Clinical Chemistry

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

Age-Specific Control and Alzheimer Disease Reference Curves and z-Scores for Glial Fibrillary Acidic Protein in Blood

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Clin Chem. 2025 Oct 13:hvaf120. doi: 10.1093/clinchem/hvaf120. Online ahead of print. ABSTRACT BACKGROUND: Serum glial fibrillary acidic protein (GFAP) is a biomarker for astrocytic injury and astrogliosis. Concentrations are elevated in numerous neurological disorders, including a pronounced increase in Alzheimer disease (AD). However, GFAP levels in the serum also increase with age. Consequently, the integration … Read more

Harnessing Personalized Nutrition and Clinical Chemistry: Opportunities to Improve Public Health

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Clin Chem. 2025 Oct 13:hvaf114. doi: 10.1093/clinchem/hvaf114. Online ahead of print. ABSTRACT BACKGROUND: The past 2 decades have seen rapid advances in the development of the concept of personalized nutrition (PN) interventions, and in its application. PN has evolved from attempts to understand the well-recognized interindividual variability in response to dietary intervention that have been … Read more

A New International Patient-Based External Quality Assessment Program to Monitor Harmonization and Standardization Efforts

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Clin Chem. 2025 Oct 10:hvaf122. doi: 10.1093/clinchem/hvaf122. Online ahead of print. ABSTRACT BACKGROUND: External quality assessment (EQA) should strive to monitor and reflect variation across laboratories and measuring systems. We introduce a newly developed patient-based EQA program named Noklus Patient Median (NOPAM) that is freely available for the participants. The results from NOPAM enable laboratories … Read more

Quantitative Analysis of a Novel Metabolite Panel to Estimate GFR (Panel eGFR) in Serum and Plasma Using LC-MS/MS

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Clin Chem. 2025 Oct 10:hvaf110. doi: 10.1093/clinchem/hvaf110. Online ahead of print. ABSTRACT BACKGROUND: Estimated glomerular filtration rate (eGFR) using creatinine (eGFRcr), cystatin C (eGFRcys), or both (eGFRcr-cys) is not sufficiently accurate in many settings, often due to non-glomerular filtration rate (GFR) determinants of the filtration markers. In principle, using a panel of endogenous markers (panel … Read more

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