Clinical chemistry and laboratory medicine最新文献

{"title":"Comprehensive evaluation of antiphospholipid antibody testing methodologies in APS diagnosis: performance comparisons across assay systems and clinical subtypes.","authors":"Yun Wang, Xu Yuan, Ting Wang, Wei Wei, Rujia Chen, Renren Ouyang, Feng Wang, Hongyan Hou, Shiji Wu","doi":"10.1515/cclm-2025-0499","DOIUrl":"https://doi.org/10.1515/cclm-2025-0499","url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>Sixty-three APS patients, 50 SLE patients, 67 disease controls, and 62 healthy controls were enrolled. aCL and aβ2GPI antibodies of IgA, IgG, and IgM isotypes were measured using six commercial platforms, including three ELISA-based systems and three CLIA-based systems. Inter-assay concordance was compared across all detection platforms, and ROC curve analysis was performed to evaluate and compare their diagnostic performance in APS.</p><p><strong>Results: </strong>Inter-assay concordance varied across platforms, with IgG isotypes showing the highest consistency and IgA exhibiting the lowest agreement. Overall, CLIA-based systems demonstrated superior classification performance compared to ELISA-based methods. The highest area under the curve (AUC) reached 0.811, with sensitivity and specificity up to 0.730 and 0.891, respectively. IgG isotypes demonstrated the best overall performance, while IgA and IgM showed greater variability. The inclusion of IgA modestly improved sensitivity in some systems, although this was sometimes accompanied by decreased specificity. LA-positive patients had higher aPL positivity rates than LA-negative ones, and aPL levels were higher in thrombotic vs. obstetric APS.</p><p><strong>Conclusions: </strong>Significant variability exists among commercial aPL detection systems. CLIA-based methods provided better consistency and diagnostic accuracy than ELISA. The inclusion of IgA provided additional diagnostic value in identifying APS patients who tested negative for aCL and aβ2GPI of the IgG and IgM isotypes.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144495012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring commutable materials for serum folate measurement: challenges in cross-method harmonization.","authors":"Xiaerbanu Nizhamuding, Qian Zhang, Lizi Jin, Rui Wu, Youli Lu, Xilian Yi, Meiwei Zhang, Jiangtao Zhang, Weiyan Zhou, Jie Zeng, Tianjiao Zhang, Chuanbao Zhang","doi":"10.1515/cclm-2024-1403","DOIUrl":"https://doi.org/10.1515/cclm-2024-1403","url":null,"abstract":"<p><strong>Objectives: </strong>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, as it validates that RMs exhibit analytical behavior equivalent to native clinical specimens when subjected to diverse folate detection platforms. This study aims to identify and characterize commutable candidate RMs for serum folate assays, with the ultimate goal of enhancing the harmonization and metrological traceability of folate measurements in clinical diagnostics.</p><p><strong>Methods: </strong>Thirty study materials and pooled clinical serum samples were measured by two isotope-dilution liquid chromatography tandem mass spectrometry methods and three immunoassays in four different laboratories. Six external quality assessment materials for endocrine, 6 trueness verification materials for vitamins, 13 processed materials and 5 candidate RMs (cRM-1,2,3,4,5) were assessed. Deming regression analysis and the difference-in-bias approach were employed to evaluate commutability.</p><p><strong>Results: </strong>cRM-3 demonstrated commutability (C or +) across all assays, being the most ideal candidate reference material in this study. Seven materials (cRM-1, cRM-2, cRM-3, TV202111, TV202012, CS-L, and RS 2W-1) were commutable for two LC-MS/MS methods regardless of the statistical method.</p><p><strong>Conclusions: </strong>The complexity of folate species in serum, differences in detection principles between immunoassays and isotope-dilution liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS) method (immunoassays using folate-binding protein with variable affinities and LC-MS/MS quantifying specific vitamers), and variations in calibration substrates among immunoassays collectively challenge the harmonization of folate measurement and commutability assessment.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144495013","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Oligoclonal banding analysis: assessing plasma use and time interval requirements for paired CSF and blood.","authors":"Lily Olayinka, Yu Chen, Karina Rodriguez-Capote, Jessica L Gifford, Caitlin Buch, Spencer Weber, Michelle L Parker, Natalia Volodko, Mathew P Estey, Dustin Proctor, Ashley Newbigging, Pierre Bordeleau, Maggie Powell, Daniel R Beriault, Joseph Macri, Victoria Higgins","doi":"10.1515/cclm-2025-0649","DOIUrl":"https://doi.org/10.1515/cclm-2025-0649","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144495014","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Isotope dilution-liquid chromatography-tandem mass spectrometry-based candidate reference measurement procedures for the quantification of total and free phenytoin in human serum and plasma.","authors":"Tobias Schierscher, Linda Salzmann, Neeraj Singh, Manuel Seitz, Janik Wild, Carina Schäfer, Friederike Bauland, Andrea Geistanger, Lorenz Risch, Christian Geletneky, Christoph Seger, Judith Taibon","doi":"10.1515/cclm-2024-0858","DOIUrl":"10.1515/cclm-2024-0858","url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>Quantitative nuclear magnetic resonance spectroscopy (qNMR) was used to determine the absolute content of the reference material, ensuring its traceability to SI units. The separation of phenytoin from potential unknown interferences was achieved with reversed-phase chromatography, utilizing a C8 column. A protein precipitation protocol was established for preparation of total phenytoin samples, while free phenytoin samples were prepared by membrane separation utilizing a commercially available ultrafiltration device. Assay validation and determination of measurement uncertainties was performed according to the guidelines of the Clinical and Laboratory Standards Institute, the International Conference on Harmonization, and the Guide to the Expression of Uncertainty in Measurement.