Clinical chemistry and laboratory medicine最新文献

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Evaluating the performance of a multiparametric IgA assay for celiac disease diagnosis. 评估乳糜泻诊断中多参数IgA检测的性能。
IF 3.7 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-08-20 DOI: 10.1515/cclm-2025-0705
Caterina Maria Gambino, Luisa Agnello, Fabio Del Ben, Anna Maria Ciaccio, Salvatore Milano, Roberta Vassallo, Francesco Cacciabaudo, Aurelio Seidita, Pasquale Mansueto, Antonio Carroccio, Marcello Ciaccio
{"title":"Evaluating the performance of a multiparametric IgA assay for celiac disease diagnosis.","authors":"Caterina Maria Gambino, Luisa Agnello, Fabio Del Ben, Anna Maria Ciaccio, Salvatore Milano, Roberta Vassallo, Francesco Cacciabaudo, Aurelio Seidita, Pasquale Mansueto, Antonio Carroccio, Marcello Ciaccio","doi":"10.1515/cclm-2025-0705","DOIUrl":"10.1515/cclm-2025-0705","url":null,"abstract":"<p><strong>Objectives: </strong>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 membrane-based enzyme immunoassay (AESKUBLOTS<sup>®</sup>) for the simultaneous detection of IgA antibodies targeting eight CD-related antigens.</p><p><strong>Methods: </strong>A retrospective, single-centre study was conducted on 180 participants: 80 with CD (30 untreated, 50 on gluten-free diet, GFD), 50 with non-celiac wheat sensitivity (NCWS), and 50 healthy controls (HC). Serum samples were analysed using the AESKU assay. Diagnostic accuracy was assessed via ROC curve analysis and 5-fold cross-validation, examining individual markers and a composite antibody score.</p><p><strong>Results: </strong>The assay demonstrated high diagnostic performance, particularly in untreated CD patients. Anti-tTG neo IgA showed the highest accuracy (AUC=0.93), followed by anti-tTG IgA (AUC=0.92). A composite score of ≥4 positive markers yielded an AUC of 0.99, while ≥6 positive markers achieved 100 % specificity and PPV, with 76.7 % sensitivity. Notably, anti-mTG IgA levels were elevated in all CD patients regardless of diet, suggesting potential utility in monitoring or identifying ongoing mucosal immune activity.</p><p><strong>Conclusions: </strong>This multiparametric IgA assay offers a sensitive, specific, and non-invasive diagnostic tool for CD. Larger, prospective studies are warranted to confirm the clinical utility and expand the applicability to broader populations.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144882282","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}
引用次数: 0
Urgent call to the European Commission to simplify and contextualize IVDR Article 5.5 for tailored and precision diagnostics. 紧急呼吁欧盟委员会简化IVDR第5.5条并将其背景化,以进行量身定制的精确诊断。
IF 3.7 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-08-20 DOI: 10.1515/cclm-2025-1033
Christa Cobbaert, Christian Schweiger, Christoph Buchta, Thomas Streichert, Florent Vanstapel, Francois Mullier, Lucas Biaggini, Ettore Capoluongo, Patrick Bossuyt, Harjit Pal Bhattoa, Tom Melvin, Michael Neumaier
{"title":"Urgent call to the European Commission to simplify and contextualize IVDR Article 5.5 for tailored and precision diagnostics.","authors":"Christa Cobbaert, Christian Schweiger, Christoph Buchta, Thomas Streichert, Florent Vanstapel, Francois Mullier, Lucas Biaggini, Ettore Capoluongo, Patrick Bossuyt, Harjit Pal Bhattoa, Tom Melvin, Michael Neumaier","doi":"10.1515/cclm-2025-1033","DOIUrl":"10.1515/cclm-2025-1033","url":null,"abstract":"<p><p>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 on the EU market or by medical laboratories that establish and operate in-house-IVDs (IH-IVDs) in their healthcare institution (network). Based on stakeholder feedback the EC aims to be informed about potential regulatory revisions by late 2025. As IH-IVDs, used in different modes, have a vital role in the EU healthcare system, the authors make the statement that Article 5.5 of the IVDR should be systemically amended, removing conditions (a) and (d) through (i) for in-house tests, while retaining conditions (b) and (c). Having the prime objectives of the IVDR in mind, i.e. patient safety and clinical utility, this opinion paper urges the EC to revise IVDR Article 5.5 to prevent disservices to patients and caregivers by taking into account available quality management infrastructure in ISO 15189:2022 accredited medical laboratories and guaranteed professionality of registered laboratory specialists, both already monitored at the level of the EU member states. By abandoning unnecessary, non-valuable requirements from Article 5.5 overregulation is prevented and the sustainability of important specialty and orphan tests, essential for patients with rare diseases, is guaranteed.