Clinical chemistry and laboratory medicine最新文献

{"title":"Association of Clinical Biochemists in Ireland Annual Conference.","authors":"","doi":"10.1515/cclm-2025-0717","DOIUrl":"https://doi.org/10.1515/cclm-2025-0717","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945285","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 therapeutic monoclonal antibodies with electrophoresis and immunofixation of serum proteins: state of knowledge and systematic review.","authors":"Sacha Pelletier, Laetitia Florent, Philippe Gillery, Jean-Baptiste Oudart","doi":"10.1515/cclm-2025-0678","DOIUrl":"https://doi.org/10.1515/cclm-2025-0678","url":null,"abstract":"<p><strong>Introduction: </strong>The increasing use of therapeutic monoclonal antibodies (t-mAbs) has improved cancer and autoimmune disorder treatment. These therapeutics can interfere with serum protein electrophoresis (SPEP) and immunofixation (IF), potentially leading to the appearance of monoclonal bands that may be misinterpreted as monoclonal gammopathies. Identifying the migration patterns and detection thresholds of t-mAbs is crucial to avoid misinterpretation in clinical laboratories.</p><p><strong>Content: </strong>A systematic review following PRISMA guidelines was conducted using Pubmed and ScienceDirect databases, with algorithm-based searches and double-blind article selection. Data on the matrix used, separation methods and type of interference were collected into an extraction table.</p><p><strong>Summary: </strong>A total of 30 articles were included and 30 t-mAbs were described. 11 t-mAbs migrated at the end of the gamma region, 12 in the mid-gamma region, 5 in the early gamma region, one in the beta-2 globulin region and one in the alpha-2 globulin region. Most t-mAbs were detectable by SPEP and IF at concentrations above 100 mg/L.</p><p><strong>Outlook: </strong>Caution is needed when a new peak appears on SPEP, as it may be mistaken for a monoclonal spike leading to misdiagnosis. Therefore, understanding the migration profiles of these t-mAbs is essential. Different methods are available to remove t-mAbs interference and could be used in daily practice.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945339","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":"Association of Clinical Biochemists in Ireland Annual Conference.","authors":"","doi":"10.1515/cclm-2025-1041","DOIUrl":"https://doi.org/10.1515/cclm-2025-1041","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945282","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":"Failure Mode and Effects Analysis (FMEA) integrating quality indicators for risk assessment of the total testing process in human papillomavirus genotyping testing: a proactive risk analysis model for molecular diagnostics.","authors":"Tingting Li, Yuting He, Yuanhao Chen, Shunwang Cao, Yi Wang, Chunmin Kang, Hongmei Wang, Cheng Zhang, Chang Wen, Peifeng Ke","doi":"10.1515/cclm-2025-0598","DOIUrl":"https://doi.org/10.1515/cclm-2025-0598","url":null,"abstract":"<p><strong>Objectives: </strong>To develop a proactive risk assessment model for human papillomavirus (HPV) genotyping testing by integrating Failure Mode and Effects Analysis (FMEA) with quality indicators (QIs), ensuring compliance with ISO 15189:2022 and improving diagnostic accuracy.</p><p><strong>Methods: </strong>A multidisciplinary team designed and performed detailed FMEA across pre-analytical, analytical, and post-analytical phases of HPV genotyping testing. To improve objectivity, we integrated Sigma metrics into the FMEA framework through a molecular diagnostics-specific model of QIs (MQI). The FMEA model systematically identified testing phases, potential failure modes, their effects, root causes, and existing controls. Risk was quantified using Severity, Occurrence (from 1-year QI data), and Detection scores (1-5 scale). Risk Priority Numbers (RPNs) were calculated (Severity × Occurrence × Detection) to prioritize failure modes, with mandatory interventions implemented for high-risk items (RPN≥40).</p><p><strong>Results: </strong>Five high-risk failure modes (e.g., sample misidentification, data analysis errors) were identified and successfully mitigated to acceptable levels (RPN<40) through process optimization and standardization, achieving RPN reductions of 20-80 %. We established a molecular diagnostics-specific MQI, comprising 14 pre-analytical, 25 analytical, and three post-analytical phase QIs. QI-based risk assessment of 35 evaluable QIs for HPV genotyping testing revealed one high-risk QI (\"Incorrect results due to information system failures\") and three medium-risk QIs, all of which were addressed through corrective actions.</p><p><strong>Conclusions: </strong>This study developed an integrated FMEA-QI model for HPV genotyping testing, establishing both a traditional FMEA framework and a molecular diagnostics-specific MQI. The combined approach improves risk assessment objectivity and enables multidimensional analysis compared to conventional methods.