Clinical Chemistry and Laboratory Medicine

Clin Chem Lab Med. 2026 Mar 16. doi: 10.1515/cclm-2026-0183. Online ahead of print. ABSTRACT OBJECTIVES: To estimate the frequency and characterize the distinctive features of the serum electrophoretic pattern associated with polyclonal elevations of IgG4, and to evaluate its clinical relevance. METHODS: A total of 127,827 serum protein electrophoresis (SPEP) analyses performed in our laboratory … Read more

Clin Chem Lab Med. 2026 Mar 17. doi: 10.1515/cclm-2026-0288. Online ahead of print. ABSTRACT OBJECTIVES: European legislation requires detailed performance evaluation of in vitro diagnostic medical devices (IVD-MD) by both commercial manufacturers (through the Conformité Européenne (CE) mark) and in-house (IH) IVDs. Little information is currently available on how CE- and IH-IVDs are mapped in … Read more

Clin Chem Lab Med. 2026 Mar 16. doi: 10.1515/cclm-2026-0168. Online ahead of print. ABSTRACT OBJECTIVES: Fluid biomarkers are central to the biological definition and diagnosis of Alzheimer’s disease (AD). Despite international recommendations, substantial variability persists in laboratory practices. This survey, promoted by the Committee: Harmonisation (C:H) of the European Federation of Clinical Chemistry and Laboratory … Read more

Clin Chem Lab Med. 2026 Mar 16. doi: 10.1515/cclm-2026-0032. Online ahead of print. ABSTRACT OBJECTIVES: Since apolipoprotein E4 (ApoE4) is associated with therapy-related adverse effects of anti-amyloid-β monoclonal antibodies in Alzheimer’s disease, such as amyloid-related imaging abnormalities, methods for determining the ApoE4 status are needed. The Lumipulse® ApoE4 and Pan-ApoE assays provide a practical approach, … Read more

Clin Chem Lab Med. 2026 Mar 13. doi: 10.1515/cclm-2026-0323. Online ahead of print. ABSTRACT The Joint Committee for Traceability in Laboratory Medicine (JCTLM) supports worldwide equivalence and comparability of measurement results in laboratory medicine to improve health care and facilitate national and international trade in in vitro diagnostic (IVD) medical devices. The 2025 biennial members … Read more

Clin Chem Lab Med. 2026 Mar 13. doi: 10.1515/cclm-2026-0309. Online ahead of print. ABSTRACT Point-of-care testing (POCT) represents a breakthrough technology in laboratory medicine that has expanded rapidly over the past three decades. Today, it accounts for approximately 25 % of all laboratory tests performed worldwide. POCT was initially implemented in critical care settings due … Read more

Clin Chem Lab Med. 2026 Mar 13. doi: 10.1515/cclm-2025-1743. Online ahead of print. ABSTRACT Neurofilament light chain (NfL) has been identified as a sensitive and broadly validated biomarker of neuroaxonal injury across multiple neurological conditions, including multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Alzheimer’s disease (AD), and atypical parkinsonian syndromes. This position paper provides a … Read more

Clin Chem Lab Med. 2026 Mar 13. doi: 10.1515/cclm-2026-0057. Online ahead of print. ABSTRACT OBJECTIVES: Measurement of the concentrations of vitamin D metabolites is clinically important because abnormal levels are associated with perturbations in calcium and phosphorus homeostasis. The objective of this study was to evaluate analytical performance of the Ionify® Vitamin D iPack that … Read more

Clin Chem Lab Med. 2026 Mar 12. doi: 10.1515/cclm-2026-0251. Online ahead of print. ABSTRACT OBJECTIVES: Cervical lymph node metastases represent a key challenge in patients with differentiated thyroid carcinoma (DTC). Fine-needle aspiration cytology (FNAC) and thyroglobulin (Tg) measurement in fine-needle washout (FNA-Tg) are widely used but have recognized limitations. Cytokeratin 19 fragment 21-1 measurement in … Read more

Clin Chem Lab Med. 2026 Mar 12. doi: 10.1515/cclm-2026-0101. Online ahead of print. ABSTRACT Clinical endocrinology relies critically on high-quality biochemical data for diagnosis, therapeutic decisions, and long-term patient monitoring. As endocrine diagnostics grow more complex due to expanding test menus, technological advances, and changing patient populations, the need for a strong, structured partnership between … Read more