Clinica Chimica Acta最新文献

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Reliable quantification of fecal elastase-1: A study on sample stability, IDK ELISA and IDK Extract® device. 粪便弹性酶-1的可靠定量:样品稳定性、IDK ELISA和IDK Extract®装置的研究。
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2026-01-01 Epub Date: 2025-08-07 DOI: 10.1016/j.cca.2025.120541
Jenny K Kiviaho, Mikko Anttonen, Henrik Alfthan, Outi Itkonen
{"title":"Reliable quantification of fecal elastase-1: A study on sample stability, IDK ELISA and IDK Extract® device.","authors":"Jenny K Kiviaho, Mikko Anttonen, Henrik Alfthan, Outi Itkonen","doi":"10.1016/j.cca.2025.120541","DOIUrl":"10.1016/j.cca.2025.120541","url":null,"abstract":"<p><p>Quantitation of fecal elastase 1 (FE-1) is a non-invasive test for pancreatic function to detect moderate or severe exocrine insufficiency. The enzyme-linked immunosorbent assays (ELISA) are well-established tests for FE-1 detection. Traditional sample preparation by manual weighing and extraction is laborious, but new sample devices allow more effective sample preparation. FE-1 in stool has good stability but systematic studies on FE-1 stability in sampling and extraction devices are lacking. We examined the stability of FE-1 in the IDK Extract® device and intact stool samples at room temperature, 4 °C or -20 °C. Furthermore, we assessed the suitability of the IDK Extract® device for FE-1 testing and compared the performance of IDK FE-1 ELISA to that of the established ScheBo assay. FE-1 is stable in IDK Extract® device and intact stool for at least 29 days at all storage temperatures tested with deviation < 20 % from day zero concentration. When compared to weighing, the IDK Extract® device proved to be a reliable tool for sample preparation. Based on common clinical decision limits of pancreatic exocrine function, the ScheBo and IDK assays showed good agreement. In conclusion, IDK FE-1 assay together with the IDK Extract® device offers an effective and reliable method to determine exocrine pancreatic insufficiency. FE-1 is stable at various temperatures and the IDK and ScheBo assays perform equally. Thus, stool samples from outpatient clinics can be transported to the analytical laboratory cost-effectively at room temperature.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120541"},"PeriodicalIF":2.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144811882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Viral detection using Clustered Regularly Interspaced Short Palindromic Repeats/CRISPR-associated protein and Argonaute nucleases. 聚类规则间隔短回文重复序列/ crispr相关蛋白和Argonaute核酸酶的病毒检测
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2026-01-01 Epub Date: 2025-08-07 DOI: 10.1016/j.cca.2025.120526
Liang Xu, Xuping Wu
{"title":"Viral detection using Clustered Regularly Interspaced Short Palindromic Repeats/CRISPR-associated protein and Argonaute nucleases.","authors":"Liang Xu, Xuping Wu","doi":"10.1016/j.cca.2025.120526","DOIUrl":"10.1016/j.cca.2025.120526","url":null,"abstract":"<p><p>Viral pandemics pose severe threats to human health and societal stability, exemplified by the COVID-19 outbreak in 2019. Conventional viral detection methods such as Polymerase chain reaction (PCR) typically require trained personnel, expensive equipment, and 2-4 h for processing. Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)/CRISPR-associated protein (Cas) and Argonaute (Ago) system-based detection methods achieve attomolar sensitivity or single-copy detection limits with single-base specificity within 1 h, without requiring complex or costly instruments. This review firstly introduces the mechanisms and functions of CRISPR/Cas systems (Cas9, Cas12, Cas13) and Ago systems. It also introduces viruses with significant social impact, and continued with reviewing applications of these systems in single and multiplex virus detection. Single viral detection includes recently developed DNA/RNA-activated Cas9 detection (DACD/RACD) using Cas9 trans-cleavage activity, Cas12-based DNA Endonuclease-targeted