Clinical Chemistry and Laboratory Medicine

Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment DataYating Maon September 17, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Sep 8. doi: 10.1515/cclm-2025-0683. Online ahead of print. ABSTRACT OBJECTIVES: To analyze the performance of laboratories in the China National External Quality Assessment Scheme (China NEQAS) for HbA2 and HbF testing, and to propose strategies for quality improvement. METHODS: Data were obtained from China NEQAS from 2013 to 2024 using … Read more

An assessment of molecular diagnosis of tuberculosis and multi-drug resistant tuberculosis testing and quality assessment: findings of an international surveyJim F Huggetton September 16, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Sep 5. doi: 10.1515/cclm-2025-0750. Online ahead of print. ABSTRACT Molecular ‘in vitro diagnostic’ (IVD) tests are established for the diagnosis of tuberculosis (TB) and multi-drug resistant TB (MDR-TB). What is less clear is how the use of TB or MDR-TB molecular IVD results differ across regions, whether corroborative tests are … Read more

Not all anti-parietal cell antibody tests are equal for diagnosing pernicious anemiaValentin Lacombeon September 16, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Sep 5. doi: 10.1515/cclm-2025-0671. Online ahead of print. ABSTRACT OBJECTIVES: Pernicious anemia (PA) is a common cause of vitamin B12 deficiency and requires a robust diagnosis to guide lifelong treatment. Anti-parietal cell antibodies (APCA) are frequently used as a diagnostic marker, but their poor specificity raises concerns about overdiagnosis, particularly … Read more

Defining the analytical characteristics of a novel high-sensitivity point-of-care troponin I assay in its intended clinical environmentJames Hatherleyon September 2, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Sep 3. doi: 10.1515/cclm-2025-0374. Online ahead of print. ABSTRACT OBJECTIVES: To assess the imprecision and stability of the point-of-care troponin I assay in the Emergency Department and its correlation and bias to two central laboratory troponin I assays (Siemens Atellica and Abbott Alinity). METHODS: Imprecision and stability testing was performed … Read more

Method comparison of plasma and CSF GFAP immunoassays across multiple platformsBurak Arslanon September 1, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Sep 2. doi: 10.1515/cclm-2025-0667. Online ahead of print. ABSTRACT OBJECTIVES: Glial fibrillary acidic protein (GFAP) is a biomarker of astrocytic activation associated with neurodegenerative diseases, neuroinflammatory disorders, and traumatic brain injury. However, the lack of standardized methods for quantifying GFAP across different immunoassay platforms poses challenges for its clinical implementation. … Read more

Interference of therapeutic monoclonal antibodies with electrophoresis and immunofixation of serum proteins: state of knowledge and systematic reviewSacha Pelletieron August 30, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Sep 1. doi: 10.1515/cclm-2025-0678. Online ahead of print. ABSTRACT INTRODUCTION: The increasing use of therapeutic monoclonal antibodies (t-mAbs) has improved cancer and autoimmune disorder treatment. These therapeutics can interfere with serum protein electrophoresis (SPEP) and immunofixation (IF), potentially leading to the appearance of monoclonal bands that may be misinterpreted as … Read more

Fecal leukocyte esterase levels predict endoscopic severity as an alternative biomarker in inflammatory bowel diseaseFeng-Pai Tsaion August 30, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Sep 1. doi: 10.1515/cclm-2025-0747. Online ahead of print. ABSTRACT OBJECTIVES: Our previous study revealed a correlation between fecal leukocyte esterase and fecal calprotectin levels. This study assessed the predictive value of fecal leukocyte esterase compared with fecal calprotectin and C-reactive protein of inflammatory bowel disease. METHODS: Patients with inflammatory bowel … Read more

Cerebrospinal fluid leptin in Alzheimer’s disease: relationship to plasma levels and to cerebrospinal amyloidElodie Bouaziz-Amaron August 30, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Sep 1. doi: 10.1515/cclm-2025-0304. Online ahead of print. ABSTRACT OBJECTIVES: Dysregulation of brain leptin signaling contributes to Alzheimer’s disease (AD) pathophysiology, but plasma leptin may not accurately reflect central nervous system activity. This study examined the correlation between plasma and cerebrospinal fluid (CSF) leptin levels and their relationship with beta-amyloid … Read more

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