Clinical Chemistry and Laboratory Medicine

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

Evaluation of stability and potential interference on the α-thalassaemia early eluting peak and immunochromatographic strip test for α-thalassaemia –SEA carrier screeningWing Kit Lamon August 16, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 18. doi: 10.1515/cclm-2025-0754. Online ahead of print. ABSTRACT OBJECTIVES: α-Thalassaemia screening is crucial for identifying carriers at risk of having offspring with haemoglobin (Hb) Bart’s hydrops fetalis syndrome. This study evaluated the performance of two potential screening methods: the α-thalassaemia early eluting peak (αEEP) identified by high-performance liquid chromatography … Read more

The importance of laboratory medicine in the management of CKD-MBD: insights from the KDIGO 2023 controversies conferenceSamuel D Vasikaranon August 16, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 15. doi: 10.1515/cclm-2025-0802. Online ahead of print. ABSTRACT Laboratory investigations are important in the clinical management and the study of chronic kidney disease-mineral and bone disorder (CKD-MBD)- including CKD-associated osteoporosis. Parathyroid hormone (PTH) is the major hormone in the regulation of bone and calcium balance but is significantly affected … Read more

Analytical and clinical evaluation of an automated high-sensitivity cardiac troponin I assay for whole bloodJin-Xing Yuon August 14, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Aug 15. doi: 10.1515/cclm-2025-0143. Online ahead of print. ABSTRACT OBJECTIVES: To evaluate the performance of the iStar high-sensitivity cardiac troponin I (hs-cTnI) assay, focusing on its sensitivity, precision, linearity, and consistency with plasma samples, and to establish sex-specific 99th percentile upper reference limits. METHODS: The iStar hs-cTnI assay was assessed … Read more

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