Clin Chem Lab Med. 2025 Aug 21. doi: 10.1515/cclm-2025-0656. Online ahead of print. ABSTRACT OBJECTIVES: ISO 15189:2022 recommends the use of quality indicators (QIs) to monitor laboratory performance and focuses on risk management and continual improvement. This study aims to compare hospital laboratory data with national and international quality specifications and to share experiences in … Read more
Clin Chem Lab Med. 2025 Aug 21. doi: 10.1515/cclm-2025-0654. Online ahead of print. ABSTRACT OBJECTIVES: Measurement uncertainty (MU) plays an important role in the interpretation of laboratory results, but data on serum proteins analyzed by immunoturbidimetry according to ISO/TS 20914 are limited. METHODS: MU of 11 serum proteins, including CRP, RF, ASO, IgG, IgA, IgM, … Read more
Clin Chem Lab Med. 2025 Aug 20. doi: 10.1515/cclm-2025-0600. Online ahead of print. ABSTRACT OBJECTIVES: The T50 Calciprotein Crystallization test (T50 test) is a novel blood-based in vitro diagnostic assay that determines the calciprotein crystallization time in patients. It is based on the one-half maximum transition time of calciprotein particle 1 (CPP1) to calciprotein particle … Read more
Clin Chem Lab Med. 2025 Aug 20. doi: 10.1515/cclm-2025-0705. Online ahead of print. ABSTRACT OBJECTIVES: Celiac disease (CD) is a systemic autoimmune disorder triggered by gluten in genetically predisposed individuals. Accurate diagnosis remains challenging due to clinical heterogeneity and reliance on invasive biopsy. This study aimed to evaluate the diagnostic performance of a novel multiparametric … Read more
Clin Chem Lab Med. 2025 Aug 20. doi: 10.1515/cclm-2025-0939. Online ahead of print. ABSTRACT OBJECTIVES: The UK National Institute for Health and Care Excellence has recommended thresholds for total vitamin B12 (B12) assays with interchangeable results for identifying B12 deficiency. We assessed the agreement between B12 methods, to evaluate whether the thresholds may be assumed … Read more
Clin Chem Lab Med. 2025 Aug 20. doi: 10.1515/cclm-2025-0357. Online ahead of print. ABSTRACT OBJECTIVES: The clinical implications of positive anti-mitochondrial antibodies (AMAs) and/or primary biliary cholangitis (PBC)-specific anti-nuclear antibodies (ANAs) in patients with normal alkaline phosphatase (ALP) remain uncertain. METHODS: Patients at The Second Hospital of Nanjing with positive AMAs/PBC-ANAs and normal ALP levels … Read more
Clin Chem Lab Med. 2025 Aug 20. doi: 10.1515/cclm-2025-1033. Online ahead of print. ABSTRACT The European Commission (EC) started targeted evaluations and public consultations regarding the EU IVDR 2017/746 to assess its effectiveness, efficiency, relevance, and EU-added value. The goal is to identify implementation challenges and unintended consequences, experienced by either IVD-manufacturers that put CE-IVDs … Read more
Clin Chem Lab Med. 2025 Aug 19. doi: 10.1515/cclm-2025-0175. Online ahead of print. ABSTRACT OBJECTIVES: Spinal muscular atrophy (SMA) is a severe inherited neuromuscular disorder with a high carrier frequency and incidence rate. An accurate molecular method for SMA genes is crucial in carrier screening, clinical diagnosis, outcome assessment and precision therapies. METHODS: Comprehensively using … Read more
Clin Chem Lab Med. 2025 Aug 18. doi: 10.1515/cclm-2025-0763. Online ahead of print. ABSTRACT Laboratory data can be meaningful only when compared with reliable reference data; therefore, the estimation of reliable reference data is just as important as the accurate measurement of measurands in patient samples. Since analyte concentrations in the human body are influenced … Read more
Clin Chem Lab Med. 2025 Aug 18. doi: 10.1515/cclm-2025-0754. Online ahead of print. ABSTRACT OBJECTIVES: α-Thalassaemia screening is crucial for identifying carriers at risk of having offspring with haemoglobin (Hb) Bart’s hydrops fetalis syndrome. This study evaluated the performance of two potential screening methods: the α-thalassaemia early eluting peak (αEEP) identified by high-performance liquid chromatography … Read more
