Clinical chemistry and laboratory medicine最新文献

{"title":"An automatic chemiluminescence immunoassay for a novel biomarker NT-IGFBP-4: analytical performance and clinical relevance in heart failure.","authors":"Shuzheng Cao, Jing Wang, Ling Li, Yu Wu, Juan Yang, Litao Zhang, Xin Shu, Hui Wang, Yisha Jing, Yi Zhang, Zhenlu Zhang","doi":"10.1515/cclm-2025-0378","DOIUrl":"https://doi.org/10.1515/cclm-2025-0378","url":null,"abstract":"<p><strong>Objectives: </strong>Insulin-like growth factor binding protein-4 (IGFBP-4) fragments are reported as emerging biomarkers for cardiovascular disease (CVD) risk assessment. To ensure data reliability and improve clinical application, the first automatic chemiluminescent immunoassay (CLIA) for NT-IGFBP-4 was developed and its distribution across CVDs was evaluated in this study.</p><p><strong>Methods: </strong>Fragment-specific monoclonal antibodies were used to develop immunoassay, followed by comprehensive analytical validation, including limit of blank (LoB), limit of detection (LoD), limit of quantification (LoQ), linearity, specificity, precision, sample type compatibility, and stability. Reference intervals for NT-IGFBP-4 were established in healthy individuals, with variations analyzed based on gender, age, body mass index (BMI), and renal function. Additionally, NT-IGFBP-4 distribution was explored in CVD patients.</p><p><strong>Results: </strong>The newly developed chemiluminescence assay demonstrated high specificity for NT-IGFBP-4, with excellent sensitivity (LoQ=1.0 ng/mL), broad linearity (1.0-1,000.0 ng/mL), and strong precision (CV≤3.0 %). It showed no interference from common endogenous substances, maintained compatible with various sample types, and remained stable under different storage conditions. Reference intervals showed slight variations by gender and age, with levels being independent of BMI but influenced by renal function. NT-IGFBP-4 levels were significantly elevated in CVDs, especially in heart failure, correlating with NYHA classification and LVEF (%), with higher levels indicating worse cardiac function.</p><p><strong>Conclusions: </strong>The new automatic NT-IGFBP-4 (CLIA) assay offers a highly specific, sensitive and precise method for quantifying IGFBP-4 fragments. Its validated performance and disease association findings would enhance its diagnostic and prognostic potential in CVD research, particularly in heart failure.</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":"144945302","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":"Method comparison of diabetes mellitus associated autoantibodies in serum specimens.","authors":"Alexander Lenard, Andreas Rapp, Steffen Busch, Peter Findeisen","doi":"10.1515/cclm-2025-0137","DOIUrl":"https://doi.org/10.1515/cclm-2025-0137","url":null,"abstract":"<p><strong>Objectives: </strong>Autoantibodies against structure elements of the pancreas are an essential part of laboratory diagnosis of diabetes mellitus. The heterogeneity of current methods and difficult inter-assay comparability of results poses challenges to both clinical interpretation as well as research integrity.</p><p><strong>Methods: </strong>We conducted a method validation study comparing the measurement of autoantibodies against glutamic acid decarboxylase (GADA), islet antigen 2 (IA-2A), and zinc transporter 8 (ZnT8A) on three commercially available platforms (EUROLabWorkstation analyzer, enzyme-linked immunosorbent assay (ELISA); iFlash 1800 (chemiluminescence immunoassay (CLIA); Maglumi 800 (CLIA)).</p><p><strong>Results: </strong>Compared to the results from EUROLabWorkstation analyzer that was routinely used in our laboratory, the Maglumi demonstrated an acceptable agreement and deviation for GADA (75.4-35.8 %) and IA-2A (71.7-50.3 %). The iFlash displayed less favorable results with agreement and deviation for GADA (51.5-108.8 %) and IA-2A (68-32.5 %). While the iFlash showed excellent agreement for ZnT8A, the Maglumi produced almost exclusively negative results below a 200 U/mL threshold which results in severe underestimation of results on the Maglumi. Overall, no consistent agreement was observed across all three parameters among the CLIA devices tested.