Clinical chemistry and laboratory medicine最新文献

{"title":"Pre-analytical phase errors constitute the vast majority of errors in clinical laboratory testing.","authors":"Yanchun Lin, Nicholas C Spies, Kimberly Zohner, Diane McCoy, Mark A Zaydman, Christopher W Farnsworth","doi":"10.1515/cclm-2025-0190","DOIUrl":"10.1515/cclm-2025-0190","url":null,"abstract":"<p><strong>Objectives: </strong>Clinical laboratory errors pose a threat to patient safety and previous studies have demonstrated that pre-analytical error is the most common error type. Our study aimed to determine the types and frequency of errors occurring in clinical laboratory testing in contemporary practice.</p><p><strong>Methods: </strong>Errors occurring in a core laboratory between 01/2022 and 05/2023 were recorded retrospectively. Errors were quantified using multiple data-streams including real-time manual technologist intervention, incidence reports filed by hospital staff/physicians, and retrospective assessment using automated reports from the lab information system (LIS). Errors were adjudicated and binned into pre-analytical, analytical, and post-analytical phases. Total test volumes were assessed in the LIS and electronic medical record.</p><p><strong>Results: </strong>There were 37,680,242 billable results reported from approximately 11,000,000 specimens during the study period. In total, 87,317 errors occurred impacting 0.23 % (2,300 ppm) of billable results and approximately 0.79 % (7,900 ppm) of specimens. Among these errors, 85,894 (98.4 %, 984,000 ppm) were in the pre-analytical, 451 (0.5 %, 5,000 ppm) were in the analytical, and 972 (1.1 %, 11,000 ppm) occurred in the post-analytical phase. Hemolysis impacting specimen integrity (60,748/87,317, 69.6 %, 696,000 ppm) was the most common error. When excluding hemolysis, there were 26,569 errors documented (0.06 %, 600 ppm of billable results), among which 94.6 %, 1.7 % (17,000 ppm) and 3.7 % (37,000 ppm) were in the pre-analytical, analytical and post-analytical phase respectively.</p><p><strong>Conclusions: </strong>Observed error rates were consistent with previous studies with pre-analytical errors comprising most errors. High prevalence of pre-analytical errors implies a need for enhanced tools for error detection and mitigation in the pre-analytical phase of testing.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143977582","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":"Comprehensive assessment of medical laboratory performance: a 4D model of quality, economics, velocity, and productivity indicators.","authors":"Pavel S Zubanov, Pavel P Tregub, Arkady S Goldberg, Mikhail A Godkov, Vasily G Akimkin","doi":"10.1515/cclm-2025-0323","DOIUrl":"10.1515/cclm-2025-0323","url":null,"abstract":"<p><p>Laboratory diagnostics play a crucial role in modern medicine and healthcare economics. The effective management of a medical laboratory is based on reliable assessment of indicators characterizing quality of testing, productivity, velocity (speed) and cost-effectiveness. The usual concepts of laboratory management focus on one or two groups of these indicators and exclude a comprehensive assessment of the effectiveness of a medical laboratory. Various guidelines and concepts (ISO, Lean, Six Sigma, etc.) often provide similar approaches but use different terms. This review discusses common options for performance indicators in medical laboratories, as well as practical experience in using these indicators to assess the overall effectiveness of the laboratory and improve medical care for patients. All indicators were divided into four broad groups: quality, economy, velocity, and productivity. Based on these four groups, we describe the new\" four-dimensional model\" for assessment of medical laboratory performance based on different combinations of indicator groups for different types of laboratories.