Clin Chem Lab Med. 2025 Aug 15. doi: 10.1515/cclm-2025-0802. Online ahead of print. ABSTRACT Laboratory investigations are important in the clinical management and the study of chronic kidney disease-mineral and bone disorder (CKD-MBD)- including CKD-associated osteoporosis. Parathyroid hormone (PTH) is the major hormone in the regulation of bone and calcium balance but is significantly affected … Read more
Clin Chem Lab Med. 2025 Aug 15. doi: 10.1515/cclm-2025-0143. Online ahead of print. ABSTRACT OBJECTIVES: To evaluate the performance of the iStar high-sensitivity cardiac troponin I (hs-cTnI) assay, focusing on its sensitivity, precision, linearity, and consistency with plasma samples, and to establish sex-specific 99th percentile upper reference limits. METHODS: The iStar hs-cTnI assay was assessed … Read more
Clin Chem Lab Med. 2025 Aug 15. doi: 10.1515/cclm-2025-0786. Online ahead of print. ABSTRACT Interpretation of laboratory test results is a comparative process that requires reference data. Such data are derived for each analyte separately, without accounting for, the interrelationships among analytes. Physicians use test panels containing multiple analytes to enhance clinical significance and improve … Read more
Clin Chem Lab Med. 2025 Aug 14. doi: 10.1515/cclm-2025-0658. Online ahead of print. ABSTRACT OBJECTIVES: Significant changes in clinical biochemical markers occur during the peri-menopausal period. Traditional population-based reference intervals (popRIs) may not reflect individual physiological variability, limiting clinical interpretation. This study aimed to establish personalized reference intervals (prRIs) for menopausal women and compare them … Read more
Clin Chem Lab Med. 2025 Aug 14. doi: 10.1515/cclm-2025-0647. Online ahead of print. ABSTRACT OBJECTIVES: Large language models (LLMs), such as OpenAI’s GPT-4o, have demonstrated considerable promise in transforming clinical decision support systems. In this study, we focused on a single but crucial task of clinical decision-making: laboratory test ordering. METHODS: We evaluated the self-consistency … Read more
Clin Chem Lab Med. 2025 Aug 14. doi: 10.1515/cclm-2025-0552. Online ahead of print. ABSTRACT OBJECTIVES: Insulin assays are used to assess insulin resistance and to aid in the diagnosis of conditions such as insulinoma and various forms of hypoglycemia. However, discrepancies among commercial assays limit their clinical and research utility. This study evaluates the current … Read more
Clin Chem Lab Med. 2025 Aug 13. doi: 10.1515/cclm-2025-0318. Online ahead of print. ABSTRACT INTRODUCTION: Intestinal permeability (IP) is a crucial index for intestinal tract integrity, reflecting intestinal barrier function, injury, diseases, and related systemic conditions. However, current mainstream testing methods are invasive and qualitative. Biomarkers for IP in body fluids offer noninvasive and quantitative … Read more
Clin Chem Lab Med. 2025 Aug 13. doi: 10.1515/cclm-2025-0775. Online ahead of print. ABSTRACT Acute, life-threatening bleeding is a relatively common but critical presentation in the emergency department (ED), needing immediate assessment and intervention to reduce morbidity and mortality. Rapid identification of the bleeding source, evaluation of hemostatic function, and timely initiation of resuscitation are … Read more
Clin Chem Lab Med. 2025 Aug 12. doi: 10.1515/cclm-2025-0863. Online ahead of print. ABSTRACT BACKGROUND: Several guidelines groups have made recommendations about how to use natriuretic peptides (NPs) to screen patients with diabetes for incipient heart failure. This group is at risk for undetected and stage B heart failure, where structural heart disease is present … Read more
Clin Chem Lab Med. 2025 Aug 12. doi: 10.1515/cclm-2025-0947. Online ahead of print. ABSTRACT As aminotransferases represent the first-level tests to detect individuals with hepatocellular damage, standardization of their measurements is a priority need for patient care. The obtaining of the harmonization in aminotransferase results is however strongly dependent on supplementation of pyridoxal-5′-phosphate (P-5-P) in … Read more