CRISPR Trans Reporter (DETECTR) with attomolar sensitivity, CRISPR/Cas13a-based Fluorescent Nanoparticle SARS-CoV-2 (CFNS) achieving 1 copy/mL sensitivity with quantum dot reporters, and amplification-free mobile phone detection detecting 31 copies/μL without amplification. Multiplex viral detection includes Microfluidic Device Integrated with CRISPR/Cas12a and Multiplex Recombinase Polymerase Amplification (MiCaR) enabling 30-plex detection through microfluidic chips with spatial discrimination, PfAgo-mediated Nucleic acid Detection (PAND) utilizing Ago-produced guide sequences for 5-plex detection, Specific High-Sensitivity Enzymatic Reporter UnLOCKing v2 (SHERLOCKv2) achieving 4-plex detection with multi-enzyme single-reaction systems, and Multiplexed Evaluation of Nucleic acids (CARMEN) supporting over 100 target assays. Finally, this review discusses challenges in CRISPR/Cas and Ago-based detection methods, including Protospacer Adjacent Motif (PAM) sequence requirements for Cas9/12, prolonged reaction times due to nucleic acid extraction/amplification, and instability of core components like nucleases and crRNAs. Detection specificity and multiplex capabilities could be further improved. Future directions are outlined for improving detection specificity, developing multiplex capabilities and advancing POCT. Developing diagnostic tools using CRISPR/Cas and Ago systems could transform molecular diagnostics, such tools promise to be easily accessible worldwide. They are essential for precise identification and strategic containment of infectious disease transmission.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120526"},"PeriodicalIF":2.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144788397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Exosomal RNA biomarkers in pancreatic ductal adenocarcinoma: Systematic review and meta-analysis. 胰腺导管腺癌的外泌体RNA生物标志物:系统回顾和荟萃分析。
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2026-01-01 Epub Date: 2025-08-06 DOI: 10.1016/j.cca.2025.120532
Amir Tiyuri, Haniyeh Hatami, Zahra Mobarezi, Mina Zareardalan, Ghazal Salari, Aida Zandi Abbas Abadi, Marziyeh Mirzazad, Anahita Ebrahimi Mojaveri, Davod Jafari
{"title":"Exosomal RNA biomarkers in pancreatic ductal adenocarcinoma: Systematic review and meta-analysis.","authors":"Amir Tiyuri, Haniyeh Hatami, Zahra Mobarezi, Mina Zareardalan, Ghazal Salari, Aida Zandi Abbas Abadi, Marziyeh Mirzazad, Anahita Ebrahimi Mojaveri, Davod Jafari","doi":"10.1016/j.cca.2025.120532","DOIUrl":"10.1016/j.cca.2025.120532","url":null,"abstract":"<p><p>Pancreatic cancer is a highly lethal malignancy, ranking tenth in incidence among all cancers and standing as the fourth leading cause of cancer-related mortality worldwide. This systematic review and meta-analysis evaluated the diagnostic performance of exosomal biomarkers for detecting pancreatic ductal adenocarcinoma (PDAC). A total of 1,666 records were identified through comprehensive searches in Scopus, Web of Science, and PubMed. After removing duplicates and screening titles, abstracts, and full texts, 15 studies comprising 1,961 individuals (971 PDAC patients and 990 controls) were included. The quality of studies was assessed using the QUADAS-2 tool, revealing potential biases mainly in patient selection and index test domains. Three biomarker categories were analyzed: exosomal microRNAs (exomiRs), cancer antigen 19-9 (CA 19-9), and glypican-1 (GPC1). ExomiRs demonstrated the highest pooled sensitivity (0.86; 95 % CI: 0.80-0.90) and lowest negative likelihood ratio (0.16; 95 % CI: 0.11-0.24), while CA 19-9 showed the highest specificity (0.91; 95 % CI: 0.84-0.95) and positive likelihood ratio (8.5; 95 % CI: 4.4-16.4). ExomiRs also had the highest diagnostic odds ratio (DOR = 35.4; 95 % CI: 18.7-67.0) and area under the SROC curve (AUC = 0.92; 95 % CI: 0.89-0.94), indicating superior diagnostic performance compared to CA 19-9 and GPC1 (AUC = 0.88 and 0.78, respectively). GPC1 consistently showed lower diagnostic metrics across all analyses. Deeks' funnel plot suggested no publication bias for CA 19-9 and GPC1, but indicated potential bias for exomiRs (P = 0.01). Overall, exomiRs appear to be promising non-invasive biomarkers for the early detection of PDAC, outperforming traditional and other exosome-based markers in diagnostic accuracy.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120532"},"PeriodicalIF":2.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
