Clinical chemistry and laboratory medicine最新文献

{"title":"Responsibility without a map: defining oversight of automated result release in the medical laboratory.","authors":"Said İncir, Kerim Erhan Palaoğlu, Osman Oğuz","doi":"10.1515/cclm-2026-1371","DOIUrl":"https://doi.org/10.1515/cclm-2026-1371","url":null,"abstract":"<p><p>Laboratory specialists have been assigned responsibility for algorithmically assisted reporting without an operational definition of what responsible oversight means. Results pass largely through rule-based approval systems, and increasingly through probabilistic models, yet the obligation attached to the specialist's name on the report has never been restated. Taking the position of the specialist who signs rather than the regulator who writes, and starting from requirements the discipline already accepts, we derive four capacities on which approving a result depends: designing the release logic and making it legible, anticipating where it will fail, correcting it when it does, and detecting that it has failed. These are not properties of a technology. Every system sits on a gradient whose position depends less on whether it uses machine learning than on what the laboratory has recorded about it. The oversight problem therefore did not arrive with machine learning but with automation, and most of what is now asked of laboratories in respect of artificial intelligence was already owed in respect of autoverification. Mapped against the four capacities, current frameworks require documentation and change control, address detection only in general terms, and nowhere require a laboratory to state in advance which results may be released without human review. Where laboratories have been asked, they report holding few of the records by which compliance could be shown. We propose a set of such records, identify what a single laboratory can and cannot reasonably do, and set out the questions the profession has not yet answered.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149012061","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":"Thyroglobulin antibody in differentiated thyroid cancer: international laboratory practice survey and the case for a dual-threshold model.","authors":"Eliane F E Wenstedt, Marco Migliardi, Ruggero Dittadi, Sjoerd A A Van Den Berg, Mario Plebani, Luca Giovanella","doi":"10.1515/cclm-2026-1063","DOIUrl":"https://doi.org/10.1515/cclm-2026-1063","url":null,"abstract":"<p><strong>Objectives: </strong>Anti-thyroglobulin antibodies (TgAb) have a dual role during the follow-up of differentiated thyroid cancer (DTC): they may interfere with thyroglobulin (Tg) immunoassays and also serve as surrogate biomarkers of disease status. However, laboratory practices for TgAb measurement and reporting remain poorly standardised. We conducted an international survey to characterize current laboratory approaches and identify opportunities for harmonization.</p><p><strong>Methods: </strong>A structured questionnaire was distributed to 120 laboratory medicine centres performing Tg and TgAb testing. The survey collected information on analytical platforms, TgAb reporting practices, positivity and interference thresholds, interference assessment strategies, and the interpretation of longitudinal TgAb changes. Results were analysed descriptively.</p><p><strong>Results: </strong>Fifty-one centres from six European countries participated (response rate, 42 %). Most laboratories (88 %) measured Tg and TgAb using assays from the same manufacturer. Marked heterogeneity was observed in quantitative TgAb reporting, definition of pathological TgAb concentrations, and thresholds considered indicative of potential Tg assay interference. Although more than half of the laboratories reported having defined an interference threshold, only two (4 %) implemented and explicitly reported separate thresholds for thyroid autoimmunity and Tg assay interference. Structured interference investigations were uncommon (26 %) and relied mainly on recovery testing, whereas predefined delta-check criteria for longitudinal TgAb interpretation were used by only 8 % of centres.</p><p><strong>Conclusions: </strong>Current laboratory practice for TgAb testing in DTC is highly heterogeneous and may contribute to inconsistent interpretation of Tg results. A dual-threshold reporting model that clearly distinguishes the diagnostic threshold for thyroid autoimmunity from the analytical threshold indicating potential Tg assay interference promote harmonization. Routine support for longitudinal TgAb interpretation, including serial trend reporting, represents an additional opportunity for laboratory specialists to enhance the management of patients with DTC.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149012121","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":"Delivering the EU Safe Hearts Plan: the essential role of laboratory medicine in cardiovascular health.","authors":"Damien Gruson, Michel Langlois, Abdurrahman Coskun, Snezana Jovicic, Anne Stavelin, Matthias Bauer, Mario Plebani, Tomas Zima","doi":"10.1515/cclm-2026-1439","DOIUrl":"https://doi.org/10.1515/cclm-2026-1439","url":null,"abstract":"<p><p>The European Union Safe Hearts Plan provides an opportunity to strengthen cardiovascular prevention, early detection, treatment, and monitoring across Europe. This EFLM position paper argues that laboratory medicine must be recognized as a central component of its implementation. Reliable and harmonized laboratory data underpin cardiovascular risk assessment, diagnosis, therapeutic guidance, longitudinal monitoring, and evaluation of population outcomes. Beyond the minimum health-check dataset, tiered and personalized pathways should integrate established biomarkers, specialist testing, and validated emerging technologies. EFLM proposes five priorities: embedding laboratory expertise in governance; translating core testing into personalized pathways; expanding equitable access through quality-assured decentralized models; linking testing to clinical action and value-based financing; and accelerating responsible innovation while strengthening professional capability. By connecting screening with diagnosis, treatment, and measurable outcomes, laboratory medicine can provide the quality, interpretation, and data infrastructure required to transform the Safe Hearts Plan from policy ambition into equitable cardiovascular health gains across Europe.