Clinica Chimica Acta最新文献

{"title":"Non-invasive biomarkers in lung cancer","authors":"Ravikumar Baskar ,&nbsp;Suresh Saravanan ,&nbsp;Vishwar Devendiran ,&nbsp;Thirunavukkarasu Palaniyandi ,&nbsp;Natarajan Alamgudi Palaniappan ,&nbsp;Mugip Rahaman Abdul Wahab ,&nbsp;Hemapreethi Surendran ,&nbsp;Safia Obaidur Rab ,&nbsp;Mohd Saeed","doi":"10.1016/j.cca.2025.120552","DOIUrl":"10.1016/j.cca.2025.120552","url":null,"abstract":"<div><div>Lung cancer is the leading cause of cancer-related deaths worldwide, with its high mortality rate largely due to challenges in early detection. Blood- and tissue-based biomarkers are widely used for diagnosis; however, they often cause patient discomfort, require complex analytical methods, and rely heavily on expert interpretation for disease staging. Non-blood-based biomarkers from sputum, urine, saliva, sweat, and exhaled breath are emerging as effective alternatives for lung cancer diagnostics. These methods are non-invasive, cost-effective, and allow safer, repeated sampling, making them suitable for prognostic use. Urine contains biomarkers such as volatile organic compounds (VOCs) and circulating tumour DNA, providing valuable metabolic insights. Saliva offers proteins, microRNAs, and exosomal biomarkers that reflect systemic disease-related changes. Sputum contains diverse molecular markers that aid early detection. Exhaled breath carries microRNAs and VOCs, representing another promising diagnostic route. Overall, non-invasive biomarker platforms significantly reduce procedural risks and enable earlier lung cancer detection. Their advancement holds substantial potential to improve patient outcomes globally.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"578 ","pages":"Article 120552"},"PeriodicalIF":2.9,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144852390","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":"Impact of fibrin in high sensitivity cardiac troponin (Hs-cTn) detection: Implications for quality control","authors":"Chijioke Noris Ezinwa","doi":"10.1016/j.cca.2025.120551","DOIUrl":"10.1016/j.cca.2025.120551","url":null,"abstract":"<div><div>High-sensitivity troponin (hs-cTn) assays are crucial in the timely diagnosis of acute myocardial infarction (AMI). However, the presence of fibrin clots, among other interfering factors, can lead to false-positive results, undermining diagnostic accuracy. This critical literature review evaluates the implications of fibrin clot detection in hs-cTn testing, emphasising the need for robust quality control measures in emergency cardiac testing. Through this review, it was shown that biomedical scientists must prevent activities during the pre-analysis stage that may lead to fibrin formation. When such situations become inevitable due to various reasons, including patients’ predispositions, several steps were outlined to confirm the diagnostic accuracy of hs-cTn in myocardial infarction. The importance of technological advancements in detecting fibrin and other potential sources of cross-reactivity or interference was also identified through a comparative analysis of some auto-analysers, proposing possible solutions to address these pitfalls as a means of promoting efficiency and quality assurance in the diagnosis of myocardial infarction through high-sensitivity troponin assays. It further exposed the limitations of these digital analysers and how they cannot independently determine the procedural and outcome quality of diagnostic medicine.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"578 ","pages":"Article 120551"},"PeriodicalIF":2.9,"publicationDate":"2025-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144854748","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":"Exosomes in preeclampsia","authors":"Asma Vafadar ,&nbsp;Zahra Heidari ,&nbsp;Pedram Bolbolizadeh ,&nbsp;Damoun Razmjoue ,&nbsp;Sajad Ehtiati ,&nbsp;Amir Savardashtaki","doi":"10.1016/j.cca.2025.120549","DOIUrl":"10.1016/j.cca.2025.120549","url":null,"abstract":"<div><div>Preeclampsia (PE) is a multifactorial pregnancy disorder marked by new-onset hypertension after 20 weeks of gestation, often accompanied by proteinuria or organ dysfunction. Affecting 4–6 % of pregnancies globally, PE remains a leading cause of maternal and fetal morbidity. While its precise etiology is not fully understood, growing evidence implicates extracellular vesicles—particularly exosomes—in its pathogenesis. These nanoscale vesicles facilitate intercellular communication by transporting bioactive molecules, including proteins, lipids, and non-coding RNAs (ncRNAs) such as miRNAs, lncRNAs, and circRNAs. In PE, placental exosomes show altered profiles that contribute to endothelial dysfunction, immune imbalance, and impaired angiogenesis. This review synthesizes current knowledge on exosome biogenesis, their diagnostic utility—especially exosomal ncRNAs as non-invasive biomarkers—and emerging therapeutic strategies, including engineered exosomes for targeted delivery. Our findings highlight the promise of exosomes as precision medicine tools in PE management.