Clinical chemistry and laboratory medicine最新文献_第7页

Vancomycin assay interference: low-level IgM paraprotein disrupts Siemens Atellica^® CH VANC assay. 万古霉素检测干扰：低水平IgM副蛋白干扰西门子Atellica®CH VANC检测。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-04-16 DOI: 10.1515/cclm-2025-0251

Stijn De Koninck, Sofie Dhaese, Katelijne Floré, Timothy Vanwynsberghe, Martine Vercammen, Veronique Stove, Louis Nevejan

引用次数: 0

Digital metrology in laboratory medicine: a call for bringing order to chaos to facilitate precision diagnostics. 检验医学中的数字计量：呼吁消除混乱，促进精确诊断。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-04-16 DOI: 10.1515/cclm-2025-0152

Madeleen Bosma, Christa Cobbaert

{"title":"Digital metrology in laboratory medicine: a call for bringing order to chaos to facilitate precision diagnostics.","authors":"Madeleen Bosma, Christa Cobbaert","doi":"10.1515/cclm-2025-0152","DOIUrl":"https://doi.org/10.1515/cclm-2025-0152","url":null,"abstract":"Laboratory medicine is faced with rapid developments in data exchange, secondary use of data and artificial intelligence. Safe exchange of laboratory data requires a suitable terminology standard. NPU, LOINC and SNOMED CT are increasingly used for this purpose, but none of these terminology standards can currently accommodate safe exchange across the full spectrum of conventional laboratory data. Furthermore, rapid technological advances in, amongst others, the 'omics' area will enforce a shift towards precision diagnostics. These emerging technologies demand an appropriate and future-proof terminology standard. Given the current and future challenges in laboratory terminologies, we here present a concept for digital metrology in laboratory medicine. Terminology standards used in laboratory medicine should be adjusted to the current state of science to allow safe data exchange and interpretation. Essential test information entails the full spectrum of pre-pre-analysis to post-post-analysis. Major improvements needed include sufficient coding detail for the molecular form of the measurand and information on metrological traceability. Furthermore, especially given the advances in precision diagnostics, it will become essential to indicate interrelationships between measurands. Herefore, integration with established taxonomies would allow improved identification of interrelationships between measurands and linkage with scientific information for multidisciplinary data science. Hence, laboratory data can further gain in specificity and value. The time has come to lay the basis for safe data exchange in the era of precision diagnostics, with a global focus. A consensus for digital metrology in laboratory medicine will be essential to move forward with health data exchange within Europe and beyond.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143968310","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}

引用次数: 0

Assessment of serum free light chain measurements in a large Chinese chronic kidney disease cohort: a multicenter real-world study. 中国慢性肾脏疾病队列中血清游离轻链测量的评估：一项多中心真实世界研究

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-04-14 DOI: 10.1515/cclm-2024-1226

Xia Luo, Xiaomeng Zhang, Xu Yuan, Pan Zhao, Wenqian Zhang, Lingyan Deng, Liming Cheng

{"title":"Assessment of serum free light chain measurements in a large Chinese chronic kidney disease cohort: a multicenter real-world study.","authors":"Xia Luo, Xiaomeng Zhang, Xu Yuan, Pan Zhao, Wenqian Zhang, Lingyan Deng, Liming Cheng","doi":"10.1515/cclm-2024-1226","DOIUrl":"https://doi.org/10.1515/cclm-2024-1226","url":null,"abstract":"Objectives: Diagnosing monoclonal gammopathy in chronic kidney disease (CKD) patients is challenging due to the complex interpretation of serum free light chain (FLC) levels. This study aimed to assess the FLC levels in a large cohort of Chinese CKD patients.Methods: We enrolled 5,287 patients with all-cause nondialysis CKD from three medical centers between February 2018 and April 2023. Central 95 % reference ranges were established using data from one center and validated in an independent subpopulation from the other two centers. The crude prevalence of light chain monoclonal gammopathy of undetermined significance (LC-MGUS) was assessed against established norms for the entire cohort and subgroups based on estimated glomerular filtration rate (eGFR).Results: A notable proportion of patients exceeded the standard reference limits for kappa (89.0 %), lambda (72.1 %), and FLC ratio (10.5 %), whereas non-eGFR-based renal reference interval identified only 0.3 % with abnormal FLC ratios. The iStopMM reference ranges showed higher out-of-range rates for absolute FLC levels in patients with preserved kidney function and lower rates in those with impaired kidney function, while the FLC ratio references remained robust across all groups. The crude prevalence of LC-MGUS was 10.4 % using standard ranges, predominantly kappa LC-MGUS (99.8 %). This prevalence decreased to 0.3 % with non-eGFR-based renal reference interval and 0.5 % with the iStopMM ranges. Using the newly established reference ranges, the crude prevalence was found to be 0.9 %.Conclusions: Our findings suggest that current FLC reference ranges are inadequate for the Chinese population, underscoring the need for eGFR-based reference ranges tailored to this demographic.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976879","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}