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871780","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}
引用次数: 0
Verification of the T50 Calciprotein Crystallization test: bias estimation and interferences. T50钙蛋白结晶试验的验证:偏差估计和干扰。
IF 3.7 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-08-20 DOI: 10.1515/cclm-2025-0600
Joyce Y Xu, Didier Falconnet, Tarah van den Berkmortel, Sandra de la Rosa, Vincent Linder, Robert de Jonge, Andreas Pasch, Marc G Vervloet, Henrike M Hamer
{"title":"Verification of the T50 Calciprotein Crystallization test: bias estimation and interferences.","authors":"Joyce Y Xu, Didier Falconnet, Tarah van den Berkmortel, Sandra de la Rosa, Vincent Linder, Robert de Jonge, Andreas Pasch, Marc G Vervloet, Henrike M Hamer","doi":"10.1515/cclm-2025-0600","DOIUrl":"10.1515/cclm-2025-0600","url":null,"abstract":"<p><strong>Objectives: </strong>The T50 Calciprotein Crystallization test (T50 test) is a novel blood-based <i>in vitro</i> 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 2 (CPP2) in serum, as detected by nephelometry. To date, the T50 test has only been performed at Calciscon AG, where the assay has been developed and is manufactured. The aim of this study was to compare the agreement and precision of the T50 test in a routine clinical laboratory. Additionally, the interference of free hemoglobin, bilirubin, lipid and low molecular weight heparin (LMWH) was analyzed in the T50 test.</p><p><strong>Methods: </strong>Serum samples were measured at both laboratory sites to determine the agreement. The CLSI EP15-A3 protocol was used to evaluate the precision. Interference was analyzed by spiking pooled serum samples with interfering analytes.</p><p><strong>Results: </strong>Both laboratories showed excellent agreement in the T50 values (y=1.002x-4). Furthermore, high precision was observed for the clinically relevant lower range of T50 with a total variation coefficient of 6.4 %. Serum samples with mid and higher ranges of T50 failed the CLSI precision criteria with a total variance of 10.1 % and 6.2 %, respectively. Lastly, no interferences were observed within the normally observed clinical serum concentrations of free hemoglobin, bilirubin, lipid, and LMWH.</p><p><strong>Conclusions: </strong>The T50 test was successfully implemented in a routine laboratory setting. Additionally, the precision and interference observed in this study largely agreed with the manufacturer's claims.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144882285","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}
引用次数: 0
Clinical significance of anti-mitochondrial antibodies and PBC-specific anti-nuclear antibodies in evaluating atypical primary biliary cholangitis with normal alkaline phosphatase levels. 抗线粒体抗体和pbc特异性抗核抗体在碱性磷酸酶水平正常的非典型原发性胆道炎中的临床意义。
IF 3.7 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-08-20 DOI: 10.1515/cclm-2025-0357
Shasha Li, Kai Zhang, Hongli Liu, Miaoyang Chen, Jialuo Wang, Yuan Yang, Yuxiang Gong, Xing Liu, Yongfeng Yang
