Clinical Chemistry and Laboratory Medicine

Towards a global framework of entrustable professional activities for undergraduate clinical laboratory interns: a competency-based approachXiaohui Zhangon October 14, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Oct 14. doi: 10.1515/cclm-2025-1178. Online ahead of print. ABSTRACT OBJECTIVES: The aim of this study is to develop a core competency-based EPAs framework for undergraduate interns in the clinical laboratory. METHODS: The EPAs framework was developed in three stages: formation of a research team, drafting of an initial EPAs framework, … Read more

Performance of GFAP and UCH-L1 compared to S100B in detecting intracranial injury: influence of age, hemolysis, neurodegenerative diseases, and extracranial fractures in a prospective cohort of over 1,000 patientsAntoine Puraveton October 8, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Oct 9. doi: 10.1515/cclm-2025-1129. Online ahead of print. ABSTRACT OBJECTIVES: To compare the diagnostic performances of GFAP and UCH-L1 with S100B in detecting intracranial injury, while investigating the impact of confounding factors. METHODS: In a large prospective cohort of 1,010 patients with mild traumatic brain injury, we first evaluated the … Read more

Towards harmonization of autoantibody detection in relation to paraneoplastic neurological syndromes (PNS): a European Survey on laboratory practicesMatthijs Oyaerton October 6, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Oct 7. doi: 10.1515/cclm-2025-1030. Online ahead of print. ABSTRACT OBJECTIVES: Detection of paraneoplastic anti-neuronal antibodies (PNS autoantibodies) aids in diagnosing the particular syndrome and guides the search for an underlying tumor. To identify opportunities for harmonization that could enhance diagnostic value, we assessed variability in autoimmune serological testing for PNS … Read more

Estimated waste generation from 1 million basic metabolic panels: a multisite U.S. studySeema Khattri Bhandarion October 6, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Oct 7. doi: 10.1515/cclm-2025-1162. Online ahead of print. ABSTRACT OBJECTIVES: Clinical laboratory operations consume large amounts of electricity and water and generate considerable quantities of solid waste. In this study, we quantified and compared the estimated solid waste produced from performing one million basic metabolic panels (BMPs) across five major … Read more

Serum neuron-specific enolase – reference interval in Danish children and the impact of preanalytical factorsJacob Rudjord Therkildsenon October 2, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Oct 3. doi: 10.1515/cclm-2025-0582. Online ahead of print. ABSTRACT OBJECTIVES: Neuron-specific enolase (NSE) is a clinically relevant biomarker used in the assessment of neuronal damage and in the diagnosis and monitoring of certain cancers. Despite its diagnostic importance, paediatric-specific reference intervals (RIs) for NSE are currently lacking. This study aimed … Read more

Post-analytical practices in clinical mass spectrometry laboratories: an international survey across 57 countriesJenny Yeuk-Ki Chengon October 1, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Oct 2. doi: 10.1515/cclm-2025-1136. Online ahead of print. ABSTRACT OBJECTIVES: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is increasingly used in clinical laboratories due to its high analytical specificity and multiplexing capabilities. While the pre-analytical and analytical phases have seen significant advances in automation, the post-analytical phase remains a bottleneck with limited … Read more

Serum N-glycans as independent predictors of the incidence of type 2 diabetes: a prospective investigation in the AEGIS cohortIago Carballoon September 30, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Jun 24;63(11):2330-2340. doi: 10.1515/cclm-2025-0045. Print 2025 Oct 27. ABSTRACT OBJECTIVES: Glycosylation is a tightly controlled co-translational and post-translational enzymatic modification. Total N-glycome profiling in blood serum/plasma provides information on the most common serum/plasma glycosylation. Total plasma N-glycome from various population samples displayed predictive ability for type 2 diabetes incidence in … Read more

Expert opinion within the context of the targeted evaluation of Regulation (EU) 2017/746 on in vitro diagnostic medical devices pursuant to Article 111 and Regulation (EU) 2024/1860Michael Vogeseron September 30, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Oct 1. doi: 10.1515/cclm-2025-0941. Online ahead of print. ABSTRACT EU laws are usually evaluated after 10 years; in the case of the IVDR, the targeted evaluation was brought forward and stakeholders in laboratory diagnostics were invited to comment. The Association of the Scientific Medical Societies in Germany (AWMF; Arbeitsgemeinschaft der … Read more

Requiem for the Passing-Bablok nonparametric regression in assessing the agreement between two measurement methodsBruno Mario Cesanaon September 28, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Sep 29. doi: 10.1515/cclm-2025-0581. Online ahead of print. ABSTRACT OBJECTIVES: Regulatory guidelines recommend non-parametric Passing-Bablok regression for evaluating the agreement between two measurement methods in laboratory settings. However, concluding for the agreement if the 95 % CI of the slope and of the intercept include 1 and 0, respectively is … Read more

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