First automated immunoassay for symmetric dimethylarginine (SDMA) with reference interval establishment. 首次对对称二甲基精氨酸(SDMA)进行自动免疫测定,建立参考区间。
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2025-09-30 DOI: 10.1016/j.cca.2025.120638
Jillian Kodger, Marilyn Strong-Townsend, Giosi Farace, Sarah Peterson, Murthy Yerramilli, Joe M El-Khoury
{"title":"First automated immunoassay for symmetric dimethylarginine (SDMA) with reference interval establishment.","authors":"Jillian Kodger, Marilyn Strong-Townsend, Giosi Farace, Sarah Peterson, Murthy Yerramilli, Joe M El-Khoury","doi":"10.1016/j.cca.2025.120638","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120638","url":null,"abstract":"<p><p>The measurement of kidney function is critical for early detection and management of acute kidney injury and chronic kidney disease. Traditional biomarkers such as creatinine and cystatin C are commonly used but have significant limitations due to factors such as muscle mass, diet, hydration, and extrarenal conditions. Creatinine-based equations have raised concerns over health equity regarding racial differences in estimates of kidney function. In response, symmetric dimethylarginine (SDMA) has emerged as a promising biomarker due to its reduced sensitivity to muscle mass and other extrarenal variables. However, the clinical adoption of SDMA has been limited by the need for more efficient, automated testing methods. This study aimed to evaluate the first fully automated immunoassay for SDMA and compare its performance to the gold-standard liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. We also established reference intervals using over five hundred samples from the Association for Diagnostics and Laboratory Medicine (formerly AACC) sample bank. Our results demonstrate that the automated IDEXX SDMA® immunoassay provides rapid, accurate, and reliable measurements, offering significant potential to introduce this biomarker to the clinical space to aid in diagnosing and treating kidney dysfunction.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120638"},"PeriodicalIF":2.9,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145211936","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Neurofilament light chain - matrix comparison and long-term stability in frozen serum. 冷冻血清中神经丝轻链基质的比较及长期稳定性。
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2025-09-30 DOI: 10.1016/j.cca.2025.120637
Lea Tybirk, Cindy Søndersø Knudsen, Tina Parkner
{"title":"Neurofilament light chain - matrix comparison and long-term stability in frozen serum.","authors":"Lea Tybirk, Cindy Søndersø Knudsen, Tina Parkner","doi":"10.1016/j.cca.2025.120637","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120637","url":null,"abstract":"<p><strong>Objective: </strong>Neurofilament light chain (NfL) is a sensitive biomarker of neuronal damage and degeneration increasingly used both in research and clinical practice. We aimed to investigate the relationship between NfL concentration in cerebrospinal fluid (CSF), serum, and lithium-heparin plasma samples, and the storage stability of NfL in serum at -20 °C.</p><p><strong>Methods: </strong>Serum and lithium-heparin plasma were compared by adding an extra lithium-heparin tube to routine serum NfL requisitions in our hospital until 50 samples were collected. Serum and CSF NfL were compared by extracting results of 955 paired samples from Danish hospitals taken within four hours of each other and analysed in our hospital laboratory. The stability of serum NfL during storage at -20 °C was assessed in 10 samples from the department of neurology, with repeated measurements performed over 12 months.