Clinical chemistry and laboratory medicine最新文献

{"title":"EQALM recommendations for the analytical performance specifications for blood smear interpretation in haematology: a need for standardization.","authors":"Stéphanie Albarède, Erika Sárkàny, Barbara De la Salle","doi":"10.1515/cclm-2025-1011","DOIUrl":"https://doi.org/10.1515/cclm-2025-1011","url":null,"abstract":"<p><strong>Objectives: </strong>The European Organization for External Quality Assurance Providers in Laboratory Medicine (EQALM) Haematology Working Group (WG) has previously provided two guidelines to support the standardization of haematology blood smear external quality assessment (EQA) (Vives CJL, Albarède S, Flandrin G, Heller S, Horvath K, Houwen B, et al. Guidelines for blood smear preparation and staining procedure for setting up an external quality assessment scheme for blood smear interpretation. Part I: control material. Clin Chem Lab Med 2004;42:922-6; Vives CJL, Van Blerk M, Albarède S, Gutierrez G, Heller S, Nordin G, et al. Guidelines for setting up an external quality assessment scheme for blood smear interpretation. Part II: survey preparation, statistical evaluation and reporting. Clin Chem Lab Med 2006;44:1039-43) but these recommendations did not include analytical performance specifications. In this paper the WG provides advice on the performance specifications for the evaluation of blood cell identification, comments on morphological characteristics and diagnostic hypothesis.</p><p><strong>Methods: </strong>To develop these specifications, the WG made a survey of the practices in use by EQALM members and provided a standard set of EQA data, provided by one of the members, for performance evaluation.</p><p><strong>Results: </strong>The results of this exercise show a variation in the performance assessment outcomes from one EQA provider to another, suggesting that a degree of standardisation would be of benefit to participating laboratories.</p><p><strong>Conclusions: </strong>The WG has provided advice on common performance specifications, based on model 1 of the Milan Consensus (Sandberg S, Fraser CG, Horvath AR, Jansen R, Jones G, Oosterhuis W, et al. Defining analytical performance specifications: consensus statement from the 1st strategic conference of the European federation of clinical chemistry and laboratory medicine. Clin Chem Lab Med 2015;53:833-5).</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145124394","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":"Does patient-based data monitoring allow us to reconsider the relationship between IQC and EQA?","authors":"Tony Badrick, John Sioufi, Derek Holzhauser","doi":"10.1515/cclm-2025-1133","DOIUrl":"https://doi.org/10.1515/cclm-2025-1133","url":null,"abstract":"<p><p>Currently, there is no accepted standard practice for determining the frequency of EQA challenge. The challenge frequency has evolved based on history and local requirements. However, EQA frequency should be based on identifying patient risks caused by poorly performing laboratories, methods, or processes in any phase of the total testing cycle. The role of IQC is to ensure result consistency from day to day and to halt reporting of results if there is an analytical failure. Historically, both activities have been based on synthetic control material. With the development of patient-based approaches to IQC and EQA, it is possible to continuously monitor analytical systems using the same patient parameter, usually the mean or median. These techniques can provide laboratories with additional information to reduce patient risk. There are limitations of Patient-Based Quality Assurance (PBQA), fundamentally the lack of middleware and connection of the analyzers to the EQA provider. It cannot be used to monitor the success of harmonization/standardization of assays to a reference measurement procedure. But the use of patient-based approaches offers an opportunity to reconsider how EQA can be undertaken and the relationship between IQC and EQA. If PBRTQC and PBQA could be implemented to provide daily peer group comparisons, then method-specific bias could be identified quickly by a laboratory. If this could be supplemented with a commutable, reference value assigned EQA program, then monitoring harmonization/standardization of assays to a reference measurement procedure could be achieved.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145124450","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":"Comparative analysis of ISO 15189:2022 with earlier versions with reference to ethics.","authors":"Sudip K Datta, Nilda Fink, Estelle Bugni, Joe Wiencek","doi":"10.1515/cclm-2025-0884","DOIUrl":"https://doi.org/10.1515/cclm-2025-0884","url":null,"abstract":"<p><strong>Objectives: </strong>The International Organisation for Standardisation (ISO) 15189 standard provides the requirements for quality and competence in medical laboratories. It aims to ensure that laboratories deliver accurate and reliable results for patient care. The first version of the same was published in 2003, followed by editions in 2007, 2012 and 2022. The objective of this article is to analyze the ethical commitments and requirements assumed to achieve reliable results in laboratory medicine incorporated in the ISO standard.</p><p><strong>Methods: </strong>We compare the concepts and changes related to ethics introduced over time in the ISO 15189 versions. We also present, a comparative study about the evolution of ethical concepts in the clinical laboratory and how these changes have been reflected in ISO 15189 standards through 2003 to 2022.</p><p><strong>Results: </strong>After a thorough comparative analysis, we observe that the ISO 15189:2022 version has strengthened the requirements for several key concepts of Ethics such as impartiality and confidentiality, and addressed the issues of laboratory users with regards to autonomy, beneficence and justice although these terminologies are not explicitly mentioned. However, several other key words and concepts have not been addressed with adequate emphasis.</p><p><strong>Conclusions: </strong>We recommend that several key concepts related to ethics may need to be included in the future revisions, especially those related to new and upcoming technologies being used in laboratory diagnostics and research.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145124344","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":"Confirmation of the value of the labile HbA_1c/HbA_1c-ratio in the presence of a Hb J-Baltimore variant: a clinical case.","authors":"Erna Lenters-Westra, Ilse Schouten, Iris van Vlodrop, Emma English","doi":"10.1515/cclm-2025-1044","DOIUrl":"https://doi.org/10.1515/cclm-2025-1044","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145112115","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":"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}