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"578 ","pages":"Article 120549"},"PeriodicalIF":2.9,"publicationDate":"2025-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144830977","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":"Demonstrating commutability of an existing certified reference material for use with an end-user measurement procedure that was not included in the original commutability assessment","authors":"W. Greg Miller ,&nbsp;Liesbet Deprez ,&nbsp;Sverre Sandberg ,&nbsp;Jesper V. Johansen ,&nbsp;Neil Greenberg ,&nbsp;Cas Weykamp ,&nbsp;Thomas Keller ,&nbsp;Jeffrey Budd ,&nbsp;Vincent Delatour ,&nbsp;Elizabeth Barczak ,&nbsp;Robert Rej ,&nbsp;Pernille Kjeilen Fauskanger ,&nbsp;Finlay MacKenzie ,&nbsp;Johanna E. Camara ,&nbsp;Alicia N. Lyle ,&nbsp;Mauro Panteghini","doi":"10.1016/j.cca.2025.120548","DOIUrl":"10.1016/j.cca.2025.120548","url":null,"abstract":"<div><div>Commutability assessment of a certified reference material (CRM) intended for use as a secondary calibrator should be performed by the CRM producer at the time the material is originally prepared. Assessment typically includes several in-vitro diagnostic (IVD) measurement procedures (MPs) in common use in medical laboratories. Due to logistical constraints, it is usually not possible to include all existing IVD-MPs in a commutability assessment. In addition, a new IVD-MP (IVD-MP_n) may be introduced into the market after a commutability assessment was performed for a given CRM. Here we provide a recommendation how to assess commutability of an existing CRM for use with an IVD-MP_n that was not included in the original commutability assessment.</div><div>The study design follows the same principles as a full commutability assessment, but it includes only the IVD-MP_n and fewer additional comparator MP(s) for which the CRM’s commutability with clinical samples was previously demonstrated. When no reference measurement procedure (RMP) is available, or when the logistics make an RMP difficult to use, other IVD-MP(s) that were part of the original commutability assessment for the CRM should be used as comparator MP(s).</div><div>When selecting a comparator IVD-MP, its performance must be carefully considered and its selectivity for the measurand should be equivalent to that of the IVD-MP_n. The CRM should have had negligible noncommutability bias with the comparator IVD-MP in the original commutability assessment. When the existing CRM meets the commutability criterion for IVD-MP_n, the CRM can be used in the calibration hierarchy of the IVD-MP_n.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"578 ","pages":"Article 120548"},"PeriodicalIF":2.9,"publicationDate":"2025-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144827637","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 predictive value of serum mRNA-RGS10 for the severity and prognosis of acute pancreatitis","authors":"Jie Li ,&nbsp;Hanhui Li ,&nbsp;Xiaoping Tan ,&nbsp;Jun Zhang ,&nbsp;Shengqi Du ,&nbsp;Yueyue Lu ,&nbsp;Qing Zhang","doi":"10.1016/j.cca.2025.120531","DOIUrl":"10.1016/j.cca.2025.120531","url":null,"abstract":"<div><h3>Objectives</h3><div>The study investigates serum RGS10 expression in acute pancreatitis (AP) patients and its prognostic value.</div></div><div><h3>Methods</h3><div>Serum samples and clinical data were collected from 104 AP patients and 34 healthy controls (HC). Whole transcriptome sequencing was performed on serum samples from three randomly selected individuals per group.</div></div><div><h3>Results</h3><div>Serum RGS10 levels were significantly higher in the moderately severe acute pancreatitis (MSAP) group compared to the mild acute pancreatitis (MAP) and HC (P &lt; 0.01). RGS10 expression was positively correlated with BISAP score, CTSI, INR, PCT, BUN, and Cr. Univariate and multivariate regression analyses identified RGS10, hydrothorax, and Ca²⁺ as independent risk factors for MSAP. RGS10 demonstrated the highest predictive accuracy for MSAP, with an accuracy of 80.0 %, sensitivity of 78.0 %, specificity of 74.1 %. Combining these indicators enhanced the predictive efficacy, achieving an accuracy of 91.2 %, sensitivity of 92.7 %, specificity of 76.3 %. Follow-up data indicated that RGS10, Cr, D-dimer, CTSI, PTAR, PLR, BUN, PT, INR, and disease severity were risk factors for recurrence AP.</div></div><div><h3>Conclusions</h3><div>RGS10 may serve as a novel biomarker for AP severity and recurrence risk.