</p><p><strong>Results: </strong>These RMPs demonstrated high selectivity and specificity, with no evidence of matrix effects, allowing quantification of total and free phenytoin in ranges of 0.640-48.0 μg/mL and 0.0800-4.80 μg/mL, respectively. Intermediate precision was <3.8 %, and repeatability was 1.4-3.8 %, over all concentration levels, for both forms of phenytoin. For total phenytoin, relative mean bias ranged from -2.7-0.3 % in native serum and from 0.0-1.1 % in lithium heparin plasma. Relative mean biases for free phenytoin were 3.5-4.1 % for both native serum and ultrafiltrates. Measurement uncertainties for single measurements and target value assignment were 1.8-2.5 % and 0.9-1.7 %, respectively, for total phenytoin. For free phenytoin, these measurement uncertainties were 2.0-3.9 % and 0.9-1.4 % for single measurements and target value assignment, respectively.</p><p><strong>Conclusions: </strong>We present a novel LC-MS/MS-based RMP for phenytoin in human serum and plasma that provides a traceable and reliable platform for the standardization of routine assays and evaluation of clinically relevant samples.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144339969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An isotope dilution-liquid chromatography-tandem mass spectrometry based candidate reference measurement procedure for the simultaneous quantification of 25-hydroxyvitamin D3 and 25-hydroxyvitamin D2 in human serum and plasma.","authors":"Kerstin Kandler, Neeraj Singh, Friederike Bauland, Elie Fux, Andrea Geistanger, Christian Geletneky, Judith Taibon","doi":"10.1515/cclm-2024-1138","DOIUrl":"10.1515/cclm-2024-1138","url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>Quantitative Nuclear Magnetic Resonance (qNMR) spectroscopic methodology has been utilized to assign absolute content (g/g) and International System of Units (SI)-traceability to the reference materials used as primary calibrators. This RMP was developed for the simultaneous quantification of 25OHD2 and 25OHD3 in human samples, utilizing supported liquid extraction (SLE) clean-up and a two-dimensional heart-cut ID-LC-MS/MS method to minimize matrix effects and prevent the co-elution of 3-Epi-25OHD3 and 3-Epi-25OHD2. The method underwent validation in accordance with current guidelines. Selectivity was assessed using spiked samples. To evaluate potential matrix effects, a post-column infusion experiment and a comparison of standard line slopes were performed. A 5-day validation study was conducted to determine precision, accuracy and trueness of the method. Measurement uncertainty for reference value assignment was evaluated in line with the Guide to the Expression of Uncertainty in Measurement (GUM). Equivalence to Joint Committee on Traceability in Laboratory Medicine (JCTLM) listed RMPs was demonstrated through the participation in the CDC Vitamin D Standardization-Certification Program (VDSCP) as well as the RELA scheme.</p><p><strong>Results: </strong>The RMP enabled the quantification of 25OHD2 and 25OHD3 within the range of 1.50 ng/mL-180 ng/mL (3.64-436 nmol/L for 25OHD2 and 3.74-449 nmol/L for 25OHD3), without interference from their respective epimer and no evidence of matrix effects. Intermediate precision was determined to be ≤4.0 % for 25OHD2 and ≤3.6 % for 25OHD3, while repeatability was ≤3.3 % for 25OHD2 and ≤2.9 % for 25OHD3 across all concentration levels. The relative mean bias for the secondary reference materials varied from -1.0 to 1.1 %, regardless of the analyte. For the spiked samples, the relative mean bias ranged from -4.2 to 1.0 % for 25OHD2 and from -3.9 to 0.9 % for 25OHD3, irrespective of all levels and matrices. Expanded measurement uncertainties (k=2) for target value assignment (n=6) were ≤3.9 % for 25OHD2 and ≤3.2 % for 25OHD3. Participation in the VDSCP and the RELA scheme showed a good agreement with results from the JCTLM listed RMPs and laboratories.</p><p><strong>Conclusions: </strong>The RMP enables the accurate, precise and consistent determination of 25OHD3 and 25OHD2. The robust performance of this method supports standardization of routine assays and guarantees traceability in the measurement of individual patient samples.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144332556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of atypical cells in detecting bladder cancer in female patients.","authors":"Yan Zhao, Enhao Zhang, Yinling Wang, Jun Zheng, Danning Jin, Hong Luan","doi":"10.1515/cclm-2025-0268","DOIUrl":"https://doi.org/10.1515/cclm-2025-0268","url":null,"abstract":"<p><strong>Objectives: </strong>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 for female bladder cancer (BC) and to observe the impact of pyuria and bacteriuria on Atyp.C concentrations.