Clinica Chimica Acta最新文献

{"title":"Reduced bracketed control concept for automated biochemistry analyzers: A reliable and cost-effective setup","authors":"Helle Glud Binderup,&nbsp;Trine Rennebod Larsen,&nbsp;Steen Antonsen","doi":"10.1016/j.cca.2025.120286","DOIUrl":"10.1016/j.cca.2025.120286","url":null,"abstract":"<div><h3>Objectives</h3><div>Today, most biochemical analytes are produced on automated analysers in continuous mode, and internal quality control (IQC) protocols often include a “critical control” analysed after maintenance and a “bracketed control” (BC) analysed periodically along with patient samples. As quality control materials and reagents are costly, the BC might be reduced to one level of IQC and include only selected analytes, covering testing principles and essential technical parts of the analyser. This study aimed to investigate whether such a reduced BC (rBC) is reliable for detecting clinically relevant analytical problems.</div></div><div><h3>Methods</h3><div>Over 8 months, we compared an rBC with nine analytes and one IQC level with a full BC (fBC) with 65 analytes and two IQC levels regarding the analytical problems revealed.</div></div><div><h3>Results</h3><div>A total of 1,463,512 patient results were produced. With the fBC and rBC, respectively, 1669 and 996 patient samples were reanalysed due to an IQC result outside acceptance limits, resulting in the correction of 311 and 222 patient results. The rBC overlooked 89 (0.061 ‰) patient results outside our correction limits, only two of which were judged to be of potentially serious clinical importance. The extra annual cost of identifying these errors in our setting is approximately 220,000 €.</div></div><div><h3>Conclusions</h3><div>In our setup, the rBC overlooked only very few errors of clinical importance. This rate might be further reduced by including in the rBC any critical tests that are not prone to patient-based real-time quality control, which should be used for remaining, relevant tests.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"573 ","pages":"Article 120286"},"PeriodicalIF":3.2,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143820452","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}

{"title":"Alpha-Fetoprotein (AFP) biosensors","authors":"Nava Moghadasian Niaki ,&nbsp;Faezeh Hatefnia ,&nbsp;Mohammad Mahdi Heidari ,&nbsp;Mahsa Tabean ,&nbsp;Ahmad Mobed","doi":"10.1016/j.cca.2025.120293","DOIUrl":"10.1016/j.cca.2025.120293","url":null,"abstract":"<div><div>Alpha-fetoprotein (AFP) is a glycoprotein mainly produced during fetal development, and elevated levels in adults are frequently associated with liver diseases, especially hepatocellular carcinoma (HCC), as well as certain germ cell tumors. Measuring AFP in biological samples is crucial for early diagnosis, monitoring disease progression, and evaluating treatment efficacy. While traditional detection methods like enzyme-linked immunosorbent assay (ELISA) and radioimmunoassay are dependable, they often face limitations such as lengthy processes, complexity, and the need for specialized equipment. In recent years, biosensing technologies have emerged as promising alternatives for detecting AFP, offering advantages like increased sensitivity, real-time monitoring, and ease of use. Various biosensing platforms, including electrochemical, optical, and piezoelectric sensors, have been developed to enable quick and specific detection of AFP. These sensors employ molecular recognition elements, such as antibodies, aptamers, or nanoparticles, to selectively bind AFP, producing a measurable signal. This article explores the structure and mechanisms of action of AFP, the diseases linked to it, and describes several biosensing technologies. It also reviews recent advancements in AFP biosensing, discussing their principles, performance, and potential applications in clinical settings. Furthermore, the article highlights the challenges and future prospects for developing cost-effective, portable, and multiplexed AFP biosensors, underscoring their potential to revolutionize early disease detection and personalized healthcare.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"573 ","pages":"Article 120293"},"PeriodicalIF":3.2,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143816862","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}

