Clinica Chimica Acta最新文献

{"title":"Standardising EQA submissions with automated defactoring of post-analytical correction factors","authors":"Tony Badrick,&nbsp;Peter Graham,&nbsp;John Soufi,&nbsp;Derek Holzhauser","doi":"10.1016/j.cca.2025.120468","DOIUrl":"10.1016/j.cca.2025.120468","url":null,"abstract":"<div><div>Post Analytical Correction Factors are routinely applied by clinical laboratories to align results from different instruments, methods, or because of the need to maintain consistent results in the face of lot-to-lot reagent variation, or if a new method introduces a bias compared to the technique from which the reference interval was derived. In any of these situations, some procedures must be followed to ensure that the factor used to align results from different methods, procedures, or reagents is valid and robust.</div><div>In addition to the problems a laboratory faces in deriving and managing these factors, poorly described procedures exist for submitting results for External Quality Assurance (EQA) challenges. Should the participant submit the factored or unfactored result? Should the laboratory remain with its peer method group or report the result it would to a laboratory referrer?</div><div>If the EQA material is commutable, the corrected bias should not be removed for the EQA purpose of laboratory assessment. However, it should be removed for metrological traceability between different instruments.</div><div>If the EQA material is not commutable, the corrected bias should be removed for laboratory assessment. Non-commutable EQA material cannot be used to evaluate metrological traceability.</div><div>The Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) has a policy of treating the EQA sample as if it were a patient but manually defactoring the final submitted results to enable valid peer group comparisons. However, there is evidence that not all laboratories complied with this policy, making it challenging to identify and troubleshooting biases.</div><div>A Factor/defector tool was developed to automatically defactor submitted results applied to survey results and allow laboratories to flag and reverse PACFs during data submission. This standardises EQA submissions across institutions, regardless of LIS or middleware configurations.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"577 ","pages":"Article 120468"},"PeriodicalIF":3.2,"publicationDate":"2025-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144562827","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":"Tumor-educated platelets: A new field in breast cancer diagnosis","authors":"Xiaoting Yang,&nbsp;Xiaojuan Li,&nbsp;Xilong Wang,&nbsp;Yuting Yang,&nbsp;Honggang Wang,&nbsp;Yang Duan","doi":"10.1016/j.cca.2025.120467","DOIUrl":"10.1016/j.cca.2025.120467","url":null,"abstract":"<div><div>Tumor-educated platelets (TEPs) represent a novel approach in liquid biopsy, offering new perspectives for diagnosing, treating, and monitoring breast cancer. Unlike traditional histopathological biopsies—the current diagnostic gold standard—TEP-based detection is minimally invasive, requiring only peripheral blood samples and overcoming limitations of repeated invasive procedures. TEPs reflect a dynamic interplay between tumor cells, platelets, and the tumor microenvironment: tumors alter platelet expression profiles while TEPs provide comprehensive molecular information about tumor genetics. This bidirectional relationship positions TEPs as highly promising biomarkers for early detection and non-invasive monitoring. Since early-stage breast cancer patients often achieve complete remission through surgery and standardized therapy, developing promising sensitivity and specific early diagnostic markers is crucial. Recently, liquid biopsy has gained significant momentum in breast cancer research, with TEPs emerging as particularly promising tools for cancer surveillance, treatment guidance, and diagnosis. This review examines TEP reprogramming mechanisms, current research advances, and the latest developments in TEP-based breast cancer applications (Graphical abstract).</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"577 ","pages":"Article 120467"},"PeriodicalIF":3.2,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144563516","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":"Evaluation of ethylglucuronide and cocaethylene as hair markers of alcohol consumption.","authors":"N M Porpiglia, S Pesavento, A Bertaso, C Casini, M Mazzola, R Gottardo, R Micciolo, L Canal, F Tagliaro, F Bortolotti","doi":"10.1016/j.cca.2025.120463","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120463","url":null,"abstract":"<p><strong>Background and aims: </strong>The concurrent use of alcohol and cocaine is known to be a harmful condition in terms of behaviour and organ damage. The identification of this condition requires the use of objective biomarkers, such as hair ethylglucuronide (hEtG) and hair cocaethylene (hCE). The aim of the present work was to investigate their presence and their possible mutual relationship in a group of cocaine users to evaluate the different potentials offered by the two analytes in the retrospective investigation of alcohol intake.