{"title":"Clinical significance of anti-mitochondrial antibodies and PBC-specific anti-nuclear antibodies in evaluating atypical primary biliary cholangitis with normal alkaline phosphatase levels.","authors":"Shasha Li, Kai Zhang, Hongli Liu, Miaoyang Chen, Jialuo Wang, Yuan Yang, Yuxiang Gong, Xing Liu, Yongfeng Yang","doi":"10.1515/cclm-2025-0357","DOIUrl":"10.1515/cclm-2025-0357","url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>Patients at The Second Hospital of Nanjing with positive AMAs/PBC-ANAs and normal ALP levels from January 2016 to July 2024 were categorized into three groups based on autoantibody profiles: [AMA/AMA-M2]<sup>+</sup>[gp210/sp100]<sup>+</sup>, [AMA/AMA-M2]<sup>+</sup>[gp210/sp100]<sup>-</sup>, and [AMA/AMA-M2]<sup>-</sup>[gp210/sp100]<sup>+</sup>. The study compared PBC diagnostic rates, clinical symptoms, laboratory results, and pathology across these groups.</p><p><strong>Results: </strong>A total of 53.3 % (88/165) of the patients showed cholangitis activity diagnosed of PBC. The PBC diagnosis rate in the three groups was 82.1 % (23/28), 48.4 % (46/95), and 45.2 % (19/42) respectively. Multivariate analysis indicated a significant association between the absence of liver disease-related etiology (p<0.001), baseline serum immunoglobulin M (IgM) exceeding 0.796 times the upper limit of normal (ULN) (p<0.001), and the diagnosis of PBC as determined by liver biopsy. In the three groups of non-PBC patients, the major pathological injury patterns were minor nonspecific reactive changes (40.0 %/28.6 %/39.1 %), inflammation (40.0 %/24.5 %/47.8 %), and fatty changes (20 %/20.4 %/4.3 %). The diagnosis included viral hepatitis, autoimmune hepatitis, fatty liver disease, vascular liver disorders, drug-induced liver injury, congenital hepatic fibrosis, and porphyria.</p><p><strong>Conclusions: </strong>Over 50 % of patients with positive PBC-specific antibodies and normal ALP have PBC. Liver biopsy is recommended when AMAs and/or PBC-specific ANAs are positive, especially when baseline serum IgM exceeds 0.796 × ULN, and when other etiologies related to liver disease are absent. The area under the curve (AUC) for these three indicators reaches 0.84.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144882280","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}
引用次数: 0
A multiplex allele specific PCR capillary electrophoresis (mASPCR-CE) assay for simultaneously analysis of SMN1/SMN2/NAIP copy number and SMN1 loss-of-function variants. 一种多重等位基因特异性PCR毛细管电泳(mASPCR-CE)方法,用于同时分析SMN1/SMN2/NAIP拷贝数和SMN1功能缺失变异。
IF 3.7 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-08-19 DOI: 10.1515/cclm-2025-0175
Yunli Lai, Xu Yang, Shijie Wei, Yajun Chen, Yanjun Cai, Wenyu Wang, Zeyan Zhong, Xuexi Yang, Wanjun Zhou
{"title":"A multiplex allele specific PCR capillary electrophoresis (mASPCR-CE) assay for simultaneously analysis of <i>SMN1/SMN2</i>/<i>NAIP</i> copy number and <i>SMN1</i> loss-of-function variants.","authors":"Yunli Lai, Xu Yang, Shijie Wei, Yajun Chen, Yanjun Cai, Wenyu Wang, Zeyan Zhong, Xuexi Yang, Wanjun Zhou","doi":"10.1515/cclm-2025-0175","DOIUrl":"10.1515/cclm-2025-0175","url":null,"abstract":"<p><strong>Objectives: </strong>Spinal muscular atrophy (SMA) is a severe inherited neuromuscular disorder with a high carrier frequency and incidence rate. An accurate molecular method for <i>SMA</i> genes is crucial in carrier screening, clinical diagnosis, outcome assessment and precision therapies.</p><p><strong>Methods: </strong>Comprehensively using the multiplex allele specific PCR (mASPCR) and capillary electrophoresis (CE), a novel single tube assay was developed to simultaneously determine the copy number of <i>SMN1</i>/<i>SMN2</i>/<i>NAIP</i> genes and five common loss-of-function variants in <i>SMN1</i>. A total of 283 genotype known subjects were detected to evaluate the accuracy, while 564 clinical random samples were double-blind detected with this assay and MLPA to assess the specificity and sensitivity.</p><p><strong>Results: </strong>This assay had high accuracy of 100 % consistency with the predetermined values in 283 genotype known subjects. Among 564 clinical random samples, the correlation between this assay and comparative method was 100 %, which showing high specificity and sensitivity.</p><p><strong>Conclusions: </strong>This mASPCR-CE assay is easy to use and cost-effective, making it suitable for routine use in molecular screening and clinical diagnosis of SMA.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871778","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}
