Clinical chemistry and laboratory medicine最新文献

{"title":"Pre-analytical and analytical validation of calcitonin measurement in fine needle aspiration cytology washout.","authors":"Amber Mater, Annemieke C Heijboer, Anita Boelen, Pim de Graaf, Koen M A Dreijerink, Jacquelien J Hillebrand","doi":"10.1515/cclm-2026-1057","DOIUrl":"https://doi.org/10.1515/cclm-2026-1057","url":null,"abstract":"<p><strong>Objectives: </strong>Current guidelines advise calcitonin measurements in washout from fine needle aspiration cytology (FNAC) upon inconclusive cytological examination of medullary thyroid cancer (MTC). (Pre-)analytical validation studies of calcitonin measurements in FNAC washout are however missing. In this study, we examined (pre-)analytical aspects of calcitonin measurements using three washout solvents, aiming to provide insights for implementation of calcitonin measurements in FNAC washout as a supplementary test for diagnosing and monitoring patients with MTC.</p><p><strong>Methods: </strong>Validation studies were performed using CytoLyt, NaCl and MultiDiluent as washout solvents. Precision (intra- and inter-assay coefficients of variation (CV)), accuracy (linearity and recovery) and storage stability of each solvent were assessed after spiking with calcitonin standard. Calcitonin measurements were performed using the serum CALCT immunoassay (Siemens, Atellica). Decision criteria were set based on CLSI and manufacturer's manual.</p><p><strong>Results: </strong>Measurements of calcitonin in MultiDiluent met all decision criteria: intra- and inter-assay CVs were ≤5.5 % and ≤9 %, serial dilutions were linear (R²=0.997) and median recovery was 148 % with limited variation. Furthermore, calcitonin concentrations remained stable (<10 % change) after storage. Measurements in CytoLyt were precise and accurate, but unstable upon storage. Measurements in NaCl only met the criteria for intra-assay CV and linearity.</p><p><strong>Conclusions: </strong>This study showed that MultiDiluent was the optimal solvent to use for calcitonin measurements in a non-serum matrix using the Atellica calcitonin immunoassay. CytoLyt performed suboptimal, while the performance of NaCl was poor. Further research is needed to validate the recommended work-up using patient-derived material.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148918830","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":"Stoichiometric calibration of ceruloplasmin activity with copper enables molar quantification and has implications for the estimation of non-ceruloplasmin-bound copper.","authors":"Alexandra M Kane, Kurt T K Giuliani, Melanie Coogan, Linda Sanders, Richard G Ruddell, Matthew Burke, Carel J Pretorius, Jacobus P J Ungerer","doi":"10.1515/cclm-2026-0510","DOIUrl":"https://doi.org/10.1515/cclm-2026-0510","url":null,"abstract":"<p><strong>Objectives: </strong>Ceruloplasmin (Cp) and non-ceruloplasmin-bound copper (NCC) are measured when evaluating liver disease and disorders of copper (Cu) metabolism. Cp mass concentration is typically determined by immunoassays that detect both apo- and holoceruloplasmin. In contrast, enzymatic assays measure Cp ferroxidase activity and are therefore specific for holoceruloplasmin. Their clinical use has been limited by the absence of a method to convert enzyme activity to molar Cp concentration and to estimate NCC.</p><p><strong>Methods: </strong>Cp ferroxidase activity and serum Cu concentrations were measured in a training dataset (n=924) to define their linear relationship and derive a conversion factor based on the stoichiometry of six Cu atoms per Cp molecule. This factor was applied to an independent validation cohort (n=12,635). Cp activity, Cp mass concentration, and serum Cu were compared, and reference intervals for Cp activity and NCC were established.</p><p><strong>Results: </strong>The calibration of Cp activity assay against Cu concentration yielded a conversion factor of 0.0030 for expressing Cp activity in molar units. Reference intervals for Cp activity were 1.5-3.7 μmol/L in males and 1.6-4.3 μmol/L in females. Comparison with nephelometric Cp measurements demonstrated a positive bias and evidence of analytical interference in a subset of samples.</p><p><strong>Conclusions: </strong>We describe a method to convert Cp ferroxidase activity to molar concentration and demonstrate its application in a large clinical cohort. This approach enables estimation of NCC, although with considerable uncertainty, and establishment of reference intervals using activity-based measurements. Measurement of Cp by enzymatic activity provides a cost-effective and analytically robust alternative to immunoassays, with advantages in specificity.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148929098","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":"Formula-dependent LDL-C threshold classification and reporting uncertainty in the UK Biobank.","authors":"Bohao Xue, Teng Ma, Cheng Shen, Xin Pan, Yichen Ling, Liangyu Chu, Wenting Yan, Ningjian Wang, Jin Li, Dachun Xu","doi":"10.1515/cclm-2026-0687","DOIUrl":"https://doi.org/10.1515/cclm-2026-0687","url":null,"abstract":"<p><strong>Objectives: </strong>Calculated low-density lipoprotein cholesterol (LDL-C) is widely reported, but formula-dependent estimation differences may alter classification near decision thresholds. We assessed formula-dependent LDL-C classification relative to direct LDL-C in UK Biobank and examined cardiovascular outcomes descriptively.</p><p><strong>Methods: </strong>We analyzed 397,490 participants after quality-control exclusions and exclusion of those with missing direct LDL-C or triglycerides ≥4.52 mmol/L (≥400 mg/dL). Friedewald, Sampson-NIH, and Martin-Hopkins estimates were compared with the UK Biobank direct LDL-C comparator at a 2.60 mmol/L (100 mg/dL) method-comparison threshold. Analyses assessed threshold discordance, triglyceride strata, apolipoprotein B (apoB)/non-high-density lipoprotein cholesterol (non-HDL-C) phenotypes, threshold-window sensitivity analyses, and narrower atherosclerotic cardiovascular disease (ASCVD) endpoints.