Clinica Chimica Acta最新文献

{"title":"Immuno-PCR: Advancements, and applications for infectious diseases diagnosis","authors":"Ayushi Kaur Bedi,&nbsp;Monika Sharma,&nbsp;Sadhna Sharma","doi":"10.1016/j.cca.2025.120409","DOIUrl":"10.1016/j.cca.2025.120409","url":null,"abstract":"<div><div>Immuno-polymerase chain reaction (I-PCR) is a hybrid technique that combines the specificity of immunoassays with the amplification power of polymerase chain reaction for highly sensitive detection of Infectious Diseases Biomarkers. Since its introduction, I-PCR has evolved through advances such as the introduction of universal streptavidin–biotin systems, nanoparticle-based amplification, magnetic bead-assisted formats and the adoption of real-time and digital PCR readouts. These improvements have enabled detection limits significantly lower than traditional immunoassays, enabling its effective application in detecting viral, bacterial, parasitic, prion, and fungal antigens, as well as host antibodies, with detection limits reaching femtogram levels. However, clinical translation remains restricted by assay complexity, background signal amplification, and the reliance on thermal cyclers and specialized equipment. Future developments focusing on simplifying assay workflows, optimizing DNA-antibody conjugation, implementing isothermal amplification methods, and designing multiplexed point-of-care diagnostic platforms are essential to overcome current limitations. Addressing these challenges through continued innovation is essential to completely harness the potential of I-PCR as a highly sensitive, rapid, and accessible diagnostic platform across diverse healthcare settings.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120409"},"PeriodicalIF":3.2,"publicationDate":"2025-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144207803","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":"MicroRNA biosensors for detection of Alzheimer’s disease","authors":"Asma Vafadar ,&nbsp;Mohammad Younesi ,&nbsp;Mohammad Ehsan Maddahi ,&nbsp;Sajad Ehtiati ,&nbsp;Hossein Moradi Kazerouni ,&nbsp;Faranak moradi khalaj ,&nbsp;Hasan Ghasemi ,&nbsp;Amir Savardashtaki","doi":"10.1016/j.cca.2025.120410","DOIUrl":"10.1016/j.cca.2025.120410","url":null,"abstract":"<div><div>Alzheimer’s disease (AD) is a critical global health problem characterized by cognitive degeneration and memory loss. Recent advancements in MicroRNA (miRNA) research have revealed their crucial role in AD development, Leading the way for early diagnosis and targeted treatments. Nanomaterials, renowned for their exceptional properties, have been integrated into biosensors to create highly sensitive and specific diagnostic tools. Among these, electrochemical biosensors, known for their simplicity and affordability, are particularly promising for clinical applications and point-of-care diagnostics. This review focuses on the application of miR-based electrochemical biosensors in early AD detection. We explore the innovative use of nanoparticles to enhance the sensitivity and specificity of these biosensors.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120410"},"PeriodicalIF":3.2,"publicationDate":"2025-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144205207","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":"Screening key genes differentially expressed in ankylosing spondylitis based on bioinformatics analysis and its clinical correlation study","authors":"Ziqi Li ,&nbsp;Xiaoya Sun ,&nbsp;Yanyu Zhao ,&nbsp;Yuxin Ren ,&nbsp;Hanqing Wu ,&nbsp;Longbao Xu ,&nbsp;Guoqing Li ,&nbsp;Mengmeng Wang ,&nbsp;Faming Pan","doi":"10.1016/j.cca.2025.120411","DOIUrl":"10.1016/j.cca.2025.120411","url":null,"abstract":"<div><h3>Objective</h3><div>This study aimed to identify potential biomarkers for Ankylosing Spondylitis (AS) through integrated bioinformatics analysis and case-control validation, thereby providing a theoretical basis for understanding the underlying pathogenesis of AS.</div></div><div><h3>Methods</h3><div>We first performed a comprehensive bioinformatics analysis integrated with a literature review to identify key candidate genes. Following this, a case-control validation study was carried out to verify the differential expression of these genes.</div></div><div><h3>Results</h3><div>Sixty-one differentially expressed genes (DEGs) were initially screened, and four key genes, ID2, PRF1, GZMB, and S100A12, were screened through comprehensive analysis and reference to relevant literature. Data from the qRT-PCR analysis indicated that the expression levels of ID2, PRF1, and GZMB were significantly reduced in patients with AS. The area under the ROC curve (AUC) indicated that among the single genes, ID2 had the best diagnostic performance, and the combined diagnostic performance of the four key genes was superior to that of ID2 alone. ID2 might regulate the apoptotic process of downstream PRF1 and GZMB through natural killer cells and CD8 cytotoxic T lymphocytes, thereby participating in the pathogenesis of AS. Furthermore, this study found that S100A12, PRF1 and GZMB were associated with multiple clinical indicators that reflected the level of inflammation or disease activity.