引用次数: 0
Kidney stones consisting of 1-methyluric acid. 由1-甲基尿酸组成的肾结石。
IF 3.7 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-08-19 DOI: 10.1515/cclm-2025-0627
Søren Risom Kristensen, Kim Hovgaard Andreassen, Lene Hyldgaard Bigum, Charlotte H Graugaard-Jensen, Jørgen Bjerggaard Jensen, Mette Thrane Øhrstrøm, Claus Gyrup Nielsen
{"title":"Kidney stones consisting of 1-methyluric acid.","authors":"Søren Risom Kristensen, Kim Hovgaard Andreassen, Lene Hyldgaard Bigum, Charlotte H Graugaard-Jensen, Jørgen Bjerggaard Jensen, Mette Thrane Øhrstrøm, Claus Gyrup Nielsen","doi":"10.1515/cclm-2025-0627","DOIUrl":"https://doi.org/10.1515/cclm-2025-0627","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871779","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}
引用次数: 0
Evaluation of stability and potential interference on the α-thalassaemia early eluting peak and immunochromatographic strip test for α-thalassaemia --SEA carrier screening. α-地中海贫血早期洗脱峰及免疫层析试纸α-地中海贫血SEA载体筛选的稳定性及潜在干扰评价
IF 3.7 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-08-18 DOI: 10.1515/cclm-2025-0754
Wing Kit Lam, Christina Pui Ying Fan, Winnie Yim Fong Law, Tsz Fung Wong, Darcy Lok Han Too, Lok Nga Ko, Anskar Yu Hung Leung, Sze Fai Yip
{"title":"Evaluation of stability and potential interference on the α-thalassaemia early eluting peak and immunochromatographic strip test for α-thalassaemia --<sup>SEA</sup> carrier screening.","authors":"Wing Kit Lam, Christina Pui Ying Fan, Winnie Yim Fong Law, Tsz Fung Wong, Darcy Lok Han Too, Lok Nga Ko, Anskar Yu Hung Leung, Sze Fai Yip","doi":"10.1515/cclm-2025-0754","DOIUrl":"https://doi.org/10.1515/cclm-2025-0754","url":null,"abstract":"<p><strong>Objectives: </strong>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 (HPLC) and an immunochromatographic strip test (ICT), focusing on stability and potential interferences.</p><p><strong>Methods: </strong>Ninety-two peripheral blood samples were used. Thirty were for assessment of αEEP and ICT stability and interference by icterus/lipaemia, and saline washing for interference removal. Diagnostic performance of αEEP and ICT were evaluated in 40 samples with glycated Hb (P2) ≥6.0 % and 22 with Hb F≥2.0 % on HPLC, using α-globin genotyping as the gold standard.</p><p><strong>Results: </strong>Both αEEP and ICT results remained stable for 14 days. Neither test was significantly affected by icterus or lipaemia, though 3 of 20 ICT results (15 %) showed discordance after saline washing. Elevated HbA<sub>1c</sub> and Hb F altered early eluting peak patterns but did not affect αEEP interpretation. For detecting --<sup>SEA</sup> mutation, αEEP showed 100 % sensitivity and 100 % specificity when P2≥6.0 % or Hb F≥2.0 %, while ICT a low specificity (45 %) when Hb F≥2.0 %.</p><p><strong>Conclusions: </strong>αEEP showed reliable performance in detecting α<sup>0</sup>-thalassaemia with --<sup>SEA</sup> mutation in all conditions tested, while ICT showed low specificity when Hb F≥2.0 %. These findings support αEEP as a reliable test for routine clinical laboratory use, while cautions should be made for ICT in case of elevated Hb F levels.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144859009","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}
引用次数: 0
Analytical and clinical evaluation of an automated high-sensitivity cardiac troponin I assay for whole blood. 全血全自动高灵敏度心肌肌钙蛋白I测定的分析和临床评价。
IF 3.7 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-08-15 DOI: 10.1515/cclm-2025-0143
Jin-Xing Yu, Kai Cui, Yang Li, Fang-Fang Yang, Fen Xu, Zhou Zhou, Ya-Hui Lin
