Clinical chemistry and laboratory medicine最新文献

{"title":"Comparative analysis of monocyte distribution width alterations in <i>Escherichia coli</i> sepsis: insights from <i>in vivo</i> and ex vivo models.","authors":"Daniela Ligi, Chiara Della Franca, Michela Pelloso, Alicia Martinez-Iribarren, Alba Leis, Erica Fabbri, Francesca Salvatori, Elena A Sukhacheva, Giorgio Brandi, Giuditta F Schiavano, Ferdinando Mannello","doi":"10.1515/cclm-2025-0487","DOIUrl":"https://doi.org/10.1515/cclm-2025-0487","url":null,"abstract":"<p><strong>Objectives: </strong>Monocyte distribution width (MDW) is an early sepsis indicator measuring monocyte heterogeneity during massive infection. We compared MDW changes in <i>Escherichia coli</i> sepsis patients with the effects of living <i>E. coli</i> and lipopolysaccharide in an <i>ex vivo</i> sepsis model. We also investigated the dynamics of monocyte morpho-functional and inflammatory responses in the sepsis model.</p><p><strong>Methods: </strong>Whole blood from healthy participants was <i>in vitro</i> stimulated with live <i>E. coli</i> (10⁶-10¹⁰ CFU/mL) and LPS (0.1-10 μg/mL). Complete blood counts, including MDW, were evaluated at different time-points using DxH 690T Hematology Analyzer (Beckman Coulter). MDW values were compared with those retrospectively obtained from sepsis patients (n=23). May-Grunwald-Giemsa-stained blood smears were analyzed by digital cell morphology (CellaVision DM software). A panel of 27 inflammatory mediators was quantified in plasma (Bio-Plex 200).</p><p><strong>Results: </strong>MDW values were early and significantly increased in a dose- and time-dependent manner by live <i>E. coli</i> and LPS treatments (p<0.01). MDW values were significantly higher in sepsis patients compared to controls and overlapped those observed in the <i>ex vivo</i> model. IL-1β, TNF-α, IL-8, MIP1-α, MIP-1β, Eotaxin, G-CSF, and PDGF-bb were significantly modulated after treatments.</p><p><strong>Conclusions: </strong>Our findings confirm the clinical utility of MDW in sepsis diagnosis and sustain the reliability of the whole blood assay as <i>ex vivo</i> sepsis model. <i>E. coli</i> and LPS directly promote early monocyte morpho-functional modifications, mirrored by high MDW values and pro-inflammatory mediators. These results improve the knowledge on the biological basis of sepsis, providing novel evidence on the usefulness of MDW in septic conditions.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145085182","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":"Pitfalls of immunoassays for diagnosis of hypoglycemia of undetermined etiology.","authors":"Adel A A Ismail","doi":"10.1515/cclm-2025-1067","DOIUrl":"https://doi.org/10.1515/cclm-2025-1067","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145085366","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":"CA-125 glycovariant assays enhance diagnostic sensitivity in the detection of epithelial ovarian cancer.","authors":"Stefanos Moukas, Katri Kuningas, Marjut Helle, Leena Kokko, Rainer Kimmig, Sabine Kasimir-Bauer, Paul Buderath, Kaisa Huhtinen","doi":"10.1515/cclm-2025-0561","DOIUrl":"https://doi.org/10.1515/cclm-2025-0561","url":null,"abstract":"<p><strong>Objectives: </strong>Ovarian cancer is the deadliest gynaecologic malignancy. Due to the lack of reliable biomarkers for the detection of the early disease, most patients are diagnosed at an advanced stage resulting in poor survival. We therefore aimed at establishing novel CA-125 glycovariant assays to improve the diagnostic sensitivity and specificity of ovarian cancer.</p><p><strong>Methods: </strong>Blood samples of 184 patients with epithelial ovarian cancers (EOC), 127 benign ovarian tumors, and 115 healthy controls were measured using GLYVAR™ Ovarian I and II assays (Uniogen) and the conventional CA-125 protein assay (CanAg CA-125 EIA, Fujirebio).</p><p><strong>Results: </strong>The two glycovariant assays differentiated benign and malignant ovarian masses with 88.0 % sensitivity at 99 % specificity, whereas CA-125 showed 72.8 % sensitivity. The improved performance was most evident in patients with borderline or moderately elevated CA-125 concentration at diagnosis, which is a challenging group for differential diagnostics. The CA-125 glycovariant assays showed 2.5 times higher sensitivity (33.3 % with CA-125 vs. 83.3 % with the CA-125 glycovariants) at 94 % specificity. CA-125 glycovariants corrected 82.4 % of false positive results given by CA-125 concentrations with the commonly used cutoff 35 U/mL. Importantly, the CA-125 glycovariant assays detected 63.6 % of early-stage serous carcinomas from benign and healthy controls with very high 99 % specificity, while CA-125 had a sensitivity of only 45.5 %, representing a 40 % increase.</p><p><strong>Conclusions: </strong>This is the first study describing the clinical performance of GLYVAR Ovarian I and II assays in ovarian cancer diagnostics. The results indicate that the CA-125 glycovariant assays have remarkable potential to improve ovarian cancer diagnostics.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145085272","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":"Adverse analytical finding with trimetazidine after ingesting contaminated melatonin tablets sold in pharmacies… leading to the suspension of the athlete.","authors":"Jean-Claude Alvarez, Pascal Kintz, Isabelle Etting","doi":"10.1515/cclm-2025-1185","DOIUrl":"https://doi.org/10.1515/cclm-2025-1185","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145085237","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":"Early autoimmune signature in a young woman: palmar erythema, capillaroscopic abnormalities, and triple autoantibody positivity including anti-nucleosome.","authors":"Angelo Nigro","doi":"10.1515/cclm-2025-0798","DOIUrl":"https://doi.org/10.1515/cclm-2025-0798","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145085298","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":"Challenging the dogma: why reviewers should be allowed to use AI tools.","authors":"Giuseppe Lippi, Karl J Lackner, Bohuslav