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
Clin Chem Lab Med. 2026 Jan 2. doi: 10.1515/cclm-2025-1202. Online ahead of print. ABSTRACT OBJECTIVES: The performance of a novel urine particle analyzer, fluidlab 2 (Anvajo GmbH, Dresden, Germany), was evaluated against phase-contrast visual microscopy according to the most recent EFLM European Urinalysis Guideline. METHODS: The fluidlab 2 device combines digital holographic microscopy with neural … Read more
Clin Chem Lab Med. 2025 Oct 9;64(2):332-342. doi: 10.1515/cclm-2025-0367. Print 2026 Jan 29. ABSTRACT OBJECTIVES: Transporting blood samples with pneumatic tube systems (PTSs) is routine in many hospitals. The influence of PTS transport on cell-free DNA (cfDNA) and circulating tumor DNA (ctDNA) analyses has not been comprehensively tested. METHODS: Paired blood samples from non-patient donors … Read more
Clin Chem Lab Med. 2025 Oct 9;64(2):489-504. doi: 10.1515/cclm-2025-0216. Print 2026 Jan 29. ABSTRACT OBJECTIVES: Ocular lymphomas are rare diseases that occur in ocular adnexa or specific intraocular regions. Although histology remains the gold standard, cytology and flow cytometry (FCM) are fundamental, mainly when a biopsy sampling is technically demanding. This study evaluated the effectiveness … Read more
Clin Chem Lab Med. 2025 Dec 30. doi: 10.1515/cclm-2025-1678. Online ahead of print. ABSTRACT The strategic direction of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) is guided by global healthcare trends, rapid technological advancements, and the evolving role of laboratory professionals in modern medicine. The aim is to position laboratory medicine as … Read more
Clin Chem Lab Med. 2025 Dec 29. doi: 10.1515/cclm-2025-1339. Online ahead of print. ABSTRACT OBJECTIVES: The Kappa Index has proven its diagnostic value for multiple sclerosis (MS), while its prognostic potential remains to be fully explored. The objective of this study is thus to investigate the value of the Kappa Index at disease onset in … Read more
Clin Chem Lab Med. 2025 Dec 29. doi: 10.1515/cclm-2025-1314. Online ahead of print. ABSTRACT Agentic artificial intelligence (AI) systems are distinguished by their ability to invoke multiple tools, compose command chains, and combine chain-of-thought reasoning with deep research to execute complex tasks and take actions. This represents a major evolution beyond machine learning and large … Read more
Clin Chem Lab Med. 2025 Dec 29. doi: 10.1515/cclm-2025-1480. Online ahead of print. ABSTRACT OBJECTIVES: Compare Elecsys (Roche) and Simoa (Quanterix) immunoassays for serum glial fibrillary acidic protein (GFAP) using our reference database and Z scores, and evaluate their prognostic value for progression independent of relapse activity (PIRA) in multiple sclerosis (MS). METHODS: Platform correlation … Read more
Clin Chem Lab Med. 2025 Dec 23. doi: 10.1515/cclm-2025-1431. Online ahead of print. ABSTRACT OBJECTIVES: Despite standardization efforts, significant inter-assay variability persists among prostate-specific antigen (PSA) tests, impacting prostate cancer (PCa) diagnosis and monitoring. We aimed to evaluate the analytical and clinical performance of the newly developed Atellica IM high-sensitivity PSA (hsPSA Atellica) assay compared … Read more
Clin Chem Lab Med. 2025 Dec 18. doi: 10.1515/cclm-2025-1476. Online ahead of print. ABSTRACT OBJECTIVES: Neurofilament light chain (NfL) is a biomarker of neuroaxonal damage in various neurological conditions, including multiple sclerosis (MS). With new analytical platforms entering the market, standardization of serum NfL (sNfL) measurement is essential. This study compared sNfL levels across three … Read more
Clin Chem Lab Med. 2025 Dec 18. doi: 10.1515/cclm-2025-0874. Online ahead of print. ABSTRACT OBJECTIVES: Free triiodothyronine (FT3) and free thyroxine (FT4) are important diagnostic markers for assessing thyroid function. However, their accurate quantification remains challenging due to low serum concentrations. Significant variability exists among current assay methods for measuring FT3 and FT4. This study … Read more