</p><p><strong>Conclusions: </strong>Our study reveals significant and clinically relevant discrepancies in the detection of GADA and IA-2A when comparing CLIA devices to the ELISA method routinely used in our laboratory. For individual antibodies up to 65 % of patients who tested positive using ELISA showed negative or borderline results on at least one CLIA device. These deviations are unpredictable and cannot be detected through standard calibration and internal control procedures.</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":"144945344","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":"Toxic beauty: acute kidney injury triggered by hair-straightening treatment.","authors":"Oscar D Pons-Belda, Paloma Livianos-Arias-Camison, Santiago Mariño-Lopez, Jorvi J Aguilar-Valero, Cassandra E Puig-Hooper","doi":"10.1515/cclm-2025-0663","DOIUrl":"https://doi.org/10.1515/cclm-2025-0663","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144944893","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":"Improvement in the turnaround time of PTH(1-84) as part of the intraoperative PTH monitoring for parathyroidectomy.","authors":"Beverly Buffart, Dragos Barglazan","doi":"10.1515/cclm-2025-0796","DOIUrl":"https://doi.org/10.1515/cclm-2025-0796","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945367","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":"Multivariate approaches to improve the interpretation of laboratory data.","authors":"Mario Plebani","doi":"10.1515/cclm-2025-1071","DOIUrl":"10.1515/cclm-2025-1071","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945352","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":"Rethinking the use of \"one-way ANOVA\" in CLSI EP15-A3 - a call for terminological precision and methodological clarity.","authors":"Chaochao Ma, Ling Qiu","doi":"10.1515/cclm-2025-1034","DOIUrl":"https://doi.org/10.1515/cclm-2025-1034","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144944960","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":"From assessment to action: experience from a quality improvement initiative integrating indicator evaluation and adverse event analysis in a clinical laboratory.","authors":"Peirong Chen, Xing Chen, Yuanzhi Xia, Xiaoliang Liang, Qiuyi Hong","doi":"10.1515/cclm-2025-0656","DOIUrl":"10.1515/cclm-2025-0656","url":null,"abstract":"<p><strong>Objectives: </strong>ISO 15189:2022 recommends the use of quality indicators (QIs) to monitor laboratory performance and focuses on risk management and continual improvement. This study aims to compare hospital laboratory data with national and international quality specifications and to share experiences in quality improvement and adverse event management.</p><p><strong>Methods: </strong>We evaluated 15 QIs from 2023 by comparing their percentages and sigma levels with those of national benchmarks to identify performance gaps. On the basis of this analysis, a series of data-driven continuous improvement projects were implemented in 2024. Adverse events were closely monitored and corrective actions were taken accordingly. Data from 2023 to 2024 were compared with national and international specifications, and statistical analysis was conducted using R Studio.</p><p><strong>Results: </strong>Excluding internal quality control and interlaboratory comparison indicators, the remaining 13 QIs generally exhibited acceptable performance (σ>3.5). Statistically significant improvements (p<0.05) were observed in seven indicators. Overall, laboratory performance was ranked relatively low at the national level but favourably at the international level. The analysis of 15 adverse events revealed that errors occurred across all testing phases and involved multiple departments.</p><p><strong>Conclusions: </strong>The quality improvement initiatives implemented in 2024 yielded measurable improvements. Effective communication and interdisciplinary collaboration are essential for reducing errors and enhancing laboratory performance.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144882284","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 measurement uncertainty for free drug concentrations using ultrafiltration.","authors":"Raúl Rigo-Bonnin, Virgínia Mas-Bosch, Francesca Canalias","doi":"10.1515/cclm-2025-0736","DOIUrl":"10.1515/cclm-2025-0736","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144882281","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":"Evaluation of measurement uncertainty of 11 serum proteins measured by immunoturbidimetric methods according to ISO/TS 20914: a 1-year laboratory data analysis.","authors":"Emine Feyza Yurt, Medine Alpdemir, Mehmet Şeneş","doi":"10.1515/cclm-2025-0654","DOIUrl":"10.1515/cclm-2025-0654","url":null,"abstract":"<p><strong>Objectives: </strong>Measurement uncertainty (MU) plays an important role in the interpretation of laboratory results, but data on serum proteins analyzed by immunoturbidimetry according to ISO/TS 20914 are limited.