Clin Chem Lab Med. 2026 Apr 13. doi: 10.1515/cclm-2026-0236. Online ahead of print. ABSTRACT OBJECTIVES: Multitarget stool tests are approved for colorectal cancer (CRC) screening. Here we developed a multitarget stool test based on the fecal immunochemical test (FIT) and two (NDRG4 and SDC2) DNA methylation markers with a simple calling algorithm. METHODS: FIT, quantitative … Read more
Clin Chem Lab Med. 2026 Apr 13. doi: 10.1515/cclm-2026-0093. Online ahead of print. ABSTRACT OBJECTIVES: To evaluate the analytical performance and clinical workflow efficiency of the Flash10 molecular point-of-care testing (POCT) system for the detection of influenza A (FluA) and influenza B (FluB) viruses. METHODS: Throat swab specimens from 178 individuals presenting with influenza-like symptoms … Read more
Clin Chem Lab Med. 2026 Apr 13. doi: 10.1515/cclm-2026-0043. Online ahead of print. ABSTRACT OBJECTIVES: Several macro-hormones have been reported to date. Among them, macroprolactinemia is a common cause of hyperprolactinemia. Growth hormone (GH) and prolactin (PRL) are anterior pituitary hormones related by structure and function. The aim of this study was to clarify the … Read more
Clin Chem Lab Med. 2026 Apr 3. doi: 10.1515/cclm-2026-0109. Online ahead of print. ABSTRACT In precision medicine protein phenotypes are foreseen that combined with pattern recognition tools exhibit great potential in guaranteeing safe and accurate test results for patient management and intervention. For discovery purposes novel high-throughput technologies have emerged and this has led to … Read more
Clin Chem Lab Med. 2026 Apr 2. doi: 10.1515/cclm-2025-1694. Online ahead of print. ABSTRACT OBJECTIVES: This study aimed to compare the analytical and clinical performance of plasma glial fibrillary acidic protein (GFAP) across three immunoassay platforms. METHODS: Plasma GFAP was measured on three immunoassay platforms (Simoa HD-X, Maccura i1000, MS-Fast Pro 160) in 302 participants … Read more
Clin Chem Lab Med. 2026 Mar 20. doi: 10.1515/cclm-2026-0112. Online ahead of print. ABSTRACT OBJECTIVES: Indirect clinical outcome-based analytical performance specifications (APS) may offer a feasible alternative to direct studies but raise questions regarding data requirements and transferability. This study aimed to determine the minimum sample size for simulation-driven APS and to investigate the impact … Read more
Clin Chem Lab Med. 2026 Mar 20. doi: 10.1515/cclm-2026-0049. Online ahead of print. ABSTRACT OBJECTIVES: Patient-based real-time quality control (PBRTQC) represents a useful complement to traditional internal quality control methods, particularly in the continuous monitoring of routine analyses. Sodium, potassium, chloride, calcium, phosphorus, and magnesium are critical for patient safety. This study aimed to evaluate … Read more
Clin Chem Lab Med. 2026 Mar 16. doi: 10.1515/cclm-2026-0234. Online ahead of print. ABSTRACT Acute kidney injury (AKI) is a frequent complication in hospitalized patients, particularly those admitted to the intensive care unit (ICU), which leads to high rates of morbidity and mortality. Under these conditions, tissue inhibitor metalloproteinases-2 (TIMP-2) and insulin-like growth factor-binding protein … Read more
Clin Chem Lab Med. 2026 Mar 18. doi: 10.1515/cclm-2026-0075. Online ahead of print. ABSTRACT More than 30 years after German reunification, the units of measurement used for laboratory medical parameters still differ between eastern and western Germany. While the eastern German states predominantly use “SI” units, “conventional” units are common in medical facilities in the … Read more
Clin Chem Lab Med. 2026 Mar 16. doi: 10.1515/cclm-2025-1526. Online ahead of print. ABSTRACT OBJECTIVES: The inclusion of neurobiomarkers (NB) into routine clinical practice remains an unresolved challenge. Among the actions recommended by leading international institutions, a key priority is the establishment of reference curves during the perinatal period. The aim of the study was … Read more
