köppl, Kerstin Kandler, Alexander Gaudl, Andrea Geistanger, Uta Ceglarek, Manfred Rauh, Christian Geletneky, Judith Taibon","doi":"10.1515/cclm-2024-0879","DOIUrl":"https://doi.org/10.1515/cclm-2024-0879","url":null,"abstract":"<p><strong>Objectives: </strong>Accurate measurement of serum cortisol is crucial for the diagnosis and management of adrenal disorders. Thus, we have developed a novel isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC MS/MS)-based candidate reference measurement procedure (RMP) to quantify cortisol in human serum/plasma, offering higher sensitivity and reliability compared to existing RMPs.</p><p><strong>Methods: </strong>Quantitative Nuclear Magnetic Resonance spectroscopic (qNMR) methodology has been utilized to assign the absolute content (g/g) and SI-traceability to the reference materials. A novel two-dimensional heart-cut liquid chromatography (LC) approach was implemented for the LC-MS/MS, combined with a supported liquid extraction (SLE) sample preparation protocol. A multi-day validation experiment assessed precision and accuracy. Reproducibility was assessed by comparing procedure results between two independent laboratories, and measurement uncertainty (MU) was evaluated in compliance with current guidelines.</p><p><strong>Results: </strong>The established RMP exhibited high sensitivity, with a quantification range of 0.800-600 ng/mL (2.21-1,655 nmol/L), exceeding the ranges of existing JCTLM-listed RMPs. Intermediate precision was ≤2.6 %, and repeatability ranged from 0.9 to 1.9 % across all concentration levels. The relative mean bias ranged from -1.3 to 1.4 % for all matrices and concentration levels. Measurement uncertainties (MU) for cortisol in single measurements were ≤2.8 % regardless of the concentration level and sample type. Using the certified International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference panel, the equivalence between the candidate RMP and the Joint Committee on Traceability in Laboratory Medicine (JCTLM) listed RMPs (NRMeth 57 and NRMeth 8) was assessed, revealing excellent agreement.</p><p><strong>Conclusions: </strong>This RMP allows for highly sensitive and reproducible determination of cortisol. The performance of the RMP facilitates the standardization of routine assays and ensures traceability in the measurement of individual patient samples.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143370395","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}

{"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":"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":"987-994"},"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}

{"title":"The potential role of leukocytes cell population data (CPD) for diagnosing sepsis in adult patients admitted to the intensive care unit.","authors":"Vincenzo Roccaforte, Giovanni Sabbatini, Rossella Panella, Massimo Daves, Paolo Formenti, Miriam Gotti, Andrea Galimberti, Marta Spreafico, Andrea Piccin, Giuseppe Lippi, Angelo Pezzi, Stefano Pastori","doi":"10.1515/cclm-2024-1202","DOIUrl":"10.1515/cclm-2024-1202","url":null,"abstract":"<p><strong>Objectives: </strong>The aim of the study was to evaluate the predictive value of cell population data (CPD) parameters in comparison with procalcitonin (PCT) and C-reactive protein (CRP) for an early diagnosis of sepsis in intensive care unit (ICU). The effect of renal function on CPD, PCT and CRP, in septic and non-septic patients was also investigated.</p><p><strong>Methods: </strong>This is a retrospective, observational and single-center study, performed with data collected from patients consecutively admitted to the ICU of the Edoardo Bassini Hospital in Milan. Patients were divided in septic and non-septic according to Sepsis-III criteria. The control group was formed by critically ill patients without sepsis. Patients with sepsis were further divided in patients with sepsis and patients with septic shock.</p><p><strong>Results: </strong>A significant difference between septic and non-septic patients was found for neutrophils complexity (NE-SSC), neutrophils fluorescence intensity (NE-SFL), width of dispersion of neutrophils fluorescence (NE-WY), monocytes complexity (MO-X), monocytes fluorescence intensity (MO-Y), PCT and CRP parameters. PCT, neutrophils sixe (NE-FSC), NE-WY, width of dispersion of neutrophils size (NE-WZ) and MO-X discriminated sepsis and septic-shock patients. CPD parameters were not influenced by renal function. CPD, PCT and CRP had a heterogeneous diagnostic performance efficiency in the prediction of sepsis. Overall, NE-SSC, NE-SFL, width of dispersion of neutrophils complexity (NE-WX), MO-X, MO-Y, PCT and CRP displayed the best diagnostic performance for sepsis.</p><p><strong>Conclusions: </strong>This study suggested that some CPD parameters (i.e., NE-SFL and MO-X) might provide useful information for diagnosis and management of sepsis.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":"1031-1042"},"PeriodicalIF":3.7,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143032151","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}

{"title":"Beyond test results: the strategic importance of metadata for the integration of AI in laboratory medicine.","authors":"Fabio Del Ben","doi":"10.1515/cclm-2025-0070","DOIUrl":"10.1515/cclm-2025-0070","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":"653-655"},"PeriodicalIF":3.8,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022165","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}