{"title":"Biomarkers for early diagnosis of rheumatoid arthritis","authors":"Yu Yi ,&nbsp;Lei Lei ,&nbsp;Ying Sun ,&nbsp;Jianfeng Mei ,&nbsp;Yanlu Zhang ,&nbsp;Jianshu Chen ,&nbsp;Guoqing Ying ,&nbsp;Yinfei Wu","doi":"10.1016/j.cca.2025.120288","DOIUrl":"10.1016/j.cca.2025.120288","url":null,"abstract":"<div><div>Rheumatoid arthritis (RA) is a chronic autoimmune disease that primarily affects the joints and can even lead to disability. No treatment can completely cure RA, and early intervention is the most effective way to improve the prognosis. Autoantibodies are important in disease diagnosis, treatment, and prognosis assessment, especially rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPAs), which have been widely used in clinical practice. Several studies have fully discussed the critical roles of RF and ACPA in the pathophysiology of RA, but fewer reviews focus on advances in RF and ACPA-related assays for early diagnosis. Therefore, this article outlines the clinical applications and predictive value of RF and ACPA in early RA diagnosis, along with emerging immunoassays published in the last five years. Additionally, it discusses the advantages and challenges of multiplex immunoassay techniques for simultaneous RF and ACPA detection. Finally, some suggestions for improving the performance of combined testing were summarized to achieve early diagnosis of RA, thereby delaying disease progression.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120288"},"PeriodicalIF":3.2,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143865229","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}

{"title":"Boron-doped diamond electrochemical biosensors","authors":"Rafa Radithya Swara ,&nbsp;Aqilla Irfa Muthia Rahma ,&nbsp;Clianta Yudin Kharismasari ,&nbsp;Dika Apriliana Wulandari ,&nbsp;Salma Nur Zakiyyah ,&nbsp;Yasuaki Einaga ,&nbsp;Yeni Wahyuni Hartati ,&nbsp;Irkham","doi":"10.1016/j.cca.2025.120285","DOIUrl":"10.1016/j.cca.2025.120285","url":null,"abstract":"<div><div>Biomarkers are essential tools for identifying and monitoring disease throughout pathogenesis, diagnosis, treatment and recovery. Advanced technology, such as electrochemical biosensors, have emerged as powerful tools as sensitive, selective and cost-efficient tools to identify biomarkers. Among these, boron-doped diamond (BDD) electrodes have gained significant attention due to their functional characteristics that include wide potential window, low background current, biocompatibility and stability. These attributes enable the precise detection of biomarkers at very low concentration even in complex biologic matrices, making BDD-based biosensors uniquely suitable for clinical and point-of-care diagnostics. This review provides a comprehensive analysis of BDD electrodes, including synthesis, material properties and surface modification techniques aimed at enhancing electrochemical performance. Furthermore, the review discusses the use of BDD-based biosensors in the early detection of major diseases such as cancer, metabolic disorders and infection. By incorporating recent advancements, this article highlights the significant potential of BDD-based electrochemical biosensors in modern medical diagnostics and provides a foundation for future research.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120285"},"PeriodicalIF":3.2,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143870417","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}

{"title":"The role of miR-21 as a biomarker and therapeutic target in cardiovascular disease","authors":"Fanlong He ,&nbsp;Wenqing Guan","doi":"10.1016/j.cca.2025.120304","DOIUrl":"10.1016/j.cca.2025.120304","url":null,"abstract":"<div><div>Cardiovascular diseases (CVDs) are the leading causes of death worldwide, accounting for a significant burden on global health systems. The complexity of CVDs arises from their multifactorial etiology, including genetic, environmental, and lifestyle factors. Early diagnosis and effective treatment remain critical for reducing mortality and improving patient outcomes, yet conventional methods often fall short in providing precise, timely information for disease management. MicroRNAs are small non-coding RNAs that regulate gene expression and play pivotal roles in various biological processes, including cardiovascular health. Among them, miR-21 has garnered significant attention due to its involvement in cardiac remodeling, fibrosis, inflammation, and hypertrophy. Elevated levels of miR-21 are frequently observed in conditions such as myocardial infarction, heart failure, and coronary artery disease, positioning it as a potential biomarker for early detection and disease progression. Furthermore, therapeutic strategies targeting miR-21, such as antagomirs and innovative delivery systems, have shown promise in preclinical studies, though challenges like off-target effects and delivery inefficiencies persist. This review aims to provide a comprehensive understanding of miR-21′s role in CVDs, addressing its potential as a diagnostic biomarker and therapeutic target. We discuss recent advancements, limitations, and future prospects in miR-21 research, emphasizing the importance of integrating this knowledge into clinical practice to improve CVD management.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120304"},"PeriodicalIF":3.2,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143842710","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}

