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
Clin Chem Lab Med. 2025 Oct 31. doi: 10.1515/cclm-2025-0868. Online ahead of print. ABSTRACT OBJECTIVES: Insulin-like growth factor-1 (IGF-1) is a peptide hormone currently lacking data surrounding its pre-analytical stability. This study aimed to investigate the impact of delaying centrifugation and analysis at different storage temperatures on the in vitro stability of IGF-1. METHODS: The … Read more
Clin Chem Lab Med. 2025 Oct 29. doi: 10.1515/cclm-2025-1234. Online ahead of print. ABSTRACT Accurate interpretation of laboratory data is a critical step in clinical decision-making. This requires the availability of reliable reference data for comparison. Reference data can be derived from various sources, including hospital or laboratory databases, groups of reference individuals, or an … Read more
Clin Chem Lab Med. 2025 Oct 29. doi: 10.1515/cclm-2025-0846. Online ahead of print. ABSTRACT OBJECTIVES: DNA methylation in short homeobox gene 2 (SHOX2) and RAS association domain family protein 1 (RASSF1A) shows significant auxiliary diagnostic value for early-stage lung cancer. However, the detection accuracy is frequently compromised because of the complexity of the analytical procedures. … Read more
Clin Chem Lab Med. 2025 Oct 29. doi: 10.1515/cclm-2025-0564. Online ahead of print. ABSTRACT OBJECTIVES: To develop and validate a machine-learning model based on routinely available biochemical and hematological parameters for detecting wrong blood in tube (WBIT) errors in hospitalized patients. METHODS: A retrospective multicenter study including one internal cohort (IC) and two external validation … Read more
Clin Chem Lab Med. 2025 Oct 29. doi: 10.1515/cclm-2025-0607. Online ahead of print. ABSTRACT Saliva, a non-invasive biofluid with a variety of biomolecules, has been increasingly recognized as a reliable specimen in the diagnostics of viral infections. Compared to the standard specimens represented by blood and nasopharyngeal swab, saliva is advantageous in non-invasive, simple collection, … Read more
Clin Chem Lab Med. 2025 Oct 28. doi: 10.1515/cclm-2025-0526. Online ahead of print. ABSTRACT BACKGROUND: Investigations into human performance and health status during long-duration spaceflights are ongoing aboard the International Space Station (ISS) and are critical for planning missions beyond Low Earth Orbit (LEO). This review evaluates the current evidence on point-of-care-testing (POCT) in space, … Read more
Clin Chem Lab Med. 2025 Oct 28. doi: 10.1515/cclm-2025-1318. Online ahead of print. ABSTRACT Recent debates have focused on the impact of analytical imprecision in high-sensitivity cardiac troponin (hs-cTnI and hs-cTnT) assays on the diagnosis of non-ST-elevation myocardial infarction (NSTEMI), based on the absolute delta thresholds for the rapid rule-in/rule-out algorithms in emergency department (ED) … Read more
Clin Chem Lab Med. 2025 Oct 23. doi: 10.1515/cclm-2025-1302. Online ahead of print. ABSTRACT OBJECTIVES: Hemolysis is a common preanalytical interference in clinical biochemistry, affecting up to 3.3 % of routine samples and contributing to approximately 60 % of rejected specimens. It results from the release of intracellular constituents, such as hemoglobin and potassium, into … Read more
Clin Chem Lab Med. 2025 Oct 23. doi: 10.1515/cclm-2025-0637. Online ahead of print. ABSTRACT OBJECTIVES: Reference intervals (RIs) are essential for interpreting laboratory test results. It is recommended that each medical laboratory establishes and reviews its own RIs. The use of direct methods is often unfeasible for most laboratories, while indirect methods are a more … Read more
Clin Chem Lab Med. 2025 Oct 23. doi: 10.1515/cclm-2025-0984. Online ahead of print. ABSTRACT OBJECTIVES: This study aims to determine reliable reference intervals (RIs) for total cortisol (TC) in adults considering the effects of both age and blood collection time, using indirect methods and machine learning approaches. METHODS: Serum TC results from blood samples collected … Read more