Clin Chem Lab Med. 2025 Aug 12. doi: 10.1515/cclm-2025-0353. Online ahead of print. ABSTRACT OBJECTIVES: Measurement of ionized calcium is frequently used in the assessment of calcium metabolism. However, the utility of ionized calcium in young children can pose a challenge. In this study, we aimed at establishing novel accurate reference ranges for ionized calcium … Read more
Clin Chem Lab Med. 2025 Aug 12. doi: 10.1515/cclm-2025-0554. Online ahead of print. ABSTRACT OBJECTIVES: Accurate 25-hydroxyvitamin D (25-(OH)D) assays are essential for defining vitamin D status and ensuring appropriate clinical decisions. Standardization efforts, including the Vitamin D Standardization Program (VDSP), aim to minimize assay variability. This study evaluates the measurement uncertainty (MU) of various … Read more
Clin Chem Lab Med. 2025 Aug 11. doi: 10.1515/cclm-2025-0501. Online ahead of print. ABSTRACT Over 50 years have elapsed since the clinical definition of non-A, non-B hepatitis and 36 years since the unveiling of hepatitis C virus (HCV) and the availability of specific serological assays, but few advances in the serological diagnosis of HCV infection … Read more
Clin Chem Lab Med. 2025 Aug 8. doi: 10.1515/cclm-2025-0644. Online ahead of print. ABSTRACT OBJECTIVES: Primary aldosteronism (PA) is an underdiagnosed yet important condition. This study aimed to evaluate the diagnostic performance of a combined protocol using oral salt loading and postural stimulation tests (PST), named the balance study, to confirm and subtype PA. METHODS: … Read more
Clin Chem Lab Med. 2025 Aug 8. doi: 10.1515/cclm-2025-0424. Online ahead of print. ABSTRACT OBJECTIVES: Quantitation of plasma amino acids (AA) is critical for the diagnosis and monitoring of inherited disorders of AA metabolism. AA analysis using ion-exchange chromatography (IEC) with post-column ninhydrin derivatization is time consuming, with run times of ∼2 h, limiting sample … Read more
Clin Chem Lab Med. 2025 Aug 8. doi: 10.1515/cclm-2025-0330. Online ahead of print. ABSTRACT OBJECTIVES: Haemolysis is a major preanalytical issue that affects potassium measurements, often leading to sample rejection and delayed clinical management. This study proposes a novel corrective model for accurate unhaemolysed potassium prediction. METHODS: Blood samples from 14 healthy volunteers were used … Read more
Clin Chem Lab Med. 2025 Aug 8. doi: 10.1515/cclm-2025-0855. Online ahead of print. ABSTRACT Since the 1980s, automation has profoundly transformed clinical laboratory operations, enhancing efficiency, standardization, and throughput. This technological evolution has enabled laboratories to meet rising testing demands, address persistent workforce shortages, and control operational costs. Beyond analytical consolidation, significant progress has been … Read more
Clin Chem Lab Med. 2025 Aug 8. doi: 10.1515/cclm-2025-0587. Online ahead of print. ABSTRACT OBJECTIVES: Accurate measurement of plasma aldosterone (ALD) and renin is important in primary aldosteronism screening and diagnosis. The high variability of ALD and renin due to salt intake, age, and sex, as well as the lack of immunoassay standardization necessitates the … Read more
Clin Chem Lab Med. 2025 Aug 1. doi: 10.1515/cclm-2024-1468. Online ahead of print. ABSTRACT OBJECTIVES: Aldosterone is over-estimated by direct immunoassay when compared to assay by LC-MS/MS. We have investigated the mechanism for this over-estimation, using dichloromethane (DCM) extraction and a unique matrix of non-synthetic aldosterone-free plasma (ALFP). METHODS: Samples used were from patients with … Read more
Clin Chem Lab Med. 2025 Jul 25. doi: 10.1515/cclm-2025-0653. Online ahead of print. ABSTRACT OBJECTIVES: Hemophagocytic lymphohistiocytosis (HLH) is a severe condition requiring timely diagnosis to initiate immunomodulatory therapy. Soluble interleukin-2 receptor (sIL-2R) and soluble CD163 (sCD163) are biomarkers crucial for making this diagnosis. This study aims to establish pediatric reference intervals (RIs) for serum … Read more
