Clinical chemistry and laboratory medicine最新文献

{"title":"Biological variation of serum transthyretin concentrations.","authors":"Anna Stefanska, Joanna Siodmiak, Łukasz Szternel, Katarzyna Bergmann, Aleksandra Wolska, Aneta Klarkowska, Judyta Ostrowska, Magdalena Krintus, Mauro Panteghini","doi":"10.1515/cclm-2025-1227","DOIUrl":"https://doi.org/10.1515/cclm-2025-1227","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145291207","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":"Cross reactivity of endogenous and exogenous 25-hydroxyvitamin D₂ in commercial vitamin D assays; an evaluation using the Dutch external quality assessment scheme.","authors":"Erika Huijser, Judith A P Bons, Annemieke C Heijboer","doi":"10.1515/cclm-2025-0761","DOIUrl":"10.1515/cclm-2025-0761","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145285807","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":"Towards a global framework of entrustable professional activities for undergraduate clinical laboratory interns: a competency-based approach.","authors":"Xiaohui Zhang, Ziyue Qin, Mengxiao Xie, Yuan Mu, Ye Jiang, Hongmei Ding, Ying Chen, Chunlei Zuo, Jing Wei, Ting Wang","doi":"10.1515/cclm-2025-1178","DOIUrl":"https://doi.org/10.1515/cclm-2025-1178","url":null,"abstract":"<p><strong>Objectives: </strong>The aim of this study is to develop a core competency-based EPAs framework for undergraduate interns in the clinical laboratory.</p><p><strong>Methods: </strong>The EPAs framework was developed in three stages: formation of a research team, drafting of an initial EPAs framework, and reviewing EPAs framework. This study employed a literature review and a modified Delphi method to construct EPAs. Furthermore, a preliminary validation of established EPAs framework was conducted among 23 interns and their supervisors.</p><p><strong>Results: </strong>A framework encompassing 10 EPAs was developed, including: occupational exposure and protection, collection of various types of clinical specimens, reception and preprocessing of various types of clinical specimens, basic manual operations for laboratory tests, basic instrument operations for laboratory tests, judgment on the releasability of test reports, notification of critical values, laboratory quality control, interpretation of test reports, communication with clinicians and patients. Experts in the two rounds of Delphi showed high enthusiasm, authority, coordination, and concentration. Scores for each EPA indicator's importance, familiarity, observability, universality, and accuracy were all exceeded 3.5 points, with a coefficient of variation below 0.25. Furthermore, expected confidence levels for each indicator were established at four key internship milestones. In pilot study, significant discrepancy were found between self- and director-assessments across most EPAs (p<0.05), with interns consistently rating themselves higher, particularly in complex tasks.</p><p><strong>Conclusions: </strong>With its robust validity and systematic structure, this EPAs framework provides a scalable model for assessing clinical laboratory interns. It effectively enhances internship competency and promotes global standardization in clinical laboratory education.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145285717","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 of GFAP and UCH-L1 compared to S100B in detecting intracranial injury: influence of age, hemolysis, neurodegenerative diseases, and extracranial fractures in a prospective cohort of over 1,000 patients.","authors":"Antoine Puravet, Vincent Sapin, Jean-Baptiste Bouillon-Minois, Bruno Pereira, Julie Durif, Benjamin Bouthors, Farès Moustafa, Jeannot Schmidt, Damien Bouvier, Charlotte Oris","doi":"10.1515/cclm-2025-1129","DOIUrl":"https://doi.org/10.1515/cclm-2025-1129","url":null,"abstract":"<p><strong>Objectives: </strong>To compare the diagnostic performances of GFAP and UCH-L1 with S100B in detecting intracranial injury, while investigating the impact of confounding factors.</p><p><strong>Methods: </strong>In a large prospective cohort of 1,010 patients with mild traumatic brain injury, we first evaluated the clinical performances of S100B and the GFAP/UCH-L1 combination. To explore the impact of pre-analytical interferences on GFAP and UCH-L1 levels, HIL indices (hemolysis, icterus, lipemia) were measured using the Atellica^® analyzer, and spiking experiments were performed with increasing concentrations of hemolysate, bilirubin, and Intralipid^®. We then assessed the influence of four confounders on biomarker specificity: age over 80 years, hemolysis, neurodegenerative diseases, and extracranial fractures. Finally, we evaluated the ability of the biomarkers to predict clinical outcomes at one month.