Clin Chem Lab Med. 2025 Oct 20. doi: 10.1515/cclm-2025-0909. Online ahead of print. ABSTRACT OBJECTIVES: Dental amalgam (50 % mercury (Hg) by weight) is a commonly used material to restore a tooth damaged by decay. In recent years, amalgam safety has become a matter of ongoing controversy. This hypothesis-testing epidemiological study evaluated the relationship between … Read more
Clin Chem Lab Med. 2025 Oct 20. doi: 10.1515/cclm-2025-0522. Online ahead of print. ABSTRACT OBJECTIVES: Precise and accurate determination of urinary cortisol is important for diagnosis and monitoring of cortisol excess and deficiency. To achieve this, a selective and specific, isotope-dilution two-dimensional heart-cut liquid chromatography-tandem mass spectrometry (LC-MS/MS)-based method was developed. METHODS: A novel, two-dimensional … Read more
Clin Chem Lab Med. 2025 Oct 20. doi: 10.1515/cclm-2025-1079. Online ahead of print. ABSTRACT OBJECTIVES: With the development of genomic technologies, the isolation of genomic DNA (gDNA) from clinical samples has become more important for both clinical diagnostics and research studies. Blood samples collected in PAXgene Blood RNA Tubes, which are typically used for RNA … Read more
Clin Chem Lab Med. 2025 Oct 20. doi: 10.1515/cclm-2024-0860. 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 (MPA). METHODS: Quantitative nuclear magnetic resonance (qNMR) spectroscopy was utilized … Read more
Clin Chem Lab Med. 2025 Oct 20. doi: 10.1515/cclm-2025-0938. Online ahead of print. ABSTRACT OBJECTIVES: Automated urine particle analyzers are increasingly employed in clinical laboratories to standardize urinalysis. These systems can reduce workload, turnaround time and the inter-observer variation. This study aimed to assess the performance of five automated urine particle analyzers in detecting and … Read more
Clin Chem Lab Med. 2025 Oct 20. doi: 10.1515/cclm-2025-1032. Online ahead of print. ABSTRACT With the advent of flow cytometry and dedicated fluorescent dyes in the 1980s, automated reticulocyte enumeration has effectively superseded conventional manual microscopy, dramatically boosting throughput and precision while, through metrics including the immature reticulocyte fraction (IRF) and reticulocyte production index (RPI), … Read more
Clin Chem Lab Med. 2025 Oct 16. doi: 10.1515/cclm-2025-1220. Online ahead of print. ABSTRACT The pre-analytical phase of laboratory testing, encompassing processes from test ordering to sample analysis, represents the most error-prone component of laboratory medicine, accounting for 68-98 % of laboratory mistakes. These errors compromise patient safety, increase healthcare costs, and disrupt operational efficiency. … Read more
Clin Chem Lab Med. 2025 Oct 14. doi: 10.1515/cclm-2025-1178. Online ahead of print. ABSTRACT OBJECTIVES: The aim of this study is to develop a core competency-based EPAs framework for undergraduate interns in the clinical laboratory. METHODS: The EPAs framework was developed in three stages: formation of a research team, drafting of an initial EPAs framework, … Read more
Clin Chem Lab Med. 2025 Oct 9. doi: 10.1515/cclm-2025-1129. Online ahead of print. ABSTRACT OBJECTIVES: To compare the diagnostic performances of GFAP and UCH-L1 with S100B in detecting intracranial injury, while investigating the impact of confounding factors. METHODS: In a large prospective cohort of 1,010 patients with mild traumatic brain injury, we first evaluated the … Read more
Clin Chem Lab Med. 2025 Oct 7. doi: 10.1515/cclm-2025-1030. Online ahead of print. ABSTRACT OBJECTIVES: Detection of paraneoplastic anti-neuronal antibodies (PNS autoantibodies) aids in diagnosing the particular syndrome and guides the search for an underlying tumor. To identify opportunities for harmonization that could enhance diagnostic value, we assessed variability in autoimmune serological testing for PNS … Read more
Clin Chem Lab Med. 2025 Oct 7. doi: 10.1515/cclm-2025-1162. Online ahead of print. ABSTRACT OBJECTIVES: Clinical laboratory operations consume large amounts of electricity and water and generate considerable quantities of solid waste. In this study, we quantified and compared the estimated solid waste produced from performing one million basic metabolic panels (BMPs) across five major … Read more