</p><p><strong>Results: </strong>Total threshold discordance was 5.96 % for Friedewald, 3.91 % for Sampson-NIH, and 3.23 % for Martin-Hopkins. Discordance increased with triglycerides. At 2.26-4.51 mmol/L (200-399 mg/dL), Friedewald had the largest negative calculated-minus-comparator difference and discordant low frequency (median difference -0.379 mmol/L; 12.9 %), whereas Martin-Hopkins had smaller differences (median -0.119 mmol/L; 4.3 %). Broad cardiovascular composite and narrower ASCVD endpoint models did not support binary threshold discordance as a stable adverse prognostic marker. Discordant low participants had higher triglycerides, body mass index (BMI), diabetes prevalence, and cholesterol-lowering medication use, but lower apoB and non-HDL-C.</p><p><strong>Conclusions: </strong>LDL-C formula selection affected classification, especially in triglyceride-rich samples near 2.60 mmol/L (100 mg/dL). Calculated LDL-C may warrant interpretation as an estimate with formula-related uncertainty near decision thresholds; non-HDL-C and, where available, apoB may provide complementary information.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148929177","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":"DIN SPEC 91532: a process-oriented framework for quality assurance in clinical mass spectrometry.","authors":"Michael Vogeser, Katharina M Rentsch, Peter Findeisen, Katharina Habler","doi":"10.1515/cclm-2026-0882","DOIUrl":"https://doi.org/10.1515/cclm-2026-0882","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148911052","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":"Cardiac troponin in pediatric cardiology: toward standardized interpretive frameworks and clinical decision limits.","authors":"Aldo Clerico, Martina Zaninotto, Mario Plebani","doi":"10.1515/cclm-2026-1248","DOIUrl":"https://doi.org/10.1515/cclm-2026-1248","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148911065","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 comparative evaluation of p-tau217 stability in serum and plasma using two validated assays.","authors":"Arthur Guthknecht, Petra Steinacker, Samir Abu-Rumeileh, Markus Otto","doi":"10.1515/cclm-2026-1243","DOIUrl":"https://doi.org/10.1515/cclm-2026-1243","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148911060","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":"Navigating the futures of laboratory medicine.","authors":"Mario Plebani, Elvar Theodorsson","doi":"10.1515/cclm-2026-1468","DOIUrl":"https://doi.org/10.1515/cclm-2026-1468","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148905182","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":"Impact of point of care testing in time to treatment decision-making in emergency departments: a systematic review.","authors":"Valentina Pecoraro, Giuseppe Banfi, Tommaso Trenti, Tommaso Fasano","doi":"10.1515/cclm-2026-0604","DOIUrl":"https://doi.org/10.1515/cclm-2026-0604","url":null,"abstract":"<p><p>The main characteristic of point-of-care testing (PoCT) is to provide rapid test results. It remains uncertain whether faster PoCT results truly improve patient management in the emergency department (ED), and how robust the supporting evidence is. This systematic review aimed to summarize the impact of PoCT in ED on time to clinical decision-making and major clinical outcomes (ED LOS, TAT, mortality, hospitalization, discharge, readmission or antibiotic administration). We searched PubMed, Embase and CENTRAL to identify studies evaluating PoCT in ED. The primary outcomes were the time to decision making and reduction in ED length of stay (LOS). We included 55 studies (approximately 142,000 subjects) evaluating molecular test for virus (n=19) or bacteria (n=2) detection, gastrointestinal infection (n=1), biochemical panel (n=12), troponin (n=9), C-reactive protein (n=2), lactate (n=3), human chorionic gonadotropin (HCG, n=2), d-dimer (n=1), monocyte distribution width (MDW, n=1), blood culture (n=1) and urinary tract infection (n=1) tests. Overall, the use PoCT reduced time to decision-making (ranged from -73 min to -96 min) and ED-LOS (MD -29.24 min 95 % CI from -46.11 to -12.38 min) compared to central laboratory testing. No significant differences were observed for major clinical outcomes. Although substantial statistical heterogeneity was identified, PoCT appears to guide faster clinical decision-making without any detrimental effects on clinical outcomes compared to standard laboratory testing. Future research should better define context dependent applications of PoCT translating faster results into meaningful changes in patient pathways and healthcare processes.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148911090","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":"Response to \"Quantifying M proteins: an analytical challenge beyond interference\".","authors":"Shanshan Liang, Wei Gan","doi":"10.1515/cclm-2026-1419","DOIUrl":"https://doi.org/10.1515/cclm-2026-1419","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148905143","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":"AWMF Position Statement on the Revision of the EU's New Legislative Framework regarding the accreditation of medical laboratories.","authors":"Michael Vogeser, Monika Brüggemann, Ulrich Sack, Christoph Weinstock, Stefan Zimmermann, Albrecht Stenzinger","doi":"10.1515/cclm-2026-0986","DOIUrl":"https://doi.org/10.1515/cclm-2026-0986","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148905146","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}