Clinical chemistry and laboratory medicine最新文献

{"title":"A survey on measurement and reporting of total testosterone, sex hormone-binding globulin and free testosterone in clinical laboratories in Europe.","authors":"Nick Narinx, Jennifer Afrakoma Nyamaah, Karel David, Vera Sommers, Joeri Walravens, Tom Fiers, Bruno Lapauw, Brigitte Decallonne, Frank Claessens, Katleen Van Uytfanghe, Jaak Billen, Pieter Vermeersch, Dirk Vanderschueren, Leen Antonio","doi":"10.1515/cclm-2024-1237","DOIUrl":"https://doi.org/10.1515/cclm-2024-1237","url":null,"abstract":"<p><strong>Objectives: </strong>To compare clinical laboratory workflows for the assessment of androgens in men, focusing on total testosterone (T), sex hormone-binding globulin (SHBG) and free T, in clinical laboratories throughout Europe.</p><p><strong>Methods: </strong>An internet-based survey that included questions related to pre-analytical, analytical and post-analytical phases of androgen measurements was distributed between December 2022 and December 2023 by clinical laboratory/chemistry and endocrine societies. A total of 124 unique records from clinical laboratories in 27 European countries were analyzed.</p><p><strong>Results: </strong>Pre-analytical requirements for total T are subject to improvement as less than half of clinical laboratories recommended adequate morning sampling time and/or sampling in a fasting state. Total T was predominantly quantified using enzyme-linked immunoassay (IA) on automated platforms, with only one in four centers using mass spectrometry (MS), while SHBG was exclusively measured by IA. Additionally, free T was used by a majority of clinical laboratories, mainly reported as approximation by calculation of free T (cFT) using the Vermeulen formula. Generally, age-stratification was the preferred means of reporting reference ranges for total T, SHBG and cFT. However, considerate variability was observed in reported lower and upper limits, leading to the necessity of interpreting test results against assay-specific reference ranges, thereby hindering comparability of results between clinical laboratories.</p><p><strong>Conclusions: </strong>Our survey highlights significant inter-laboratory variability for the assessment of androgen status in men, implying non-commutability of clinical test results between different centers. In addition, we observed poor adherence to pre-analytical recommendations. These findings advocate for continued harmonization efforts of measurement procedures for SHBG and total/free T.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604199","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":"Establishing sex- and age-related reference intervals of serum glial fibrillary acid protein measured by the fully automated lumipulse system.","authors":"Luisa Agnello, Caterina Maria Gambino, Anna Maria Ciaccio, Rosaria Vincenza Giglio, Concetta Scazzone, Martina Tamburello, Giuseppina Candore, Giulia Accardi, Anna Aiello, Fabio Del Ben, Marcello Ciaccio","doi":"10.1515/cclm-2025-0093","DOIUrl":"https://doi.org/10.1515/cclm-2025-0093","url":null,"abstract":"<p><strong>Objectives: </strong>To establish the reference intervals (RIs) of serum glial fibrillary acid protein (GFAP) measured by the fully automated Lumipulse system.</p><p><strong>Methods: </strong>The study population consisted of 340 healthy individuals, including 251 blood donors and 89 outpatients, with a median age of 56 years. Serum GFAP levels were measured by the Lumipulse G GFAP assay on the fully automated platform Lumipulse G1200 (FUJIREBIO Inc., Tokyo, Japan). GFAP RIs (2.5th and 97.5th percentiles) were calculated for the overall population and stratified by age and sex groups. For the overall population, males, and females partitions, we employed the nonparametric methods, while for the age-and-sex groups we employed the \"robust\" method, as recommended by CLSI.</p><p><strong>Results: </strong>The RI in the whole population was 10.4-92.0 pg/mL. When considering sex differences, females showed higher levels of serum GFAP than males across all age groups. A positive correlation was observed between age and GFAP (Spearman's rho=0.55, p<0.001). Specifically, the biomarker was stable until 60 years, while individuals aged>60 years demonstrated significantly and considerably higher levels than younger age groups. Additionally, in the 50-60 age group, we observed gender-related differences, with females having increased levels than males.</p><p><strong>Conclusions: </strong>GFAP levels are influenced by both age and sex. Accordingly, we established RIs of serum GFAP, taking into consideration age and sex-related differences.