Clin Chem Lab Med. 2025 Oct 3. doi: 10.1515/cclm-2025-0582. Online ahead of print. ABSTRACT OBJECTIVES: Neuron-specific enolase (NSE) is a clinically relevant biomarker used in the assessment of neuronal damage and in the diagnosis and monitoring of certain cancers. Despite its diagnostic importance, paediatric-specific reference intervals (RIs) for NSE are currently lacking. This study aimed … Read more
Clin Chem Lab Med. 2025 Oct 2. doi: 10.1515/cclm-2025-1136. Online ahead of print. ABSTRACT OBJECTIVES: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is increasingly used in clinical laboratories due to its high analytical specificity and multiplexing capabilities. While the pre-analytical and analytical phases have seen significant advances in automation, the post-analytical phase remains a bottleneck with limited … Read more
Clin Chem Lab Med. 2025 Jun 24;63(11):2330-2340. doi: 10.1515/cclm-2025-0045. Print 2025 Oct 27. ABSTRACT OBJECTIVES: Glycosylation is a tightly controlled co-translational and post-translational enzymatic modification. Total N-glycome profiling in blood serum/plasma provides information on the most common serum/plasma glycosylation. Total plasma N-glycome from various population samples displayed predictive ability for type 2 diabetes incidence in … Read more
Clin Chem Lab Med. 2025 Oct 1. doi: 10.1515/cclm-2025-0941. Online ahead of print. ABSTRACT EU laws are usually evaluated after 10 years; in the case of the IVDR, the targeted evaluation was brought forward and stakeholders in laboratory diagnostics were invited to comment. The Association of the Scientific Medical Societies in Germany (AWMF; Arbeitsgemeinschaft der … Read more
Clin Chem Lab Med. 2025 Sep 29. doi: 10.1515/cclm-2025-0581. Online ahead of print. ABSTRACT OBJECTIVES: Regulatory guidelines recommend non-parametric Passing-Bablok regression for evaluating the agreement between two measurement methods in laboratory settings. However, concluding for the agreement if the 95 % CI of the slope and of the intercept include 1 and 0, respectively is … Read more
Clin Chem Lab Med. 2025 Sep 29. doi: 10.1515/cclm-2025-0461. Online ahead of print. ABSTRACT New technologies and advances in human biology are paving the way for better patient management and outcomes in laboratory medicine. Precision diagnostics, as an essential component of P5 medicine, implies a shift towards selective testing of defined measurands, enabling a higher … Read more
Clin Chem Lab Med. 2025 Sep 25. doi: 10.1515/cclm-2025-0817. Online ahead of print. ABSTRACT OBJECTIVES: To investigate the staining and serological characteristics of AC-30 pattern. METHODS: A total of 184 participants were recruited from patients who underwent routine antinuclear antibody testing between 2022 and 2023 at Peking Union Medical College Hospital. Cohort 1 (n=47) showed … Read more
Clin Chem Lab Med. 2025 Sep 25. doi: 10.1515/cclm-2025-0985. Online ahead of print. ABSTRACT OBJECTIVES: High-sensitivity cardiac troponin T (hs-cTnT) is used in pediatric healthcare to diagnose and assess the prognosis of various cardiac diseases, such as acute myocarditis, congenital heart disease, dilated cardiomyopathy, and heart failure. However, the standardized age-related reference intervals, 99th percentile … Read more
Clin Chem Lab Med. 2025 Sep 25. doi: 10.1515/cclm-2025-1014. Online ahead of print. ABSTRACT The definition of analytical performance specifications (APS) by the Milan model 1b is based on indirect approaches investigating the impact of analytical performance of the laboratory test on clinical classification and thereby on the probability of patient outcomes. As direct diagnostic … Read more
Clin Chem Lab Med. 2025 Sep 25. doi: 10.1515/cclm-2025-1160. Online ahead of print. ABSTRACT Electronic health records will increasingly aggregate longitudinal laboratory results from multiple providers, but availability alone does not guarantee safe interpretation. We present guidance, developed by laboratory professionals with the DGKL medical informatics division, for cumulative displays that are clinically meaningful. The … Read more
