Clinical Chemistry and Laboratory Medicine

Impact of analytical bias on machine learning models for sepsis prediction using laboratory dataMeryem Rumeysa Yesilon May 29, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 May 28. doi: 10.1515/cclm-2025-0491. Online ahead of print. ABSTRACT OBJECTIVES: Machine learning (ML) models, using laboratory data, support early sepsis prediction. However, analytical bias in laboratory measurements can compromise their performance and validity in real-world settings. We aimed to evaluate how analytically acceptable bias may affect the validity and generalizability … Read more

Regulating the future of laboratory medicine: European regulatory landscape of AI-driven medical device software in laboratory medicineHikmet Can Çubukçuon May 29, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 May 28. doi: 10.1515/cclm-2025-0482. Online ahead of print. ABSTRACT Artificial intelligence (AI) is rapidly transforming laboratory medicine, impacting medical devices and healthcare practices. Despite these advancements, AI-based medical device software (MDSW) introduces a new layer of complexity in regulatory compliance. This paper outlines the regulatory landscape for MDSW and AI-driven … Read more

Serum biomarkers as early indicators of outcomes in spontaneous subarachnoid hemorrhageAnna Maria Auricchioon May 29, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 May 28. doi: 10.1515/cclm-2025-0309. Online ahead of print. ABSTRACT OBJECTIVES: Spontaneous subarachnoid hemorrhage (sSAH) is a life-threatening neurological event with high morbidity and mortality. Predicting patient outcomes remains challenging, necessitating novel prognostic tools. This study evaluates the prognostic value of central and systemic serum biomarkers, including S100, neuron-specific enolase (NSE), … Read more

Commutability evaluation of glycated albumin candidate EQA materialsRui Wuon May 29, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 May 28. doi: 10.1515/cclm-2025-0507. Online ahead of print. ABSTRACT OBJECTIVES: In clinical practice, glycated albumin (GA), as a key biomarker reflecting the level of blood glucose control in the short and medium term, has been widely used in the diagnosis and efficacy monitoring of diabetes. However, the consistency of GA … Read more

Understanding the circulating forms of cardiac troponin: insights for clinical practicePanpan Lvon May 29, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 May 28. doi: 10.1515/cclm-2024-1236. Online ahead of print. ABSTRACT Ischemic heart disease remains the leading cause of death globally, with acute coronary syndrome (ACS) being the main reason for emergency hospital admissions and thus representing a significant health care issue worldwide. Cardiac troponin I (cTnI) and cardiac troponin T (cTnT) … Read more

Effect of long-term frozen storage on stability of kappa free light chain indexMartin Schmidaueron May 28, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 May 8. doi: 10.1515/cclm-2025-0125. Online ahead of print. ABSTRACT OBJECTIVES: To investigate whether frozen storage duration influences κ-FLC index. METHODS: CSF and serum samples of patients with multiple sclerosis collected for routine diagnostic purposes had been stored at -20 °C. κ-FLC and albumin concentrations were measured at two different timepoints, … Read more

An isotope dilution-liquid chromatography-tandem mass spectrometry-based candidate reference measurement procedure for the quantification of 17β-estradiol in human serum and plasmaMyriam Otton May 28, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 May 26. doi: 10.1515/cclm-2024-1255. Online ahead of print. ABSTRACT OBJECTIVES: A new candidate isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS)-based reference measurement procedure (RMP) has been developed for the accurate and precise quantification of 17β-estradiol (E2) in human serum and plasma covering a measurement range from 0.400 to 5,000 pg/mL (1.47-18,357 … Read more

Candidate reference measurement procedure based on isotope dilution-two dimensional-liquid chromatography-tandem mass spectrometry for the quantification of androstenedione in human serum and plasmaMyriam Otton May 27, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 May 23. doi: 10.1515/cclm-2024-1135. Online ahead of print. ABSTRACT OBJECTIVES: Androstenedione (ASD) is a biomarker used in the diagnosis of hyperandrogenism and adrenal hyperplasia. Therefore, accurate measurement of serum ASD is pivotal in clinical settings. We aimed to develop a novel highly selective reference measurement procedure (RMP) based on isotope … Read more

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