Clin Chem Lab Med. 2025 Dec 17. doi: 10.1515/cclm-2025-1315. Online ahead of print. ABSTRACT OBJECTIVES: Prognostication in patients with severe acute brain injury (SABI) in the Intensive Care Unit (ICU) is complex, often requiring early decisions on life-sustaining therapy. Serum biomarkers such as neurofilament light (NFL), glial fibrillary acidic protein (GFAP) and neuron specific enolase … Read more
Clin Chem Lab Med. 2025 Dec 17. doi: 10.1515/cclm-2025-1450. Online ahead of print. ABSTRACT This scoping review followed the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines to systematically map the current landscape of artificial intelligence (AI) and machine learning (ML) applications in the field of thrombosis and hemostasis … Read more
Clin Chem Lab Med. 2025 Dec 16. doi: 10.1515/cclm-2025-0719. Online ahead of print. ABSTRACT OBJECTIVES: Vitamin K homologues are essential to human health, and their concentrations in biological samples serve as valuable diagnostic biomarkers. This study was aimed to develop a method for determining vitamins K1 (phylloquinone, VK1) and K2 (menaquinone, MK-4) in human serum. … Read more
Clin Chem Lab Med. 2025 Dec 15. doi: 10.1515/cclm-2025-1434. Online ahead of print. ABSTRACT The discovery of circulating tumor DNA (ctDNA) prompted many scientists and companies to apply this new technology for cancer diagnostics. One valuable application of ctDNA is in the screening for cancer. This procedure has been coined “liquid biopsy” and unlike classical … Read more
Clin Chem Lab Med. 2025 Dec 15. doi: 10.1515/cclm-2025-1299. Online ahead of print. ABSTRACT OBJECTIVES: The soluble urokinase plasminogen activator receptor (suPAR) is a well-established biomarker of immune activation, reflecting the severity of systemic inflammation. Recent evidence showed increasing interest in suPAR as a prognostic marker, with elevated levels consistently associated with greater disease severity … Read more
Clin Chem Lab Med. 2025 Dec 10. doi: 10.1515/cclm-2025-1336. Online ahead of print. ABSTRACT OBJECTIVES: The aim of this study was to evaluate the impact of introducing an autonomous courier in a clinical laboratory, focusing on specimen turnaround time (TAT). We assessed whether high-frequency robotic transport from the central accessioning area to analytical sections could … Read more
Clin Chem Lab Med. 2025 Dec 10. doi: 10.1515/cclm-2025-1484. Online ahead of print. ABSTRACT OBJECTIVES: Accurate determination of blood potassium levels in neonates presents significant clinical challenges, primarily attributable to technical difficulties in phlebotomy procedures and the elevated susceptibility of neonatal blood samples to hemolysis. This study aimed to develop and validate a hemoglobin-based mathematical … Read more
Clin Chem Lab Med. 2025 Dec 3. doi: 10.1515/cclm-2025-0894. Online ahead of print. ABSTRACT OBJECTIVES: This study aimed to perform an extended analytical verification of the Immunoglobulin Isotypes (GAM) for the EXENT® Analyzer (EXENT®-GAM) assay, a MALDI-TOF mass spectrometry-based method for detecting and quantifying serum M-proteins in patients with plasma cell dyscrasias, and to compare … Read more
Clin Chem Lab Med. 2025 Dec 1. doi: 10.1515/cclm-2025-0514. Online ahead of print. ABSTRACT OBJECTIVES: Progesterone regulates reproductive processes and is used clinically to monitor ovarian function in people experiencing fertility problems. Measuring serum progesterone is challenging as it is highly protein-bound and exists at very low physiological levels. An isotope dilution-liquid chromatography-tandem mass spectrometry-based … Read more
Clin Chem Lab Med. 2025 Dec 1. doi: 10.1515/cclm-2025-0179. Online ahead of print. ABSTRACT OBJECTIVES: Dehydroepiandrosterone sulfate (DHEAS), the sulfate ester of dehydroepiandrosterone, is one of the most common steroid hormones in the human body and the precursor of several other androgens. It is primarily used as a diagnostic or prognostic indicator in adrenal and … Read more