Clin Chem Lab Med. 2025 Sep 24. doi: 10.1515/cclm-2025-1133. Online ahead of print. ABSTRACT Currently, there is no accepted standard practice for determining the frequency of EQA challenge. The challenge frequency has evolved based on history and local requirements. However, EQA frequency should be based on identifying patient risks caused by poorly performing laboratories, methods, … Read more
Clin Chem Lab Med. 2025 Sep 24. doi: 10.1515/cclm-2025-0884. Online ahead of print. ABSTRACT OBJECTIVES: The International Organisation for Standardisation (ISO) 15189 standard provides the requirements for quality and competence in medical laboratories. It aims to ensure that laboratories deliver accurate and reliable results for patient care. The first version of the same was published … Read more
Clin Chem Lab Med. 2025 Sep 24. doi: 10.1515/cclm-2025-1011. Online ahead of print. ABSTRACT OBJECTIVES: The European Organization for External Quality Assurance Providers in Laboratory Medicine (EQALM) Haematology Working Group (WG) has previously provided two guidelines to support the standardization of haematology blood smear external quality assessment (EQA) (Vives CJL, Albarède S, Flandrin G, Heller … Read more
Clin Chem Lab Med. 2025 Sep 22. doi: 10.1515/cclm-2025-0593. Online ahead of print. ABSTRACT OBJECTIVES: Identifying the potential sources of bias in the direct measurement of low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) is important. In this study, we aimed to investigate the effect of remnant cholesterol on LDL-C and HDL-C levels measured … Read more
Clin Chem Lab Med. 2025 Sep 18. doi: 10.1515/cclm-2025-0487. Online ahead of print. ABSTRACT OBJECTIVES: Monocyte distribution width (MDW) is an early sepsis indicator measuring monocyte heterogeneity during massive infection. We compared MDW changes in Escherichia coli sepsis patients with the effects of living E. coli and lipopolysaccharide in an ex vivo sepsis model. We … Read more
Clin Chem Lab Med. 2025 Sep 18. doi: 10.1515/cclm-2025-0561. Online ahead of print. ABSTRACT OBJECTIVES: Ovarian cancer is the deadliest gynaecologic malignancy. Due to the lack of reliable biomarkers for the detection of the early disease, most patients are diagnosed at an advanced stage resulting in poor survival. We therefore aimed at establishing novel CA-125 … Read more
Clin Chem Lab Med. 2025 Sep 15. doi: 10.1515/cclm-2025-0841. Online ahead of print. ABSTRACT The integration of artificial intelligence (AI) and machine learning (ML) into laboratory medicine shows promise for advancing diagnostic, prognostic, and decision-support tools; however, routine clinical implementation remains limited and heterogeneous. Laboratory data presents unique methodological and semantic complexities – method dependency, … Read more
Clin Chem Lab Med. 2025 Sep 12. doi: 10.1515/cclm-2025-1159. Online ahead of print. ABSTRACT OBJECTIVES: Oral squamous cell carcinoma (OSCC) is the most prevalent form of squamous cell carcinomas of the head and neck (SCCHN), accounting for over 90 % of all oral cavity malignancies (approximately 275,000 new cases are worldwide diagnosed annually). Early-stage oral … Read more
Clin Chem Lab Med. 2025 Sep 10. doi: 10.1515/cclm-2025-0949. Online ahead of print. ABSTRACT OBJECTIVES: To investigate the relationship between uracilemia (U) and dihydropyrimidine dehydrogenase (DPD) activity in peripheral blood mononuclear cells (PBMC) and whether they are influenced by renal or hepatic impairment. METHODS: This retrospective study included 176 cancer patients with pre-treatment U (UPLC-MSMS … Read more
Clin Chem Lab Med. 2025 Sep 10. doi: 10.1515/cclm-2025-0691. Online ahead of print. ABSTRACT The concept of value, defined as health outcomes achieved per monetary unit spent, has profoundly reshaped modern healthcare delivery. While Value-Based Healthcare models have permeated many clinical disciplines, laboratory medicine has been slow to integrate this paradigm shift. In this opinion … Read more
