Márcia Regina R. Scalcon , Aline J. Waclawovsky , Felipe B. Schuch , Marijn M. Speeckaert , Rafael N. Moresco
{"title":"Proteomic biomarkers in psoriatic arthritis","authors":"Márcia Regina R. Scalcon , Aline J. Waclawovsky , Felipe B. Schuch , Marijn M. Speeckaert , Rafael N. Moresco","doi":"10.1016/j.cca.2025.120244","DOIUrl":"10.1016/j.cca.2025.120244","url":null,"abstract":"<div><div>Psoriasis (PsO) is a chronic inflammatory skin disease that affects 2–3% of the adult population worldwide. Psoriatic arthritis (PsA) is a chronic inflammatory arthropathy that occurs in 20–30% of PsO patients. PsA is characterized by a heterogeneous clinical phenotype that makes diagnosis and treatment challenging. Currently, diagnosis is predominantly based on clinical findings, highlighting the need for reliable biomarkers to improve diagnostic precision, refine prognostic evaluations, and guide personalized therapeutic strategies. Recent advances in proteomic methodologies have provided novel insights into the pathophysiology and diagnosis of PsA. This review synthesizes the current evidence on protein biomarkers associated with PsA, focusing on non-targeted chromatographic proteomic approaches. These methodologies can enable comprehensive analysis of diverse biological specimens, facilitating the identification of candidate proteins that could be incorporated into targeted enzymatic and immunological panels for routine clinical practice in the future. Our review identified 72 isolated proteins and one protein combination with potential diagnostic utility for PsA, with particular emphasis on biomarkers such as NAD-dependent sirtuin-2 deacetylase (SIRT2), stress-induced phosphoprotein 1 (STIP1), and thymosin β4 (TMSB4X). Despite the growing interest in proteomic approaches for PsA, additional investigations with larger, well-stratified patient cohorts are necessary to validate these findings, establish robust diagnostic biomarkers, and facilitate their clinical implementation.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"572 ","pages":"Article 120244"},"PeriodicalIF":3.2,"publicationDate":"2025-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647380","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}
Asma Vafadar , Sajad AlaviManesh , Mohammad Ehsan Maddahi , Mehdi Alizadeh , Ahmad Movahedpour , Amir Savardashtaki
{"title":"Exosome biosensors for detection of prostate cancer","authors":"Asma Vafadar , Sajad AlaviManesh , Mohammad Ehsan Maddahi , Mehdi Alizadeh , Ahmad Movahedpour , Amir Savardashtaki","doi":"10.1016/j.cca.2025.120243","DOIUrl":"10.1016/j.cca.2025.120243","url":null,"abstract":"<div><div>Prostate cancer (PCa) is a highly life-threatening disease in men, causing numerous deaths worldwide. As PCa is often diagnosed at a late stage, current diagnostic methods can be invasive and sometimes lead to unnecessary treatments. Therefore, new non-invasive approaches are needed to detect biomarkers for more rapid and accurate PCa diagnosis. Exosomes, extracellular vesicles, provide valuable insights into cellular health and disease progression. Recent studies have indicated the potential use of exosomes as biomarkers for diagnosing PCa. Developing fast, reliable, and sensitive methods for exosome detection is essential. Biosensors, powerful analytical tools for biological samples, have become increasingly crucial in exosome analysis. This review summarizes recent advancements in biosensor technology for exosome detection and provides insights into future perspectives. The goal is to encourage innovative biosensor-based approaches for exosome detection and contribute to the early diagnosis and clinical monitoring of various diseases.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"571 ","pages":"Article 120243"},"PeriodicalIF":3.2,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143631858","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":"RNA biosensors for detection of pancreatic cancer","authors":"Mohammad-Jalil Zare-Mehrjardi , Mahtab Hatami-Araghi , Majid Jafari-Khorchani , Zahra Oushyani Roudsari , Mortaza Taheri-Anganeh , Mona Abdolrahmat , Hassan Ghasemi , Saleh Aiiashi","doi":"10.1016/j.cca.2025.120237","DOIUrl":"10.1016/j.cca.2025.120237","url":null,"abstract":"<div><div>Pancreatic cancer is recognized as one of the most lethal types of cancer globally, characterized by a high mortality rate and a bleak prognosis, which greatly contributes to cancer-related deaths. Forecasts suggest that by 2030, pancreatic cancer will exceed other cancer types in prevalence. The disease presents considerable difficulties owing to the lack of prominent symptoms in its early stages, restricted options for early detection, rapid progression, and unfavorable outcomes. Presently, traditional methods for diagnosing pancreatic cancer primarily rely on imaging techniques. However, these methods often entail significant costs, require considerable time, and necessitate specialized skills for both operating the equipment and interpreting the resulting images. To