</p><p><strong>Materials and methods: </strong>209 hair specimens, previously collected from cocaine users in the context of re-issuing of the driving license, were analysed for the presence of CE and EtG.</p><p><strong>Results: </strong>Out of the 108 individuals who tested positive for hCE, only 57 resulted also positive for hEtG (52.8 %) (above our limit of quantification, i.e. 0.05 ng/mg for the former and 3 pg/ mg for the latter). Conversely, in a group of 101 hCE negative, 63 samples tested hEtG positive (62.4 %).</p><p><strong>Conclusions: </strong>the observed findings highlighted the advantage, in terms of improvement of diagnostic sensitivity, of an integrated use of the two metabolites for a reliable investigation strategy based on alcohol hair markers.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120463"},"PeriodicalIF":3.2,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144564636","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":"Corrigendum to \"Practical sustainable laboratory medicine\" [Tony Badrick, Guzin Aykal, Tuija Mannisto, John Anetor, On behalf of the Task Force on the Environmental Impact of Laboratory Medicine, PII: S0009-8981(25)00307-9 Reference: CCA 120428]: CCA 2025 PII: S0009-8981(25)00307.","authors":"Tony Badrick, Guzin Aykal, Tuija Mannisto, John Anetor","doi":"10.1016/j.cca.2025.120452","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120452","url":null,"abstract":"","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120452"},"PeriodicalIF":3.2,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144552486","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":"HDAC3 in neurodevelopmental disorders: Molecular mechanisms and targeted intervention","authors":"Hassna Chourri ,&nbsp;Ruping Liu ,&nbsp;Mainak Sengupta ,&nbsp;Rakesh Kumar Panjaliya ,&nbsp;Parimal Das ,&nbsp;Anjana Munshi ,&nbsp;Jinghua Li ,&nbsp;Baiyu Qi ,&nbsp;Mingqin Zhu ,&nbsp;Jianping Wen ,&nbsp;Santasree Banerjee","doi":"10.1016/j.cca.2025.120455","DOIUrl":"10.1016/j.cca.2025.120455","url":null,"abstract":"<div><div>Autosomal dominant neurodevelopmental disorders are increasingly linked to genetic mutations that interfere with brain development and function. Among the genes implicated, <em>HDAC3</em> plays a central role as an epigenetic regulator, maintaining chromatin structure and controlling gene expression. Mutations in <em>HDAC3</em> have been associated with developmental delays, intellectual disabilities, and autism spectrum disorder. This narrative review explores recent genetic, molecular, and clinical research on <em>HDAC3</em> and its involvement in autosomal dominant neurodevelopmental disorders. A comprehensive and detailed literature search was done, mainly focusing on studies that examine the gene’s molecular functions, pathogenic variants, and clinical outcomes. Beyond its role in gene silencing and chromatin remodeling, <em>HDAC3</em> is also critical for neural differentiation and synaptic plasticity. <em>HDAC3</em> interacts with nuclear receptor co-repressors such as NCoR and SMRT, which are important for transcriptional repression during brain development. Recent studies have demonstrated that HDAC3 dysfunction can lead to abnormalities in cortical layering and neuron subtype specification. Moreover, HDAC3 is involved in regulating oxidative stress and neuroinflammation, processes that are critical for sustaining neural health. Experimental HDAC3 inhibitors are being explored as potential therapeutic agents to reverse epigenetic abnormalities and improve neurological outcomes in model systems. The review discusses emerging therapeutic strategies, including pharmacological targeting and gene-editing approaches. Continued research is essential to better understand <em>HDAC3</em> mutations, expand genetic screening, and develop targeted treatments for individuals affected by these rare but impactful disorders.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"577 ","pages":"Article 120455"},"PeriodicalIF":3.2,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144522070","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":"Aptamer-based electrochemical biosensors for progesterone detection: Advancing point-of-care diagnostics","authors":"Farag M.A. Altalbawy ,&nbsp;Fadhil Faez Sead ,&nbsp;Prakash Kanjariya ,&nbsp;Malatesh Akkur ,&nbsp;Rishabh Thakur ,&nbsp;Anbarasi Jebaselvi G.D. ,&nbsp;Satish Choudhury ,&nbsp;Yashpal Yadav ,&nbsp;Muyassar Norberdiyeva ,&nbsp;Khursheed Muzammil","doi":"10.1016/j.cca.2025.120459","DOIUrl":"10.1016/j.cca.2025.120459","url":null,"abstract":"<div><div>Progesterone detection has emerged as a critical area in reproductive health monitoring, clinical diagnostics, and environmental analysis. While accurate, traditional detection methods often require complex laboratory setups