</p><p><strong>Results: </strong>Very strong correlations were observed between serum and lithium-heparin plasma (Spearman's rho = 0.98) and between serum and CSF (Spearman's rho = 0.80). A small positive bias of 3.7 % was found for lithium-heparin plasma versus serum, while the median CSF/serum ratio was 54.5 (range: 1.6-385.6). In both comparisons, considerable variability across individual sample pairs was observed, independent of NfL concentration. In the stability study, the mean change from baseline was -7.1 % (95 %CI: -1.7 %; -12.6 %) after 12 months at -20 °C.</p><p><strong>Conclusions: </strong>NfL concentrations in different matrices were highly correlated, but due to variability across pairs, we recommend using the same matrix to monitor individual patients. Serum NfL concentrations remained stable during 12 months at -20 °C.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120637"},"PeriodicalIF":2.9,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145211896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Glycated albumin is a useful marker for early screening of undiagnosed prediabetes and diabetes in patients presenting to a metropolitan emergency department. 糖化白蛋白是一个有用的标志物,早期筛查未确诊的前驱糖尿病和糖尿病患者提出到城市急诊科。
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2025-09-29 DOI: 10.1016/j.cca.2025.120624
Julie Sherfan, Gail Del Olmo, Myron Lee, Andrew Ah-Loo, David R Sullivan, Ian D Caterson
{"title":"Glycated albumin is a useful marker for early screening of undiagnosed prediabetes and diabetes in patients presenting to a metropolitan emergency department.","authors":"Julie Sherfan, Gail Del Olmo, Myron Lee, Andrew Ah-Loo, David R Sullivan, Ian D Caterson","doi":"10.1016/j.cca.2025.120624","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120624","url":null,"abstract":"<p><strong>Background: </strong>Glycated albumin (GA) is formed from the non-enzymatic reaction of glucose with lysine residues of the albumin molecule. Its concentration reflects glycaemia in the preceding 3 weeks and has been proposed as an alternative marker in conditions when HbA1c is not accurate.</p><p><strong>Methods: </strong>Patients presenting to the emergency department of a small metropolitan hospital were screened for diabetes and prediabetes using HbA1c, glycated albumin and fructosamine.</p><p><strong>Results: </strong>Our in-house derived reference interval in adults >18 years old was 163 to 280 mmol/mol (9.2-15.8 %). GA levels in chronic kidney disease and hypoalbuminaemia patients were not different from non-diabetic, apparently healthy group. GA and fructosamine were found to be equally good at identifying patients at risk of prediabetes and diabetes. A GA level of ≥274 mmol/mol (16 %) had a diagnostic sensitivity and specificity of 65 % and 77 % in identifying prediabetes risk (AUC = 0.709) and GA ≥ 308 mmol/mol (17 %) had a sensitivity of 76 % and specificity of 92 % in identifying those at risk of diabetes (AUC = 0.863). GA has a poor correlation with HbA1c (R = 0.410) and a GA of 458 mmol/mol (26 %) equated to an HbA1c of 48 mmol/mol (7 %).</p><p><strong>Conclusion: </strong>Our study provides further evidence that GA can be used as an effective mid-term glycaemic marker in screening for prediabetes and diabetes in patients presenting to the emergency department.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120624"},"PeriodicalIF":2.9,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145205751","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
MicroRNA biomarkers in psoriasis. 银屑病中的MicroRNA生物标志物。
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2025-09-29 DOI: 10.1016/j.cca.2025.120633
Shikha Singh, Medha Rajappa