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149012088","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":"The correct use of the unit symbols U/L and IU/L.","authors":"Kuenyoul Park, Madeleen Bosma, FatmaMeriç Yılmaz, Sridevi Devaraj, Koh Furuta, Young Bae Lee Hansen, Gunnar Nordin","doi":"10.1515/cclm-2026-1397","DOIUrl":"https://doi.org/10.1515/cclm-2026-1397","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149001360","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":"Filling the gaps in high-priority reference materials for implementing metrological traceability in laboratory medicine.","authors":"Mauro Panteghini, Christa M Cobbaert, Vincent Delatour, Liesbet Deprez, Anja Kessler, Magdalena Krintus, Gavin O'Connor, Karen Phinney, Sverre Sandberg, Dewei Song, Claudia Swart, Christian Vogl, Robert Wielgosz","doi":"10.1515/cclm-2026-1332","DOIUrl":"https://doi.org/10.1515/cclm-2026-1332","url":null,"abstract":"<p><p>The global harmonization of measurements in laboratory medicine is facilitated by the development and implementation of reference measurement systems, including suitable certified reference materials (CRMs). There are, however, a relatively small number of CRM producers worldwide. In the context of limited resources, strategic prioritization and coordinated action among CRM producers are critical. This position paper summarizes a Joint Committee for Traceability in Laboratory Medicine (JCTLM) workshop held in May 2026 that addressed the prioritization issue and relied on feedback from standardization leaders, experts in the field, and representatives of CRM producers. The workshop goals were to: a) determine whether ongoing activities can meet high-priority CRM development and maintenance needs; b) assess existing prioritization exercises and their level of consistency; and c) make recommendations on how to optimize processes for filling gaps in CRM availability, maintaining CRM supply, and avoiding unnecessary CRM redundancy. The identified stakeholder gaps and needs, the proposed solutions to address these needs, and an outline of a global coordination framework to optimize CRM coverage are discussed.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149007739","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":"Reply to: Albumin-adjusted (\"corrected\") calcium should no longer be reported: a position statement from the Joint IOF Working Group and IFCC Committee on Bone Metabolism and EFLM Committee on CKD.","authors":"Iain Louis Ballantine, Gary Weaving, Kate Elizabeth Shipman","doi":"10.1515/cclm-2026-0904","DOIUrl":"https://doi.org/10.1515/cclm-2026-0904","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148955148","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":"Digital and computational morphology in hematology: current platforms, clinical evidence, and future requirements.","authors":"Gina Zini","doi":"10.1515/cclm-2026-1265","DOIUrl":"https://doi.org/10.1515/cclm-2026-1265","url":null,"abstract":"<p><strong>Introduction: </strong>Morphologic examination of peripheral blood and bone marrow remains central to the diagnosis and classification of hematologic disorders. Conventional optical microscopy, however, is labor-intensive, dependent on operator expertise, and affected by interobserver variability. Digital morphology has developed from automated image acquisition and cell pre-classification into a broader field that includes whole-slide imaging, remote review, quantitative morphometry, and artificial intelligence-based analysis.</p><p><strong>Content: </strong>This review examines current applications of digital morphology in peripheral blood, bone marrow aspirates, malaria detection, and body-fluid analysis. Commercial platforms are evaluated with particular attention to the distinction between raw automated pre-classification, expert digital post-classification, and comparison with independent optical microscopy. Digital systems generally perform well for common mature leukocyte populations but remain less reliable for rare or diagnostically critical cells, including blasts, abnormal lymphoid cells, plasma cells, and intermediate maturation stages. Research systems increasingly extend analysis from individual-cell classification to whole-slide, specimen-level, and patient-level assessment.</p><p><strong>Summary: </strong>Digital morphology can improve standardization, image traceability, remote consultation, education, proficiency testing, quality assurance, and selected aspects of laboratory workflow. Its clinical value depends on appropriate validation, transparent reporting of reference methods, recognition of algorithm-specific failure modes, and clearly defined criteria for expert review and conventional microscopy. Human expertise remains essential not only for validating results but also for adapting cell taxonomies and interpretive rules to evolving classifications of hematologic diseases.