{"title":"Proteomics in decoding cancer: A review","authors":"Elaheh Gheybi ,&nbsp;Pejman Hosseinzadeh ,&nbsp;Vahid Tayebi-Khorrami ,&nbsp;Mehdi Rostami ,&nbsp;Mohammad Soukhtanloo","doi":"10.1016/j.cca.2025.120302","DOIUrl":"10.1016/j.cca.2025.120302","url":null,"abstract":"<div><div>Cancer remains the second leading cause of death worldwide, posing a significant global health challenge. Extensive research has revealed common biological characteristics across cancer cells, forming the foundation for developing innovative diagnostic and therapeutic strategies. To better understand these shared traits, advanced measurement technologies are critical. Proteomics, the large-scale study of proteins and their functions, has emerged as a transformative tool for uncovering the complexities of cancer biology. This approach provides an in-depth view of cellular activities and protein interactions, offering unprecedented insights into cancer progression and treatment. Unlike traditional methods that investigate specific pathways in isolation, proteomics enables simultaneous analysis of thousands of proteins, generating a comprehensive understanding of cancer biology. This review explores the mechanisms underlying proteomics, its application to understanding cancer hallmarks, and its potential to transform clinical approaches. By examining proteomics’ role in metastasis, angiogenesis, proliferation, and resistance mechanisms, this study highlights its contributions to cancer diagnosis, treatment, and personalized medicine. Additionally, prospects in integrating proteomics with other −omics fields and advancements in computational analysis will be discussed. This work aims to illuminate the path toward more effective, precise, and individualized cancer care through proteomics innovations.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120302"},"PeriodicalIF":3.2,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143848050","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}

{"title":"Clinical implications of serum adropin and clusterin in chronic renal failure patients who received hemodialysis","authors":"Feng Gu ,&nbsp;Yanfeng Wu ,&nbsp;Jingyuan Lu ,&nbsp;Penghui Zhang ,&nbsp;Hualin Qi","doi":"10.1016/j.cca.2025.120287","DOIUrl":"10.1016/j.cca.2025.120287","url":null,"abstract":"<div><h3>Background</h3><div>Both Adropin and Clusterin are associated with cardiovascular and cerebrovascular diseases. Unfortunately, the clinical implications of them in Chronic renal failure (CRF) population remains largely unclear.</div></div><div><h3>Methods</h3><div>We included 356 CRF patients received hemodialysis. Determination of serum concentrations of Adropin and Clusterin were performed by ELISA.The optimal cutoff values of Adropin or Clusterin for cardiovascular and cerebrovascular complications/death were determined by receiver operating characteristics (ROC) curve analysis. The prognostic value of Adropin and Clusterin was evaluated using Kaplan–Meier survival curves, log-rank tests, and Cox proportional hazards models.</div></div><div><h3>Results</h3><div>Baseline serum Adropin significantly decreased, while serum Clusterin elevated in CRF patients who suffered cardiovascular or cerebrovascular implications during hemodialysis. Both decreased baseline serum Adropin and increased serum Clusterin showed potentials for predicting cardiovascular/cerebrovascular implications during hemodialysis in CRF patients. Reduced baseline serum Adropin indicated poor prognosis in CRF patient during hemodialysis, whereas increased baseline serum Clusterin indicated poor prognosis in CRF patient during hemodialysis. Combining baseline serum Adropin and Clusterin detection achieved better performance for predicting prognosis in CRF patients.</div></div><div><h3>Conclusion</h3><div>We demonstrated that decreased Adropin, or increased Clusterin could be novel but useful tool for predicting cardiovascular/cerebrovascular complications and overall survival. Importantly, combination of Adropin and Clusterin detection might be help to construct new management system for CRF patients to effectively improve their prognosis in the future.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"573 ","pages":"Article 120287"},"PeriodicalIF":3.2,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143823308","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}

{"title":"Early detection of unusual cryoglobulinemia from automated cell counts and blood films","authors":"Bob Smit ,&nbsp;Ilse JE Kouijzer ,&nbsp;Wilbert AG van der Meijden ,&nbsp;Ayden Kleij ,&nbsp;Corrie M de Kat Angelino ,&nbsp;Charissa Wijnands ,&nbsp;Laura Belt ,&nbsp;Annette Vendel ,&nbsp;Raphaël Duivenvoorden ,&nbsp;Joannes FM Jacobs","doi":"10.1016/j.cca.2025.120290","DOIUrl":"10.1016/j.cca.2025.120290","url":null,"abstract":"<div><div>Cryoglobulins are circulating immunoglobulins characterized by reversible cold-induced precipitation. The process of serum cryoprecipitation, performed at 4 °C, takes three to seven days, which leads to delays in obtaining cryoglobulinemia lab-results. Here, we report two cases of cryoglobulinemia, each with distinct cryoglobulin-induced features that were identifiable through automated hemocytometry and blood smear analysis. The blood smear showed neutrophilic inclusions and amorphous extra-cellular material, and the automated hematology analyzer displayed abnormal scatterplots. All these unique features positively correlated with the duration the blood sample was kept at room temperature prior to analysis. These hemocytometric abnormalities may serve as early indicators for the diagnosis of cryoglobulinemia, potentially aiding the detection of this condition.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"573 ","pages":"Article 120290"},"PeriodicalIF":3.2,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143816804","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}