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143584704","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":"Unveiling the power of R: a comprehensive perspective for laboratory medicine data analysis.","authors":"Chaochao Ma, Ling Qiu","doi":"10.1515/cclm-2024-1193","DOIUrl":"https://doi.org/10.1515/cclm-2024-1193","url":null,"abstract":"<p><p>R language has gained traction in laboratory medicine for its statistical power and dynamic tools like RMarkdown and RShiny. However, there is limited literature summarizing R packages and functions tailored for laboratory medicine, making it difficult for clinical laboratory workers to access these tools. Additionally, varying algorithms across R packages can lead to inconsistencies in published reports. This review addresses these challenges by providing an overview of R's evolution and its key features, followed by a summary of statistical methods implemented in R, including platform comparisons, precision verification, factor analysis, and the establishment of reference intervals (RIs). We also highlight the development and validation of predictive models using techniques such as linear and logistic regression, decision trees, random forests, support vector machines, naive Bayes, K-Nearest Neighbors, k-means clustering, and backpropagation neural networks - all implemented in R. To ensure transparency and reproducibility in research, a checklist is provided for authors publishing papers using R for data analysis in laboratory medicine. In the final section, the potential of R in big data analytics is explored, focusing on standardized reporting through RMarkdown and the creation of user-friendly data visualization platforms with RShiny. Moreover, the integration of large language models (LLMs), such as ChatGPT, is discussed for their benefits in enhancing R programming, automating reporting, and offering insights from data analysis, thus improving the efficiency and accuracy of laboratory data analysis.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143596405","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":"Determining the minimum blood volume required for laboratory testing in newborns.","authors":"Janne Cadamuro, Martin Wald, Cornelia Mrazek, Florian Giesriegl, Sylvia Mink, Daniel Weghuber","doi":"10.1515/cclm-2025-0243","DOIUrl":"https://doi.org/10.1515/cclm-2025-0243","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143584618","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":"Isotope dilution-liquid chromatography-tandem mass spectrometry-based candidate reference measurement procedures for the quantification of 24<i>(R)</i>,25-dihydroxyvitamin D2 and 24<i>(R)</i>,25-dihydroxyvitamin D3 in human serum and plasma.","authors":"Kerstin Kandler, Michael Stadlmeier, Neeraj Singh, Friederike Bauland, Andrea Geistanger, Christian Geletneky, Judith Taibon","doi":"10.1515/cclm-2024-1139","DOIUrl":"https://doi.org/10.1515/cclm-2024-1139","url":null,"abstract":"<p><strong>Objectives: </strong>Isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC MS/MS)-based candidate reference measurement procedures (RMPs) for the quantification of 24,25(OH)₂D2 and 24,25(OH)₂D3 in human serum and plasma are presented.</p><p><strong>Methods: </strong>Quantitative nuclear magnetic resonance (qNMR) spectroscopic methodology was utilized to assign absolute content (g/g) and SI-traceability to reference materials used as primary calibrators. For liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis a two-dimensional heart cut LC approach, in combination with a supported liquid extraction protocol, was established to mitigate matrix effects and prevent co-elution of interferences. Selectivity was determined by spiking the internal standards and similar compounds, in human serum. A post-column infusion experiment and comparison of standard line slopes was performed to evaluate matrix effects. Precision and accuracy were assessed via a multi-day validation experiment, utilizing certified secondary reference materials from the National Institute of Standards and Technology (NIST). Measurement uncertainty (MU) was evaluated per the Guide to the Expression of Uncertainty in Measurement (GUM). To demonstrate equivalence with the JCTLM-listed RMP, certified secondary reference materials were utilized. Additionally, a method comparison study was conducted with the 24,25(OH)₂D3 method used by the CDC Vitamin D Reference Laboratory.