Clin Chem Lab Med. 2025 Jul 25. doi: 10.1515/cclm-2025-0200. Online ahead of print. ABSTRACT OBJECTIVES: Use of machine learning (ML) in diagnostics offers promise to optimise interpretation of laboratory data and guide clinical decision-making. For this, ML-based outputs should provide robustly reproducible results at least as good as the underlying laboratory data. The objective of … Read more
Clin Chem Lab Med. 2025 Jul 18. doi: 10.1515/cclm-2025-0651. Online ahead of print. ABSTRACT Theranos was a biotechnology company which, in the 2010s, promised to revolutionize traditional clinical chemistry testing by using novel technology, microvolumes of blood obtained by finger pricks, and performance of tests outside traditional clinical chemistry laboratories, such as in pharmacies. Theranos … Read more
Clin Chem Lab Med. 2025 Jul 16. doi: 10.1515/cclm-2025-0181. Online ahead of print. ABSTRACT OBJECTIVES: Tacrolimus has been a cornerstone of immunosuppressive therapy over the past two decades. Due to its narrow therapeutic window and pharmacokinetic variability, drug monitoring is vital for enhancing the efficacy and safety during therapy. In the present study, we evaluated … Read more
Clin Chem Lab Med. 2025 Jul 15. doi: 10.1515/cclm-2025-0641. Online ahead of print. ABSTRACT OBJECTIVES: Diagnostic stewardship aims to optimize laboratory testing practices by ensuring appropriate test utilization while minimizing unnecessary testing. However, the nationwide monitoring systems for laboratory test utilization remain underdeveloped. In this study, we analyzed nationwide health insurance claims data to identify … Read more
Clin Chem Lab Med. 2025 Jul 14. doi: 10.1515/cclm-2025-0616. Online ahead of print. ABSTRACT Under the Age-Friendly Health System initiative, “What Matters” is defined as knowing the older adult’s specific health outcome goals and care preferences. This involves multiple settings of care (e.g., hospital, skilled nursing facility, outpatient visits) and can include end-of-life care. However, … Read more
Clin Chem Lab Med. 2025 Jul 14. doi: 10.1515/cclm-2025-0508. Online ahead of print. ABSTRACT OBJECTIVES: The 2023 ACR/EULAR criteria aim to improve the classification of antiphospholipid syndrome (APS). This study aims to validate these criteria and compare clinical and laboratory domains between classified and non-classified patients. METHODS: A retrospective cohort study was conducted at the … Read more
Clin Chem Lab Med. 2025 Jul 11. doi: 10.1515/cclm-2025-0133. Online ahead of print. ABSTRACT INTRODUCTION: Late-night salivary cortisol (LNSC), which assesses the loss of the circadian rhythm of cortisol, is one of the first-line tests performed to diagnose Cushing’s syndrome (CS). Unfortunately, access to LNSC is still limited in some institutions. Alternatively, midnight serum cortisol … Read more
Clin Chem Lab Med. 2025 Jul 10. doi: 10.1515/cclm-2025-0022. Online ahead of print. ABSTRACT OBJECTIVES: Copeptin, a stable and simple-to-measure surrogate marker for arginine vasopressin (AVP), demonstrates excellent clinical values, particularly in diagnosing polyuria-polydipsia syndromes. However, conventional immunoassay methods are limited and lack comparability. Our aim was to establish a targeted liquid chromatography-tandem mass spectrometry … Read more
Clin Chem Lab Med. 2025 Jul 7. doi: 10.1515/cclm-2025-0539. Online ahead of print. ABSTRACT OBJECTIVES: Frequent blood sampling in vulnerable patient groups, such as prematurely born infants, can lead to significant blood loss and increased transfusion needs. Current pre-analytical technology requires comparably large blood volumes and leads to discarding of cells. This study investigates a … Read more
Clin Chem Lab Med. 2025 Jul 3. doi: 10.1515/cclm-2025-0306. Online ahead of print. ABSTRACT OBJECTIVES: The acquired, somatic JAK2V617F mutation is the most common molecular aberration in patients with myeloproliferative neoplasms (MPN) and also significantly involved in the regulation of T cell immunity. PD-1, PD-L1 and CTLA-4 are key immune checkpoint regulators that are elevated … Read more