{"title":"Are the benefits of External Quality Assessment (EQA) recognized beyond the echo chamber?","authors":"Finlay MacKenzie","doi":"10.1515/cclm-2025-0020","DOIUrl":"10.1515/cclm-2025-0020","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":"841-843"},"PeriodicalIF":3.7,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142945803","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}

{"title":"Annual meeting of the Royal Belgian Society of Laboratory Medicine (RBSLM): \"A Neurological Journey: Brain Teasers for Laboratory Medicine\".","authors":"","doi":"10.1515/cclm-2024-1434","DOIUrl":"10.1515/cclm-2024-1434","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":"eA99-eA143"},"PeriodicalIF":3.8,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142945802","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}

{"title":"An untargeted metabolomics approach to evaluate enzymatically deconjugated steroids and intact steroid conjugates in urine as diagnostic biomarkers for adrenal tumors.","authors":"Nora Vogg, Eleanor North, Arne Gessner, Felix Fels, Markus R Heinrich, Matthias Kroiss, Max Kurlbaum, Martin Fassnacht, Martin F Fromm","doi":"10.1515/cclm-2024-1337","DOIUrl":"10.1515/cclm-2024-1337","url":null,"abstract":"<p><strong>Objectives: </strong>Urinary steroid profiling after hydrolysis of conjugates is an emerging tool to differentiate aggressive adrenocortical carcinomas (ACC) from benign adrenocortical adenomas (ACA). However, the shortcomings of deconjugation are the lack of standardized and fully validated hydrolysis protocols and the loss of information about the originally conjugated form of the steroids. This study aimed to evaluate the quality of the deconjugation process and investigate novel diagnostic biomarkers in urine without enzymatic hydrolysis.</p><p><strong>Methods: </strong>24 h urine samples from 40 patients with ACC and 40 patients with ACA were analyzed by untargeted metabolomics using liquid chromatography-high-resolution mass spectrometry both unmodified and after hydrolysis with arylsulfatase/glucuronidase from <i>Helix pomatia.</i> Both approaches were compared regarding the differentiation of ACC vs. ACA via ROC analyses and to evaluate the hydrolyzation efficiency of steroid conjugates.</p><p><strong>Results: </strong>Steroid glucuronides were fully deconjugated, while some disulfates and all monosulfates were still largely detectable after enzymatic hydrolysis, suggesting incomplete and variable deconjugation. In unhydrolyzed urine, steroid monosulfates showed the best differentiation between ACC and ACA (highest AUC=0.983 for C₂₁H₃₂O₆S, followed by its isomer and two isomers with the molecular formula C₂₁H₃₂O₇S). Moreover, several disulfates were highly abundant and increased in ACC compared to ACA.</p><p><strong>Conclusions: </strong>This work highlights the limitations of hydrolyzing steroid conjugates before analysis and shows a possible superiority of a direct analysis approach compared to a hydrolysis approach from a methodological point of view and regarding diagnostic accuracy. Several steroid conjugates were found as promising diagnostic biomarkers for differentiation between ACC and ACA.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":"1004-1015"},"PeriodicalIF":3.8,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930037","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}

{"title":"Analytical characteristics and performance of a new hs-cTnI method: a multicenter-study.","authors":"Tommaso Fasano, Antonio Fortunato, Greta Giacomini, Alberto Aimo, Marco Moretti, Valentina Viola, Jacopo Sabbatinelli, Giorgia Farneti, Paolo Maltoni, Rino Biguzzi, Vittorio Sambri, Nadia Di Marco, Andrea Ripoli, Aldo Clerico","doi":"10.1515/cclm-2024-0905","DOIUrl":"10.1515/cclm-2024-0905","url":null,"abstract":"<p><strong>Objectives: </strong>The present multicenter study was designed to evaluate the analytical performance and the 99th percentile value of the reference healthy population i.e., 99th percentile upper reference limit of the MAGLUMI^® CLIA high-sensitivity cardiac troponin I (hs-cTnI) method.</p><p><strong>Methods: </strong>Analytical performances and the 99th percentile URL value of the chemi-luminescent-immuno-assay (CLIA) method were evaluated using validated and standardized experimental protocols. Two cohorts including healthy adult individuals were enrolled. The first one included 989 blood donor volunteers (489 women and 500 men) aged 18-70 years (mean age 43 years, interquartile range 31-54 years). The second population included 47 healthy individuals (31 women and 16 men, mean age 78 years, interquartile range 73-81 years) aged≥71 years.</p><p><strong>Results: </strong>The distributions of hs-cTnI levels in both sexes are highly right-skewed, and men show significantly (p=0.0028) higher biomarker values than women. Moreover, in both sexes the hs-cTnI levels progressively increase after the 55 years. In the multivariate analysis (n=958), hs-cTnI was found to be significantly associated to NT-proBNP (p<0.0001), sex (p<0.0001) and BMI (p=0.0424). The 99th percentile URL values, calculated using the bootstrap method in the total reference heathy population (age≥18 years), were: Females (n=521): 5.93 ng/L (CI 95 % 5.29-8.48), Males (n=516): 9.79 ng/L (CI 95 % 6.37-17.41 ng/L), Total Population (n=1,037): 7.18 ng/L (CI 6.08-12.20 ng/L).</p><p><strong>Conclusions: </strong>The MAGLUMI CLIA method met all the criteria for an hs-cTnI assay recommended by international guidelines. The hs-cTnI values measured with the CLIA method are higher in men compared to women at the same age, and also progressively increase after the age>55 years.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":"821-830"},"PeriodicalIF":3.8,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930047","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}