overcome these obstacles, the use of biosensors has been proposed as a potentially valuable tool for the early detection of pancreatic cancer. MicroRNAs (miRs), a type of small non-coding RNA molecules, have emerged as highly sensitive molecular diagnostic tools that have the potential to function as precise indicators for a range of diseases, including cancer. Biosensors have been suggested as a potential solution for tackling these challenges, offering a promising approach for the early detection of pancreatic cancer. Small non-coding RNA molecules known as MicroRNAs (miRs) have become recognized as extremely sensitive molecular diagnostic tools and can act as precise biomarkers for different diseases, such as cancer. Moreover, this manuscript presents a thorough summary of the latest innovations in nano-biosensors that have been specifically developed for the identification of non-coding RNAs related to pancreatic cancer.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"571 ","pages":"Article 120237"},"PeriodicalIF":3.2,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143610105","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}
Siyuan Sheng , Jianhui Guo , Chuangang Lu , Xia Hu
{"title":"Non-coding RNAs in thoracic disease: Barrett’s esophagus and esophageal adenocarcinoma","authors":"Siyuan Sheng , Jianhui Guo , Chuangang Lu , Xia Hu","doi":"10.1016/j.cca.2025.120242","DOIUrl":"10.1016/j.cca.2025.120242","url":null,"abstract":"<div><div>Esophageal adenocarcinoma (EAC) is a highly aggressive malignancy with increasing incidence and poor survival rates, primarily due to late-stage diagnosis. This cancer often develops from Barrett’s Esophagus (BE), a precancerous condition linked to chronic gastroesophageal reflux disease (GERD). The transition from BE to EAC is a complex multistep process involving numerous genetic, epigenetic, and molecular changes that lead to the malignant transformation of the esophageal epithelium. Despite advancements in understanding the molecular mechanisms underlying EAC, early detection and effective treatment options remain limited, highlighting an urgent need for innovative diagnostic and therapeutic strategies. Recent research has focused on non-coding RNAs (ncRNAs), which play crucial roles in regulating gene expression and cellular processes relevant to cancer progression. Various types of ncRNAs, including microRNAs, long non-coding RNAs, and circular RNAs, have been implicated in the development of BE and EAC by modulating key signaling pathways such as Wnt/β-catenin and NF-κB. Additionally, ncRNAs are stable in biological fluids, presenting opportunities for their use as non-invasive biomarkers for early detection and monitoring of EAC. This review aims to elucidate the involvement of ncRNAs in the progression from BE to EAC, their potential as therapeutic targets, and their emerging roles in intercellular communication. We will also discuss the challenges in translating ncRNA research into clinical applications, emphasizing their promise in revolutionizing early detection and treatment strategies for EAC.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"571 ","pages":"Article 120242"},"PeriodicalIF":3.2,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143613754","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}
Maria Arélin , Frauke Hornemann , Andreas Merkenschlager , Ronald Biemann , Uta Ceglarek , Julia Klinkhammer , Ronny Baber , Wieland Kiess , Juergen Kratzsch , Mandy Vogel
{"title":"Pediatric reference values of VEGF-D derived from a German population-based cohort of healthy children","authors":"Maria Arélin , Frauke Hornemann , Andreas Merkenschlager , Ronald Biemann , Uta Ceglarek , Julia Klinkhammer , Ronny Baber , Wieland Kiess , Juergen Kratzsch , Mandy Vogel","doi":"10.1016/j.cca.2025.120241","DOIUrl":"10.1016/j.cca.2025.120241","url":null,"abstract":"<div><h3>Background</h3><div>Vascular endothelial growth factor D (VEGF-D) is a growth-factor involved in the development of blood vessels and lymphatics in tissues all over the human body. Interestingly, VEGF-D serum levels are increased in certain tumor entities. For tuberous sclerosis complex (TSC), a rare genetic disease associated with (benign) tumor growth, VEGF-D is already implemented as a diagnostic and therapeutic biomarker to monitor onset and progress of lymphangioleiomyomatosis (LAM), one of the noncancerous tumor manifestations in mainly female adult TSC patients.</div><div>To date only adult VEGF-D serum cut off values are established and used as a diagnostic tool in LAM.</div><div>Neither cut off nor pediatric reference values for VEGF-D serum levels are known, our study aims to provide reliable pediatric VEGF-D results in samples from healthy children and adolescents.</div></div><div><h3>Methods</h3><div>We analyzed 2003 samples provided by healthy children aged 0.25–18 years participating in the prospective longitudinal population-based cohort study „LIFE Child“ in Leipzig, Germany. Serum VEGF-D levels were measured by enzyme-linked immunoassay.