Clin Chem Lab Med. 2025 Jun 27. doi: 10.1515/cclm-2025-0499. Online ahead of print. ABSTRACT OBJECTIVES: Antiphospholipid syndrome (APS) is an autoimmune disorder characterized by thrombosis and obstetric complications associated with antiphospholipid antibodies (aPLs). This study aimed to compare the diagnostic performance of six commercial assay systems for detecting aCL and aβ2GPI antibodies. METHODS: Sixty-three APS … Read more
Clin Chem Lab Med. 2025 Jun 26. doi: 10.1515/cclm-2024-1403. Online ahead of print. ABSTRACT OBJECTIVES: Commutability is a critical attribute for reference materials (RMs) employed in standardization and calibration activities, it ensures the accuracy and equivalence of analytical results across heterogeneous measurement systems and laboratories. In the context of folate quantification, commutability holds particular significance, … Read more
Clin Chem Lab Med. 2025 Jun 23. doi: 10.1515/cclm-2024-0858. Online ahead of print. ABSTRACT OBJECTIVES: An isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS)-based candidate reference measurement procedure (RMP) was developed and validated to accurately measure serum and plasma concentrations of total and free phenytoin. METHODS: Quantitative nuclear magnetic resonance spectroscopy (qNMR) was used to determine the … Read more
Clin Chem Lab Med. 2025 Jun 20. doi: 10.1515/cclm-2024-1138. Online ahead of print. ABSTRACT OBJECTIVES: An isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS)-based candidate reference measurement procedure (RMP) for the quantification of 25-hydroxyvitamin D2 (25OHD2) and 25-hydroxyvitamin D3 (25OHD3) in human serum and plasma is presented. METHODS: Quantitative Nuclear Magnetic Resonance (qNMR) spectroscopic methodology has been … Read more
Clin Chem Lab Med. 2025 Jun 18. doi: 10.1515/cclm-2025-0268. Online ahead of print. ABSTRACT OBJECTIVES: Atypical or malignant urothelial cells may be identified with a research parameter of atypical cells (Atyp.C) using a fully automated urine particle analyzer in routine urinalysis. This study aimed to determine whether Atyp.C can serve as an effective screening tool … Read more
Clin Chem Lab Med. 2025 Jun 18. doi: 10.1515/cclm-2025-0286. Online ahead of print. ABSTRACT The indirect immunofluorescence assay (IFA) on HEp-2 cells is the prevailing method used to screen for autoantibodies in the investigation of systemic autoimmune diseases (SAID). When positive, the titer provides a semi-quantitative assessment of the autoantibody serum concentration whereas the immunofluorescence … Read more
Clin Chem Lab Med. 2025 Jun 16. doi: 10.1515/cclm-2025-0076. Online ahead of print. ABSTRACT OBJECTIVES: Heavy Metals (HMs) concentrations vary with living environments, diet, and personal habits. This study aims to establish health-related reference intervals (RIs) for selected HMs in healthy, non-occupationally exposed young adults living in an urban environment. METHODS: The Uni4Me study enrolled … Read more
Clin Chem Lab Med. 2025 Jun 9. doi: 10.1515/cclm-2025-0433. Online ahead of print. ABSTRACT The sweat test is used as a biological marker of cystic fibrosis transmembrane conductance regulator (CFTR) dysfunction, but there is growing recognition that sweat chloride concentrations of people with cystic fibrosis (CF) can overlap with those without CF. There are also … Read more
Clin Chem Lab Med. 2025 Jun 4. doi: 10.1515/cclm-2025-0238. Online ahead of print. ABSTRACT OBJECTIVES: Type 1 diabetes (T1D) is a chronic autoimmune disease causing β-cell destruction, hyperglycemia, and lifelong insulin dependence that can lead to severe complications like ketoacidosis, with a 1 % mortality rate in newly diagnosed patients. A significant breakthrough in T1D … Read more