</div></div><div><h3>Conclusions</h3><div>We identified four key DEGs via bioinformatics analysis and further validated them in case-control studies. The results indicated that these DEGs might serve as potential molecular targets for the diagnosis and treatment of AS.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120411"},"PeriodicalIF":3.2,"publicationDate":"2025-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144205208","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":"Unexploited opportunities in oral disease biosensors and digital health integration","authors":"Hichem Moulahoum,&nbsp;Faezeh Ghorbanizamani","doi":"10.1016/j.cca.2025.120401","DOIUrl":"10.1016/j.cca.2025.120401","url":null,"abstract":"<div><div>Oral pathologies such as oral cancer, oral potentially malignant disorders (OPMDs), oral squamous cell carcinoma (OSCC), represent significant global health challenges owing to their prevalence, complex management, and impact on patient quality of life. Traditional diagnostic approaches, though effective, are often limited by their invasiveness, lack of sensitivity, and inability to provide real-time monitoring. Biosensors, particularly colorimetric and electrochemical types, offer promising alternatives by enabling rapid, non-invasive detection of disease-related biomarkers in saliva or breath. However, current biosensor applications in oral health are predominantly designed for single-time measurements, with limited capabilities for continuous monitoring and integration with digital health platforms. This narrative review synthesizes literature published in the last 10 years from major databases, focusing on recent advances in salivary biosensors for oral disease monitoring, with emphasis on OSCC and OPMDs. The review also explores the emerging role of artificial intelligence and digital platforms in transforming biosensor data into clinically meaningful insights. Addressing these areas could enhance the practicality and accessibility of biosensors, offering a proactive approach to oral healthcare and improving patient outcomes. This paper underscores the need for interdisciplinary collaboration to bridge current technological gaps, paving the way for a future where personalized, preventative care in oral pathology becomes standard practice.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120401"},"PeriodicalIF":3.2,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144178820","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 laboratory directorship in Asia-Pacific and North America: Current practices and pathways to global framework development","authors":"Mohammad Erfan Zare ,&nbsp;Atefeh Nasir Kansestani ,&nbsp;Reza Meshkani ,&nbsp;Kannan Vaidyanathan ,&nbsp;Chao Qi ,&nbsp;Guangwei Dai ,&nbsp;Feng Zhao ,&nbsp;Rui An ,&nbsp;Jun Zhang","doi":"10.1016/j.cca.2025.120407","DOIUrl":"10.1016/j.cca.2025.120407","url":null,"abstract":"<div><div>Clinical laboratories are essential to modern healthcare, playing a critical role in diagnosing, monitoring, and managing diseases. Laboratory directors, as the highest authority in the laboratory, are responsible for overseeing operations, ensuring test accuracy, maintaining quality control, and safeguarding patient safety. These directors are highly qualified professionals, but the qualifications required for the role vary significantly across countries. In some countries, medical doctors (MDs) are the standard, while in others, non-MD clinical scientists are eligible for the position. This variation presents challenges, leading to ongoing discussions in scientific societies about the best pathways to prepare individuals for this critical role. This debate underscores the need to balance clinical expertise with specialized scientific knowledge to meet the evolving demands of laboratory medicine. To address these challenges, establishing a global common pathway for laboratory directorship qualifications is essential. Recognizing the diversity of qualification systems across countries is crucial for developing a pathway that can be globally adaptable and applicable to various healthcare contexts. Drawing inspiration from successful models around the world will be key in shaping such a framework. Europe, with its well-documented qualification frameworks, has made significant efforts toward harmonizing standards for laboratory directorship. However, data on qualification systems in regions like Asia-Pacific and North America remain limited. This review aims to evaluate the current qualification requirements in these regions, compare them to established models, and discuss the feasibility of creating a globally standardized pathway for laboratory director qualifications. The findings could serve as the foundation for developing a more detailed, common curriculum by international scientific societies such as the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), addressing the demands of various countries.