引用次数: 0

Defining dried blood spot diameter: implications for measurement and specimen rejection rates. 定义干血斑直径：对测量和标本拒绝率的影响。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-04-14 DOI: 10.1515/cclm-2025-0183

Nick Flynn, Stuart J Moat

{"title":"Defining dried blood spot diameter: implications for measurement and specimen rejection rates.","authors":"Nick Flynn, Stuart J Moat","doi":"10.1515/cclm-2025-0183","DOIUrl":"https://doi.org/10.1515/cclm-2025-0183","url":null,"abstract":"Objectives: Dried blood spot (DBS) specimen acceptance guidelines recommend rejecting specimens based on DBS size, often expressed as a diameter. Computer vision methods can estimate DBS size from images obtained from standalone equipment, smartphone cameras or existing laboratory instrumentation. However, no consensus definition of DBS diameter exists. We assessed how different DBS diameter definitions affect measurement and specimen rejection rates.Methods: We compared computer vision estimates of DBS diameter on 1,991 DBS using two different calculation methods and on 22 DBS where paired images were taken from either side of the filter paper. We modelled the impact on specimen rejection rate in >163,000 DBS specimens.Results: Two different calculation methods for DBS diameter showed a mean difference <0.1 mm for circular DBS. Greater variability was observed for incorrectly applied DBS with a mean (standard deviation) difference of 0.29 (0.41) mm. DBS diameter measured from the front of the filter paper was approximately 0.41 (0.25) mm larger than from the back of the filter paper. Changing the DBS diameter definition could more than double the number of insufficient DBS (<8 mm), potentially leading to 4,000 additional repeat collections annually in the UK newborn screening programme.Conclusions: DBS diameter definition can have a small but important and easily avoidable impact on measurement, impacting specimen rejection rates. We recommend that DBS diameter is defined as the diameter of a circle with equal area to the DBS, when measured from the opposite side of the filter paper to blood application.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976098","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}

引用次数: 0

Cascading referencing of terms and definitions. 术语和定义的级联引用。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-04-11 DOI: 10.1515/cclm-2025-0144

Christoph Buchta, Wolfgang Huf, Tony Badrick

引用次数: 0

Supporting prioritization efforts of higher-order reference providers using evidence from the Joint Committee for Traceability in Laboratory Medicine database. 使用来自实验室医学数据库可追溯性联合委员会的证据，支持高阶参考提供者的优先级工作。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-04-11 DOI: 10.1515/cclm-2025-0401