</p><p><strong>Results: </strong>The RMP allowed quantification of 24,25(OH)2D2 and 24,25(OH)2D3 within the range of 0.150-18.0 ng/mL (0.350-42.0 nmol/L 24,25(OH)₂D2 and 0.360-43.2 nmol/L 24,25(OH)₂D3) without interference from structurally-related compounds and no evidence of matrix effects. Intermediate precision was ≤2.3 % for 24,25(OH)₂D2 and ≤2.9 % for 24,25(OH)₂D3; repeatability was ≤1.4 % for 24,25(OH)₂D2 and ≤2.1 % for 24,25(OH)₂D3, across all concentration levels. The relative mean bias was -4.5 to 2.9 % for 24,25(OH)₂D2, and -3.7 to 3.6 % for 24,25(OH)₂D3. Expanded MU for reference value assignment for 24,25(OH)₂D2 and 24,25(OH)₂D3 for reference value assignment was ≤2.5 %, regardless of concentration level and sample type. Passing-Bablok regression revealed strong agreement between the 24,25(OH)₂D3 results from the candidate RMPs and those provided by the CDC Vitamin D Reference Laboratory.</p><p><strong>Conclusions: </strong>These RMPs permit accurate and reproducible determination of 24,25(OH)₂D2 and 24,25(OH)₂D3. Implementation of these methods supports routine assay standardization and patient sample measurement with confirmed traceability.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556017","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":"Interference of hypertriglyceridemia on total cholesterol assay with the new CHOL2 Abbott method on Architect analyser.","authors":"Mélina Terrasse, Denis Monneret, Laurent Desmurs, Fanny Zhao, Sabine Zaepfel, Mathilde Di Filippo, Régine Cartier, Oriane Marmontel","doi":"10.1515/cclm-2024-1441","DOIUrl":"https://doi.org/10.1515/cclm-2024-1441","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556015","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":"Research on the development of image-based Deep Learning (DL) model for serum quality recognition.","authors":"Dongliang Man, Xiaotao Yang, Wei Du, Hanjia Ye, Yi Shi, Yifu Guan, Shuang Zhang, Ke Yun, Yuan Jiang, Xiaoxu Han, Hong Shang","doi":"10.1515/cclm-2024-1219","DOIUrl":"https://doi.org/10.1515/cclm-2024-1219","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556020","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":"Exploring the extent of post-analytical errors, with a focus on transcription errors - an intervention within the VIPVIZA study.","authors":"Malin Mickelsson, Kim Ekblom, Kristina Stefansson, Anders Själander, Ulf Näslund, Johan Hultdin","doi":"10.1515/cclm-2025-0009","DOIUrl":"https://doi.org/10.1515/cclm-2025-0009","url":null,"abstract":"<p><strong>Objectives: </strong>We examined the magnitude of transcription errors in lipid variables in the VIPVIZA study and assessed whether education among the research personnel reduced the error frequency at follow-up. We also examined how the errors affected the SCORE2 risk prediction algorithm for cardiovascular disease, which includes lipid parameters, as this could lead to an incorrect treatment decision.</p><p><strong>Methods: </strong>The VIPVIZA study includes assessment of lipid parameters, where results for total cholesterol, triglycerides, HDL cholesterol, and calculated LDL cholesterol are transcribed into the research database by research nurses. Transcription errors were identified by recalculating LDL cholesterol, and a difference>0.15 indicated a transcription error in any of the four lipid parameters. To assess the presence of risk category misclassification, we compared the individual's SCORE2 risk category based on incorrect lipid levels to the SCORE2 categories based on the correct lipid levels.</p><p><strong>Results: </strong>The transcription error frequency was 0.55 % in the 2019 VIPVIZA research database and halved after the educational intervention to 0.25 % in 2023. Of the 39 individuals who had a transcription error in total or HDL cholesterol (with the possibility of affecting the SCORE2 risk category based on non-HDL cholesterol), six individuals (15 %) received an incorrect risk category due to the error.</p><p><strong>Conclusions: </strong>Transcription errors persist despite digitalisation improvements. It is essential to minimise transcriptions in fields outside the laboratory environment, as we observed that critical decisions also rely on accurate information such as the SCORE2-risk algorithm, which is dependent on lab results but not necessarily reported by the laboratory.