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945380","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 vitamins A and E results truly traceable and clinically useful? A practical and critical inquiry.","authors":"Raúl Rigo-Bonnin, Estel Julià-Quiñones, Anna Escalante-Vilanova, Irene Aliart-Fernández","doi":"10.1515/cclm-2025-0714","DOIUrl":"https://doi.org/10.1515/cclm-2025-0714","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945322","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 serum Golgi protein 73 concentrations.","authors":"Anna Stefanska, Joanna Siodmiak, Katarzyna Bergmann, Łukasz Szternel, Aleksandra Wolska, Aneta Klarkowska, Judyta Koneszko, Magdalena Krintus, Mauro Panteghini","doi":"10.1515/cclm-2025-1029","DOIUrl":"https://doi.org/10.1515/cclm-2025-1029","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945365","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":"Quality assurance using patient split samples: recommendations for primary healthcare laboratories.","authors":"Anne Stavelin, Eva Rønneseth, Anne Lise Fossum, Stein Binder, Camilla Aker, Maria Kim Nguyen, Sverre Sandberg","doi":"10.1515/cclm-2025-0818","DOIUrl":"https://doi.org/10.1515/cclm-2025-0818","url":null,"abstract":"<p><strong>Objectives: </strong>The increasing adoption of point-of-care testing (POCT) in primary healthcare highlights the need for robust quality assurance (QA) procedures to ensure result reliability. The patient split sample approach, i.e. comparing POCT and central laboratory results from the same patient, can be a valuable QA tool, though practical guidance for its implementation remains scarce. This study aimed to develop clear, user-friendly recommendations for non-laboratory personnel in primary healthcare laboratories on when and how to perform such comparisons and to recommend acceptable limits for the compared results.</p><p><strong>Methods: </strong>In 2023, an expert group was established, composed of medical specialists in laboratory medicine, researchers, and laboratory advisors. The recommendations were formulated based on relevant literature, the professional experience of the group members, and Noklus' educational framework for primary care laboratories. Pragmatic acceptability limits were established taking several approaches into account. The draft recommendations were audited among more than 120 Noklus employees and final consensus was reached in 2024.</p><p><strong>Results: </strong>Comparing POCT results with central laboratory results is recommended when: (A) no suitable EQA program exists for a given POCT; (B) appropriate internal quality control materials are lacking or inadequate; or (C) POCT results contradict clinical expectations. Acceptable limits for the compared results were set at 15 or 20 %, depending on the measurand. Results outside these limits should be reviewed using a structured checklist.</p><p><strong>Conclusions: </strong>These are the first published recommendations for using patient split samples in primary healthcare that are designed to be simple and user-friendly for non-laboratory personnel, facilitating widespread adoption.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945292","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":"Age distorts the interpretation of FIB-4.","authors":"Arne Åsberg, Gunhild Garmo Hov, Lena Løfblad","doi":"10.1515/cclm-2025-0615","DOIUrl":"https://doi.org/10.1515/cclm-2025-0615","url":null,"abstract":"<p><strong>Objectives: </strong>To determine whether the diagnostic accuracy of the liver fibrosis marker FIB-4 and the likelihood ratios (LRs) of specific FIB-4 values vary with age.</p><p><strong>Methods: </strong>We used a published dataset of 540 patients diagnosed with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis. Liver biopsy showed no or early fibrosis in 391 patients, and advanced fibrosis in 149. For each group we established the relation between the mean of the natural logarithm of FIB-4 (log(FIB-4)) and age, and the standard deviation (SD) of log(FIB-4) and age. Using a parametric method, we calculated the area under the ROC curve of FIB-4 as a function of the difference in mean values of log(FIB-4) between the two groups, and the ratio of the SDs of log(FIB-4). LRs were calculated as functions of age at 35, 50 and 65 years, using a parametric method.</p><p><strong>Results: </strong>The mean log(FIB-4) increased with age in both groups. The SDs of log(FIB-4) did not change with age. There was a trend towards decreasing diagnostic accuracy with age, but this finding did not reach statistical significance. The area under the ROC curve was 0.73 using a parametric method that accounted for age, and 0.79 using a traditional non-parametric method that did not account for age. The LRs of specific FIB-4 values decreased with age.</p><p><strong>Conclusions: </strong>Age distorts the estimation of both diagnostic accuracy and LRs.