Clinical Chemistry

Challenges in Hb A1c Point-of-Care Testing: Only 6 of 19 Hb A1c Point-of-Care Devices Meet IFCC and NGSP Certification Criteria on Independent Evaluation

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Clin Chem. 2025 May 26:hvaf059. doi: 10.1093/clinchem/hvaf059. Online ahead of print. ABSTRACT BACKGROUND: Access to Hb A1c testing in low- and middle-income countries (LMICs) can be limited, especially in rural areas. This has led to an increased interest in the potential role of point-of-care testing (POCT) for Hb A1c. The analytical performance of many of … Read more

Plasma Neprilysin in Heart Failure: Response Dynamics and Clinical Associations Are Immunoassay Dependent

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Clin Chem. 2025 May 21:hvaf056. doi: 10.1093/clinchem/hvaf056. Online ahead of print. ABSTRACT BACKGROUND: Discordance among published findings on the plasma concentrations, response dynamics, and clinical associations of plasma neprilysin (NEP) in health and heart failure (HF) require clarification. METHOD: Using a newly developed glycosylation-sensitive monoclonal antibody sandwich ELISA (NEPCVRI), plasma NEP was measured in 99 … Read more

Automated and Decentralized Genomic Profiling of Plasma Cell-Free DNA for Identification of Targetable and Resistance Alterations in Advanced Solid Tumors

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Clin Chem. 2025 May 5:hvaf045. doi: 10.1093/clinchem/hvaf045. Online ahead of print. ABSTRACT BACKGROUND: Existing circulating cell-free DNA (cfDNA) assays are primarily centralized, requiring specialized sample handling and transportation. Implementing a flexible, decentralized sequencing system at point of care, with minimal technical oversight, can enhance turnaround times and patient access to genomic profiling. In this study, … Read more

Biological Variation of Erythrocyte Total, Metal-Free, and Zinc Protoporphyrin IX in Patients with Erythropoietic Protoporphyria and Healthy Subjects: Implications for Clinical Interpretation and Monitoring

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Clin Chem. 2025 May 2:hvaf055. doi: 10.1093/clinchem/hvaf055. Online ahead of print. ABSTRACT BACKGROUND: There is a lack of robust biological variation (BV) data for porphyria-related biomarkers. Our study aimed to estimate BV of erythrocyte total, metal-free, and zinc protoporphyrin IX in patients with erythropoietic protoporphyria (EPP) and healthy subjects and to explore the clinical implications … Read more

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