Clin Chem Lab Med. 2026 Mar 16. doi: 10.1515/cclm-2026-0174. Online ahead of print. ABSTRACT Laboratory errors represent a critical yet underestimated threat to patient safety, with 26-30 % of reported errors adversely affecting patient care. Despite extensive scientific literature, no sustainable, open-access platform exists that allows laboratory professionals to rapidly access comprehensive information on error … Read more
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
Clin Chem Lab Med. 2026 Mar 12. doi: 10.1515/cclm-2025-1169. Online ahead of print. ABSTRACT OBJECTIVES: Accurate measurement of 17α-hydroxyprogesterone (17-OHP) in human serum and plasma is required for steroid profiling, to ensure the appropriate diagnosis of congenital adrenal hyperplasia. Therefore, an isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS)-based candidate reference measurement procedure (RMP) to quantify 17-OHP … Read more
Clin Chem Lab Med. 2026 Mar 5. doi: 10.1515/cclm-2025-1493. Online ahead of print. ABSTRACT OBJECTIVES: To determine the prevalence and clinical associations of rare HEp 2 indirect immunofluorescence ANA patterns and to evaluate their relationships with disease categories, ANA titers, and expression form. METHODS: We retrospectively analyzed 366,524 ANA tests performed between 2018 and 2024 … Read more
Clin Chem Lab Med. 2026 Mar 10. doi: 10.1515/cclm-2025-1366. Online ahead of print. ABSTRACT OBJECTIVES: The quantification of linezolid in serum and plasma matrices is crucial for therapeutic drug monitoring and pharmacokinetic studies. A reference measurement procedure (RMP) was developed and validated to provide accurate, precise, and reliable measurements, fit for its intended use while … Read more
Clin Chem Lab Med. 2026 Mar 5. doi: 10.1515/cclm-2026-0210. Online ahead of print. ABSTRACT A challenge in the implementation of rapid risk-stratification algorithms for patients with suspected acute coronary syndrome is the turnaround time for cardiac troponin (cTn) from blood sampling to reporting of results. Measurement of cTn in whole blood using point of care … Read more
Clin Chem Lab Med. 2026 Mar 3. doi: 10.1515/cclm-2026-0042. Online ahead of print. ABSTRACT Hemophilia A and B are X-linked hemorrhagic disorders, characterized by low/dysfunctional factor (F)VIII or FIX, respectively. The history of hemophilia treatment has evolved remarkably over time from the introduction of cryoprecipitate in the 1960s to plasma-derived factors in the 1970s. The … Read more
Clin Chem Lab Med. 2026 Mar 3. doi: 10.1515/cclm-2026-0083. Online ahead of print. ABSTRACT OBJECTIVES: We evaluated the diagnostic performance of the Atellica HEMA 580 hematology analyzer for complete blood count (CBC) parameters compared with the ADVIA 2120i and assessed its capability to flag abnormal cells, and determined optimal cut-offs for immature myeloid cell detection. … Read more
Clin Chem Lab Med. 2026 Mar 2. doi: 10.1515/cclm-2026-0088. Online ahead of print. ABSTRACT OBJECTIVES: Antiphospholipid antibodies (aPLs) are closely associated with recurrent spontaneous abortion (RSA) and adverse pregnancy outcomes (POs). Non-criteria aPLs may aid in diagnosing seronegative aPL-related RSA, but their limited performance often leads to missed or delayed diagnosis. This study aimed to … Read more
Clin Chem Lab Med. 2026 Mar 2. doi: 10.1515/cclm-2025-1679. Online ahead of print. ABSTRACT OBJECTIVES: Primary aldosteronism (PA) is a common cause of secondary hypertension. To address the specificity limits of immunoassays, we developed and validated an LC-MS/MS method for urinary aldosterone and tetrahydroaldosterone and established method-matched reference intervals for excretion in 24 h urine. … Read more
Clin Chem Lab Med. 2026 Feb 20. doi: 10.1515/cclm-2025-1376. Online ahead of print. ABSTRACT INTRODUCTION: Accurate assessment of T-cell clonality is key for diagnosing mature T-cell neoplasms. TRBC1-based flow cytometry provides a rapid, robust, and cost-efficient approach. This systematic review and meta-analysis assessed the diagnostic accuracy of TRBC1 flow cytometry (TRBC1-FC) for detecting T-cell clonality … Read more
Clin Chem Lab Med. 2026 Feb 5. doi: 10.1515/cclm-2025-1693. Online ahead of print. ABSTRACT OBJECTIVES: This stability study aimed to evaluate the stability of 48 biochemical analytes in pooled serum samples derived from leftover sera over 14 days at room temperature (RT) and at 2-10 °C, and to assess the consistency of storage effects across … Read more
