Clinical Chemistry and Laboratory Medicine

Clin Chem Lab Med. 2026 May 13. doi: 10.1515/cclm-2026-0590. Online ahead of print. ABSTRACT Harmonization in laboratory medicine is increasingly recognized as a fundamental requirement to ensure interchangeable laboratory information, avoid confusion among users, and ultimately improve patient safety. However, current evidence continues to highlight substantial gaps in harmonization across several dimensions of the total … Read more

Clin Chem Lab Med. 2026 May 11. doi: 10.1515/cclm-2026-0554. Online ahead of print. NO ABSTRACT PMID:42107068 | DOI:10.1515/cclm-2026-0554

Clin Chem Lab Med. 2026 May 11. doi: 10.1515/cclm-2025-1727. Online ahead of print. ABSTRACT OBJECTIVES: Pathological conditions may result in clinical chemical values exceeding the linearity range of laboratory methods. In clinical practice, not all tests require exact numerical values for patient management, as useful information can still be provided when results are reported to … Read more

Clin Chem Lab Med. 2026 May 11. doi: 10.1515/cclm-2026-0624. Online ahead of print. NO ABSTRACT PMID:42106163 | DOI:10.1515/cclm-2026-0624

Clin Chem Lab Med. 2026 May 11. doi: 10.1515/cclm-2026-0377. Online ahead of print. ABSTRACT A widely accepted approach to setting Analytical Performance Specifications (APS) in laboratory medicine is the Milan models. Milan model 1b is an approach where APS are developed based on patient classification, or clinical decision-making, noting that these factors link to the … Read more

Clin Chem Lab Med. 2026 May 11. doi: 10.1515/cclm-2026-0153. Online ahead of print. ABSTRACT OBJECTIVES: Few studies have systematically evaluated the factors contributing to laboratory errors in the analytical phase. This study analyzed five years of retest data to determine the frequency and characteristics of analytical errors across routine blood chemistry parameters, identify analytes most … Read more

Clin Chem Lab Med. 2026 May 5. doi: 10.1515/cclm-2026-0395. Online ahead of print. ABSTRACT OBJECTIVES: Plasma phosphorylated tau at threonine 217 (p-tau217) has emerged as a highly accurate blood-based biomarker of Alzheimer’s disease (AD) pathology. As disease-modifying anti-amyloid therapies enter clinical practice, scalable biomarkers with robust and clinically interpretable decision thresholds are required. However, evidence … Read more

Clin Chem Lab Med. 2026 May 7. doi: 10.1515/cclm-2025-1137. Online ahead of print. ABSTRACT OBJECTIVES: This study developed a pseudoviral human rhinovirus (HRV) reference material using pseudovirus technology and integrating RT-dPCR with HPLC-IDMS to achieve accurate HRV RNA quantification, aiming to standardize HRV detection across labs and platforms. METHODS: We developed an RT-digital PCR (RT-dPCR) … Read more

Clin Chem Lab Med. 2026 May 7. doi: 10.1515/cclm-2026-0580. Online ahead of print. ABSTRACT Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was introduced to enhance patient safety and ensure the availability of safe and effective diagnostics across the European Union. However, its implementation has led to substantial unintended consequences, including certification bottlenecks, … Read more

Clin Chem Lab Med. 2026 May 6. doi: 10.1515/cclm-2026-0289. Online ahead of print. ABSTRACT OBJECTIVES: To evaluate the real-world impact of Point-of-Care Testing on care timeliness and patient flow in the emergency department. METHODS: A before-and-after, matched-cohort study was conducted involving 25,291 patients with Emergency Severity Index levels 3-4. A POCT group (n=8,746) was compared … Read more