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Analytical Error of Cardiac Troponin and Impact on the Performance of Accelerated Diagnostic Protocols in Patients with Acute Chest Pain

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Clin Chem. 2025 Oct 14:hvaf116. doi: 10.1093/clinchem/hvaf116. Online ahead of print. ABSTRACT BACKGROUND: This study simulates how assay-specific bias influences the diagnostic performance of 0/1-h accelerated diagnostic protocols (ADPs) for 3 different high-sensitivity cardiac troponin (hs-cTn) assays. METHODS: We included 1493 patients presenting with chest pain. hs-cTnT (Roche Diagnostics), hs-cTnI from Abbott Diagnostics (hs-cTnI-A), and … Read more

Regulatory Fragmentation in Europe and Its Risks for Patient Access and Safety: Subcontracting Work Flow Steps of In-House Diagnostic Procedures

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Clin Chem. 2025 Oct 14:hvaf123. doi: 10.1093/clinchem/hvaf123. Online ahead of print. ABSTRACT The European Union (EU) In Vitro Diagnostic Regulation (IVDR) imposes stringent obligations on laboratories using in-house in vitro diagnostic devices (IH-IVDs), yet offers limited clarity on whether discrete work flow steps may be subcontracted while maintaining compliance with Article 5(5). This Special Report … Read more

The role of AI in pre-analytical phase – use casesHikmet Can Çubukçuon October 15, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Oct 16. doi: 10.1515/cclm-2025-1220. Online ahead of print. ABSTRACT The pre-analytical phase of laboratory testing, encompassing processes from test ordering to sample analysis, represents the most error-prone component of laboratory medicine, accounting for 68-98 % of laboratory mistakes. These errors compromise patient safety, increase healthcare costs, and disrupt operational efficiency. … Read more

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

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