Mauro Panteghini, Robert Wielgosz

{"title":"Supporting prioritization efforts of higher-order reference providers using evidence from the Joint Committee for Traceability in Laboratory Medicine database.","authors":"Mauro Panteghini, Robert Wielgosz","doi":"10.1515/cclm-2025-0401","DOIUrl":"https://doi.org/10.1515/cclm-2025-0401","url":null,"abstract":"The Joint Committee for Traceability in Laboratory Medicine (JCTLM) database represents a valuable resource for implementing metrological traceability in laboratory medicine. Three main database users can be identified: (a) in vitro diagnostic (IVD) manufacturers, using the database information for meeting ISO 17511:2020 requirements, (b) laboratory professionals, for defining the quality of their test results, and (c) providers of higher-order certified reference materials (CRM) and reference measurement procedures (RMP), to be helped in improving the suitability of their products, if needed, and assistance with prioritizing their future efforts. In this report, we focus on the utility of the information provided (or still not provided) by the JCTLM database on this last category of users. Two types of information are discussed: (a) the use of listed CRMs as common calibrators intended to transfer trueness from the top of the calibration hierarchy to commercial IVD calibrators, and (b) the measurement uncertainty (MU) of CRM certified values and the reproducibility characteristics of RMP measurements, considering their impact on the MU of clinical samples, when compared to maximum allowable MU (MAU). The discussion output is a recommendation for suppliers to respond urgently to the need to provide higher-order references (CRMs and/or RMPs) for a number of key analytes that are currently lacking or do not yet fully meet quality criteria related to: (a) commutability assessment, (b) contribution to MAU fulfilment, and (c) demonstration of the extent of equivalence to an already listed higher-order reference.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143983824","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}

引用次数: 0

Dr. Morley Donald Hollenberg. An extraordinary scientist, teacher and mentor. 莫雷·唐纳德·霍伦伯格博士。一位杰出的科学家、老师和导师。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-04-11 DOI: 10.1515/cclm-2025-0405

Katerina Oikonomopoulou, Eleftherios P Diamandis

引用次数: 0

Clostebol detection after transdermal and transmucosal contact. A systematic review. 经皮及经黏膜接触后的大便检测。系统回顾。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-04-11 DOI: 10.1515/cclm-2025-0331

Vincenzo Giannicola Menditto, Giulia Rossetti, Alessia Ferrarini, Angela Peghetti, Maria Domenica Camerlingo, Giovanni Pomponio

{"title":"Clostebol detection after transdermal and transmucosal contact. A systematic review.","authors":"Vincenzo Giannicola Menditto, Giulia Rossetti, Alessia Ferrarini, Angela Peghetti, Maria Domenica Camerlingo, Giovanni Pomponio","doi":"10.1515/cclm-2025-0331","DOIUrl":"https://doi.org/10.1515/cclm-2025-0331","url":null,"abstract":"Introduction: To analyze the available evidence about the correlation between the presence of detectable amounts of clostebol metabolites in urine and the transdermal or transmucosal contact of clostebol.Content: A systematic review was performed. A systematic search was conducted in PubMed/MEDLINE, Scopus, Web of Science and the Cochrane library databases. Criteria for including studies were clinical studies reporting: (i) adult subjects; (ii) detection of urine clostebol metabolites derived from transdermal or transmucosal contact of clostebol.Summary: Seven papers pertinent to our questions were found: 3 case reports, one experimental study and 3 case reports with an experimental section for a total of 32 subjects. The median concentration of urine clostebol's metabolite 4-chloro-androst-4-en-3α-ol-17-one, M1 was 0.5 ng/mL (range 0.086-4.000 ng/mL; 25%-75 % IQ: 0.5-0.9 ng/mL) and 8.1 ng/mL (range 1.0-36.6 ng/mL; 25%-75 % IQ: 2.8-22.0 ng/mL), in subjects with indirect and direct exposure of clostebol, respectively (p=0.005).Outlook: We found consistent data that the detection of M1 in urine can be reconcilable with a transdermal or transmucosal contact of clostebol. In the cases of indirect exposure, the urine concentrations of M1 seem to be far lower than the concentrations found in case of direct exposure.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143977145","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}

引用次数: 0

Cell population data for early detection of sepsis in patients with suspected infection in the emergency department. 急诊科疑似感染患者脓毒症早期检测的细胞群数据

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-04-11 DOI: 10.1515/cclm-2025-0180

Marta Cancella De Abreu, Caren Brumpt, Timothé Sala, Nathalie Oueidat, Martin Larsen, Pierre Hausfater