Clin Chem Lab Med. 2026 Feb 6. doi: 10.1515/cclm-2024-1266. Online ahead of print. ABSTRACT OBJECTIVES: This study presents a candidate reference measurement procedure (RMP) for testosterone quantification in human serum and plasma, utilizing isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC MS/MS). METHODS: The developed LC-MS/MS method employs a two-dimensional heart-cut LC approach combined with solid-phase extraction … Read more
Clin Chem Lab Med. 2026 Feb 17. doi: 10.1515/cclm-2025-1670. Online ahead of print. ABSTRACT OBJECTIVES: Screening for primary aldosteronism (PA) using the aldosterone:renin ratio (ARR) has suboptimal diagnostic accuracy, particularly in females. We assessed whether accuracy could be improved using sex-specific relationships of aldosterone with renin. METHODS: Plasma aldosterone and renin were measured in 442 … Read more
Clin Chem Lab Med. 2026 Feb 12. doi: 10.1515/cclm-2025-1138. Online ahead of print. ABSTRACT OBJECTIVES: The clinical utility of serum bone turnover markers (BTMs) in managing osteoporosis in the elderly is constrained by the absence of personalized reference intervals (prRI) based on biological variation (BV). METHODS: This longitudinal study tracked monthly serum levels of β-CTX, … Read more
Clin Chem Lab Med. 2026 Feb 13. doi: 10.1515/cclm-2025-1722. Online ahead of print. ABSTRACT OBJECTIVES: Identifying individuals with vitamin B12 (B12) deficiency is challenging due to poor harmonization across total B12 assays. To establish clinically meaningful thresholds for the Roche assay, we characterized B12 concentrations associated with deficiency by comparing individuals with macrocytic anemia and … Read more
Clin Chem Lab Med. 2026 Feb 17. doi: 10.1515/cclm-2026-0115. Online ahead of print. ABSTRACT OBJECTIVES: The acute coronary syndrome (ACS) is a leading cause of morbidity and mortality worldwide, with timely diagnosis being critical for improving outcomes. Since high-sensitivity cardiac troponin (hs-cTn) assays have become the gold standard for detecting myocardial injury, this study aimed … Read more
Clin Chem Lab Med. 2026 Feb 16. doi: 10.1515/cclm-2026-0149. Online ahead of print. ABSTRACT Lipoprotein(a) (Lp(a)) has the reputation of being the most misunderstood metric in laboratory medicine. The unique apolipoprotein(a) (apo(a)) in Lp(a) is very heterogenous, the kringle IV domain of apo(a) being formed by 12-50 kringles due to 3 to ∼40 KIV2 repeats. … Read more
Clin Chem Lab Med. 2026 Feb 17. doi: 10.1515/cclm-2025-1440. Online ahead of print. ABSTRACT OBJECTIVES: The adrenal glands are the main source of 11-oxygenated androgens (11-OAs), including the potent 11-ketotestosterone (11-KT) and the weaker metabolites 11β-hydroxyandrostenedione (11-OHA4), 11β-hydroxytestosterone (11-OHT) and 11-ketoandrostenedione (11-KA4). Due to their adrenal origin, 11-OAs allow the differentiation of adrenal and extra-adrenal-produced … Read more
Clin Chem Lab Med. 2026 Feb 6. doi: 10.1515/cclm-2025-1531. Online ahead of print. ABSTRACT OBJECTIVES: Clinical intent for laboratory testing (“indication”) is rarely recorded in structured form, limiting contextual interpretation, auditability, and utilization stewardship. We developed a comprehensive, and clinically applicable framework that standardizes laboratory test indications and links them to indication-dependent utilization and interpretation. … Read more
Clin Chem Lab Med. 2026 Feb 3. doi: 10.1515/cclm-2025-1565. Online ahead of print. ABSTRACT OBJECTIVES: Antiphosphatidylserine/prothrombin (aPS/PT) antibodies are promising non-criteria aPLs associated with antiphospholipid syndrome (APS) manifestations. Their influence on long-term outcomes and damage remains uncertain. To assess aPS/PT antibodies association with accrual damage and severe APS disease phenotypes, focusing on their potential for … Read more
Clin Chem Lab Med. 2026 Feb 3. doi: 10.1515/cclm-2025-1731. Online ahead of print. ABSTRACT Recent advances in blood-based biomarkers for neurodegenerative diseases present promising opportunities for earlier diagnosis and more effective disease monitoring. However, challenges in standardizing sample collection, processing protocols, and data reporting continue to hinder reproducibility, limit cross-study comparability, and delay clinical adoption. … Read more