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143980236","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":"Detecting cardiac injury: the next generation of high-sensitivity cardiac troponins improving diagnostic outcomes.","authors":"Giuseppe Lippi, Carl J Lavie, Fabian Sanchis-Gomar","doi":"10.1515/cclm-2025-0418","DOIUrl":"10.1515/cclm-2025-0418","url":null,"abstract":"<p><p>Cardiac injury, encompassing a spectrum of heart muscle damage, requires prompt and accurate diagnosis to improve patient outcomes. Early detection using cardiac biomarkers is vital for timely intervention and reducing mortality. This review highlights the role of high-sensitivity cardiac troponins (hs-cTns) in diagnosing cardiac injury. This article offers an overview of cardiac injury, including its causes, diagnostic challenges, and the evolution of biomarkers, up to the development and commercialization of \"high-sensitivity\" (hs-) cTns. The molecular structure of cardiac isoforms cTnI and cTnT, release kinetics, guidelines incorporation, diagnostic performance, and clinical application will be analyzed. It is concluded that the advent of hs-cTn assays has further expanded diagnostic capabilities by enabling the detection of low-level cTn elevations, which were previously undetectable using conventional methods. This enhanced sensitivity allows earlier identification of even minor cardiac injuries, facilitating prompt intervention and improving patient outcomes. However, this increased sensitivity also introduces interpretive challenges in understanding the nature of cardiac involvement, especially in distinguishing mild cTn elevations that may signify non-ischemic cardiac injury or be associated with other non-cardiac conditions.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143988703","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":"Standardization challenges in antipsychotic drug monitoring: insights from a national survey in Chinese TDM practices.","authors":"Weiyan Zhou, Jie Zeng, Linhui Zhang, Jiangtao Zhang, Yuhang Deng, Qianwen Zhang, Haoyu Deng, Jing Wang, Haijian Zhao, Chuanbao Zhang, Wenxiang Chen, Jie Ma","doi":"10.1515/cclm-2025-0186","DOIUrl":"https://doi.org/10.1515/cclm-2025-0186","url":null,"abstract":"<p><strong>Objectives: </strong>Therapeutic drug monitoring (TDM) is critical for optimizing antipsychotic therapy, yet inter-laboratory comparability in China remains poor. Unstandardized practices risk suboptimal dosing and adverse effects, highlighting the need for standardization. This study evaluated TDM practices for six antipsychotics (olanzapine, clozapine, risperidone, quetiapine, aripiprazole, and paliperidone), focusing on inter-laboratory variability, quality control material suitability, and measurement system differences.</p><p><strong>Methods: </strong>Four processed serum samples (two frozen, two lyophilized) containing the six antipsychotic drugs were distributed to over 100 laboratories. The analyses utilized LC-MS/MS, chemiluminescence immunoassays, and HPLC. Sample homogeneity, stability, matrix effects, and method precision, and accuracy were assessed systematically.</p><p><strong>Results: </strong>Significant inter-laboratory variability occurred for six antipsychotics. Only quetiapine met the external quality assessment (EQA) requirements, with inter-laboratory coefficients of variation (CVs) ranging from 12.08 to 15.23 %. Others, especially olanzapine (CVs: 43.48-45.30 %), had poor precision (CVs>15 %). The study revealed that commercial <i>in vitro</i> diagnostic kits generally provided more consistent results compared to laboratory-developed tests. However, even with commercial kits, some drugs, such as aripiprazole, still showed substantial deviations. Lyophilized samples surpassed frozen ones in stability and EQA suitability, which exhibited comparable matrix effects across most assay systems.</p><p><strong>Conclusions: </strong>Urgent standardization of Chinese TDM practices is needed, including harmonized systems and traceable calibrators. While commercial kits enhance result consistency, further efforts are required to harmonize performance across manufacturers. Lyophilized materials are optimal for EQA due to their stability and ease of transport. These findings offer actionable insights to improve the quality and comparability of antipsychotic TDM in clinical practice.