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"578 ","pages":"Article 120531"},"PeriodicalIF":2.9,"publicationDate":"2025-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144820742","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":"Machine learning-based optimization of the prostate health index for prostate cancer detection","authors":"Miroslav Stojadinovic ,&nbsp;Bogdan Milicevic ,&nbsp;Slobodan Jankovic","doi":"10.1016/j.cca.2025.120540","DOIUrl":"10.1016/j.cca.2025.120540","url":null,"abstract":"<div><div>The Prostate Health Index (PHI) is composed of the prostate-specific antigen (PSA), free PSA (fPSA), and the [-2]pro-PSA isoform (p2PSA). The aim of the study was to modify the PHI using machine learning (ML) and to compare its prognostic performance with traditional PHI for any-, low- and high-grade prostate cancer (PCa) detection on biopsy. To obtain better-balanced data set we used the over-sampling strategy. The extreme gradient boosting was considered as an ML algorithm. Predictive performance was quantified by the area under the curve (AUC), multiclass classification measures, calibration, and decision curve analysis. We used the feature importance and the SHapley Additive exPlanations value for interpretation of the model. There were 200 patients in the initial pool, but after resampling, the dataset had equal number of data points for each cancer grade (114), i.e. 342 data points in total. The AUC of the modified PHI was significantly higher than those of the traditional PHI (0.898 vs 0.808, 0.868 vs 0.581, and 0.983 vs 0.74) for any, low-grade, and high-grade PCa. The modified PHI had higher net benefit compared to the traditional PHI. However, the ML PHI model had sigmoid-shaped reliability plots. The p2PSA had the highest influence, and the fPSA was the most important factor for risk estimate by the ML PHI. The modified ML PHI model for predicting histological grade of PCa showed superior performance in comparison to the traditional PHI. However, additional studies are required before it can be integrated into routine clinical care.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"578 ","pages":"Article 120540"},"PeriodicalIF":2.9,"publicationDate":"2025-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144820741","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":"Advances in electrochemical biosensors for early detection of rheumatoid arthritis","authors":"Elmurod Egamberdiev ,&nbsp;Nurali Shavazi ,&nbsp;Mustafa Jawad Kadham ,&nbsp;Shaxnoza Kasimova ,&nbsp;Nilufar Mamatmusayeva ,&nbsp;Dildorakhon Nabieva ,&nbsp;Guloyim Avezova ,&nbsp;Madina Bekchanova ,&nbsp;Sanat Chuponov ,&nbsp;Nigina Rustamova ,&nbsp;Feruza Oripova ,&nbsp;Nigora Dustova ,&nbsp;Gulchehra Ikhtiyarova","doi":"10.1016/j.cca.2025.120547","DOIUrl":"10.1016/j.cca.2025.120547","url":null,"abstract":"<div><div>Electrochemical biosensors have emerged as pivotal technologies for the early detection of rheumatoid arthritis (RA), a chronic autoimmune disease characterized by joint inflammation and destruction. This paper reviews the advancements in biosensing platforms, particularly focusing on the detection of anti-citrullinated peptide antibodies (ACPAs) and other biomarkers relevant to RA diagnosis. By integrating nanotechnology and innovative electrochemical methods, these biosensors offer increased sensitivity, specificity, and rapid results, facilitating timely therapeutic interventions. The review also highlights the challenges and future directions in biosensor technology, emphasizing the importance of personalized medicine and real-time monitoring in improving patient outcomes.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"578 ","pages":"Article 120547"},"PeriodicalIF":2.9,"publicationDate":"2025-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144820740","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":"Measurement uncertainty for practical use – applied in hematology","authors":"Wytze P. Oosterhuis ,&nbsp;Abdurrahman Coskun ,&nbsp;Sverre Sandberg ,&nbsp;Parvana Mikailova ,&nbsp;Elvar Theodorsson ,&nbsp;on behalf of the EFLM Committee: Practical Guide to Implement Measurement Uncertainty","doi":"10.1016/j.cca.2025.120546","DOIUrl":"10.1016/j.cca.2025.120546","url":null,"abstract":"<div><div>Uncertainty of measurements in clinical laboratories should be monitored, reported, and documented as required by accreditation standards. The conceived complexity of calculation methods described by current guidelines such as ISO 20914 favors a more pragmatic, utilitarian approach. For that reason an alternative approach was applied for measurement uncertainty (MU) calculations in a conglomerate of seven laboratories with eleven measurement systems. MU was based on internal quality control results and for the routine hematological parameters. Graphical and variance component analysis was used to identify factors causing diverging results. MU for hematological tests, but not for all derived parameters were within the MU-APS limits (MAU) based on biological variation. It was demonstrated that MU of a diverging measuring system in the conglomerate could be improved by a correction procedure. In conclusion, that MU could be derived for hematological tests in a conglomerate of laboratories. All the parameters of cellular counting (except indices) were within the specifications based on biological variation. Factors causing deviating results within the conglomerate could be identified and significantl improved.