and extended analysis times. Electrochemical biosensors have transformed point-of-care diagnostics by offering commercially accessible, highly sensitive, and specific detection methods. The advancement of biosensor technology addresses the growing demand for rapid, cost-effective, and accurate analytical tools that function beyond conventional laboratory settings. Among various biorecognition elements, aptamer short, single-stranded DNA or RNA molecules have emerged as promising alternatives to traditional antibodies and enzymes because of their high specificity, affordability, and batch-to-batch consistency. Electrochemical aptamer biosensors (E-ABs) utilize aptamer sequences tethered to a self-assembled monolayer on a gold electrode, facilitating efficient electron transfer upon substrate binding. This mechanism enables rapid and continuous signal transduction, making E-ABs well suited for detecting biomarkers in bodily fluids, with applications spanning clinical diagnostics and in vivo monitoring. The integration of aptamer-based electrochemical biosensing into point-of-care testing represents a significant step toward portable, multiplexed, and cost-efficient diagnostic solutions.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"577 ","pages":"Article 120459"},"PeriodicalIF":3.2,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144549758","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":"CSF biomarkers in leak detection: A systematic review & meta-analysis of diagnostic test accuracy (DTA) studies","authors":"Saraswathi N Bhat ,&nbsp;Girish Thunga ,&nbsp;Asha Kamath ,&nbsp;Ramesh Chandrababu ,&nbsp;A. Rohit ,&nbsp;Prajwal Shetty ,&nbsp;Guruprasad Kalthur ,&nbsp;Revathi P Shenoy","doi":"10.1016/j.cca.2025.120458","DOIUrl":"10.1016/j.cca.2025.120458","url":null,"abstract":"<div><h3>Background</h3><div>Cerebrospinal fluid (CSF) leaks result from dural tears due to traumatic and non-traumatic causes, potentially leading to meningitis, intracranial infections, subdural hematomas, and even death. Neuroimaging is still the standard diagnostic tool but presents economic and logistical challenges. Non-invasive biochemical methods offer valuable first-line diagnostics. This systematic review and meta-analysis evaluate the accuracy of CSF biomarkers in detecting leaks.</div></div><div><h3>Objective</h3><div>To assess the diagnostic accuracy of CSF biomarkers in suspected CSF leak cases.</div></div><div><h3>Methods</h3><div>A comprehensive search was conducted across electronic databases and citation mining from the date of inception till February 2025. The study, registered on PROSPERO (CRD42024601252), followed PRISMA 2020 guidelines. Of 455 retrieved studies, eighteen met inclusion criteria; seventeen were used for <em>meta</em>-analysis, involving 1,914 patients.</div></div><div><h3>Results</h3><div>Pooled CSF leak prevalence was 31 %. Pooled sensitivity and specificity were 0.96 (95 % CI: 0.869–0.988) and 0.946 (0.746–0.991) for Beta-2-transferrin (B2T), and 0.949 (0.909–0.972) and 0.999 (0.945–1) for Beta-trace protein (BTP). Diagnostic odds ratios (DOR) were 418.09 (48.582–3597.985) for B2T and 14,566.52 (387.368–547,756.3) for BTP.</div></div><div><h3>Conclusion</h3><div>CSF biomarkers show high diagnostic accuracy, offering a promising alternative to neuroimaging. Standardizing biomarker thresholds and assay methodologies are crucial for reliability. Further research should address confounding factors and variability to enhance diagnostic effectiveness.</div><div><strong>Prospero registration</strong>: The above systematic review has been registered in PROSPERO Registration Id: CRD42024601252.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"577 ","pages":"Article 120458"},"PeriodicalIF":3.2,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144549972","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":"Aptamer-based biosensors for troponin detection.","authors":"Suleiman Ibrahim Mohammad, Hamza Abu Owida, Badrea Al Oraini, Asokan Vasudevan, Anber Abraheem Shlash Mohammad, Nawaf Alshdaifat, Mahmoud Musa AlAwaysheh, Mohammad Faleh Ahmmad Hunitie","doi":"10.1016/j.cca.2025.120457","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120457","url":null,"abstract":"<p><p>Cardiac troponin is recognized as a valuable diagnostic for the early detection of acute myocardial infarction. Biosensors are great alternatives to electrocardiograms, chest X-rays, and other laboratory-based immunoassays because they can detect increased levels of cardiovascular protein biomarkers in the blood right after a myocardial infarction. They are also ideal for use as point-of-care platforms. Aptamers provide a compelling alternative to antibodies for analytical applications. Recently, aptamer-based biosensors, or aptasensors, have garnered significant attention for their ability to provide accessible and sensitive detection of cardiac troponin. This review presents a clear and concise overview of the recent advancements in various types of aptasensors, including fluorescence, surface plasmon resonance, colorimetric methods, surface-enhanced Raman scattering, electrochemical detection, and lateral flow assays, all developed for the determination of troponin.