Clinical chemistry and laboratory medicine最新文献

{"title":"Hemolysis detection using the GEM 7000 at the point of care in a pediatric hospital setting: does it affect outcomes?","authors":"Ridwan B Ibrahim, Nazmin Bithi, Charlene Hernandez, Hanna Uhrova, Brandy D Recio, Sridevi Devaraj","doi":"10.1515/cclm-2025-0890","DOIUrl":"https://doi.org/10.1515/cclm-2025-0890","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144820703","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":"Supplementation of pyridoxal-5'-phosphate in aminotransferase reagents: a matter of patient safety.","authors":"Mauro Panteghini","doi":"10.1515/cclm-2025-0947","DOIUrl":"https://doi.org/10.1515/cclm-2025-0947","url":null,"abstract":"<p><p>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 aminotransferase reagents as this exclusively enables reporting of measured values on clinical samples that are traceable to the IFCC reference measurements procedures, representing the highest metrological level defining the respective measurable enzyme quantity. The lack of P-5-P addition in the employed commercial reagents is the most frequent cause of unacceptably biased results of aminotransferases, which opposes to consistency of results across laboratories and commercial assays. Nevertheless, only about one-third of medical laboratories include P-5-P in their aminotransferase measurements. This demonstrates a lack of awareness of the clinical benefits of P-5-P supplementation, which is not just an analytical preference, but it represents a laboratory priority for providing a high-quality service in pertinent clinical situations.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144815925","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":"HCV serology: an unfinished agenda.","authors":"Claudio Galli, Mario Plebani","doi":"10.1515/cclm-2025-0501","DOIUrl":"10.1515/cclm-2025-0501","url":null,"abstract":"<p><p>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 have occurred. Testing for anti-HCV is still based on the detection of reactivity towards the structural Core region of HCV, which appears to be dominant throughout the different phases of infection, plus antibodies towards antigens expressed by several non-structural regions. Unlike testing for other viral diseases, antibodies towards the envelope region are not detectable by the first line assays employed for screening or diagnosis and are scarcely represented in the supplementary assays employed to confirm the reactivity by screening assays. Clinical laboratories are often confronting issues on samples that give discrepant results among assays and are not confirmed by supplemental testing. Results obtained on those samples are usually labelled as 'indeterminate' and are often considered as false positive - though a true reference to define anti-HCV positivity is still lacking. The diagnostic answer is then deprived of clinical significance and affects patient management and counselling. The only advance, though not recent, has been the availability of assays detecting the HCV core antigen, which is considered as a surrogate of HCV RNA, with lesser sensitivity but bearing some operational and economic advantages in diagnosis and population screening, and lately of assays combining HCV antigen and anti-HCV detection. This paper summarizes the history of HCV serology and provides some insights on its limitations and potential developments.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798347","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":"Oral salt loading combined with postural stimulation tests for confirming and subtyping primary aldosteronism.","authors":"Jenny Yeuk Ki Cheng, Wai Shan Clara Lo, Teresa Kam Chi Tsui, Wing Kar Edith Chow, Kitty Kit Ting Cheung, Ronald Ching Wan Ma, Risa Ozaki, Chung Shun Ho","doi":"10.1515/cclm-2025-0644","DOIUrl":"https://doi.org/10.1515/cclm-2025-0644","url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>We retrospectively analyzed the data of 402 patients with either confirmed PA or essential hypertension who underwent the balance study. Biochemical markers were measured using liquid chromatography-tandem mass spectrometry. Receiver operating characteristic curves were used to assess the diagnostic performance. The cut-off values for biochemical markers were determined by Youden J's statistics.</p><p><strong>Results: </strong>For PA confirmation, urinary aldosterone (UALD; area under the curve [AUC] 0.894), urinary tetrahydroaldosterone (UTHA; AUC 0.875), the sum of UALD and UTHA (SUM; AUC 0.884), and supine plasma aldosterone (PALD; AUC 0.902) showed comparable performance. Corresponding cut-offs were: UALD>38 nmol/day, UTHA>160 nmol/day, SUM>259 nmol/day, and supine PALD>273 pmol/L. For PA subtyping, the difference or ratio between erect and supine PALD in PST achieved an AUC of 0.90. An increase of less than 19 pmol/L or less than 5 % from a supine to an erect position suggested an aldosterone-producing adenoma.