Clin Chem Lab Med. 2025 Nov 28. doi: 10.1515/cclm-2025-1338. Online ahead of print. ABSTRACT Laboratory errors are an important component of medical errors and are predominantly associated with the extra-analytical phases of the total testing process, particularly the pre-pre-analytical and post-post-analytical phases, which are largely dependent on clinical activities but also require laboratory support. The … Read more
Clin Chem Lab Med. 2025 Nov 20. doi: 10.1515/cclm-2025-1060. Online ahead of print. ABSTRACT Recreational nitrous oxide (N2O) use has emerged as a growing public health concern, with increasing reports of neurological, psychiatric, and thrombotic complications. This position paper from the EFLM Committee on Biological Markers of Nitrous Oxide Abuse highlights the urgent need for … Read more
Clin Chem Lab Med. 2025 Nov 26. doi: 10.1515/cclm-2025-1258. Online ahead of print. ABSTRACT OBJECTIVES: The Fourth Universal Definition of Myocardial Infarction recommends high-sensitivity cardiac troponin (hs-cTn) as the preferred biomarker for diagnosing myocardial infarction. This study evaluated the analytical and clinical performance of a novel hs-cTnT chemiluminescence immunoassay (CLIA) developed by Mindray. METHODS: Analytical … Read more
Clin Chem Lab Med. 2025 Nov 24. doi: 10.1515/cclm-2025-1312. Online ahead of print. ABSTRACT OBJECTIVES: The accurate and timely identification and notification of critical results (CR) are crucial to ensure patient safety and is an integral part of the process of medical validation of laboratory results. The objective of the study was to evaluate whether … Read more
Clin Chem Lab Med. 2025 Nov 20. doi: 10.1515/cclm-2025-1462. Online ahead of print. ABSTRACT OBJECTIVES: To maximize participation in the international standardization effort, this recommendation aims to update the international guidance of the Working Group on Laboratory Errors and Patient Safety of the International Federation of Clinical Chemistry and Laboratory Medicine by identifying a limited … Read more
Clin Chem Lab Med. 2025 Nov 17. doi: 10.1515/cclm-2025-0782. Online ahead of print. ABSTRACT OBJECTIVES: To prevent intoxication with 5-fluorouracil (5-FU) during chemotherapy, the initial measurement of plasma uracil levels has recently been recommended by the European Medicines Agency. Here we present and compare two new chromatographic methods for analysis of uracil in plasma. Two … Read more
Clin Chem Lab Med. 2025 Nov 14. doi: 10.1515/cclm-2025-0888. Online ahead of print. ABSTRACT Capillary blood sampling is gaining recognition as a patient-centered alternative to traditional venipuncture. Its main advantages are that it is less invasive, reduces patient discomfort, and potentially can be performed without the direct supervision of a healthcare professional. These features could … Read more
Clin Chem Lab Med. 2025 Nov 13. doi: 10.1515/cclm-2025-1002. Online ahead of print. ABSTRACT OBJECTIVES: As (a lack of) vitamin D has been linked to a wide variety of chronic diseases, there is growing interest in generating robust epidemiological data. Consequently, the need for large-scale biological sample collection has increased. In this context, dried blood … Read more
Clin Chem Lab Med. 2025 Nov 12. doi: 10.1515/cclm-2025-0778. Online ahead of print. ABSTRACT OBJECTIVES: Procalcitonin (PCT) is increasingly used to support sepsis diagnosis, but its role in predicting outcomes remains uncertain, particularly in low-resource settings. We evaluated whether single and serial PCT measurements were associated with 28-day mortality in critically ill adults with suspected … Read more
Clin Chem Lab Med. 2025 Nov 11. doi: 10.1515/cclm-2025-0728. Online ahead of print. ABSTRACT OBJECTIVES: Laboratories are required to routinely verify reported reference intervals (RIs), but common verification methods like the CLSI-EP28-A3c binomial test are often impractical due to sample collection requirements. Indirect verification methods like equivalence limits (ELs) use routine data from patient care … Read more