</p><p><strong>Outlook: </strong>Future progress will require representative multicenter datasets, harmonized morphologic terminology, external validation, interoperability with laboratory information systems, and continuous monitoring after software or hardware updates. Integration of morphology with quantitative hematology, flow cytometry, cytogenetics, genomics, and clinical data may support more comprehensive computational diagnosis. Digital platforms may also broaden access to specialist expertise, training, and quality programs in resource-limited institutions and regions, provided that infrastructure, governance, and professional competency are adequately supported.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148955096","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":"Interference by saline-based reconstitution of lyophilized quality control plasma in 75 routine laboratory tests.","authors":"Christoph Buchta, Christian Bieglmayer, Andreas Bietenbeck, Andrea Griesmacher, Wolfgang Hübl, Stylianos Kapiotis, Alireza Karimi, Peter Quehenberger, David Springer, Lukas Weseslindtner, Svitlana Demyanets","doi":"10.1515/cclm-2026-1310","DOIUrl":"https://doi.org/10.1515/cclm-2026-1310","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148955138","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":"Bacteriuria screening with the new automated platform AutionMax-AutionEye: when to culture.","authors":"Rosanna Falbo, Paola Cosentino, Domenico Tripodi, Pierluigi Congedo, Valerio Leoni","doi":"10.1515/cclm-2026-0885","DOIUrl":"https://doi.org/10.1515/cclm-2026-0885","url":null,"abstract":"<p><strong>Objectives: </strong>Urinary tract infections (UTIs) are very common in clinical practice. Urine culture remains the cornerstone of UTI diagnosis, but urinalysis screening for bacteriuria can improve workflow. The aim of the study was to screen for significant bacteriuria using Aution Eye AI-4510, a flow cell digital urine sediment image analyzer recently introduced in Italy.</p><p><strong>Methods: </strong>1,096 consecutive urine samples were studied. Samples were classified into three population groups: total population (n=1,096), 0-16 years (n=79), and >65 years (n=450). Each group was subdivided into females and males. At the established cut-offs, leukocyte (WBC) count, bacterial (BACT) count, or their combination with an and/or criterion, were then used to determine positivity. Results were compared to urine culture results obtained from the same samples.</p><p><strong>Results: </strong>Best screening was found in all groups, except the pediatric one, when WBC and BACT counts were combined. The total population group performed the best: at the defined cut-offs (WBC≥177; BACT≥1,000.5), sensitivity (SE) was 90.2 %, negative predictive value (NPV) was 96.9 %. The pediatric group showed inferior screening performance: the NPV was 78.8 % and the SE was 36.4 %. In the two subgroups of >65 years, males exhibited a strong screening reliability (DOR=36.2), while females showed a poor one (DOR=11.2).</p><p><strong>Conclusions: </strong>Our findings show that the Aution Eye AI-4510 is an effective tool for screening urine samples. It quickly excludes patients who test negative for significant bacteriuria from further culturing, reducing unneeded urine cultures, and lowering expenses and workload. Furthermore, clinical decisions can be anticipated when screening is negative.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148918820","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":"The Dutch colon cancer screening programme as an example of adopting indirect-outcome-based analytical performance specifications using a virtual analyser concept.","authors":"Marith Van Schrojenstein Lantman, Anja De Jong, Petra Van Der Groep, Evelien A Kemper, Monique De Groot, Renée Vossen, Karin Mohrmann, Joop Ten Kate, Marieke A M Frasa, Marc H M Thelen","doi":"10.1515/cclm-2026-0319","DOIUrl":"https://doi.org/10.1515/cclm-2026-0319","url":null,"abstract":"<p><p>To ensure reported laboratory results are of adequate quality, it is paramount that the set analytical performance specifications (APS) are tailored to the intended uses of the measurand. For measurands with a pivotal position in the clinical pathway, APS should be set based on clinical outcome. This paper, written as a result of an outcome-based-APS-summit in Prague, gives practical guidance on how to set outcome-based APS. Two approaches are mentioned with distinct starting points of the required performance (how much clinical misclassification do we allow, and which APS fulfils that premise) or the current performance (what is the effect of the current analytical performance characteristics (APC) on how much misclassification occurs). Importantly, APS should not just be set, but also requires monitoring, which method depends on the utilization of the test in clinical practice. The laboratory can monitor APS for so-called mother-daughter systems, individual analysers or a virtual-analyser system. This paper discusses the pros and cons of these approaches. To highlight the scope of clinically consequential outcomes for which APS can be set and monitored, the Faecal Immunochemical Testing for human haemoglobin (FIT), used for the Dutch Colorectal Cancer Screening programme (CRC-Screening), is used as an example. Here, APS were based on a clinically consequential intermediate outcome, i.e. analytically induced variability in colonoscopy referral rate (±0.5 %), and implemented as a virtual analyser system, dividing the APS budget of 10 % equally across four sources of FIT variation: reagent/calibrator lot variation, sampling buffer lot variation, within-analyser variation, and between-analyser variation.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148929129","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}