</p><p><strong>Conclusions: </strong>This combined protocol using oral salt loading and PST could help confirm a diagnosis of PA and predict the subtype. UTHA and supine PALD may add value to UALD for PA confirmation, whereas the erect/supine PALD ratio from PST could assist in PA subtyping. Further studies are required to validate these findings.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798348","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":"Establishment of region-, age- and sex-specific reference intervals for aldosterone and renin with sandwich chemiluminescence immunoassays.","authors":"Lin-Lin Cao, Bing Gu, Liqiong Yao, Gang Li, Chunling Wang, Huijun Cui, Ran Xu, Hui Wang","doi":"10.1515/cclm-2025-0587","DOIUrl":"https://doi.org/10.1515/cclm-2025-0587","url":null,"abstract":"<p><strong>Objectives: </strong>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 establishment of region-, age-, sex- and assay-specific reference intervals (RIs). This study established RIs for ALD and renin using novel sandwich chemiluminescent immunoassays.</p><p><strong>Methods: </strong>ALD and renin were measured on a fully automated chemiluminescence platform (Maglumi X8, Snibe, China). The analytic performances were estimated following CLSI guidelines. A total of 2,281 healthy participants from Beijing, Jiangsu, Henan, Gansu and Guangdong were recruited.</p><p><strong>Results: </strong>Total imprecision were 1.42-5.09 % for ALD and 1.07-4.11 % for renin. The maximum dilution rates were 50× and 10× for ALD and renin. Interferences of 22 and six interferents for ALD and renin were acceptable. The sandwich ALD immunoassay results highly correlated with LC-MS/MS (<i>r</i>=0.994). The RI of ALD was partitioned based on salt intake, with central 95 % RIs for males of 16.9-185 ng/L (46.8-513 pmol/L) in Guangdong and 26.5-242 ng/L (73.5-671 pmol/L) in other four regions. Females showed an age-dependent decline in ALD levels (RIs in Guangdong: 26.9-442 ng/L [74.6-1,226 pmol/L, 18-40 years], 32.4-326 ng/L [89.9-904 pmol/L, 41-60 years], 21.2-199 ng/L [58.8-552 pmol/L, >60 years], whereas males exhibited no significant change. Renin RIs: females: 3.43-89.2 mU/L (18-40 years), 0.92-67.1 mU/L (41-60 years), 0.66-55 mU/L (>60 years); males: 2.23-95.1 mU/L (≤60 years), 1.71-68.9 mU/L (>60 years).</p><p><strong>Conclusions: </strong>This is the first study to establish accurate ALD and renin RIs for sandwich immunoassays. Region-, age- and sex-specific RIs were recommended, which will enhance the accuracy of clinical screening and diagnosis of primary aldosteronism.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144793628","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":"Total laboratory automation: fit for its intended purposes?","authors":"Mario Plebani","doi":"10.1515/cclm-2025-0855","DOIUrl":"https://doi.org/10.1515/cclm-2025-0855","url":null,"abstract":"<p><p>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 made through the integration of pre-analytical and post-analytical phases, thereby improving the overall quality of the Total Testing Process (TTP). Despite the well-recognized benefits of Total Laboratory Automation (TLA) - notably improved worker safety and faster turnaround times - a number of limitations have emerged, particularly concerning operational challenges and the lack of evidence for clinical effectiveness. Future improvements should focus on the integration of pre-pre-analytical processes, miniaturization of testing platforms, consolidation of all laboratory medicine subspecialties, and enhanced data management. However, the most critical issue remains the limited evidence supporting the impact of TLA on key clinical outcomes - such as reduced length of stay in emergency departments and hospital wards, optimized diagnostic-therapeutic pathways, improved quality of care, and reduced morbidity and mortality.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144793629","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":"Response to the editorial by Karl Lackner.","authors":"Marith van Schrojenstein Lantman, Marc Thelen","doi":"10.1515/cclm-2025-0334","DOIUrl":"https://doi.org/10.1515/cclm-2025-0334","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144741358","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":"Accelerating time from result to clinical action: impact of an automated critical results reporting system.","authors":"Elisa M Aponte, Amos J Shemesh, Taylor Kalomeris, Bulent Oral, Stanley Diaz, Yaxin Li, He S Yang, Melissa M Cushing, Zhen Zhao","doi":"10.1515/cclm-2025-0711","DOIUrl":"https://doi.org/10.1515/cclm-2025-0711","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144728424","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}