</div></div><div><h3>Results</h3><div>VEGF-D levels in healthy children and adolescents show age-and gender specific variations.</div><div>We showed a significant difference between girls and boys in post pubertal VEGF-D levels. Especially the fact, that girls showed higher VEGF-D levels with advancing stages of puberty is underlining the importance of estrogen metabolism in context of VEGF-D mediated cell proliferation, angiogenesis and associated disease mechanisms.</div></div><div><h3>Conclusion</h3><div>Knowing VEGF-D levels in growing healthy young children and adolescents could help to recognize early disease progression of LAM in individuals at risk especially young women suffering from TSC. Further studies are needed on VEGF-D serum levels in children, especially the impact of estrogen metabolism on VEGF-D should be investigated further.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"571 ","pages":"Article 120241"},"PeriodicalIF":3.2,"publicationDate":"2025-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143601551","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}
Jean-Marc Giannoli , Anne Vassault , Anna Carobene , Armand Perret Liaudet , Ivan M Blasutig , Pradeep Kumar Dabla , Ji Lin , Annette Thomas , José Antonio Tesser Poloni , Qing H Meng , Egon P Amann , on behalf of the International Federation of Clinical Chemistry, Laboratory Medicine Task Force on Global Lab Quality TF-GLQ
{"title":"Ensuring internal quality control practices in medical Laboratories: IFCC recommendations for practical applications based on ISO 15189:2022","authors":"Jean-Marc Giannoli , Anne Vassault , Anna Carobene , Armand Perret Liaudet , Ivan M Blasutig , Pradeep Kumar Dabla , Ji Lin , Annette Thomas , José Antonio Tesser Poloni , Qing H Meng , Egon P Amann , on behalf of the International Federation of Clinical Chemistry, Laboratory Medicine Task Force on Global Lab Quality TF-GLQ","doi":"10.1016/j.cca.2025.120240","DOIUrl":"10.1016/j.cca.2025.120240","url":null,"abstract":"<div><div>This document describes the guidance on implementing and monitoring an IQC strategy that fulfills the requirements of the Standard ISO 15189:2022. It also explores the practical application of these principles in daily IQC processes within medical laboratories. The goal is to provide a practical, user-friendly resource that not only explains the Standard’s requirements but also equips laboratory professionals with the tools and knowledge needed to enhance diagnostic reliability.</div><div>To support laboratory professionals in this task, this document follows the structure and content of the ISO 15189:2022 Standard and provides a risk-based approach in consideration of the practical needs for quantitative results. Specific aspects such as the selection and assessment of IQC materials, the definition of control frequency, the definition of acceptable limits, the application of statistical rules, results from different sources comparability and strategies for handling non-conformities, quality indicators and determination of uncertainty of measurement are discussed in depth. Where relevant, excerpts from the ISO 15189:2022 Standard are included, with clarifications and actionable recommendations to facilitate implementation.</div><div>This document focuses on the crucial role of IQC in the accreditation process, particularly in the identification of risks, their mitigation through corrective actions and the implementation of improvements to prevent errors and control potential risks in the medical laboratory, ensuring patient safety in daily practice.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"571 ","pages":"Article 120240"},"PeriodicalIF":3.2,"publicationDate":"2025-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143596419","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":"Comparison of the newly formulated beckman access free T4 (Thyroxine) assay on the DXI 800 analyzer with the current Beckman free T4 (Thyroxine) assay for biotin Interference: New assay is free from biotin interference","authors":"Kameron Pierce, Bailey Countryman, Melody Nelson, Amitava Dasgupta","doi":"10.1016/j.cca.2025.120239","DOIUrl":"10.1016/j.cca.2025.120239","url":null,"abstract":"<div><h3>Background</h3><div>Biotin causes significant positive interference with Free T4 (thyroxine) measurement using the current Beckman assay. Recently, Beckman reformulated the FT4 assay to overcome biotin interference. We compared the effect of biotin on both current and newly formulated FT4 assays.</div></div><div><h3>Materials and Methods</h3><div>Three serum pools were prepared using specimens containing various amounts of FT4. Aliquots of each pool were supplemented with various amounts of biotin. Then FT4 concentrations were measured by both the current and new FT4 assay. In addition, three volunteers ingested 10 mg of biotin. Specimens were drawn prior to the administration of biotin and 2 h post-biotin ingestion. FT4 concentration was measured before and after biotin administration using both assays.