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143530984","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":"External quality assessment of the manual tilt tube technique for prothrombin time testing: a report from the IFCC-SSC/ISTH Working Group on the Standardization of PT/INR.","authors":"Claudia van Rijn, Charmane Abdoel, Shanti Baktawar, Petra Herbel, Anja Jünschke, Michelle Bryant, Steve Kitchen, Erica Scalambrino, Marigrazia Clerici, Anne Stavelin, Piet Meijer, Christa M Cobbaert, Antonius M H P van den Besselaar","doi":"10.1515/cclm-2024-1446","DOIUrl":"https://doi.org/10.1515/cclm-2024-1446","url":null,"abstract":"<p><strong>Objectives: </strong>Detailed technical instructions have been made for harmonization of the prothrombin time (PT) test using the manual tilt tube technique (MTT). The MTT has been proposed as the reference measurement procedure for PT and international normalized ratio (INR). An external quality assessment (EQA) scheme has been developed specifically for calibration laboratories performing the harmonized MTT. Here we report the results of the first 10 surveys of this new EQA scheme and investigate whether there is improvement in performance over time and in comparison with previous studies.</p><p><strong>Methods: </strong>Four deep-frozen plasma samples with different PT levels were dispatched to 4 European laboratories. PT's were determined by eight operators. All operators used the same PT reagent (recombinant human). Various measures of PT variation were defined, i.e. within-operator, within-survey, within-run, between-operator, and between-survey coefficient of variation. Between-operator variation (CV_S) was calculated from the each operator's mean PT.</p><p><strong>Results: </strong>The median within-operator variation of all operators varied from 1.3 to 2.3 %. Some operators improved their performance, others did not. Between-operator CV (CV_S) ranged from 1.0 to 2.2 %. Overall, the between-operator and within-operator variation using the harmonized MTT was lower than in a previously published multicentre calibration study. Overall, the within-operator variation was low and did not change significantly over time.</p><p><strong>Conclusions: </strong>within-operator and between-operator variation of the PT measured with the harmonized MTT were low when compared with previous studies. The results suggest that the average within-operator variation of the eight operators in this study is as low as possible.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143536766","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":"Estimation of the allowable total error of the absolute CD34+ cell count by flow cytometry using data from UK NEQAS exercises 2004-2024.","authors":"Bruno Brando, Liam Whitby, Arianna Gatti, Alison Whitby, Federico Di Credico, Stuart Scott","doi":"10.1515/cclm-2025-0065","DOIUrl":"https://doi.org/10.1515/cclm-2025-0065","url":null,"abstract":"<p><strong>Objectives: </strong>The knowledge of the measurement uncertainty (MU) of a diagnostic laboratory test is essential to keep the reliability of laboratory results under control, is requested by regulatory bodies, and for the clinician to be aware of the grey zone of variability around the reported values. The calculation of the percent allowable total error (%aTE) defines the levels of acceptable and optimal MU for each measurand. The CD34+ hemopoietic precursor cell level in blood, as a flow cytometric measurand, still lacks reliable MU and %aTE indicators.</p><p><strong>Methods: </strong>%aTE of the absolute count of CD34+ cells in stabilized peripheral blood has been evaluated using a UKNEQAS database of 69,294 valid results entries from the Stem Cell Enumeration EQA/PT Programme over the last 20 years. The state-of-the-art (SOTA) desirable performance achievable by 80 % of participants and the optimal performance by the best laboratories were calculated at four levels of absolute CD34+ cell counts, from 0 to 10 to >50 cells/μL.</p><p><strong>Results: </strong>Double platform users displayed worse %aTE as compared to single platform users in both periods, with a general trend to improvement with time. Single platform users in the 2014-2024 decade performed best, with a flat %aTE trend over the years. The SOTA-based %aTE were calculated for each method and every decision-making cell level, showing relatively narrow ranges.</p><p><strong>Conclusions: </strong>Our EQA/PT study with stabilized peripheral blood CD34+ cell suspensions reliably estimated the %aTE of the absolute CD34+ cell count, mostly related to the purely analytical variability and devoid of the preanalytical interferences caused by the decay of fresh samples.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143530983","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}