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120457"},"PeriodicalIF":3.2,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144552485","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":"Genomic and clinical characterization of carbapenem-resistant Citrobacter freundii isolates in a tertiary hospital (2013–2021)","authors":"Hui Xie,&nbsp;Jia Li,&nbsp;Chang Liu,&nbsp;Jie Zheng,&nbsp;Shuo Gao,&nbsp;Han Shen,&nbsp;Xiaoli Cao","doi":"10.1016/j.cca.2025.120460","DOIUrl":"10.1016/j.cca.2025.120460","url":null,"abstract":"<div><h3>Background</h3><div>The emergence of carbapenem-resistant <em>Citrobacter freundii</em> (CRCF) poses a significant threat to public health, particularly among high-risk populations.</div></div><div><h3>Objective</h3><div>To characterize the genomic epidemiology of CRCF and analyse the clinical features and risk factor associated with CRCF acquisition.</div></div><div><h3>Methods</h3><div>A total of 21 CRCF strains were collected from Nanjing Drum Tower Hospital from 2012 to 2021. Following whole genome sequencing and assembly, the distribution of drug resistance genes, mobile genetic element, plasmid replicons as well as sequence type (ST) was analysed. Clinical data were collected from patients isolated with CRCF and CSCF to explore potential risk factors for CRCF acquisition.</div></div><div><h3>Results</h3><div>Among the 21 CRCF strains, <em>bla</em>_NDM-1 (n = 18, 85.7 %) was the most common ARGs, followed by <em>sul1</em> (n = 17, 80.9 %). Diverse STs were found and the most common ST type was ST17 (n = 4, 19.0 %) and ST396 (n = 3, 14.3 %). Among the 21plasmid replicons, IncX3 (n = 11, 52.4 %) was the most prevalent. Sixteen Insertion sequences (ISs) and 3 transposons (Tns) were identified, and IS<em>6100</em> (n = 17, 81.0 %) were the most frequent. Co-occurrence of <em>mph(A)</em> and IS<em>6100</em> were observed in fifteen <em>C. freundii</em>. Of the 21 patients with CRCF infection/colonization, the median age was 62.7 years (19–88 years), of which 17 (80.9 %) were male, 11 (52.4 %) were elderly patients (&gt;65 years), 17 (80.9 %) were hospitalized for more than 10 days. In addition, hypertension (n = 12, 57.1 %) was the main underlying diseases. Risk factor analysis showed that invasive procedures (P = 0.032) was an independent risk factor for CRCF acquisition.</div></div><div><h3>Conclusion</h3><div>Our study showed that <em>bla</em>_NDM-1 was the main gene conferring resistance to carbapenem. Multiple STs identified in the 21 strains showed a genetic diversity of CRCF. Existence of kinds of ISs and Tns among these strains indicated the key role played by these mobile genetic elements. CRCF infection/colonization mainly happened in male elderly patients with the hypertension being the main underlying diseases. Avoiding invasive procedures may be helpful in decreasing the CRCF acquisition.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"577 ","pages":"Article 120460"},"PeriodicalIF":3.2,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144522341","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":"Exosome biosensors for the detection of breast cancer","authors":"Mohammad Hassan Sadeghi ,&nbsp;Niloufar Kheradi ,&nbsp;Shima Nazem ,&nbsp;Soumayeh Amirsaadat ,&nbsp;Maryam Ashourpour ,&nbsp;Sara Aghakhani Chegeni ,&nbsp;Sepideh Sohrabi ,&nbsp;Maryam Zamani Sani ,&nbsp;Ahmad Movahedpour ,&nbsp;Elham Norouz Dolatabadi ,&nbsp;Sajad Ehtiati","doi":"10.1016/j.cca.2025.120456","DOIUrl":"10.1016/j.cca.2025.120456","url":null,"abstract":"<div><div>Breast cancer, the most common malignancy in women, is difficult to identify early with conventional techniques like biopsy and mammography, which are frequently invasive and prone to false negative results. Exosome-based detection is a novel, non-invasive diagnostic technique made possible by recent developments in biosensor technology. Exosomes, which are tiny extracellular vesicles released by cells, include biomarkers including microRNAs and oncogenic proteins that offer vital information about the occurrence and spread of breast cancer. By identifying exosomal biomarkers, biosensors use high sensitivity, specificity, and real-time analysis to facilitate early cancer detection, individualized treatment plans, and better patient outcomes. This review explores the biology of exosomes and their roles in intercellular communication, cancer progression, and therapeutic potential. It further examines the development and application of electrochemical, optical, and electrical biosensors for the detection of breast cancer-derived exosomes.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"577 ","pages":"Article 120456"},"PeriodicalIF":3.2,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144552487","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}