Clinical Chemistry and Laboratory Medicine

Proposed laboratory diagnostic workflow in the Italian national screening program for type 1 diabetesLucia Babinion July 29, 2026 at 10:00 am

July 29, 2026 by ccinfoadmin

Clin Chem Lab Med. 2026 Jul 30. doi: 10.1515/cclm-2026-0536. Online ahead of print. ABSTRACT Population screening for type 1 diabetes (T1D) using pancreatic islet autoantibodies is increasingly recognized as a promising strategy to reduce diabetic ketoacidosis and identify individuals during the presymptomatic stages of the disease. In Italy, Law 130/2023 and the implementing decree of … Read more

The severity of harm score database: an evidence-based foundation for laboratory test risk analysisHikmet Can Çubukçuon July 28, 2026 at 10:00 am

July 28, 2026 by ccinfoadmin

Clin Chem Lab Med. 2026 Jul 29. doi: 10.1515/cclm-2026-0875. Online ahead of print. ABSTRACT BACKGROUND: Patient risk management has become central to clinical laboratory quality standards, including the Clinical and Laboratory Standards Institute (CLSI) EP23 2nd edition (CLSI EP23-ED2), International Organization for Standardization (ISO) 15189:2022, ISO 22367:2026, and ISO 14971:2019. A key component of risk … Read more

Performance validation of mass spectrometry for detecting urinary Bence Jones protein and evaluation of its clinical application in multiple myeloma and amyloidosisYu Chenon July 28, 2026 at 10:00 am

July 28, 2026 by ccinfoadmin

Clin Chem Lab Med. 2026 Jul 29. doi: 10.1515/cclm-2026-0469. Online ahead of print. ABSTRACT OBJECTIVES: Traditional urine immunofixation electrophoresis (uIFE) is cumbersome, has limited sensitivity, and is subjectively interpreted. This is especially problematic in renal impairment where accumulation of polyclonal free light chains may pseudonormalize the serum free light chain (sFLC) ratio, compromising its reliability … Read more

Improving the performance of biochemical genetic testing through external quality assessmentKatrin Freiburghauson July 28, 2026 at 10:00 am

July 28, 2026 by ccinfoadmin

Clin Chem Lab Med. 2026 Jul 29. doi: 10.1515/cclm-2026-0815. Online ahead of print. ABSTRACT OBJECTIVES: External quality assessment (EQA) is essential for ensuring reliable biochemical genetic testing. This study evaluated long-term performance trends in ERNDIM quantitative EQA schemes, including special assays in serum (SAS), special assays in urine (SAU), purines and pyrimidines in urine (PPU), … Read more

Prospective evaluation of a multi-gene cfDNA methylation assay for CRC screening in a high-risk cohortYing Lion July 28, 2026 at 10:00 am

July 28, 2026 by ccinfoadmin

Clin Chem Lab Med. 2026 Jul 29. doi: 10.1515/cclm-2026-0185. Online ahead of print. ABSTRACT OBJECTIVES: Colorectal cancer (CRC) screening is crucial for early detection, yet the invasiveness of the gold-standard colonoscopy limits compliance. To address the limitation, this study proposes a novel multi-target free DNA methylation model and evaluated its risk stratification performance for CRC … Read more

Evaluating Cobas® b101 for lipid profile and SCORE2 risk assessment from capillary blood in population screeningAntoine Villeminon July 27, 2026 at 10:00 am

July 27, 2026 by ccinfoadmin

Clin Chem Lab Med. 2026 Jul 28. doi: 10.1515/cclm-2026-0570. Online ahead of print. ABSTRACT OBJECTIVES: Cardiovascular disease (CVD) is a leading cause of mortality worldwide. Emerging lung cancer screening in smokers may offer an opportunity for simultaneous cardiovascular risk evaluation. We developed a mobile CT screening unit and assessed the feasibility of integrating dyslipidemia screening … Read more

The ISO 15189-IVDR dilemma in medical laboratory practiceIheb Elkaibion July 27, 2026 at 10:00 am

July 27, 2026 by ccinfoadmin

Clin Chem Lab Med. 2026 Jul 27. doi: 10.1515/cclm-2026-0864. Online ahead of print. ABSTRACT INTRODUCTION: To analyse the structural and operational divergences between NF EN ISO 15189:2022 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in the context of medical laboratory practice in Europe. CONTENT: This article provides a structured comparative analysis … Read more

Risk outcome assessment with novel long-T ITC complex and high sensitivity troponin I and T in patients with suspected acute coronary syndromes: MERITnI substudyFred S Appleon July 26, 2026 at 10:00 am

July 26, 2026 by ccinfoadmin

Clin Chem Lab Med. 2026 Jul 27. doi: 10.1515/cclm-2026-0790. Online ahead of print. ABSTRACT OBJECTIVES: Understanding whether the novel long-T ITC complex might assist in interpreting clinical prognostic utility compared to established cardiac biomarkers is needed. We determined long term major adverse cardiac events (MACE) and all-cause mortality (ACM) predicated on novel long-T ITC complex … Read more

The BV calculator: a free, open-source web app for estimation of within-subject and between-subject biological variationHikmet Can Çubukçuon July 24, 2026 at 10:00 am

July 24, 2026 by ccinfoadmin

Clin Chem Lab Med. 2026 Jul 27. doi: 10.1515/cclm-2026-0863. Online ahead of print. ABSTRACT OBJECTIVES: Biological variation (BV) data are essential for many purposes in laboratory medicine, however, the complex statistical analysis remains a barrier for delivery of BV data. This study describes the development of a web-based BV Calculator based on the Biological Variation … Read more

Pediatric reference intervals for 27 routine chemistry analytes in healthy children and adolescents on the Roche cobas pro platformBenjamin Jungon July 24, 2026 at 10:00 am

July 24, 2026 by ccinfoadmin

Clin Chem Lab Med. 2026 Jul 27. doi: 10.1515/cclm-2026-0627. Online ahead of print. ABSTRACT OBJECTIVES: Accurate interpretation of pediatric laboratory test results requires robust age- and sex-specific reference intervals (RIs). Undertaking studies to establish RIs across the pediatric age range is particularly challenging due to rapid physiological changes during growth and development. While the Roche … Read more