Melichar, Shiyang Pan, Peter Schlattmann, Ronda Greaves, Philippe Gillery, Mario Plebani","doi":"10.1515/cclm-2025-1180","DOIUrl":"10.1515/cclm-2025-1180","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145085190","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":"Permitting disclosed AI assistance in peer review: parity, confidentiality, and recognition.","authors":"Anna Carobene","doi":"10.1515/cclm-2025-1140","DOIUrl":"https://doi.org/10.1515/cclm-2025-1140","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145112091","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":"EFLM checklist for the assessment of AI/ML studies in laboratory medicine: enhancing general medical AI frameworks for laboratory-specific applications.","authors":"Anna Carobene, Janne Cadamuro, Glynis Frans, Hanoch Goldshmidt, Zeljiko Debeljak, Sander De Bruyne, William van Doorn, Johannes Elias, Habib Özdemir, Salomon Martin Perez, Helena Lame, Alexander Tolios, Federico Cabitza, Andrea Padoan","doi":"10.1515/cclm-2025-0841","DOIUrl":"10.1515/cclm-2025-0841","url":null,"abstract":"<p><p>The integration of artificial intelligence (AI) and machine learning (ML) into laboratory medicine shows promise for advancing diagnostic, prognostic, and decision-support tools; however, routine clinical implementation remains limited and heterogeneous. Laboratory data presents unique methodological and semantic complexities - method dependency, analyte-specific variation, and contextual sensitivity-not adequately addressed by general-purpose AI reporting guidelines. To bridge this gap, the EFLM Committee on Digitalisation and Artificial Intelligence (C-AI) proposes an expanded checklist to support assessment of requirements and recommendations for the development of AI/ML models based on laboratory data. Building upon the widely adopted ChAMAI checklist (Checklist for assessment of medical AI), our proposal introduces six additional items, each grounded in the CRoss Industry Standard Process for Data Mining (CRISP-DM) framework and tailored to the specificities of laboratory workflows. These extensions address: (1) explicit documentation of laboratory data characteristics; (2) consideration of biological and analytical variability; (3) the role of metadata and peridata in contextualizing results; (4) analyte harmonization and standardization practices; (5) rigorous external validation with attention to dataset similarity; and (6) the implementation of FAIR data principles for transparency and reproducibility. Together, these recommendations aim to foster robust, interpretable, and generalizable AI systems that are fit for deployment in clinical laboratory settings. By incorporating these laboratory-aware considerations into model development pipelines, researchers and practitioners can enhance both the scientific rigor and practical applicability of AI tools. We advocate for the adoption of this extended checklist by developers, reviewers, and regulators to promote trustworthy and reproducible AI in laboratory medicine.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145085324","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":"Tafasitamab interference in immunofixation electrophoresis.","authors":"Rebecca S Treger, Susan L Fink","doi":"10.1515/cclm-2025-1015","DOIUrl":"https://doi.org/10.1515/cclm-2025-1015","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145079698","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":"Predictive genomic medicine enlarges the spectrum of predisposing mutations for head and neck cancers via a panel of 56 genes selected for human neoplasia in Southern Italy: a pilot study.","authors":"Federica Di Maggio, Giulia Togo, Ettore Pavone, Alessandra Calabrese, Petra Claudia Camilla D'Orsi, Maria Luisa Marciano, Giovanni Marino, Franco Ionna, Francesco Salvatore, Marcella Nunziato","doi":"10.1515/cclm-2025-1159","DOIUrl":"https://doi.org/10.1515/cclm-2025-1159","url":null,"abstract":"<p><strong>Objectives: </strong>Oral squamous cell carcinoma (OSCC) is the most prevalent form of squamous cell carcinomas of the head and neck (SCCHN), accounting for over 90 % of all oral cavity malignancies (approximately 275,000 new cases are worldwide diagnosed annually). Early-stage oral squamous cell carcinoma (T1 and T2) has a 5-year survival rate of up to 80 %. Survival rates decrease to 20-30 % at later stages (T3-T4). Each year, there are between 275,000 and 300,000 new cases of OSCC, and over 150,000 deaths worldwide. OSCC are usually non-hereditary tumors, although familial epidemiology has been recently reported.</p><p><strong>Methods: </strong>From 2022 to 2024, we enrolled 56 patients from the complex structure of maxillofacial surgery and ORL, National Cancer Institute - IRCCS - Fondazione G. Pascale. The individuals enrolled underwent molecular testing via a multigene panel of 56 genes related to cancer predisposition customized in our laboratory. The panel included <i>BRCA1</i> and <i>BRCA2</i>.</p><p><strong>Results: </strong>We identified a total of 7 pathogenic mutations annotated in clinical databases as ClinVar, in <i>BRCA2</i> (two different variants), <i>BRCA1</i>, <i>MUTYH</i>, <i>BRIP1</i>, <i>FANCM</i> and <i>FANCC</i> genes (approximately 12.5 % of our patients). The results show a frequent predisposition to head and neck tumors similar to or even greater than that observed in other types of neoplasia, such as breast and ovarian cancers or colon cancer), with a predisposition of approximately 10 %.</p><p><strong>Conclusions: </strong>Our results confirm that, similarly to other more studied tumors, predictive genomic medicine can play a crucial role in the early identification of germline mutations in head and neck cancers. This approach should be considered for the early detection of OSCC particularly for individuals at increased risk, e.g., those with a family history of the disease, who may also be candidates for targeted molecular therapies based on their genetic profile.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145079745","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}