</p><p><strong>Methods: </strong>MU of 11 serum proteins, including CRP, RF, ASO, IgG, IgA, IgM, C3, C4, ceruloplasmin, transferrin, and β2-microglobulin, were estimated using 1-year internal quality control (IQC) data obtained from Roche Cobas analyzers. MU was calculated using uncertainty and calibrator uncertainty according to ISO/TS 20914, assuming negligible deviation from external quality assessment data. Analytical performance specification (APS) models were selected according to the EFLM APS selection criteria, and maximum allowable uncertainty (MAU) values were determined based on sources such as EFLM models and literature.</p><p><strong>Results: </strong>IgA and RF were the only two analytes that met the required and minimum MAU values, respectively, at both IQC levels. MU values for CRP, ceruloplasmin, transferrin, and β2-microglobulin exceeded targets at both levels. MU for C3, C4, IgG, and IgM exceeded the minimum MAU at IQC1 but remained acceptable at IQC2. MU values for ASO were calculated as 10.01 and 7.22 % but could not be evaluated due to a lack of reference data. Assay precision should be improved for CRP, IgG, IgM, ceruloplasmin, transferrin, and β2-microglobulin. Use of updated calibration materials for CRP may help reduce MU.</p><p><strong>Conclusions: </strong>Maintaining acceptable precision over a long period remains a challenge for serum proteins analyzed by immunoturbidimetry, highlighting the need for methodological improvements and stricter quality monitoring. In this context, MU assessment is crucial.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144882283","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":"Assessing the harmonization of current total vitamin B12 measurement methods: relevance and implications.","authors":"Bruno Mario Cesana, Simona da Molin, Nuthar Jassam, Julian H Barth, Sabrina Buoro, Martina Tosi, Gianvincenzo Zuccotti, Santica Marcovina, Simona Ferraro","doi":"10.1515/cclm-2025-0939","DOIUrl":"10.1515/cclm-2025-0939","url":null,"abstract":"<p><strong>Objectives: </strong>The UK National Institute for Health and Care Excellence has recommended thresholds for total vitamin B12 (B12) assays with interchangeable results for identifying B12 deficiency. We assessed the agreement between B12 methods, to evaluate whether the thresholds may be assumed applicable to all assays.</p><p><strong>Methods: </strong>A total of 19 External Quality Assessment (EQA) exercises (1791 determinations) based on human subjects-pool materials and 97 serum samples were retrieved to characterize the agreement between Alinity and Architect (Abbott Diagnostics), Access DXi (Beckman Coulter Diagnostics), Atellica and ADVIA Centaur (Siemens Healthcare Solution) compared to Cobas (Roche Diagnostics), considered as comparator because its calibrator traceability to the World Health Organisation (WHO) International Standard (IS) code 03/178. Ordinary least squares and Bland-Altman were used for this purpose.</p><p><strong>Results: </strong>Abbott and Beckman methods overestimated and underestimated, respectively, B12 concentrations vs. Roche and the other methods. We reported similar systematic or proportional error patterns between EQA and serum samples. Only Beckman was affected by both errors. Due to the wide Limit of Agreement Interval, we cannot confidently conclude on the agreement between Roche and the other methods. However, the inter-method bias was well lower than the desirable goal of 9.4 % for Abbott Architect and also lower for Siemens ADVIA Centaur.</p><p><strong>Conclusions: </strong>The recommended thresholds for serum total B12 should not be assumed applicable to all assays, due to the poor agreement among the currently available methods, a limitation that persists despite the release of the WHO IS 03/178.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144882279","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}