</p><p><strong>Results: </strong>S100B and the GFAP/UCH-L1 combination showed sensitivities of 96 and 100 %, and specificities of 25 and 27 %, respectively. False positives were significantly associated with age >80 and extracranial fractures for S100B; with age >80 and neurodegenerative diseases for GFAP; and with age >80, hemolysis, and extracranial fractures for UCH-L1. UCH-L1 levels were markedly increased by hemolysis, starting at 400 mg/L of hemoglobin. Age was the only confounding factor to significantly affect specificity. Using age-adjusted thresholds in patients over 80 increased specificity to 30 % for S100B and 33 % for GFAP/UCH-L1. Overall, the biomarkers exhibited limited predictive value and performed poorly for one-month clinical outcomes.</p><p><strong>Conclusions: </strong>S100B and the GFAP/UCH-L1 combination demonstrated very high sensitivities, close to 100 %, with specificities of approximately 30 % for the diagnosis of intracranial lesions. Age-adjusted thresholds improve specificity in older patients, supporting their clinical implementation. This study also provides the first evidence that hemolysis significantly elevates UCH-L1 concentrations from 400 mg/L of hemoglobin.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145249933","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":"Estimated waste generation from 1 million basic metabolic panels: a multisite U.S. study.","authors":"Seema Khattri Bhandari, Kwaku Twum, Erving T Laryea, Yaqing Du, Raeshun T Glover, Rachel G Brackbill, William Butler, Khushbu Patel, Christopher W Farnsworth, Christina C Pierre, Steven W Cotten, Joesph R Wiencek","doi":"10.1515/cclm-2025-1162","DOIUrl":"https://doi.org/10.1515/cclm-2025-1162","url":null,"abstract":"<p><strong>Objectives: </strong>Clinical laboratory operations consume large amounts of electricity and water and generate considerable quantities of solid waste. In this study, we quantified and compared the estimated solid waste produced from performing one million basic metabolic panels (BMPs) across five major high-throughput chemistry analyzer systems commonly used in the United States. Additionally, we estimated the carbon emissions associated with the electricity and water usage of each analyzer to better understand their environmental impact.</p><p><strong>Methods: </strong>Five academic medical centers each using a different clinical chemistry analyzer system, collected their respective annual vendor purchase data (January 2022-December 2022). Consumables including reagent cartridges, packaging boxes, inserts associated with reagents, calibrators, and QC materials were categorized and weighed separately. Solid waste estimates for one million BMPs were calculated based on institutional testing volumes. Water and electricity usage for the analyzer systems was obtained and estimated CO₂ emissions (CO₂e) were determined using standard emission factors and calculators.</p><p><strong>Results: </strong>The study found that performing one million BMPs on wet chemistry analyzer platforms, Abbott, Beckman, Roche and Siemens generated 995 kg, 1,274 kg, 579 kg and 489 kg of solid waste respectively while the dry chemistry Ortho system produced 160,593 kg. The majority of waste across all platforms was plastic. Annualized CO₂e from electricity and water use totaled to 69,665 kg CO₂e.</p><p><strong>Conclusions: </strong>Analysis of BMPs generates substantial amounts of solid waste and CO₂e across major diagnostic platforms. These findings emphasize the urgent need for sustainability strategies in diagnostic laboratories to address their environmental footprint.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145231452","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":"Towards harmonization of autoantibody detection in relation to paraneoplastic neurological syndromes (PNS): a European Survey on laboratory practices.","authors":"Matthijs Oyaert, Marco Schreurs, David Goncalves, Dina Patel, Ravishankar Sargur, Carol Stanley, Monica Probst, Marie-Agnès Durey, Jan Damoiseaux, Carolien Bonroy","doi":"10.1515/cclm-2025-1030","DOIUrl":"https://doi.org/10.1515/cclm-2025-1030","url":null,"abstract":"<p><strong>Objectives: </strong>Detection of paraneoplastic anti-neuronal antibodies (PNS autoantibodies) aids in diagnosing the particular syndrome and guides the search for an underlying tumor. To identify opportunities for harmonization that could enhance diagnostic value, we assessed variability in autoimmune serological testing for PNS across laboratories.