Clin Chem Lab Med. 2026 Feb 3. doi: 10.1515/cclm-2025-1606. Online ahead of print. ABSTRACT OBJECTIVES: Clinical laboratories play a vital role in healthcare but are also among the most resource-intensive hospital units. High energy and water consumption, extensive use of single-use plastics, and the generation of non-recyclable biomedical waste present major environmental challenges. This study … Read more
Clin Chem Lab Med. 2026 Feb 3. doi: 10.1515/cclm-2025-1322. Online ahead of print. ABSTRACT OBJECTIVES: Despite growing interest in artificial intelligence (AI) and machine learning (ML), many laboratory professionals lack experience with developing in-house AI systems or implementing those supplied by external providers. The IFCC Committee on AI in Laboratory Medicine (C-AILM) conducted a survey … Read more
Clin Chem Lab Med. 2026 Feb 2. doi: 10.1515/cclm-2025-1499. Online ahead of print. ABSTRACT OBJECTIVES: Diagnosing atypical IgG4-mediated anti-glomerular basement membrane (anti-GBM) disease is challenging because conventional serological assays poorly detect IgG4 antibodies. Here we study which commercial assays are affected and we describe proof-of-concept of improved IgG4 anti-GBM detection. METHODS: To investigate the scope … Read more
Clin Chem Lab Med. 2026 Jan 28. doi: 10.1515/cclm-2025-1320. Online ahead of print. ABSTRACT OBJECTIVES: The reliability of cerebrospinal fluid (CSF) and serum biomarkers depends on sample integrity, which is strongly influenced by storage conditions. While -80 °C is considered the gold standard for long-term preservation, it requires specialized infrastructure, whereas -20 °C is more … Read more
Clin Chem Lab Med. 2026 Jan 28. doi: 10.1515/cclm-2025-1387. Online ahead of print. ABSTRACT OBJECTIVES: Newborn screening for congenital hypothyroidism (CH) relies on thyroid-stimulating hormone (TSH) levels from dried blood spots (DBS). We investigated whether incorporating TSH variation across serial DBS could improve prediction of CH in term and preterm infants with complex risk profiles. … Read more
Clin Chem Lab Med. 2026 Jan 28. doi: 10.1515/cclm-2025-1647. Online ahead of print. ABSTRACT OBJECTIVES: Accurate B-lineage assignment in acute leukemia is critical for therapeutic decisions. While nuclear expression of PAX5 protein (nPAX5) is a highly reliable marker for B-cell differentiation, its conventional assessment by time-consuming immunohistochemistry (IHC) is not ideal for rapid diagnosis. This … Read more
Clin Chem Lab Med. 2026 Jan 28. doi: 10.1515/cclm-2025-1461. Online ahead of print. ABSTRACT OBJECTIVES: Testing for high-sensitivity cardiac troponin (hs-cTn) often occurs following pediatric cardiac surgery, although evidence regarding its utility remains heterogeneous. This study aimed to assess the prognostic value of postoperative hs-cTnT patterns detected within 48 h after cardiac surgery. METHODS: Serum … Read more
Clin Chem Lab Med. 2026 Jan 26. doi: 10.1515/cclm-2025-1155. Online ahead of print. ABSTRACT OBJECTIVES: 5α-dihydrotestosterone (DHT) is a potent androgen, related to male sexual development and irreversibly synthesized from testosterone via 5α-reductase. Dysfunctions in the 5α-reductase system, locally or globally, can have substantial health impacts; measurement of both DHT levels and the testosterone-DHT ratio … Read more
Clin Chem Lab Med. 2026 Jan 26. doi: 10.1515/cclm-2025-1225. Online ahead of print. ABSTRACT OBJECTIVES: This study aims to explore the biological variability of calcium homeostasis biomarkers, including calcium, phosphate, magnesium, 25-OH vitamin D, 1,25-OH vitamin D, and parathyroid hormone (PTH), and to develop a model that predicts PTH concentrations based on these parameters. METHODS: … Read more
Clin Chem Lab Med. 2026 Jan 26. doi: 10.1515/cclm-2025-1371. Online ahead of print. ABSTRACT OBJECTIVES: Voriconazole is an antifungal agent measured in serum and plasma for therapeutic drug monitoring. This study aimed to develop a robust isotope-dilution liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS) reference measurement procedure (RMP) to ensure accurate and reliable quantification in compliance with … Read more