{"title":"Immuno-PCR: A high-sensitivity approach for biomarker analysis","authors":"Hansen Shi ,&nbsp;Biyun Zeng ,&nbsp;Qiping Wei ,&nbsp;Zhu Yuan ,&nbsp;Jingjie Peng ,&nbsp;Peijun Zhang ,&nbsp;Tiancai Liu ,&nbsp;Tao Zeng","doi":"10.1016/j.cca.2025.120289","DOIUrl":"10.1016/j.cca.2025.120289","url":null,"abstract":"<div><div>The integration of immunology and molecular biology, Immuno-Polymerase Chain Reaction, ie, Immuno-PCR, (iPCR), is an innovative cutting-edge detection strategy that holds significant promise for the identification of pathophysiologic biomarkers present at very low concentration or those inherently unstable. iPCR, known for superior sensitivity and specificity, has proven valuable in early disease diagnosis, monitoring and prognosis. This review summarizes the current applications of iPCR in detecting various disease biomarkers including those related to cancer, infection, autoimmune, cardiovascular, and neurological disease. We introduce the principle, advantages and limitations, specific applications, and clinical significance of iPCR, thereby promoting the widespread application of this technology in disease diagnosis. This technology facilitates early detection and intervention, enhances patient outcomes and survival rates, and is a valuable reference for future research and applications.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"573 ","pages":"Article 120289"},"PeriodicalIF":3.2,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143820451","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}

{"title":"Uniformity and stability of saliva composition based on glucose concentration analysis","authors":"Kuncheng Chen ,&nbsp;Song Wang ,&nbsp;Pian Zhong ,&nbsp;Yeping Peng ,&nbsp;Junzhe Lu ,&nbsp;Lanlan Liu ,&nbsp;Jinmei He ,&nbsp;Weiqiang Liu","doi":"10.1016/j.cca.2025.120283","DOIUrl":"10.1016/j.cca.2025.120283","url":null,"abstract":"<div><div>Saliva holds promise as a biomarker for glucose monitoring due to its non-invasive and self-collection characteristics. However, its viscosity may lead to uneven glucose distribution, reflecting the uniformity of saliva, and individual glycemic control factors such as diet may affect salivary glucose concentration, reflecting the stability of saliva. To address these concerns, this study aims to evaluate the uniformity and stability of salivary glucose concentrations.</div><div>Macro-rheological properties (shear viscosity, elastic modulus, and viscous modulus) and micro-morphological characteristics of saliva were analyzed using a rheometer and Scanning Electron Microscopy and Energy-Dispersive X-ray Spectroscopy (SEM-EDS) techniques. Salivary glucose uniformity and stability were assessed under room-temperature static conditions, fasting saliva over a one-month period, and in postprandial states.</div><div>Results showed that saliva exhibits shear-thinning behavior, with shear viscosity decreasing from 0.1 Pa∙s to 0.001 Pa∙s as shear rate increases from 0.1 to 150 s⁻¹. This shear-thinning property, linked to the porous glycoprotein network observed through micro-morphological analysis, may influence analyte distribution. Despite the inherent viscosity, salivary glucose concentrations demonstrated high uniformity: 89 % of fasting samples and 92 % of postprandial samples showed less than 10 % variation when divided into three portions.</div><div>Regarding stability, salivary glucose levels in healthy individuals remained consistently more stable than those in diabetic patients across various conditions, including static room-temperature storage of fasting saliva, fasting saliva over one month, and postprandial saliva. For example, fasting glucose levels over one month in diabetic patients (7.38 ± 6.3 mg/dL) were higher and less stable than those observed in healthy individuals (1.674 ± 0.72 mg/dL).</div><div>This study confirms that fasting salivary glucose is both homogeneous and sufficiently stable, supporting its potential as a viable biomarker for blood glucose monitoring.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"573 ","pages":"Article 120283"},"PeriodicalIF":3.2,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143816863","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}