{"title":"MicroRNA biomarkers in psoriasis.","authors":"Shikha Singh, Medha Rajappa","doi":"10.1016/j.cca.2025.120633","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120633","url":null,"abstract":"<p><p>Psoriasis, a T-helper mediated chronic inflammatory autoimmune skin disease, has significant socioeconomic burden worldwide. Unfortunately, etiology and underlying pathophysiology remains unclear. Although several biologics have substantially improved therapy, recurrence is common. The identification of reliable biomarkers for early diagnosis, prognosis, and therapeutic response remain significant challenges. Advances in omic technologies has enabled new approaches in biomarker discovery including microRNAs. These small non-coding RNA molecules that have emerged as promising biomarkers due to their regulatory roles in immune filtration, keratinocyte proliferation, apoptosis and inflammatory pathways in psoriasis. This review unites evidence on the prognostic and diagnostic potential of miRNAs in psoriasis and highlighting their altered expression profiles in psoriatic lesions and circulation. Specific miRNAs, such as miR-21, miR-31, miR-99a, miR-146a, miR-125b, and miR-203, miR-138, miR-155 in pathogenesis are explored as well as their association with disease severity, treatment response, and comorbidities. Furthermore, the integration of miRNA profiling with advanced omics technologies and machine learning provides a framework for developing predictive algorithms. The review consolidates the potential of miRNAs to guide personalized treatment strategies and their utility in monitoring therapeutic efficacy. Future research focusing on standardizing miRNA-based assays, integrating miRNA signatures with other omics approaches to enhance therapeutic outcomes and exploring their mechanistic roles may pave the way for their clinical translation as reliable biomarkers in management of disease.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120633"},"PeriodicalIF":2.9,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145205800","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Multicenter clinical validation of a novel rapid single-integrated TAT immunoassay and combined thrombosis biomarker panel for venous thromboembolism risk stratification in colorectal cancer. 用于结直肠癌静脉血栓栓塞风险分层的新型快速单集成TAT免疫测定和联合血栓生物标志物面板的多中心临床验证。
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2025-09-29 DOI: 10.1016/j.cca.2025.120631
Meng Liu, Chaolin Guo, Hongsheng Zhou, Ziyan Xie, Yankun Yang, Kuiqi Jin, Jianqi Nie, Jinhua Xiao, Yang Sun, Zhonghu Bai
{"title":"Multicenter clinical validation of a novel rapid single-integrated TAT immunoassay and combined thrombosis biomarker panel for venous thromboembolism risk stratification in colorectal cancer.","authors":"Meng Liu, Chaolin Guo, Hongsheng Zhou, Ziyan Xie, Yankun Yang, Kuiqi Jin, Jianqi Nie, Jinhua Xiao, Yang Sun, Zhonghu Bai","doi":"10.1016/j.cca.2025.120631","DOIUrl":"10.1016/j.cca.2025.120631","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to validate the reliability of a novel point-of-care testing technology for measuring the thrombin-antithrombin III complex (TAT) and to evaluate its utility in evaluating venous thromboembolism (VTE) risk and enabling dynamic monitoring in patients with colorectal cancer (CRC).</p><p><strong>Design and methods: </strong>The novel immunoassay for TAT measurement was assessed against a reference system. Biomarker levels-including TAT, plasmin-α2-antiplasmin complex (PIC), thrombomodulin (TM), and tissue plasminogen activator-inhibitor complex (tPAIC)-were quantified in patients with CRC and healthy controls. Statistical analyses were conducted to assess differences among various groups. Receiver operating characteristic (ROC) curve analysis was employed to evaluate the predictive performance of biomarkers for VTE risk stratification.</p><p><strong>Results: </strong>The novel TAT assay showed excellent correlation with the reference method (r > 0.99). All biomarkers were significantly elevated in CRC patients compared to healthy controls (p < 0.001), with TAT and PIC levels increasing by 3.5-fold and 2.4-fold, respectively. Significant differences in the levels of TAT, PIC, and tPAIC were also observed between CRC patients with VTE and those without VTE (p < 0.001). Advanced-stage patients showed a median TAT concentration 1.8-fold higher than early-stage patients (p < 0.001). ROC analysis revealed strong predictive performance for TAT and the combined biomarker model, with an area under the curve (AUC) of 0.9544, sensitivity of 90.5 %, and specificity of 93.5 %.