Clinical Chemistry and Laboratory Medicine

Failure Mode and Effects Analysis (FMEA) integrating quality indicators for risk assessment of the total testing process in human papillomavirus genotyping testing: a proactive risk analysis model for molecular diagnosticsTingting Lion August 29, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 29. doi: 10.1515/cclm-2025-0598. Online ahead of print. ABSTRACT OBJECTIVES: To develop a proactive risk assessment model for human papillomavirus (HPV) genotyping testing by integrating Failure Mode and Effects Analysis (FMEA) with quality indicators (QIs), ensuring compliance with ISO 15189:2022 and improving diagnostic accuracy. METHODS: A multidisciplinary team designed and … Read more

False-positive cardiac troponin I values due to macrotroponin in healthy athletes after COVID-19Angelika Hammerer-Lercheron August 25, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Jun 17. doi: 10.1515/cclm-2025-0427. Online ahead of print. ABSTRACT OBJECTIVES: Cardiac troponins (cTn) are used to detect and quantify acute cardiomyocyte injury. In patients presenting with symptoms that could indicate myocarditis, elevated cTn concentrations typically mandate cardiac catheterization and heart muscle biopsy or cardiac magnetic resonance imaging (CMR). Accordingly, increased … Read more

Age distorts the interpretation of FIB-4Arne Åsbergon August 25, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 26. doi: 10.1515/cclm-2025-0615. Online ahead of print. ABSTRACT OBJECTIVES: To determine whether the diagnostic accuracy of the liver fibrosis marker FIB-4 and the likelihood ratios (LRs) of specific FIB-4 values vary with age. METHODS: We used a published dataset of 540 patients diagnosed with non-alcoholic fatty liver disease (NAFLD) … Read more

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

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