Clinical Chemistry and Laboratory Medicine

Quality assurance using patient split samples: recommendations for primary healthcare laboratoriesAnne Stavelinon August 25, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 26. doi: 10.1515/cclm-2025-0818. Online ahead of print. ABSTRACT OBJECTIVES: The increasing adoption of point-of-care testing (POCT) in primary healthcare highlights the need for robust quality assurance (QA) procedures to ensure result reliability. The patient split sample approach, i.e. comparing POCT and central laboratory results from the same patient, can … Read more

An automatic chemiluminescence immunoassay for a novel biomarker NT-IGFBP-4: analytical performance and clinical relevance in heart failureShuzheng Caoon August 22, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 25. doi: 10.1515/cclm-2025-0378. Online ahead of print. ABSTRACT OBJECTIVES: Insulin-like growth factor binding protein-4 (IGFBP-4) fragments are reported as emerging biomarkers for cardiovascular disease (CVD) risk assessment. To ensure data reliability and improve clinical application, the first automatic chemiluminescent immunoassay (CLIA) for NT-IGFBP-4 was developed and its distribution across … Read more

An innovative immunoassay for accurate aldosterone quantification: overcoming low-level inaccuracy and renal dysfunction-associated interferenceKaijuan Wangon August 22, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 25. doi: 10.1515/cclm-2025-0743. Online ahead of print. ABSTRACT OBJECTIVES: Accurate quantification of aldosterone is critical for screening and diagnosing primary aldosteronism (PA). Current competitive chemiluminescence immunoassays (cCLIA) overestimate plasma aldosterone concentration (PAC) compared to liquid chromatography-tandem mass spectrometry (LC-MS/MS). However, LC-MS/MS is technically demanding and time-consuming, limiting its widespread … Read more

Validation of a plasma GFAP immunoassay and establishment of age-related reference values: bridging analytical performance and routine implementationBurak Arslanon August 22, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 25. doi: 10.1515/cclm-2025-0870. Online ahead of print. ABSTRACT OBJECTIVES: Glial fibrillary acidic protein (GFAP) is a well-established biomarker of astrocytic activation associated with neurodegenerative diseases, neuroinflammatory disorders, and traumatic brain injury. With increasing interest in blood-based biomarkers, the need for analytically validated assays and reliable reference intervals is critical … Read more

Method comparison of diabetes mellitus associated autoantibodies in serum specimensAlexander Lenardon August 22, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 25. doi: 10.1515/cclm-2025-0137. Online ahead of print. ABSTRACT OBJECTIVES: Autoantibodies against structure elements of the pancreas are an essential part of laboratory diagnosis of diabetes mellitus. The heterogeneity of current methods and difficult inter-assay comparability of results poses challenges to both clinical interpretation as well as research integrity. METHODS: … Read more

From assessment to action: experience from a quality improvement initiative integrating indicator evaluation and adverse event analysis in a clinical laboratoryPeirong Chenon August 20, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 21. doi: 10.1515/cclm-2025-0656. Online ahead of print. ABSTRACT OBJECTIVES: ISO 15189:2022 recommends the use of quality indicators (QIs) to monitor laboratory performance and focuses on risk management and continual improvement. This study aims to compare hospital laboratory data with national and international quality specifications and to share experiences in … Read more

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