Clin Chem Lab Med. 2025 Jun 2. doi: 10.1515/cclm-2025-0148. Online ahead of print. ABSTRACT OBJECTIVES: Home blood sampling for clinical purposes has gained much interest. This study validates the recently developed Topper-based capillary blood collection procedure for 15 commonly used chemistry analytes. METHODS: A total of 120 study participants (21 healthy volunteers and 99 patients) … Read more
Clin Chem Lab Med. 2025 May 30. doi: 10.1515/cclm-2025-0549. Online ahead of print. ABSTRACT Since several years, sports authorities, including national anti-doping organisations and the World Anti-Doping Agency (WADA) have published that the consumption of food supplements can be at risk for athletes due to potential contamination by prohibited substances. Despite these warnings, supplements are … Read more
Clin Chem Lab Med. 2025 May 30. doi: 10.1515/cclm-2025-0265. Online ahead of print. ABSTRACT OBJECTIVES: To evaluate the characteristics of an immunochemical urinary free light chains (uFLC) test in screening and quantifying Bence Jones proteinuria (BJP) and its potential application in laboratory practice as an alternative to the gold standard method, urine immunofixation (UIFE) and … Read more
Clin Chem Lab Med. 2025 May 28. doi: 10.1515/cclm-2025-0302. Online ahead of print. ABSTRACT OBJECTIVES: This study aimed to develop and validate a machine learning (ML) model utilizing cerebrospinal fluid (CSF) body fluid parameters from hematology analyzers to screen for malignant cells. METHODS: We analyzed 643 consecutive CSF samples from patients with central nervous system … Read more
Clin Chem Lab Med. 2025 May 28. doi: 10.1515/cclm-2025-0482. Online ahead of print. ABSTRACT Artificial intelligence (AI) is rapidly transforming laboratory medicine, impacting medical devices and healthcare practices. Despite these advancements, AI-based medical device software (MDSW) introduces a new layer of complexity in regulatory compliance. This paper outlines the regulatory landscape for MDSW and AI-driven … Read more
Clin Chem Lab Med. 2025 May 28. doi: 10.1515/cclm-2025-0309. Online ahead of print. ABSTRACT OBJECTIVES: Spontaneous subarachnoid hemorrhage (sSAH) is a life-threatening neurological event with high morbidity and mortality. Predicting patient outcomes remains challenging, necessitating novel prognostic tools. This study evaluates the prognostic value of central and systemic serum biomarkers, including S100, neuron-specific enolase (NSE), … Read more
Clin Chem Lab Med. 2025 May 28. doi: 10.1515/cclm-2025-0507. Online ahead of print. ABSTRACT OBJECTIVES: In clinical practice, glycated albumin (GA), as a key biomarker reflecting the level of blood glucose control in the short and medium term, has been widely used in the diagnosis and efficacy monitoring of diabetes. However, the consistency of GA … Read more
Clin Chem Lab Med. 2025 May 28. doi: 10.1515/cclm-2025-0491. Online ahead of print. ABSTRACT OBJECTIVES: Machine learning (ML) models, using laboratory data, support early sepsis prediction. However, analytical bias in laboratory measurements can compromise their performance and validity in real-world settings. We aimed to evaluate how analytically acceptable bias may affect the validity and generalizability … Read more
Clin Chem Lab Med. 2025 May 28. doi: 10.1515/cclm-2024-1236. Online ahead of print. ABSTRACT Ischemic heart disease remains the leading cause of death globally, with acute coronary syndrome (ACS) being the main reason for emergency hospital admissions and thus representing a significant health care issue worldwide. Cardiac troponin I (cTnI) and cardiac troponin T (cTnT) … Read more
Clin Chem Lab Med. 2025 May 8. doi: 10.1515/cclm-2025-0125. Online ahead of print. ABSTRACT OBJECTIVES: To investigate whether frozen storage duration influences κ-FLC index. METHODS: CSF and serum samples of patients with multiple sclerosis collected for routine diagnostic purposes had been stored at -20 °C. κ-FLC and albumin concentrations were measured at two different timepoints, … Read more
Clin Chem Lab Med. 2025 May 26. doi: 10.1515/cclm-2024-1255. Online ahead of print. ABSTRACT OBJECTIVES: A new candidate isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS)-based reference measurement procedure (RMP) has been developed for the accurate and precise quantification of 17β-estradiol (E2) in human serum and plasma covering a measurement range from 0.400 to 5,000 pg/mL (1.47-18,357 … Read more