</p><p><strong>Methods: </strong>The European Autoimmunity Standardisation Initiative (EASI) developed a questionnaire addressing testing methods, digital tools, interpretation, clinical context, and quality assurance. This was distributed through two external quality assessment (EQA) providers (UK NEQAS and IfQ Lübeck) to clinical labs routinely performing PNS autoantibody assays.</p><p><strong>Results: </strong>Among 139 responding laboratories, 78 % perform both cerebellum indirect immunofluorescence (IIF) and line/dot blot assays on serum and cerebrospinal fluid (76 %). Alignment on sample dilution (61 %) and conjugate type (70 %) is variable. Differences in antigen composition and reporting strategies contribute to variability in line/dot blot testing. Digitization is widespread for line/dot blot data (87 %) but limited for cerebellum IIF (31 %). About 53 % use testing algorithms that vary by sample type and requested antibodies. Internal quality control is performed by 89 % (IIF) and 48 % (line/dot blot), mainly using commercial controls. Nearly half (43 %) participate in multiple EQA programs; 46 % (IIF) and 42 % (line/dot blot) have ISO15189 certification, with 20 % planning certification. Positivity rates are low (<6 % in 73 % of labs), indicating low pre-test probability. While only 46 % restrict testing by discipline, most labs access clinical context (84 %) and interact with clinicians (63 %).</p><p><strong>Conclusions: </strong>Considerable variability exists in PNS autoantibody assay execution, reporting, and quality control. Introducing lab-specific recommendations may harmonize practices and improve diagnostic quality.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145231445","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":"Serum neuron-specific enolase - reference interval in Danish children and the impact of preanalytical factors.","authors":"Jacob Rudjord Therkildsen, Cindy Søndersø Knudsen, Tina Parkner","doi":"10.1515/cclm-2025-0582","DOIUrl":"https://doi.org/10.1515/cclm-2025-0582","url":null,"abstract":"<p><strong>Objectives: </strong>Neuron-specific enolase (NSE) is a clinically relevant biomarker used in the assessment of neuronal damage and in the diagnosis and monitoring of certain cancers. Despite its diagnostic importance, paediatric-specific reference intervals (RIs) for NSE are currently lacking. This study aimed to establish paediatric RIs for NSE in serum and to evaluate the influence of preanalytical factors on NSE measurements.</p><p><strong>Methods: </strong>Residual serum samples from routine allergy testing in 242 Danish children (aged 0.1-17.9 years) were analysed using the Roche Elecsys^® NSE assay on a Cobas platform. Both traditional non-parametric, age-partitioned RIs and continuous RIs derived via quantile regression were established. In addition, we assessed the impact of preanalytical variables, including haemolysis, and evaluated a previously proposed correction method for haemolysed samples within this cohort.</p><p><strong>Results: </strong>Both the non-parametric and continuous approaches yielded consistent RIs, showing an age-dependent decline in serum NSE concentrations irrespective of sex. The traditional age-partitioned RI (95th percentile, one-sided) indicated upper limits of 36.9 μg/L and 32.0 μg/L for the age groups 0-5 and 6-17 years of age, based on samples with haemolysis <10 mg/dL haemoglobin.</p><p><strong>Conclusions: </strong>This study defines age-specific paediatric RIs for serum NSE, demonstrating a physiological decline with age and highlighting higher NSE levels in healthy children compared to adults. Furthermore, within a limited range, a previously proposed simple linear correction method was validated for adjusting NSE values in mildly haemolysed samples using the newly established RIs.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145205776","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":"Post-analytical practices in clinical mass spectrometry laboratories: an international survey across 57 countries.","authors":"Jenny Yeuk-Ki Cheng, Brett C McWhinney, Avis C McWhinney, Danijela Kocic, Damien Gruson, Ronda F Greaves, Chung Shun Ho","doi":"10.1515/cclm-2025-1136","DOIUrl":"https://doi.org/10.1515/cclm-2025-1136","url":null,"abstract":"<p><strong>Objectives: </strong>Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is increasingly used in clinical laboratories due to its high analytical specificity and multiplexing capabilities. While the pre-analytical and analytical phases have seen significant advances in automation, the post-analytical phase remains a bottleneck with limited standardisation. This survey aimed to identify gaps, benchmark practices against guidelines, and inform recommendations for improving consistency and quality in post-analytical data handling.