{"title":"Cell population data for early detection of sepsis in patients with suspected infection in the emergency department.","authors":"Marta Cancella De Abreu, Caren Brumpt, Timothé Sala, Nathalie Oueidat, Martin Larsen, Pierre Hausfater","doi":"10.1515/cclm-2025-0180","DOIUrl":"https://doi.org/10.1515/cclm-2025-0180","url":null,"abstract":"Objectives: Traditional biomarkers used for sepsis diagnosis have limited sensitivity and specificity and, so far, are not recommended for sepsis diagnosis. We aimed to evaluate diagnostic accuracy of XN-9000® hematology analyzer derived cell population data (CPD) for sepsis.Methods: We conducted a cross-sectional cohort study on patients admitted to an emergency department (ED) with a suspicion of infection, having a complete blood count with differential (CBC-Diff). CBC-Diff were performed on XN-9000® analyzer (Sysmex, Kobe, Japan). CPD were measured routinely for each CBC-Diff ordered by ED physician. They include: neutrophils-related - Neut-GI and Neut-RI; monocytes-related - Mono-X, Mono-Z, Re-Mono and Mono-Y; IG referring to immature granulocytes; and lymphocytes-related - As-lymp and Re-lymp. Intensive care infection (ICIS) and neutrophile and monocyte (NEMO) scores were calculated using several CPD parameters. Diagnostic performance of each biomarker was computed together with receiver operating characteristic curves for sepsis diagnosis (according to Sepsis-3 definition).Results: A total of 1,155 patients with a suspicion of infection were included and 230 had sepsis. Median age was 64 years and 49 % were female. Except for lymphocyte count with an area under the receiver operating characteristic (AUROC) of 0.67 (95 % confidential interval 0.63-0.70), the other CPD exhibited modest performances with AUROC under 0.65. The ICIS and NEMO scores had a modest performance with AUROC of 0.56 (0.52-0.61) and 0.55 (0.51-0.59) respectively.Conclusions: None of the biomarkers and scores tested demonstrated sufficient diagnostic accuracy to be recommended for routine sepsis screening in the ED.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143990301","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}

引用次数: 0

Clinical vs. statistical significance: considerations for clinical laboratories. 临床与统计意义：临床实验室的考虑。

IF 3.8 2区医学

Clinical chemistry and laboratory medicine Pub Date : 2025-04-08 DOI: 10.1515/cclm-2025-0219

Hamit Hakan Alp, Mai Thi Chi Tran, Corey Markus, Chung Shun Ho, Tze Ping Loh, Rosita Zakaria, Brian R Cooke, Elvar Theodorsson, Ronda F Greaves

{"title":"Clinical vs. statistical significance: considerations for clinical laboratories.","authors":"Hamit Hakan Alp, Mai Thi Chi Tran, Corey Markus, Chung Shun Ho, Tze Ping Loh, Rosita Zakaria, Brian R Cooke, Elvar Theodorsson, Ronda F Greaves","doi":"10.1515/cclm-2025-0219","DOIUrl":"https://doi.org/10.1515/cclm-2025-0219","url":null,"abstract":"Amongst the main perspectives when evaluating the results of medical studies are statistical significance (following formal statistical testing) and clinical significance. While statistical significance shows that a factor's observed effect on the study results is unlikely (for a given alpha) to be due to chance, effect size shows that the factor's effect is substantial enough to be clinically useful. The essence of statistical significance is \"negative\" - that the effect of a factor under study probably did not happen by chance. In contrast, effect size and clinical significance evaluate whether a clinically \"positive\" effect of a factor is effective and cost-effective. Medical diagnoses and treatments should never be based on the results of a single study. Results from numerous well-designed studies performed in different circumstances are needed, focusing on the magnitude of the effects observed and their relevance to the medical matters being studied rather than on the p-values. This paper discusses statistical inference and its relevance to clinical importance of quantitative testing in clinical laboratories. To achieve this, we first pose questions focusing on fundamental statistical concepts and their relationship to clinical significance. The paper also aims to provide examples of using the methodological approaches of superiority, equivalence, non-inferiority, and inferiority studies in clinical laboratories, which can be used in evidence-based decision-making processes for laboratory professionals.","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143802765","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}

引用次数: 0