Clin Chem Lab Med. 2025 Nov 11. doi: 10.1515/cclm-2025-0385. Online ahead of print. ABSTRACT OBJECTIVES: The potential relationship between cardiac troponin (cTn) composition and etiologies of myocardial injury may provide diagnostic insights for myocardial infarction (MI). We compared the performance of novel ternary cTnI-cTnT-TnC complex (ITC) assays with high-sensitivity (hs)-cTnI and hs-cTnT in differentiating MI … Read more
Clin Chem Lab Med. 2025 Nov 10. doi: 10.1515/cclm-2025-0546. Online ahead of print. ABSTRACT OBJECTIVES: Fecal immunochemical tests (FITs) from various manufacturers yield different results, leading to variable positivity rates and clinical performance. These differences can influence the healthcare costs of a colorectal cancer screening program (CRC-SP), specifically when switching among FIT manufacturers. The analytical … Read more
Clin Chem Lab Med. 2025 Nov 10. doi: 10.1515/cclm-2025-1052. Online ahead of print. ABSTRACT OBJECTIVES: A candidate reference measurement procedure (RMP) based on isotope dilution (ID) liquid chromatography-tandem mass spectrometry (LC-MS/MS) was developed and validated to accurately measure serum and plasma concentrations of mycophenolic acid glucuronide (MPAG). METHODS: Quantitative nuclear magnetic resonance (qNMR) spectroscopy was … Read more
Clin Chem Lab Med. 2025 Nov 10. doi: 10.1515/cclm-2025-0867. Online ahead of print. ABSTRACT OBJECTIVES: Calcitonin (CT) is the established biomarker for medullary thyroid carcinoma (MTC), but its measurement is hampered by analytical limitations. Procalcitonin (PCT) and pro-gastrin-releasing peptide (ProGRP) have been proposed as alternative or complementary markers, yet the diagnostic value of ProGRP remains … Read more
Clin Chem Lab Med. 2025 Nov 10. doi: 10.1515/cclm-2025-1240. Online ahead of print. ABSTRACT External Quality Assessment (EQA) is central to quality assurance in laboratory medicine, providing independent measures of tests trueness, and inter-laboratory comparability. Traditional EQA schemes, designed around stable and well-characterised measurands, have been successful in routine analytes such as electrolytes and liver … Read more
Clin Chem Lab Med. 2025 Nov 5. doi: 10.1515/cclm-2025-1055. Online ahead of print. ABSTRACT OBJECTIVES: To validate urine as a suitable matrix for copeptin measurements, derive a urinary copeptin/creatinine ratio in an apparently healthy sample of the population, and assess pre-analytical conditions such as collection type and storage temperatures that affect stability and recovery. METHODS: … Read more
Clin Chem Lab Med. 2025 Nov 4. doi: 10.1515/cclm-2025-1056. Online ahead of print. ABSTRACT Monoclonal gammopathies (MGs) represent a diverse group of plasma cell disorders that range from asymptomatic premalignant conditions to aggressive malignancies such as multiple myeloma (MM). Mass spectrometry (MS) based serum analysis offers a non-invasive, highly sensitive alternative to conventional techniques for … Read more
Clin Chem Lab Med. 2025 Nov 4. doi: 10.1515/cclm-2025-1053. Online ahead of print. ABSTRACT OBJECTIVES: An isotope dilution liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS)-based candidate reference measurement procedure (cRMP) was developed and validated to measure serum and plasma concentrations of the total and free form of valproic acid. METHODS: Quantitative nuclear magnetic resonance spectroscopic methodology was … Read more
Clin Chem Lab Med. 2025 Nov 3. doi: 10.1515/cclm-2025-0979. Online ahead of print. ABSTRACT OBJECTIVES: Measuring creatinine levels is essential for assessing kidney function. However, traditional venous sampling poses challenges in terms of sample collection, storage, and transportation. Recently, dried blood spot (DBS) analysis has emerged as a potential alternative for measuring creatinine levels, although … Read more
Clin Chem Lab Med. 2025 Oct 31. doi: 10.1515/cclm-2025-0824. Online ahead of print. ABSTRACT OBJECTIVES: MicroRNA-192-5p, a liver-enriched miRNA downregulated in hepatocellular carcinoma (HCC), is a promising biomarker, but its clinical use is limited by technical challenges in detecting low-abundance plasma miRNAs. This study innovatively uses droplet digital PCR (ddPCR) with locked nucleic acid (LNA)-modified … Read more