</p><p><strong>Methods: </strong>A descriptive electronic survey with 53 questions was distributed via the IFCC mailing list and collaborating organisations from May to July 2024. Questions covered participant characteristics, post-analytical quality indicators (e.g., chromatograms, calibration curves, ion ratios), quality assurance, and data management. Responses were benchmarked against three LC-MS/MS guidelines.</p><p><strong>Results: </strong>Of 311 initial responses, 203 valid submissions from 57 countries were analysed. Laboratories reported diverse throughput: low (<100 samples/week, n=50), medium (100-2,000 samples/week, n=125), and high (>2,000 samples/week, n=28). Key findings included inconsistent acceptance criteria (e.g., variable ion ratios and signal-to-noise thresholds), reliance on manual data transcription (38 % of laboratories), and continued use of in-house spreadsheets. Practices often deviated from guidelines, with opportunities identified for harmonisation and automation.</p><p><strong>Conclusions: </strong>In collaboration with the clinical mass spectrometry community, the IFCC-ETD developed six key recommendations from this survey to address challenges and enhance consistency, quality, and efficiency in post-analytical data handling.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198566","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":"Expert opinion within the context of the targeted evaluation of Regulation (EU) 2017/746 on <i>in vitro</i> diagnostic medical devices pursuant to Article 111 and Regulation (EU) 2024/1860.","authors":"Michael Vogeser, Monika Brüggemann, Ulrich Sack, Christoph Weinstock, Stefan Zimmermann, Albrecht Stenzinger","doi":"10.1515/cclm-2025-0941","DOIUrl":"https://doi.org/10.1515/cclm-2025-0941","url":null,"abstract":"<p><p>EU laws are usually evaluated after 10 years; in the case of the IVDR, the targeted evaluation was brought forward and stakeholders in laboratory diagnostics were invited to comment. The Association of the Scientific Medical Societies in Germany (AWMF; Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e.V.), recognises a relevant need to amend the IVDR with regard to <i>in-vitro</i>-diagnostic medical devices that are manufactured and used in healthcare facilities but are not placed on the EU market. Inadequate overregulation is recognised and should be corrected as part of the generally required reduction of bureaucracy.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145191475","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":"Requiem for the Passing-Bablok nonparametric regression in assessing the agreement between two measurement methods.","authors":"Bruno Mario Cesana, Paolo Antonelli","doi":"10.1515/cclm-2025-0581","DOIUrl":"https://doi.org/10.1515/cclm-2025-0581","url":null,"abstract":"<p><strong>Objectives: </strong>Regulatory guidelines recommend non-parametric Passing-Bablok regression for evaluating the agreement between two measurement methods in laboratory settings. However, concluding for the agreement if the 95 % CI of the slope and of the intercept include 1 and 0, respectively is incorrect since the agreement assessment must focus on a null hypothesis of not equivalence and an alternative hypothesis of equivalence.</p><p><strong>Methods: </strong>We exhaustively simulated appropriate structural models with several values of slope, intercept and measurement error by keeping equal variances and means of the two methods. We calculated the slope and intercept bias of four regressions: non-parametric Passing-Bablok, Theil, Ordinary Least Squares and Deming. In addition, we calculated the percentages of the agreement according to the not shareable Passing-Bablok suggestion. Furthermore, we calculated the percentages of the 95 % CI of the slope and of the intercept included within sensible equivalence thresholds for assessing the agreement.</p><p><strong>Results: </strong>Passing-Bablok procedure gives unbiased estimates, a little more and less biased than those from Deming's regression. The percentages of rejecting the hypothesis of no-agreement, according to the wrong Passing-Bablok's approach are correctly near to 0.05 Type I error under the agreement and also for 0.990≤slopes≤1.005. However, they are too low for slopes >1.05 and <0.950.</p><p><strong>Conclusions: </strong>The Passing-Bablok 95 % CIs are too wide for being included in sensible agreement thresholds according to a population equivalence model and, finally, this approach cannot be considered under the best agreement model of the individual equivalence.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145181874","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}