Clinical chemistry and laboratory medicine最新文献

{"title":"Impact of delayed centrifugation on the stability of 32 biochemical analytes in blood samples collected in serum gel tubes and stored at room temperature.","authors":"María Sanz-Felisi, Paula Tauler-Quetglas, Teresa Escartín-Díez, Ariadna Arbiol-Roca, Dolors Dot-Bach","doi":"10.1515/cclm-2025-0109","DOIUrl":"https://doi.org/10.1515/cclm-2025-0109","url":null,"abstract":"<p><strong>Objectives: </strong>Evaluate the stability of 32 biochemical analytes in venous blood samples stored at 18-25 °C under different time delays prior to centrifugation.</p><p><strong>Methods: </strong>A prospective study was conducted involving 33 healthy volunteers. Four venous blood samples were collected from each participant. One sample was designated as baseline and processed immediately according to the tube manufacturer's guidelines for centrifugation and analysis. The remaining three samples were stored under predefined conditions and centrifuged at different time intervals before undergoing analysis.</p><p><strong>Results: </strong>Acceptable stability over the maximum storage time of 8 h was observed for 25 of the analytes tested in this study. However, direct bilirubin became unstable at 6 h and triglycerides at 8 h of storage prior to centrifugation. Calcium, gamma-glutamyl transferase, glucose, inorganic phosphate and potassium were found to be unstable in serum after 4 h of delayed centrifugation.</p><p><strong>Conclusions: </strong>A delay in centrifugation of samples affected the stability of several analytes evaluated in the study, resulting in changes in their concentration or integrity. The analytical results for these analytes cannot be considered reliable as they do not meet the standards required for clinical validation. This underscores the importance of following stringent pre-analytical protocols to maintain the accuracy and reliability of laboratory diagnostic results.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143623451","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":"Concordance between the updated Elecsys cerebrospinal fluid immunoassays and amyloid positron emission tomography for Alzheimer's disease assessment: findings from the Apollo study.","authors":"Henrik Schinke, Magnus Förnvik Jonsson, Mayme Gummesson, Rikard Nilsson, Stefanie Gaupp, Ekaterina Manuilova, Silja McIlwrick, Jan-Philipp Weinberger, Sandra Rutz, Margherita Carboni, Erik Stomrud","doi":"10.1515/cclm-2024-1476","DOIUrl":"10.1515/cclm-2024-1476","url":null,"abstract":"<p><strong>Objectives: </strong>The Apollo study was designed to support the clinical performance verification of the adjusted cutoffs of the Elecsys^® β-Amyloid(1-42) (Aβ₄₂) cerebrospinal fluid (CSF) II, β-Amyloid(1-40) (Aβ₄₀) CSF, Phospho-Tau (181P) (pTau) CSF and Total-Tau (tTau) CSF immunoassays (Roche Diagnostics International Ltd) for measuring fresh CSF samples, and assess the concordance of the Elecsys CSF pTau/Aβ₄₂, tTau/Aβ₄₂ and Aβ₄₂/Aβ₄₀ ratios, as well as Aβ₄₂ alone, with amyloid positron emission tomography (PET) visual read status.</p><p><strong>Methods: </strong>The primary study endpoint was to assess the concordance of the Elecsys CSF ratios and Aβ₄₂ alone with amyloid PET visual read status using fresh CSF samples collected from individuals with subjective cognitive decline or mild cognitive impairment, handled with a new routine-use pre-analytical procedure and measured with the Elecsys CSF immunoassays. The sample stability after 1- to 13-week storage at -20 °C was also investigated in an exploratory analysis.</p><p><strong>Results: </strong>Of 108 screened individuals, 91 met the eligibility criteria, of whom 44.0 % were amyloid PET-positive and 56.0 % amyloid PET-negative. Positive percent agreement (PPA) and negative percent agreement, respectively, were 0.800 and 0.882 for pTau/Aβ₄₂, 0.775 and 0.902 for tTau/Aβ₄₂, and 0.950 and 0.824 for Aβ₄₂/Aβ₄₀. For Aβ₄₂, PPA was 0.975 and negative likelihood ratio was 0.039. Overall, 33 samples (36.3 %) were frozen at -20 °C for 1-13 weeks. All concentration recoveries were within 100 ± 10 % when stored at -20 °C for ≤8 weeks.</p><p><strong>Conclusions: </strong>Elecsys CSF ratios and Aβ₄₂ alone may be reliable alternatives to amyloid PET for identifying amyloid positivity in clinical practice.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604207","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":"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":"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":"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":"Patient risk management in laboratory medicine: an international survey to assess the severity of harm associated with erroneous reported results.","authors":"Lucas Peltier, Sophie Van Aelst, Bart Peeters, Jean-Baptiste Raimbourg, John Yundt-Pacheco","doi":"10.1515/cclm-2024-1477","DOIUrl":"https://doi.org/10.1515/cclm-2024-1477","url":null,"abstract":"<p><strong>Objectives: </strong>Patient risk management is an essential subject for clinical laboratory which is now central in main international laboratory quality standards (e.g., ISO 15989:2022; ISO 22367:2020 and CLSI EP23^2nd). Risk analysis is a necessary part of risk management which requires categorizing the severity of patient harm from a laboratory failure. However, this subjective task is not currently the subject of any recommendation and little literature about this topic. To remedy that, we conducted an international survey of medical biology professionals, asking them to rate a panel of 20 analytes the harm potentially induced by an erroneous reported result.</p><p><strong>Methods: </strong>The survey was published by Bio-Rad^® to their customers base and the public with a dedicated webpage. The survey proposes to assign for the submitted analytes the amount of harm among five pre-defined categories of harm: negligible, minor, serious, critical, and catastrophic. Participants were also asked to specify their demographic characteristics.</p><p><strong>Results: </strong>The questionnaires of 267 respondents coming from 43 countries were analyzed to allocate for each analyte a specific harm category. We highlight that almost all parameters (19/20) were categorized with at least a serious harm category and that none were associated with the negligible category.</p><p><strong>Conclusions: </strong>This study constitutes the first international attempt to investigate how the laboratory community thinks about patient harm from an erroneous reported result. These results provide support to document the laboratory risk management policy which must now be centered on patient risk.</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":"143536771","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":"Performance evaluation of large language models with chain-of-thought reasoning ability in clinical laboratory case interpretation.","authors":"He S Yang, Jieli Li, Xin Yi, Fei Wang","doi":"10.1515/cclm-2025-0055","DOIUrl":"https://doi.org/10.1515/cclm-2025-0055","url":null,"abstract":"","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":"143536776","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":"Setting analytical performance specification by simulation (Milan model 1b).","authors":"Hui Qi Low, Andrea Rita Horvath, Tze Ping Loh, Mario Plebani, Chun Yee Lim","doi":"10.1515/cclm-2025-0121","DOIUrl":"https://doi.org/10.1515/cclm-2025-0121","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143432414","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}