{"title":"Behind the scenes of EQA – characteristics, capabilities, benefits and assets of external quality assessment (EQA): Part II – EQA cycles","authors":"Christoph Buchta, Rachel Marrington, Barbara De la Salle, Stéphanie Albarède, Tony Badrick, Heidi Berghäll, David Bullock, Wim Coucke, Vincent Delatour, Wolf-Jochen Geilenkeuser, Andrea Griesmacher, Gitte M Henriksen, Jim F Huggett, Peter B Luppa, Jonna Pelanti, Paola Pezzati, Sverre Sandberg, Michael Spannagl, Marc Thelen, Veronica Restelli, Lucy A Perrone","doi":"10.1515/cclm-2024-1290","DOIUrl":"10.1515/cclm-2024-1290","url":null,"abstract":"<p><p>External quality assessment (EQA) cycles are the smallest complete units within EQA programs that laboratories can use to obtain external assessments of their performance. In each cycle, several samples are distributed to the laboratories registered for participation, and ideally, EQA programs not only cover the examination procedures but also the pre- and post-examination procedures. The properties and concentration range of measurands in individual samples are selected with regard to the intended challenge for the participants so that each sample fulfils its purpose. This aims to ensure the most significant possible information gain in every cycle using the lowest possible number of EQA samples and thus, under economically optimal conditions. Participants examine samples and the results are reported to the EQA provider, who compares them with the target values for individual measurands in every sample. The EQA provider assesses the laboratory performance, and finally communicates the assessment results to the participant. The participants evaluate the outcomes of the assessment of their examination results and can draw conclusions in the case of both failing and passing and, if necessary, define improvement measures. After completion, each cycle is evaluated by the provider so that limitations and weaknesses of the EQA program can be identified and appropriate measures taken, or to confirm its continued suitability and appropriateness.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":"859-867"},"PeriodicalIF":3.7,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142926810","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}

{"title":"Behind the scenes of EQA – characteristics, capabilities, benefits and assets of external quality assessment (EQA): Part V – Benefits for stakeholders other than participants","authors":"Christoph Buchta, Barbara De la Salle, Rachel Marrington, Andrés Aburto Almonacid, Stéphanie Albarède, Tony Badrick, David Bullock, Christa M Cobbaert, Wim Coucke, Vincent Delatour, Ana Paula Faria, Wolf-Jochen Geilenkeuser, Andrea Griesmacher, Jim F Huggett, Viktoriia Ianovska, Martin Kammel, Anja Kessler, Günther F Körmöczi, Piet Meijer, Armandina Miranda, Dina Patel, Paola Pezzati, Sverre Sandberg, Harald Schennach, Christian R Schweiger, Karin Schwenoha, Michael Spannagl, Heungsup Sung, Marc Thelen, Cas Weykamp, Heinz Zeichhardt, Veronica Restelli, Lucy A Perrone","doi":"10.1515/cclm-2024-1293","DOIUrl":"10.1515/cclm-2024-1293","url":null,"abstract":"<p><p>External quality assessment (EQA) enhances patient safety through the evaluation of the quality of laboratory-based and point of care testing. Regulatory agencies and accreditation organizations utilize the results and the laboratory's response to them as part of assessing the laboratory's fitness to practice. In addition, where EQA samples are commutable and the assigned value has been determined using reference measurement procedures (RMPs), EQA data contributes to the verification of metrological traceability of assays as part of the post-market surveillance of <i>in vitro</i> diagnostic (IVD) medical devices (IVD-MDs). More broadly, the scientific and medical communities use EQA data to demonstrate that medical laboratory examination procedures are fit for clinical purposes, to evaluate common reference intervals, and inclusion of data in clinical databases. Scientific groups, the IVD industry, reference laboratories and National Metrology Institutes can work with EQA providers to identify measurands, which should urgently be supported by the development of reference materials or methods. The ability of health systems to respond effectively to fast-evolving medical challenges, such as the Coronavirus Disease-19 (COVID-19) pandemic, is reliant on EQA to demonstrate confidence in the performance of new laboratory methods and testing services. EQA providers are uniquely positioned to assess the performance of IVD-MDs in addition to individual laboratories and testing sites. Although the primary focus of EQA providers remains the improvement of the performance of individual laboratories, there are many stakeholders who benefit from EQA performance data.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":"898-915"},"PeriodicalIF":3.7,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142926812","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}