</p><p><strong>Conclusions: </strong>The novel TAT immunoassay represents a reliable system for clinical application. Furthermore, a combined biomarker model enhances VTE risk stratification in CRC patients, providing a valuable strategy for personalized anticoagulant therapy and dynamic monitoring.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120631"},"PeriodicalIF":2.9,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145205798","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
ICBCCR: A new path for harmonization and clinical verification on a multi-center real-world cohort of 278703. ICBCCR:在278703个多中心真实队列中协调和临床验证的新途径
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2025-09-27 DOI: 10.1016/j.cca.2025.120632
Penghui Zhang, Zhiwu Dong, Yingting Wu, Lufei Jiang, Huiling Fang, Xue Yuan, Houqun Ying, Chong Chen, Xin Chang, Xinxin Ren, Manman Zhang, Wenqing Chu, Lianxiang Xing, Keliang Huang, Weiyi Wu, Yuqing Zhu
{"title":"ICBCCR: A new path for harmonization and clinical verification on a multi-center real-world cohort of 278703.","authors":"Penghui Zhang, Zhiwu Dong, Yingting Wu, Lufei Jiang, Huiling Fang, Xue Yuan, Houqun Ying, Chong Chen, Xin Chang, Xinxin Ren, Manman Zhang, Wenqing Chu, Lianxiang Xing, Keliang Huang, Weiyi Wu, Yuqing Zhu","doi":"10.1016/j.cca.2025.120632","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120632","url":null,"abstract":"<p><strong>Background: </strong>In this study, we aimed to develop a novel harmonization algorithm to achieve the conversion from current results to harmonized results directly and perform a clinical verification on a multi-center real-world cohort of 278,703.</p><p><strong>Methods: </strong>Sixty patient samples were collected as harmonization reference materials to develop and internally validate the harmonization algorithm. We assessed the harmonization effectiveness through multiple dimensions such as method comparison and evaluation. Then, the harmonization algorithm was performed on 278,703 sample results. We compared the distributions of the harmonized results from different in vitro diagnostic measurement devices through the Bhattacharyya distance.</p><p><strong>Results: </strong>After harmonized by the novel algorithm, equivalent results were obtained among 5 in vitro diagnostic measurement devices for MYO with mean percent differences from -1.5 % to -0.1 % and the 95 % limits of agreement from 14.1 % to 20.3 % and for CK-MB with mean percent differences from -0.2 % to 1.1 % and the 95 % limits of agreement from 14.5 % to 36.6 %. The coefficients of variation of the results for the same sample presented a significant decrease from 20.6 % to 4.6 % for MYO and from 38.6 % to 5.3 % for CK-MB. Furthermore, after the harmonization algorithm was performed on 278,703 sample results from the real world, the Bhattacharyya distance decreased from 0.0046 to 0.0019 for MYO and from 0.0949 to 0.0049 for CK-MB after harmonization, respectively.</p><p><strong>Conclusions: </strong>The novel algorithm is a new path for harmonization only based on current results and its clinical applicability has been fully verified in the real world.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120632"},"PeriodicalIF":2.9,"publicationDate":"2025-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145191029","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Corrigendum to "The predictive value of serum mRNA-RGS10 for the severity and prognosis of acute pancreatitis" [Clin. Chim. Acta 578 (2026) 120531]. “血清mRNA-RGS10对急性胰腺炎严重程度和预后的预测价值”的勘误表[临床。詹。学报578(2026):120531。
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2025-09-27 DOI: 10.1016/j.cca.2025.120622
Jie Li, Hanhui Li, Xiaoping Tan, Jun Zhang, Shengqi Du, Yueyue Lu, Qing Zhang
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