</p><p><strong>Methods: </strong>Patients were classified into six groups: primary BC, recurrent BC, post-treatment monitoring of BC, other urological tumors, pyuria and bacteriuria, and controls. Atyp.C concentrations were compared across these groups, and its diagnostic performance for BC or pyuria and bacteriuria was analyzed. Logistic regression determined whether Atyp.C was an independent risk factor for BC or pyuria and bacteriuria. Subsequently, key factors contributing to abnormal Atyp.C elevations were investigated.</p><p><strong>Results: </strong>The median Atyp.C concentrations were significantly elevated in both primary (2.9/µL) and recurrent BC cases (4.0/µL) compared to patients with pyuria and bacteriuria (2.0/µL) and controls (1.7/µL) (p<0.01). Diagnostic performance of Atyp.C to detect primary female BC reached an area under curve of 0.818 when combined with age and urine conductivity. Multivariate analysis confirmed Atyp.C as an independent risk factor for BC in women. Falsely increased Atyp.C concentrations were caused by WBC clumps, clue cells covered by bacteria, and macrophages.</p><p><strong>Conclusions: </strong>Atyp.C did not reach sufficient specificity for screening of BC in women with existing pyuria or bacteriuria. WBC clumps, macrophages and clue cells contributed to falsely positive Atyp.C counts.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144316034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The spectrum of nuclear patterns with stained metaphase chromosome plate: morphology nuances, immunological associations, and clinical relevance.","authors":"Wilson de Melo Cruvinel, Guilherme Guerra Ferreira, Lais Laura de Souza, Wilson da Costa Veloso Neto, Clayson Moura Gomes, Paulo Luiz Carvalho Francescantonio, Luis Eduardo Coelho Andrade","doi":"10.1515/cclm-2025-0286","DOIUrl":"https://doi.org/10.1515/cclm-2025-0286","url":null,"abstract":"<p><p>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 pattern indicates the possible autoantibody specificities. The Brazilian Consensus on ANA Patterns (BCA) and the International Consensus on ANA Patterns (ICAP) provide recommendations for the harmonization on the pattern nomenclature and test reporting. Nuclear patterns are among the most frequent in the clinical laboratory and some of them are highly relevant in the diagnosis of SAID. Nuclear patterns with stained metaphase plate (MP) indicate autoantibodies against chromatin components or against chromatin-bound antigens. These include the nuclear homogeneous (AC-1), nuclear dense fine speckled (AC-2), Topo 1-like (AC-29), and nuclear fine speckled with stained MP (AC-30) patterns. The Brazilian consensus has also classified the <i>quasi</i>-homogeneous nuclear pattern (QH). The correct identification of these patterns is important because each one is associated with different autoantibody specificities and clinical scenarios. However, the recognition of the nuances in texture of the staining pattern and other specific features that characterize each of them may be challenging for the analyst at the microscope. This review focuses on the morphological characteristics, immunological identities, and clinical relevance of nuclear patterns with stained MP. The aim is to assist laboratory analysts and clinicians in identifying and interpreting these patterns, thus optimizing the use of the HEp-2 IFA test in the investigation of patients under suspicion of SAID.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144316035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality indicators: an evolving target for laboratory medicine.","authors":"Mario Plebani","doi":"10.1515/cclm-2025-0674","DOIUrl":"https://doi.org/10.1515/cclm-2025-0674","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144309648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A single dose of 20-mg of ostarine is detectable in hair.","authors":"Jean-Claude Alvarez, Isabelle Etting","doi":"10.1515/cclm-2025-0633","DOIUrl":"https://doi.org/10.1515/cclm-2025-0633","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144309647","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Health-related reference intervals for heavy metals in non-exposed young adults.","authors":"Chiara Di Resta, Francesco Paleari, Assunta Naclerio, Floriana Iannace, Roberto Leone, Ivan Shashkin, Marco Fumagalli, Chiara Sacco, Lucia Bellocchi, Massimo Locatelli, Giuseppe Banfi, Paola M V Rancoita, Rossella Tomaiuolo","doi":"10.1515/cclm-2025-0076","DOIUrl":"https://doi.org/10.1515/cclm-2025-0076","url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>The <i>Uni4Me</i> study enrolled 154 healthy university volunteers (median age: 23 years) to assess the concentrations of seven heavy metals (lead, nickel, cadmium, zinc, chromium, cobalt, and mercury) using Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) and Inductively Coupled Plasma-Optical Emission Spectroscopy (ICP-EOS). CLSI guidelines were followed to estimate the 2.5th and 97.5th percentiles as RIs.</p><p><strong>Results: </strong>Most metals were detected at low concentrations. Zinc showed consistent physiological levels in all participants. Mercury and chromium were the most frequently detected, indicating potential environmental or dietary exposure.</p><p><strong>Conclusions: </strong>This study defines baseline values for HMs in an urban, healthy, young adult population. These results may support future biomonitoring efforts and public health initiatives targeting subclinical exposure in non-occupationally exposed populations.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144293459","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}