Clin Chem Lab Med. 2025 Sep 10. doi: 10.1515/cclm-2025-0530. Online ahead of print. ABSTRACT OBJECTIVES: To evaluate the consistency of seven enzymatic glycated albumin (GA) assays in pregnant women based on a multicenter study. METHODS: Samples were collected from pregnant women at three different gestational stages: 4-13 weeks (n=150), 24-28 weeks (n=300, including 150 GDM … Read more
Clin Chem Lab Med. 2025 Sep 8. doi: 10.1515/cclm-2025-0481. Online ahead of print. ABSTRACT OBJECTIVES: Our study sought to determine the usefulness of biomarkers of systemic inflammation (C-reactive protein (CRP), procalcitonin (PCT) and proadrenomedullin (proADM)) on hospital admission, as compared to the CURB65 score, for predicting 30- and 90-day mortality in patients hospitalized for community … Read more
Clin Chem Lab Med. 2025 Sep 8. doi: 10.1515/cclm-2025-0610. Online ahead of print. ABSTRACT OBJECTIVES: Neurofilament light (NfL) is an established biofluid marker of neuroaxonal injury for neurological diseases. Several high-throughput and sensitive immunoassays have been developed to quantify NfL in blood and cerebrospinal fluid (CSF), facilitating the use of NfL as a biomarker in … Read more
Clin Chem Lab Med. 2025 Sep 8. doi: 10.1515/cclm-2025-0536. Online ahead of print. ABSTRACT OBJECTIVES: In 2023, Croatia implemented a screening program for familial hypercholesterolemia (FH) targeting children entering the first grade of primary school. The program is based on total cholesterol (TC) concentration measurements. This pilot study aimed to assess and compare TC results … Read more
Clin Chem Lab Med. 2025 Sep 8. doi: 10.1515/cclm-2025-0683. Online ahead of print. ABSTRACT OBJECTIVES: To analyze the performance of laboratories in the China National External Quality Assessment Scheme (China NEQAS) for HbA2 and HbF testing, and to propose strategies for quality improvement. METHODS: Data were obtained from China NEQAS from 2013 to 2024 using … Read more
Clin Chem Lab Med. 2025 Sep 5. doi: 10.1515/cclm-2025-0750. Online ahead of print. ABSTRACT Molecular ‘in vitro diagnostic’ (IVD) tests are established for the diagnosis of tuberculosis (TB) and multi-drug resistant TB (MDR-TB). What is less clear is how the use of TB or MDR-TB molecular IVD results differ across regions, whether corroborative tests are … Read more
Clin Chem Lab Med. 2025 Sep 5. doi: 10.1515/cclm-2025-0671. Online ahead of print. ABSTRACT OBJECTIVES: Pernicious anemia (PA) is a common cause of vitamin B12 deficiency and requires a robust diagnosis to guide lifelong treatment. Anti-parietal cell antibodies (APCA) are frequently used as a diagnostic marker, but their poor specificity raises concerns about overdiagnosis, particularly … Read more
Clin Chem Lab Med. 2025 Sep 3. doi: 10.1515/cclm-2025-0374. Online ahead of print. ABSTRACT OBJECTIVES: To assess the imprecision and stability of the point-of-care troponin I assay in the Emergency Department and its correlation and bias to two central laboratory troponin I assays (Siemens Atellica and Abbott Alinity). METHODS: Imprecision and stability testing was performed … Read more
Clin Chem Lab Med. 2025 Sep 2. doi: 10.1515/cclm-2025-0667. Online ahead of print. ABSTRACT OBJECTIVES: Glial fibrillary acidic protein (GFAP) is a biomarker of astrocytic activation associated with neurodegenerative diseases, neuroinflammatory disorders, and traumatic brain injury. However, the lack of standardized methods for quantifying GFAP across different immunoassay platforms poses challenges for its clinical implementation. … Read more
Clin Chem Lab Med. 2025 Sep 1. doi: 10.1515/cclm-2025-0678. Online ahead of print. ABSTRACT INTRODUCTION: The increasing use of therapeutic monoclonal antibodies (t-mAbs) has improved cancer and autoimmune disorder treatment. These therapeutics can interfere with serum protein electrophoresis (SPEP) and immunofixation (IF), potentially leading to the appearance of monoclonal bands that may be misinterpreted as … Read more