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143969121","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":"Promising protein biomarkers for early gastric cancer: clinical performance of combined detection.","authors":"Weifeng Shen, Hui Zhou, Lanqing Li, Wei Liu, Qinqin Lou, Claire Y Tong, Junshun Gao, Junli Gao, Pingyang Shao","doi":"10.1515/cclm-2024-1510","DOIUrl":"https://doi.org/10.1515/cclm-2024-1510","url":null,"abstract":"<p><strong>Objectives: </strong>In the early stage of gastric cancer (GC), identifying cancer-specific biomarkers is a key step in the disease screening process. This study aims to explore the clinical value of five novel protein biomarkers and their combination (5 MP) for GC early diagnosis.</p><p><strong>Methods: </strong>The candidate biomarkers were mined from TCGA, GTEx, and CPTAC databases. The clinical value of the five biomarkers and 5 MP in the early diagnosis from healthy control, benign gastric disease (BGD), precancerous lesions (PLGC), early GC (EGC), and GC was evaluated by receiver operator characteristic curve (ROC), the area under the curve (AUC), sensitivity, specificity, and accuracy.</p><p><strong>Results: </strong>Five candidate biomarkers, COL10A1, GKN1, GKN2, LIPF, and REG4, were mined from TCGA, GTEx, and CPTAC databases. In the training cohort, the five proteins were confirmed to be differentially expressed in the serum of control, BGD, EGC, and GC. COL10A1 has the highest AUC of a single protein in control vs. EGC (0.857). GKN2 has the highest AUC of a single protein in BGD vs. EGC (0.822). 5 MP has an AUC of 0.890 in Control vs. EGC, and 0.854 in BGD vs. EGC. In the validation cohort, 5 MP has an AUC of 0.834 in PLGC vs. GC, and 0.839 in PLGC vs. EGC.</p><p><strong>Conclusions: </strong>Our findings suggest that COL10A1, GKN1, GKN2, LIPF, and REG4 are useful non-invasive serum biomarkers for GC diagnosis. Combination detection (5 MP) has enhanced early diagnosis of GC and distinguishing between benign and malignant gastric diseases.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143985781","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":"Beyond the Hydrashift assay: the utility of isoelectric focusing for therapeutic antibody and paraprotein detection.","authors":"Rieke Reiter, Christoph Mann, Wolfgang Andreas Nockher","doi":"10.1515/cclm-2025-0352","DOIUrl":"https://doi.org/10.1515/cclm-2025-0352","url":null,"abstract":"<p><strong>Objectives: </strong>In serum immunofixation electrophoresis, therapeutic monoclonal antibodies (tmAbs) can be misinterpreted as paraproteins. Strategies to circumvent these interferences include the use of anti-tmAb antibodies, which led to the development of the Hydrashift assay. However, this assay is exclusively available for the Sebia platform and limited to specific tmAbs, such as daratumumab (DmAb) and isatuximab (ImAb). Furthermore, we observed some cases in which complete shifting of tmAbs by the Hydrashift Assay was questionable. This study aimed to explore isoelectric focusing (IEF) as an alternative, widely applicable method for clinical laboratories.</p><p><strong>Methods: </strong>First, the neutralization capacity of the DmAb and ImAb Hydrashift assay was assessed by testing undiluted tmAb samples. Second, DmAb and ImAb were spiked into paraprotein-containing samples in clinically relevant concentrations and analyzed by the Hydrashift assay and IEF. Presence of unshifted tmAb and identification of tmAb and paraproteins were examined in these samples and routinely collected patient samples.</p><p><strong>Results: </strong>The Hydrashift assay reliably shifted up to 0.5 g/L DmAb and up to 1.5 g/L ImAb. IEF was found to be equally effective as the Hydrashift assay in identifying antibody interferences and detecting paraproteins. Additionally, IEF successfully identified two pseudo-monoclonal gammopathies as oligoclonal and detected other therapeutic antibodies.</p><p><strong>Conclusions: </strong>Insufficient neutralization capacity of the Hydrashift Assay was not observed within the clinically relevant range of investigated tmAb concentrations. IEF offers a simple and flexible alternative to the Hydrashift assay for distinguishing tmAbs from paraproteins. Its advantages include broader applicability to various tmAbs and independency from specific commercial platforms.