Clin Chem Lab Med. 2026 Jan 26. doi: 10.1515/cclm-2025-0994. Online ahead of print. ABSTRACT OBJECTIVES: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) offers substantial analytical advantages over traditional immunoassay methods, including greater specificity and robustness. Conventional LC-MS/MS methods are labor-intensive, requiring highly trained, dedicated laboratory staff. The Cobas® i 601 analyzer (Roche Diagnostics International Ltd., Rotkreuz, Switzerland) … Read more
Clin Chem Lab Med. 2026 Jan 22. doi: 10.1515/cclm-2025-1156. Online ahead of print. ABSTRACT OBJECTIVES: Dehydroepiandrosterone (DHEA) is a steroid prohormone and important precursor for estrogen and testosterone biosynthesis. For differential diagnosis of sexual development disorders (e.g., polycystic ovary syndrome, congenital adrenal hyperplasia), accurate measurement of DHEA in clinical testing is essential. To address that … Read more
Clin Chem Lab Med. 2026 Jan 22. doi: 10.1515/cclm-2026-0041. Online ahead of print. ABSTRACT The Meeting on Science, Quality and Value of Laboratory Medicine was held on 11 December 2025 in Padua, immediately preceding the 7th European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Conference on the Preanalytical Phase. For organizational reasons, the meeting … Read more
Clin Chem Lab Med. 2026 Jan 19. doi: 10.1515/cclm-2025-0458. Online ahead of print. ABSTRACT OBJECTIVES: Multiplex arrays offer a high-throughput, cost-effective means for quantifying multiple analytes simultaneously, essential for large-scale biomarker research. However, the shared reactive environment in multiplex assays could lead to variations in results compared to single plex assays, potentially impacting outcomes. This … Read more
Clin Chem Lab Med. 2026 Jan 15. doi: 10.1515/cclm-2026-0023. Online ahead of print. ABSTRACT Laboratory medicine lies at the core of modern healthcare, enabling timely diagnosis, effective patient monitoring, and increasingly personalized therapeutic strategies. Over the past decades, automation has profoundly reshaped the role of clinical laboratories, substantially enhancing their contribution to clinical outcomes, operational … Read more
Clin Chem Lab Med. 2026 Jan 14. doi: 10.1515/cclm-2025-0791. Online ahead of print. ABSTRACT OBJECTIVES: Severe fever with thrombocytopenia syndrome virus (SFTSV) is a tick-borne pathogen that can cause a fatality rate as high as 12-50 %, posing a significant threat to public health. SFTSV is prevalent in mountainous and hilly regions with relatively poor … Read more
Clin Chem Lab Med. 2026 Jan 12. doi: 10.1515/cclm-2025-1644. Online ahead of print. ABSTRACT BACKGROUND: Method-comparison studies in laboratory medicine are routinely interpreted using regression-based or Bland-Altman analyses. Although useful descriptively, these statistical procedures are frequently misapplied to infer “agreement”, “equivalence”, or “interchangeability”. Such interpretations overlook essential metrological conditions – including the definition of the … Read more
Clin Chem Lab Med. 2026 Jan 12. doi: 10.1515/cclm-2025-1428. Online ahead of print. ABSTRACT OBJECTIVES: The rapid emergence of highly potent synthetic opioids represents a growing challenge for forensic and clinical laboratories. METHODS: We report the first identification in Europe of methiodone (IC-26) and the first detection in France of cychlorphine in drug samples collected … Read more
Clin Chem Lab Med. 2026 Jan 9. doi: 10.1515/cclm-2025-1222. Online ahead of print. ABSTRACT OBJECTIVES: To establish evidence-based analytical performance specifications (APS), specifically allowable total error (TEa), for five fundamental semen analysis parameters (sperm concentration, progressive motility, total motility, morphology, and vitality) in China utilizing the state-of-the-art model, and to compare these specifications with existing … Read more
Clin Chem Lab Med. 2026 Jan 9. doi: 10.1515/cclm-2025-1101. Online ahead of print. ABSTRACT OBJECTIVES: Evolution is difficult to predict for some patients at emergency department (ED). The soluble urokinase plasminogen activator receptor (suPAR) is a non-specific prognostic inflammatory blood biomarker with a high negative predictive value for pejorative outcomes. The aim of this study … Read more