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945372","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 innovative immunoassay for accurate aldosterone quantification: overcoming low-level inaccuracy and renal dysfunction-associated interference.","authors":"Kaijuan Wang, Hongying Cong, Zhangwei Gao, Xiaojing Gao, Wei Zhang, Xiaocui Shi, Zhou Zhou","doi":"10.1515/cclm-2025-0743","DOIUrl":"https://doi.org/10.1515/cclm-2025-0743","url":null,"abstract":"<p><strong>Objectives: </strong>Accurate quantification of aldosterone is critical for screening and diagnosing primary aldosteronism (PA). Current competitive chemiluminescence immunoassays (cCLIA) overestimate plasma aldosterone concentration (PAC) compared to liquid chromatography-tandem mass spectrometry (LC-MS/MS). However, LC-MS/MS is technically demanding and time-consuming, limiting its widespread clinical utility. Therefore, a novel two-step sandwich chemiluminescence immunoassay (sCLIA) for accurate quantification of PAC was systematically evaluated.</p><p><strong>Methods: </strong>Precision, trueness, linear range, and maximum dilution factor of the new immunoassay were comprehensively validated. In a multicenter study involving 2,696 samples from seven Chinese centers, PAC measurements were performed in parallel using sCLIA, cCLIA, and LC-MS/MS. The study specifically focused on evaluating the assay's performance at low aldosterone concentrations and in patients with chronic kidney disease (CKD), investigating potential interference from renal impairment by comparing the consistency between immunoassays and LC-MS/MS results across different CKD stages.</p><p><strong>Results: </strong>The sCLIA exhibited excellent analytical performance for PAC measurement, with intra-assay imprecision <4.64 % and bias <5.71 % against certificated reference materials. The assay exhibited a wide reportable range (30-100,000 ng/L) with a limit of quantification at 30 ng/L and dilution capability ≥50-fold. Compared to cCLIA, sCLIA showed superior agreement with LC-MS/MS, particularly at low PAC concentrations (<110 ng/L) and in subjects with reduced renal function (eGFR<60 mL/min/1.73 m²).</p><p><strong>Conclusions: </strong>This novel sCLIA method exhibited excellent analytical performance, combining the practical advantages of immunoassays with LC-MS/MS accuracy, thereby offering an ideal solution for large-scale primary aldosteronism screening in clinical practice.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945289","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":"Validation of a plasma GFAP immunoassay and establishment of age-related reference values: bridging analytical performance and routine implementation.","authors":"Burak Arslan, Ulf Andreasson, Elzbieta Rembeza, Markus Axelsson, Lenka Novakova, Bjørn-Eivind Kirsebom, Tormod Fladby, Anna Dittrich, Silke Kern, Ingmar Skoog, Kaj Blennow, Henrik Zetterberg, Hlin Kvartsberg","doi":"10.1515/cclm-2025-0870","DOIUrl":"https://doi.org/10.1515/cclm-2025-0870","url":null,"abstract":"<p><strong>Objectives: </strong>Glial fibrillary acidic protein (GFAP) is a well-established biomarker of astrocytic activation associated with neurodegenerative diseases, neuroinflammatory disorders, and traumatic brain injury. With increasing interest in blood-based biomarkers, the need for analytically validated assays and reliable reference intervals is critical for routine clinical implementation. This study aimed to analytically validate the MSD S-Plex^® GFAP immunoassay for plasma and to establish age-stratified reference intervals in an apparently healthy population.</p><p><strong>Methods: </strong>This study was conducted in two phases. First, key analytical validation parameters - including repeatability, intermediate precision, measurement range, interferences, and sample stability - were evaluated following Clinical and Laboratory Standards Institute (CLSI) and published protocol guidelines. Second, reference intervals were derived from 579 apparently healthy individuals aged 17-91 years using a right-sided non-parametric percentile method. Age-specific upper reference limits were calculated for three predefined age groups, and a continuous age-dependent centile model was applied.</p><p><strong>Results: </strong>MSD S-Plex^® GFAP assay demonstrated strong analytical performance, with coefficients of variation for repeatability and intermediate precision below 12 %. After accounting for the 1:2 dilution ratio, the validated measurement range was 0.425-1760 ng/L, with all calibration residuals remaining within ±15 %. GFAP concentrations were unaffected by hemolysis (p=0.85) and remained stable for up to 7 days at 4 °C and under frozen storage conditions. Age-stratified upper reference limits for plasma GFAP were established as 38 pg/mL (18-<50 years), 73 pg/mL (≥50-<70 years), and 156 pg/mL (≥70 years). Additionally, sex-related differences were observed after age 50, with females showing higher absolute GFAP levels than males. A strong positive correlation between age and plasma GFAP levels was observed (Spearman's r=0.832, p<0.0001).</p><p><strong>Conclusions: </strong>This study demonstrates the robust analytical performance of the MSD S-Plex^® GFAP assay and establishes age-related reference values for plasma GFAP. These findings support its suitability for routine clinical use and enhance its applicability in the diagnosis and monitoring of central nervous system (CNS) pathologies, such as neurodegenerative diseases, neuroinflammatory disorders, and acute brain injuries, within biomarker-supported clinical algorithms.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144944950","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}