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120407"},"PeriodicalIF":3.2,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144198380","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":"tRNA Fragments in Diabetes Mellitus","authors":"Jiqing Zhang ,&nbsp;Mu Liu ,&nbsp;Zhongjun Li","doi":"10.1016/j.cca.2025.120405","DOIUrl":"10.1016/j.cca.2025.120405","url":null,"abstract":"<div><div>This review summarizes the research progress on tRNA-derived small RNAs (tsRNAs) in diabetes mellitus and diabetic complications. tsRNAs, categorized into tRNA-derived stress-induced RNAs (tiRNAs) and tRNA-derived fragments (tRFs), are involved in gene expression, protein translation, apoptosis, and intercellular communication. As a class of regulatory non-coding RNAs, tsRNAs exhibit significant roles in diabetes mellitus. Specifically, tRF-1:31-Glu-CTC-1-M2 shows early diagnostic value in gestational diabetes mellitus (GDM), while 5′ValCAC combined with miR-23b-3p distinguishes maternally inherited diabetes from type 2 diabetes mellitus (T2DM) (AUC = 1.00). tsRNAs demonstrate specific expression in diabetic complications: tRF-3001a and tRF-30 are elevated in diabetic retinopathy (DR) vitreous samples and tRF-Gly-CCC-039 exacerbates diabetic foot ulcer (DFU) progression. Furthermore, specific fragments like 5′tiRNA-His-GTG and tiRNA-Val are implicated in neurovascular dysfunction during DR progression. These findings present novel insights into the precise diagnosis and therapeutic management of diabetes mellitus and diabetic complications, underscoring the considerable translational potential of tsRNAs in clinical applications.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120405"},"PeriodicalIF":3.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144168426","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":"Graphene-based biosensors for PSA","authors":"Siddig Ibrahim Abdelwahab ,&nbsp;Manal Mohamed Elhassan Taha ,&nbsp;Khaled A. Sahli ,&nbsp;Hatem Ahmed Salem Alqhtani ,&nbsp;Abdullah Farasani ,&nbsp;Nizar A. Khamjan ,&nbsp;Humaid Al-shamsi ,&nbsp;Jobran M. Moshi ,&nbsp;Saeed Alshahrani ,&nbsp;Ahmad Assiri ,&nbsp;Marwa Qadri ,&nbsp;Syam Mohan","doi":"10.1016/j.cca.2025.120406","DOIUrl":"10.1016/j.cca.2025.120406","url":null,"abstract":"<div><div>Prostate cancer is a leading cause of cancer-related mortality among men worldwide. Early and accurate detection is critical for effective treatment and improved patient outcomes. Although prostate-specific antigen (PSA) remains the primary biomarker for screening, conventional assays often lack the sensitivity and specificity required for reliable diagnostics. In this review, we evaluate the emerging role of graphene-based biosensors in PSA detection and their potential to transform prostate cancer diagnostics. Graphene’s exceptional properties including a high surface-to-volume ratio and outstanding electrical conductivity make it an ideal platform for biosensing applications. We classify graphene-based sensors into three categories: electrochemical sensors, field-effect transistors (FETs), and fluorescence-based sensors, and discuss the mechanisms by which each detects PSA. Strategies for integrating graphene with other nanomaterials to enhance analytical performance are highlighted. We also assess the clinical feasibility of these platforms, emphasizing their rapid response times, high accuracy, and minimally invasive operation. Finally, we discuss current challenges and future perspectives for translating graphene-based PSA biosensors from laboratory research to routine clinical practice.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120406"},"PeriodicalIF":3.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144191588","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":"Cell-free DNA methylation and its potential as a biomarker in liquid biopsy: A systematic review","authors":"Min Pan ,&nbsp;Xinling Cheng ,&nbsp;Huike Chen ,&nbsp;Yuxian Feng ,&nbsp;Zeyu Ma ,&nbsp;Qinyu Ge ,&nbsp;Jing Tu","doi":"10.1016/j.cca.2025.120403","DOIUrl":"10.1016/j.cca.2025.120403","url":null,"abstract":"<div><div>DNA methylation is a critical epigenetic modification that regulates gene expression. Changes in cell-free DNA (cfDNA) methylation typically precede the clinical manifestations of diseases. Trace amounts in body fluid samples, fragmented feature, and high background noise are the challenges to be addressed before implementation of cfDNA methylation assay in clinical application. With advances in genomic analysis and methylation detection technologies, analysis of cfDNA methylation has emerged as a promising biomarker for early diagnosis, prognostic prediction, and tracing tissue origin. The tissue-specific methylation patterns of cfDNA further facilitate the determination of its tissue of origin, making cfDNA methylation invaluable in liquid biopsies. This review highlights the advanced technologies to analyze methylated cfDNA, summarizes the recent progress of cfDNA methylation assays in clinical applications, and underscores the value of the integration of cfDNA methylation with multi-omics analysis in future research.