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976913","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":"IFCC recommendations for internal quality control practice: a missed opportunity.","authors":"Hikmet Can Çubukçu, Marc Thelen, Mario Plebani, Mauro Panteghini","doi":"10.1515/cclm-2025-0486","DOIUrl":"https://doi.org/10.1515/cclm-2025-0486","url":null,"abstract":"<p><p>The IFCC Task Force on Global Lab Quality (TF-GLQ) has recently released a new guidance for internal quality control (IQC) practice through an approach translating the general principles as stated in the ISO 15189:2022 standard to a series of practical recommendations. The paper contains however important inaccuracies and shortcomings that, in our opinion, make it a missed opportunity for providing a updated guidance for laboratory professionals. In particular, four important issues are discussed: a) how to design IQC strategies in the traceability era, b) how to define IQC acceptance limits, c) how to estimate measurement uncertainty using IQC data, and d) how to manage comparability between the results provided by different analyzers in the same laboratory. Our analysis underscores the necessity for a more systematic, updated, and evidence-based approach to produce an IQC recommendation in line with the IFCC tradition.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143984283","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":"Reconciling reference ranges and clinical decision limits: the case of thyroid stimulating hormone.","authors":"Luca Giovanella","doi":"10.1515/cclm-2025-0483","DOIUrl":"https://doi.org/10.1515/cclm-2025-0483","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143983802","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":"Contradictory definitions give rise to demands for a right to unambiguous definitions.","authors":"Christoph Buchta, Svitlana Demyanets, Jesper Johansen, Gunnar Nordin, Young Bae Hansen","doi":"10.1515/cclm-2025-0402","DOIUrl":"https://doi.org/10.1515/cclm-2025-0402","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143981768","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":"Potential coeliac disease in children: a single-center experience.","authors":"Luisa Lonoce, Simona Ferraro, Luca Lalli, Luisa Abbattista, Chiara Hruby, Cristina Cocuccio, Cecilia Mantegazza, Elena Groppali, Fabio Pasotti, Francesca Severino, Gianvincenzo Zuccotti, Elena Pozzi","doi":"10.1515/cclm-2025-0098","DOIUrl":"https://doi.org/10.1515/cclm-2025-0098","url":null,"abstract":"<p><strong>Objectives: </strong>Potential coeliac disease (PCD) is defined by the presence of positive CD-specific autoantibodies with a normal/extremely mildly damaged intestinal mucosa. This study sought to examine the progression of PCD in children maintaining a gluten-containing diet and to identify risk factors associated with the onset of CD. A comparative literature review was conducted to assess the results in the context of existing evidence.</p><p><strong>Methods: </strong>A retrospective cohort study was performed on 67 children diagnosed with PCD between January 2005 and January 2022, with a maximum follow up of 53 months. The associations between baseline clinical characteristics and the development of CD were assessed using hazard ratios (HR).</p><p><strong>Results: </strong>Nineteen percent (19 %) (12/67, cumulative incidence) of PCD children, with a median age of 4.3 years, progressed to CD during a median follow up period of 30 months. A fluctuating trend in tissue transglutaminase IgA (tTG-IgA) levels was observed in 35.8 % (24/67) of the children, while 46.2 % (31/67) showed tTG-IgA negativization. In univariable analysis, the presence of autoimmune disease and one-year increase in age at diagnosis were significantly associated with CD progression [HR=17.7 (95%CI: 3.0-106.8; p=0.0017) and HR=1.3 (95%CI: 1.1-1.5; p=0.0125), respectively].</p><p><strong>Conclusions: </strong>Our study confirms that only a small proportion of PCD children progress to CD. It also highlights that advancing age and the presence of autoimmune disease are the main risk factors for the development of villous atrophy. A better understanding of tTG-IgA trend during follow up could help in the management of PCD children.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143984300","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}