Clinical Chemistry and Laboratory Medicine

Australasian guideline for the performance of sweat chloride testing 3rd edition: to support cystic fibrosis screening, diagnosis and monitoringJohn Massieon June 6, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Jun 9. doi: 10.1515/cclm-2025-0433. Online ahead of print. ABSTRACT The sweat test is used as a biological marker of cystic fibrosis transmembrane conductance regulator (CFTR) dysfunction, but there is growing recognition that sweat chloride concentrations of people with cystic fibrosis (CF) can overlap with those without CF. There are also … Read more

A comparison of current methods to measure antibodies in type 1 diabetesMaria Infantinoon June 3, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Jun 4. doi: 10.1515/cclm-2025-0238. Online ahead of print. ABSTRACT OBJECTIVES: Type 1 diabetes (T1D) is a chronic autoimmune disease causing β-cell destruction, hyperglycemia, and lifelong insulin dependence that can lead to severe complications like ketoacidosis, with a 1 % mortality rate in newly diagnosed patients. A significant breakthrough in T1D … Read more

Validation of (self-collected) capillary blood using a topper collection system as alternative for venous sampling for 15 common clinical chemistry analytesRümeysa Geujaron June 3, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 Jun 2. doi: 10.1515/cclm-2025-0148. Online ahead of print. ABSTRACT OBJECTIVES: Home blood sampling for clinical purposes has gained much interest. This study validates the recently developed Topper-based capillary blood collection procedure for 15 commonly used chemistry analytes. METHODS: A total of 120 study participants (21 healthy volunteers and 99 patients) … Read more

No fault or negligence after an adverse analytical finding due to a contaminated supplement: mission impossible. Two examples involving trimetazidinePascal Kintzon June 3, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 May 30. doi: 10.1515/cclm-2025-0549. Online ahead of print. ABSTRACT Since several years, sports authorities, including national anti-doping organisations and the World Anti-Doping Agency (WADA) have published that the consumption of food supplements can be at risk for athletes due to potential contamination by prohibited substances. Despite these warnings, supplements are … Read more

Immunochemical measurement of urinary free light chains and Bence Jones proteinuriaLaura Michettion June 3, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 May 30. doi: 10.1515/cclm-2025-0265. Online ahead of print. ABSTRACT OBJECTIVES: To evaluate the characteristics of an immunochemical urinary free light chains (uFLC) test in screening and quantifying Bence Jones proteinuria (BJP) and its potential application in laboratory practice as an alternative to the gold standard method, urine immunofixation (UIFE) and … Read more

Machine learning algorithms with body fluid parameters: an interpretable framework for malignant cell screening in cerebrospinal fluidXianfei Yeon May 29, 2025 at 10:00 am

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Clin Chem Lab Med. 2025 May 28. doi: 10.1515/cclm-2025-0302. Online ahead of print. ABSTRACT OBJECTIVES: This study aimed to develop and validate a machine learning (ML) model utilizing cerebrospinal fluid (CSF) body fluid parameters from hematology analyzers to screen for malignant cells. METHODS: We analyzed 643 consecutive CSF samples from patients with central nervous system … Read more

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

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