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120403"},"PeriodicalIF":3.2,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144184821","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":"Creatine kinase in prostate cancer: A biosensor-driven diagnostic paradigm","authors":"Surya Nath Pandey ,&nbsp;Ehssan Moglad ,&nbsp;Gaurav Gupta ,&nbsp;H. Malathi ,&nbsp;Laxmidhar Maharana ,&nbsp;Sami I. Alzarea ,&nbsp;Imran Kazmi ,&nbsp;Abida Khan","doi":"10.1016/j.cca.2025.120402","DOIUrl":"10.1016/j.cca.2025.120402","url":null,"abstract":"<div><h3>Background</h3><div>Prostate cancer (PC) remains a leading cause of cancer-related morbidity in men worldwide. Emerging evidence suggests that the brain-type creatine kinase isoenzyme (CK-BB) is overexpressed in PC tissue and correlates with tumor progression. However, conventional assays for CK-BB lack the sensitivity and rapid turnaround required for routine clinical use.</div></div><div><h3>Methods/Technology</h3><div>We reviewed recent advances in CK-BB-targeted biosensors across three platform categories. First, electrochemical sensors enhanced with nanomaterials such as graphene and gold nanoparticles have produced amplified current or impedance signals for ultra-sensitive CK-BB detection. Second, optical sensors, including fluorescence and surface plasmon resonance systems that incorporate quantum dots and plasmonic nanoparticles, offer label-free real-time monitoring. Third, emerging formats, from paper-based strips to wearable devices and microfluidic lab-on-a-chip assays, promise point-of-care applicability. Integration of artificial intelligence (AI) with microfluidics was also evaluated for automated, real-time CK-BB profiling.</div><div>Key findings</div><div>Nanomaterial-modified electrodes achieved detection limits for CK-BB in the low picogram-per-milliliter range, outperforming standard immunoassays in both assay speed (minutes versus hours) and analytical sensitivity. Clinical discrimination between malignant and benign prostatic conditions exceeded 85 percent accuracy in small patient cohorts, demonstrating the potential diagnostic value of CK-BB biosensing. Nevertheless, device reproducibility and matrix interference remain significant challenges, and only a few platforms have progressed beyond proof-of-concept to larger-scale clinical validation. Preliminary applications of machine-learning algorithms to sensor output show promise in reducing false positives and automating interpretation.</div></div><div><h3>Conclusion</h3><div>CK-BB-targeted biosensors hold considerable promise as an adjunct to prostate-specific antigen testing by enabling faster, more sensitive detection of metabolic changes associated with prostate cancer. To facilitate translation into routine clinical practice, future efforts must focus on standardizing calibration protocols, validating performance in diverse patient populations, and addressing manufacturing and regulatory hurdles. Moreover, coupling CK-BB detection with multiplexed biomarker panels and AI-driven analysis may further enhance diagnostic precision and support truly personalized management of prostate cancer.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120402"},"PeriodicalIF":3.2,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144184826","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":"Extracellular fluid miRNAs in PCOS","authors":"Saba Hadi ,&nbsp;Seyed Hossein Khoshraftar ,&nbsp;Amir Hossein Kiani Darabi ,&nbsp;Anahita Soleimani ,&nbsp;Hamid Reza Nejabati","doi":"10.1016/j.cca.2025.120404","DOIUrl":"10.1016/j.cca.2025.120404","url":null,"abstract":"<div><div>Polycystic ovary syndrome (PCOS) is a prevalent endocrine condition that impacts both reproductive and metabolic functioning. Despite thorough research, the exact causes of PCOS remain unclear. Recent studies indicate that microRNAs (miRNAs), which are small non-coding RNAs that regulate gene expression, could be crucial for comprehending PCOS. This review article investigates the variations in extracellular fluids miRNAs expression in individuals diagnosed with PCOS and assesses their viability as diagnostic biomarkers, and determines their involvement in the mechanisms underlying the disease. The related reports show that miRNA expression profiles demonstrate notable differences between PCOS patients and healthy subjects. Several miRNAs exhibit dysregulation in essential biological processes such as follicular development, steroidogenesis, insulin signaling, and metabolic pathways. These results imply that miRNAs could lead to hormonal imbalances and metabolic problems linked to PCOS. The variations in miRNA expression noted in patients with PCOS underscore their possible role as biomarkers for the early detection and characterization of the condition. Continued investigation into miRNA-based diagnostic and therapeutic strategies may enhance our comprehension of PCOS. and facilitate the advancement of more precise therapeutic alternatives.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120404"},"PeriodicalIF":3.2,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144168396","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}