</div></div><div><h3>Results</h3><div>The newly formulated FT4 assay correlated well with the current FT4 assay. In the presence of biotin, FT4 concentrations were increased significantly using the current assay. However, negligible changes were observed using the newly formulated assay. We also observed similar results in vivo within the volunteer specimens.</div></div><div><h3>Conclusion</h3><div>The newly formulated Beckman Access FT4 assay is free from biotin interference up to a very high biotin concentration of 3500 ng/mL.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"571 ","pages":"Article 120239"},"PeriodicalIF":3.2,"publicationDate":"2025-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143596417","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 phenotypes and biomarkers in chronic urticaria","authors":"Aray Batyrbayeva , Zhanat Ispayeva , Marat Pashimov , Jamilya Kaibullayeva , Madina Baidildayeva , Uldana Kapalbekova , Elmira Tokmurzayeva , Olga Plakhotina , Arailym Maldybayeva , Asem Salmanova , Leila Kuandykova , Kamila Turebekova","doi":"10.1016/j.cca.2025.120233","DOIUrl":"10.1016/j.cca.2025.120233","url":null,"abstract":"<div><div>The medical field faces considerable challenges in treating chronic urticaria (CU), which includes both chronic spontaneous urticaria (CSU) and chronic inducible urticaria, owing to its varied nature. The complexity of this condition stems from multiple factors: varying disease mechanisms, different ways in which symptoms manifest, and inconsistent treatment outcomes. Although both forms of CU display hives that persist beyond six weeks, they have distinct causes and progression patterns. This study examines CSU specifically, exploring its various manifestations and associated biological indicators. Currently, there is a pressing need to identify reliable, accessible biomarkers for CSU to enhance diagnosis and develop targeted treatments. Better insights into how specific disease patterns are related to biological markers would significantly improve our understanding of CSU development and enhance patient treatment approaches.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"571 ","pages":"Article 120233"},"PeriodicalIF":3.2,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143579760","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}
Binbin Zhao , Aolin Zhu , Qian Zhang , Ziyue Li , Yongwei Zhang , Meng Liu , Hao Zhou , Tingwei Liu , Xuelei Zhou , Jiutong Li , Jun Zhao , Xinxia Li
{"title":"Establishment of a R-Sphere labelled immunoassay platform and its rapid combined quantitative detection of ketamine and morphine in serum","authors":"Binbin Zhao , Aolin Zhu , Qian Zhang , Ziyue Li , Yongwei Zhang , Meng Liu , Hao Zhou , Tingwei Liu , Xuelei Zhou , Jiutong Li , Jun Zhao , Xinxia Li","doi":"10.1016/j.cca.2025.120225","DOIUrl":"10.1016/j.cca.2025.120225","url":null,"abstract":"<div><h3>Background and aims</h3><div>Ketamine and morphine are among the most commonly abused drugs. Ketamine is classified as a new psychoactive substance, while morphine represents the opioid class. These two substances may exhibit synergistic or antagonistic effects in their pharmacological actions, and their combined abuse could lead to more severe health risks, such as respiratory depression. Therefore, simultaneous detection is crucial for comprehensive monitoring of drug abuse. This study developed a test strip capable of detecting both ketamine (KET) and morphine (MOP) in serum, utilizing Raman spectroscopy technology to meet the needs of various application scenarios.</div></div><div><h3>Methods</h3><div>A mixture of Raman microsphere-labelled KET and MOP antibodies was mixed with a mixed standard solution of KET and MOP and added dropwise to the sample pad of the prepared KET and MOP co-assay test strip, chromatographed for 10 min, and then the Raman spectra and Raman signals at the T-line were detected using a Raman spectrometer.</div></div><div><h3>Results</h3><div>The KET and MOP showed good correlation with the Raman signal response values in the concentration ranges of 0.0–100.0 ng/mL and 0.0–4.0 ng/mL, and the limits of detection (LODs) were 1.1986 ng/mL and 0.0113 ng/mL with the coefficients of variation (CV) of less than 10 %, the recoveries were in the ranges of 90 %-110 %, and interfering substances had no effect on the detection results.</div></div><div><h3>Conclusion</h3><div>In this study, we developed a method for the quantitative detection of KET and MOP based on the spectroscopic properties of Raman microsphere (R-Sphere) and the principle of competitive immunity, which has the advantages of simple operation, rapidity, high sensitivity, and the possibility of combined detection, which makes the detection efficiency greatly improved.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"571 ","pages":"Article 120225"},"PeriodicalIF":3.2,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143579761","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}