Clin Chem Lab Med. 2026 Jan 8. doi: 10.1515/cclm-2025-1695. Online ahead of print. ABSTRACT The secondary scientific use of routine laboratory data will increasingly rely on LOINC as a semantic standard, particularly within the European Health Data Space (EHDS). LOINC enables the aggregation of large data sets from clinical care for research purposes, particularly in … Read more
Clin Chem Lab Med. 2026 Jan 8. doi: 10.1515/cclm-2025-1126. Online ahead of print. ABSTRACT OBJECTIVES: This study aimed to evaluate the feasibility of robotic venipuncture in clinical settings and compare its performance with manual venipuncture in terms of blood specimen quality and test results. METHODS: From March to April 2025, 63 participants (35 females, 28 … Read more
Clin Chem Lab Med. 2026 Jan 7. doi: 10.1515/cclm-2025-1361. Online ahead of print. ABSTRACT OBJECTIVES: Plasma renin activity (PRA) measures the rate of renin converting angiotensinogen to angiotensin I in circulation and reflects the function of renin-angiotensin-aldosterone system (RAAS). The study aimed to demonstrate the performance of the MAGLUMI Angiotensin I assay for the measurement … Read more
Clin Chem Lab Med. 2026 Jan 6. doi: 10.1515/cclm-2025-1205. Online ahead of print. ABSTRACT OBJECTIVES: Our aim is to determine whether drone transport introduces relevant variability in analytical results and to assess its suitability for integration into routine hospital laboratory operations. METHODS: A two-phase study was conducted. The stability phase involved three sets of samples … Read more
Clin Chem Lab Med. 2026 Jan 6. doi: 10.1515/cclm-2025-1632. Online ahead of print. ABSTRACT Nowadays, we are facing major changes in the landscape of test harmonization through metrological traceability approach, all expected to promote equivalence of reported laboratory results. However, having traceability tools in place does not automatically mean that metrological traceability is correctly implemented. … Read more
Clin Chem Lab Med. 2026 Jan 6. doi: 10.1515/cclm-2025-1605. Online ahead of print. ABSTRACT OBJECTIVES: Lipoprotein(a) is an atherogenic particle causative of atherosclerotic cardiovascular disease. Novel treatments have been developed that lower lipoprotein(a) to unprecedented levels with cardiovascular outcomes trials ongoing. Many guidelines recommend testing once in the lifetime of everyone, but testing rates remain … Read more
Clin Chem Lab Med. 2026 Jan 5. doi: 10.1515/cclm-2025-1287. Online ahead of print. ABSTRACT OBJECTIVES: Dried blood spot (DBS) sampling enables convenient at-home blood collection, suitable for patients needing regular check-ups, such as those receiving testosterone replacement therapy (TRT). This study assessed the feasibility and reliability of DBS sampling for monitoring testosterone concentrations in patients … Read more
Clin Chem Lab Med. 2026 Jan 5. doi: 10.1515/cclm-2025-1523. Online ahead of print. ABSTRACT OBJECTIVES: Serum protein electrophoresis is one of the keystone investigations for screening for monoclonal proteins and assessing the serum protein profile. The newly released Helena V8ultra capillary electrophoresis system has been evaluated. METHODS: In total, 164 serum samples were assessed on … Read more
Clin Chem Lab Med. 2026 Jan 5. doi: 10.1515/cclm-2025-1270. Online ahead of print. ABSTRACT OBJECTIVES: Complement inhibitor pegcetacoplan binds to C3 and its activation product C3b. Pegcetacoplan has been approved for the treatment of paroxysmal nocturnal hemoglobinuria. Because pegcetacoplan exerts broad inhibition of the complement cascade its efficacy is also investigated in numerous other diseases … Read more
Clin Chem Lab Med. 2026 Jan 5. doi: 10.1515/cclm-2025-1199. Online ahead of print. ABSTRACT OBJECTIVES: To investigate the feasibility of at-home collection of liquid capillary blood samples for clinical chemistry analyses. METHODS: Kidney transplant recipients performed a fingerprick to collect capillary blood samples. Samples were kept at room temperature for 24 h before further processing. … Read more