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"578 ","pages":"Article 120546"},"PeriodicalIF":2.9,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144815938","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":"Within- and Between-Subject biological variation estimates of serum free light immunoglobulin chains in healthy individuals in Turkey","authors":"Müjgan Ercan ,&nbsp;Esra Fırat Oğuz ,&nbsp;Mehmet Özcan ,&nbsp;Hamit Hakan Alp","doi":"10.1016/j.cca.2025.120545","DOIUrl":"10.1016/j.cca.2025.120545","url":null,"abstract":"<div><div>Serum light immunoglobulin chains (LCs) are critical biomarkers for the diagnosis, prognosis, and treatment response monitoring in monoclonal plasma cell dyscrasias. Robust performance standards based on biological variation (BV) data are essential for optimizing patient care. This study aimed to provide updated BV estimates for serum free LCs (κ and λ) as well as their κ/λ LC ratio. Serum samples from 25 healthy volunteers (10 men, 15 women) were collected weekly over approximately 9 weeks. Serum free LCs were measured in duplicate using the Roche Cobas c501 analyzer. BV estimates with 95 % confidence intervals were calculated using coefficient of variation (CV) in ANOVA for the entire group and by sex, following assessments for outliers, normality, steady-state conditions, and variance homogeneity. The within-subject BV (CV_I) estimates were 9.2 %, 8.6 %, 6.6 % for free κ, free λ, free κ/λ ratio, respectively. The between-subject BV (CV_G) estimates were 24.6 %, 26.6 %, and 17.5 %for free κ, free λ and free κ/λ ratio, respectively. No significant sex differences were observed for CV_I with the exception of free κ and free κ/λ ratio or CV_G in serum free LCs and their ratio. Free LCs and their κ/λ ratio exhibited marked individuality. Analytical performance specifications (APSs) for desirable imprecision and bias ranged 3.9 %–5.4 %, 4.3 %–5.8 % and 2.9 %–4.6 % for free κ, free λ and free κ/ λ ratio, respectively. This study provides updated, well-characterized BV estimates for serum free (κ and λ) and free κ/λ ratio, providing essential data to define APSs. The individuality of κ and λ underscores the importance of prioritizing reference change values over traditional reference intervals for improved diagnosis and monitoring in clinical practice.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"578 ","pages":"Article 120545"},"PeriodicalIF":2.9,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144809456","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":"Circulating tumor DNA methylation in colorectal cancer: a meta-analysis","authors":"Zhipeng Pan ,&nbsp;Guoqing Li ,&nbsp;Hanqing Wu ,&nbsp;Faming Pan","doi":"10.1016/j.cca.2025.120543","DOIUrl":"10.1016/j.cca.2025.120543","url":null,"abstract":"<div><h3>Objectives</h3><div>To synthetically evaluate the diagnostic performance of circulating tumor DNA (ctDNA) methylation for colorectal cancer (CRC).</div></div><div><h3>Methods</h3><div>Relevant articles published before March 4, 2025 were searched. The pooled sensitivity, specificity, positive and negative likelihood ratio, diagnostic odds ratio (DOR), and the areas under the summary receiver operating characteristic curve (AUC) were calculated. Subgroup analysis and <em>meta</em>-regression were used to evaluate potential sources of heterogeneity.</div></div><div><h3>Results</h3><div>Totally, 147 articles containing 15,133 CRC patients were included in this <em>meta</em>-analysis. The pooled sensitivity, specificity and DOR of ctDNA methylation were 0.655, 0.902 and 20.662, respectively, yielding an AUC of 0.8851. Meanwhile, the combination of ctDNA methylation and carcinoembryonic antigen (CEA) achieved an AUC of 0.9269, with a sensitivity of 0.804, with a specificity of 0.904. Subgroup and <em>meta</em>-regression analyses indicated that the diagnostic value of multiple genes (AUC = 0.9059) and digital PCR assay (AUC = 0.8907) was higher than that of single gene and other assays. Gene dosage and detection method might be the sources of heterogeneity. There was no publication bias among these articles.</div></div><div><h3>Conclusion</h3><div>The overall performance of ctDNA methylation had great diagnostic accuracy for the early screening and diagnosis of CRC, especially after combining with CEA, but many open questions remain before clinical application.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"578 ","pages":"Article 120543"},"PeriodicalIF":2.9,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144815937","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}