Flow Cytometry in Acute Myeloid Leukemia (AML): A Critical Tool for Accurate Diagnosis, Classification, and Monitoring

Clin Chem. 2025 Oct 23:hvaf111. doi: 10.1093/clinchem/hvaf111. Online ahead of print. ABSTRACT BACKGROUND: Flow cytometry is a crucial diagnostic tool in hematopathology. It supports the identification and follow-up of hematolymphoid neoplasms by providing detailed immunophenotypic data and quantification, and is applicable to various specimen types. CONTENT: Classification and management of acute myeloid leukemia (AML), the … Read more

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

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

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

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

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