Clin Chem Lab Med. 2025 May 23. doi: 10.1515/cclm-2024-1135. Online ahead of print. ABSTRACT OBJECTIVES: Androstenedione (ASD) is a biomarker used in the diagnosis of hyperandrogenism and adrenal hyperplasia. Therefore, accurate measurement of serum ASD is pivotal in clinical settings. We aimed to develop a novel highly selective reference measurement procedure (RMP) based on isotope … Read more
Clin Chem Lab Med. 2025 May 22. doi: 10.1515/cclm-2025-0189. Online ahead of print. ABSTRACT OBJECTIVES: Histamine, mainly produced in mast cells (MC), plays a key role in allergy and inflammation. Measuring its urinary metabolites, N-methylhistamine (NMH) and 1-methyl-4-imidazoleacetic acid (MIMA), is essential in assessing histamine-related pathologies. Patients with concurrent systemic mastocytosis (SM) and hereditary alpha … Read more
Clin Chem Lab Med. 2025 May 22. doi: 10.1515/cclm-2025-0448. Online ahead of print. ABSTRACT OBJECTIVES: Quality indicator (QI) monitoring is essential to quality assurance for point of care testing (POCT). QI standardization is needed in the POCT field to provide clear guidance to hospitals and produce National and International benchmarks. A central aim was to … Read more
Clin Chem Lab Med. 2025 May 22. doi: 10.1515/cclm-2025-0409. Online ahead of print. ABSTRACT OBJECTIVES: Antigen excess (AE) or high dose hook-effect can seriously affect the reported concentration of an analyte, which may impact clinical decisions. This study analyze to what extent the Roche Elecsys® Myoglobin assay is affected by antigen excess and how this … Read more
Clin Chem Lab Med. 2025 May 22. doi: 10.1515/cclm-2025-0319. Online ahead of print. ABSTRACT OBJECTIVES: Coagulation test results may be affected by hemolysis, icterus and/or lipemia (HIL). Detailed guidelines for HIL-management are missing, both for manual and automatic HIL-checks. The aim of this survey was to provide an overview of the practical procedures for the … Read more
Clin Chem Lab Med. 2025 May 22. doi: 10.1515/cclm-2025-0210. Online ahead of print. ABSTRACT OBJECTIVES: The aim of this study was to carry out a cross-analysis of the morphological abnormalities (MA) and the electrophoretic profile (EP) of blood samples suspect for heterozygous haemoglobinopathies (HTZ HGP). Screening for HTZ HGP was based on erythrocyte parameters provided … Read more
Clin Chem Lab Med. 2025 May 22. doi: 10.1515/cclm-2025-0170. Online ahead of print. ABSTRACT OBJECTIVES: Anti-nuclear antibodies (ANA) testing on indirect immunofluorescence (IIF) has been for a long time the gold standard assay in the diagnosis of rheumatic diseases; more recently different solid phase assays (SPA) have been recommended to increase specificity of positive results. … Read more
Clin Chem Lab Med. 2025 May 22. doi: 10.1515/cclm-2025-0311. Online ahead of print. ABSTRACT OBJECTIVES: To describe the structure of vitamin D metabolome and investigate the possible cause of high serum levels of C3 epimers of 25-(OH)D in preterm infants, we compared the vitamin D metabolites in umbilical cord blood with serum samples taken at … Read more
Clin Chem Lab Med. 2025 May 5. doi: 10.1515/cclm-2025-0418. Online ahead of print. ABSTRACT Cardiac injury, encompassing a spectrum of heart muscle damage, requires prompt and accurate diagnosis to improve patient outcomes. Early detection using cardiac biomarkers is vital for timely intervention and reducing mortality. This review highlights the role of high-sensitivity cardiac troponins (hs-cTns) … Read more
Clin Chem Lab Med. 2025 May 5. doi: 10.1515/cclm-2025-0490. Online ahead of print. ABSTRACT After the dissemination of a manifesto for the implementation of value-based laboratory medicine (VBLM) and a Strategic Conference dedicated to this issue, a novel initiative of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) is to be initiated with … Read more
