Clinical Chemistry and Laboratory Medicine

Evaluation of measurement uncertainty of 11 serum proteins measured by immunoturbidimetric methods according to ISO/TS 20914: a 1-year laboratory data analysisEmine Feyza Yurton August 20, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 21. doi: 10.1515/cclm-2025-0654. Online ahead of print. ABSTRACT OBJECTIVES: Measurement uncertainty (MU) plays an important role in the interpretation of laboratory results, but data on serum proteins analyzed by immunoturbidimetry according to ISO/TS 20914 are limited. METHODS: MU of 11 serum proteins, including CRP, RF, ASO, IgG, IgA, IgM, … Read more

Verification of the T50 Calciprotein Crystallization test: bias estimation and interferencesJoyce Y Xuon August 20, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 20. doi: 10.1515/cclm-2025-0600. Online ahead of print. ABSTRACT OBJECTIVES: The T50 Calciprotein Crystallization test (T50 test) is a novel blood-based in vitro diagnostic assay that determines the calciprotein crystallization time in patients. It is based on the one-half maximum transition time of calciprotein particle 1 (CPP1) to calciprotein particle … Read more

Evaluating the performance of a multiparametric IgA assay for celiac disease diagnosisCaterina Maria Gambinoon August 20, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 20. doi: 10.1515/cclm-2025-0705. Online ahead of print. ABSTRACT OBJECTIVES: Celiac disease (CD) is a systemic autoimmune disorder triggered by gluten in genetically predisposed individuals. Accurate diagnosis remains challenging due to clinical heterogeneity and reliance on invasive biopsy. This study aimed to evaluate the diagnostic performance of a novel multiparametric … Read more

Assessing the harmonization of current total vitamin B12 measurement methods: relevance and implicationsBruno Mario Cesanaon August 19, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 20. doi: 10.1515/cclm-2025-0939. Online ahead of print. ABSTRACT OBJECTIVES: The UK National Institute for Health and Care Excellence has recommended thresholds for total vitamin B12 (B12) assays with interchangeable results for identifying B12 deficiency. We assessed the agreement between B12 methods, to evaluate whether the thresholds may be assumed … Read more

Clinical significance of anti-mitochondrial antibodies and PBC-specific anti-nuclear antibodies in evaluating atypical primary biliary cholangitis with normal alkaline phosphatase levelsShasha Lion August 19, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 20. doi: 10.1515/cclm-2025-0357. Online ahead of print. ABSTRACT OBJECTIVES: The clinical implications of positive anti-mitochondrial antibodies (AMAs) and/or primary biliary cholangitis (PBC)-specific anti-nuclear antibodies (ANAs) in patients with normal alkaline phosphatase (ALP) remain uncertain. METHODS: Patients at The Second Hospital of Nanjing with positive AMAs/PBC-ANAs and normal ALP levels … Read more

Urgent call to the European Commission to simplify and contextualize IVDR Article 5.5 for tailored and precision diagnosticsChrista Cobbaerton August 19, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 20. doi: 10.1515/cclm-2025-1033. Online ahead of print. ABSTRACT The European Commission (EC) started targeted evaluations and public consultations regarding the EU IVDR 2017/746 to assess its effectiveness, efficiency, relevance, and EU-added value. The goal is to identify implementation challenges and unintended consequences, experienced by either IVD-manufacturers that put CE-IVDs … Read more

A multiplex allele specific PCR capillary electrophoresis (mASPCR-CE) assay for simultaneously analysis of SMN1/SMN2/NAIP copy number and SMN1 loss-of-function variantsYunli Laion August 18, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 19. doi: 10.1515/cclm-2025-0175. Online ahead of print. ABSTRACT OBJECTIVES: Spinal muscular atrophy (SMA) is a severe inherited neuromuscular disorder with a high carrier frequency and incidence rate. An accurate molecular method for SMA genes is crucial in carrier screening, clinical diagnosis, outcome assessment and precision therapies. METHODS: Comprehensively using … Read more

Reference intervals in value-based laboratory medicine: a shift from single-point measurements to metabolic variation-based modelsAbdurrahman Coskunon August 16, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 18. doi: 10.1515/cclm-2025-0763. Online ahead of print. ABSTRACT Laboratory data can be meaningful only when compared with reliable reference data; therefore, the estimation of reliable reference data is just as important as the accurate measurement of measurands in patient samples. Since analyte concentrations in the human body are influenced … Read more

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