{"title":"Analytical and clinical evaluation of an automated high-sensitivity cardiac troponin I assay for whole blood.","authors":"Jin-Xing Yu, Kai Cui, Yang Li, Fang-Fang Yang, Fen Xu, Zhou Zhou, Ya-Hui Lin","doi":"10.1515/cclm-2025-0143","DOIUrl":"https://doi.org/10.1515/cclm-2025-0143","url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>The iStar hs-cTnI assay was assessed using the Drawray iStar 500 analyzer. Key performance metrics such as the limits of blank (LoB), detection (LoD) and quantitation (LoQ), precision, linearity, and agreement between sample types were evaluated according to Clinical and Laboratory Standards Institute (CLSI) guidelines. A methodological comparison was performed with the Abbott ARCHITECT hs-cTnI assay, and cross-reactivity with others troponins was assessed.</p><p><strong>Results: </strong>The iStar hs-cTnI assay demonstrated robust sensitivity with a LoB of 0.09 ng/L and LoD of 0.31 ng/L. The LoQ was 0.79 ng/L for 20 % coefficient of variation (CV) and 1.85 ng/L for 10 % CV. Precision testing revealed CVs of 1.4-4.8 % near the 99th percentile upper reference limit (URL). The assay exhibited excellent linearity (r=1.00) and high agreement between whole blood and plasma samples (slope=0.936). Methodological comparison with the Abbott ARCHITECT hs-cTnI showed a high correlation coefficient of 0.983. Cross-reactivity with skeletal muscle troponin I, cardiac troponin C, and cardiac troponin T was negligible. In healthy individuals, the overall 99th percentile URL was 16 ng/L, with sex-specific values of 18 ng/L for males and 14 ng/L for females.</p><p><strong>Conclusions: </strong>The iStar hs-cTnI assay demonstrates high sensitivity and precision, supporting it suitable for the rapid diagnosis of acute myocardial infarction using whole blood samples. Its high agreement with plasma and established sex-specific URL support its potential for clinical use in acute coronary syndrome management.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144854757","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}
引用次数: 0
From metabolic profiles to clinical interpretation: multivariate approaches to population-based and personalized reference intervals and reference change values. 从代谢谱到临床解释:基于人群和个性化参考区间和参考变化值的多变量方法。
IF 3.7 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-08-15 DOI: 10.1515/cclm-2025-0786
Abdurrahman Coskun, Jasmin Weninger, Ali Canbay, Mustafa Kemal Özçürümez
{"title":"From metabolic profiles to clinical interpretation: multivariate approaches to population-based and personalized reference intervals and reference change values.","authors":"Abdurrahman Coskun, Jasmin Weninger, Ali Canbay, Mustafa Kemal Özçürümez","doi":"10.1515/cclm-2025-0786","DOIUrl":"https://doi.org/10.1515/cclm-2025-0786","url":null,"abstract":"<p><p>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 the accuracy of decision-making. However, current interpretation practices apply reference intervals and reference change values in a univariate manner - that is, each analyte in the panel is interpreted independently and no reference data are available to interpret the panel as a whole. Yet, metabolism is a network of biomolecules, each of which is related to others. Therefore, a multivariate approach - based on the correlations among biomolecules - can provide a more informative reference than univariate approaches and can be used more effectively in the interpretation of laboratory data. This concept can be summarized by a motto: <i>Combine single tests into meaningful groups, but interpret the group as a single clinical entity.</i> In this opinion paper, we present a practical approach for obtaining reference data for both reference intervals and reference change values to interpret laboratory test panels composed of related analytes.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144854758","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}
引用次数: 0
The importance of laboratory medicine in the management of CKD-MBD: insights from the KDIGO 2023 controversies conference. 检验医学在CKD-MBD管理中的重要性:来自KDIGO 2023争议会议的见解
IF 3.7 2区 医学
Clinical chemistry and laboratory medicine Pub Date : 2025-08-15 DOI: 10.1515/cclm-2025-0802
Samuel D Vasikaran, Konstantinos Makris, Harjit Pal Bhattoa, Tomáš Zima, Pierre Delanaye, Pieter Evenepoel, Hanne Skou Jørgensen, Mathias Haarhaus, Eugene McCloskey, Giovanni Lombardi, Etienne Cavalier
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