Clinica Chimica Acta最新文献

{"title":"An interference in bilirubin detection: Pulmonary marginal zone lymphoma presenting monoclonal cryoglobulin.","authors":"Yi Li, Liangqiong Zhou, Kangyi Wang, Xiaoge Luo, Liqun Zhang, Kaiyong Cai","doi":"10.1016/j.cca.2024.120066","DOIUrl":"10.1016/j.cca.2024.120066","url":null,"abstract":"<p><p>Marginal zone lymphoma (MZL) of the lung is an indolent B-cell lymphoma. The peripheral blood of most patients with pulmonary MZL contains low or undetectable monoclonal immunoglobulin (M protein) levels. In this case, the clinical laboratory discovered that the pulmonary MZL patient not only associated with high concentration of monoclonal IgG-type protein but also exhibited obvious gel formation characteristics that interfered with clinical biochemistry tests. Thus, the role of M protein in total bilirubin determination was examined in this study. Total bilirubin detection curve difference comparison between monoclonal IgG protein and polyclonal immunoglobulin, interference experiments, and dilution elimination experiments were conducted. These experiments revealed not only a positive correlation between M protein interference in bilirubin detection with its concentration, but also M protein-specific interference distinct from polyclonal immunoglobulin. We employed the R and EmpowerStat statistical systems to evaluate the correlation between serum monoclonal protein and total bilirubin absorbance curve data. Multivariate analysis revealed a nonlinear correlation between with globulin (GLB) and square root transformed curve optical density (OD) data. The receiver operating characteristic (ROC) curve analysis indicated an area under the curve (AUC) of 0.852 for the GLB ≥ 31.9 g/L subgroup using combined curve indicators. Our findings can enhance clinical M protein screening and scientific assessment of the populations requiring serum protein electrophoresis testing, thereby reducing the rate of missed diagnoses in the M protein population.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120066"},"PeriodicalIF":3.2,"publicationDate":"2024-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142794341","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":"Quality control frequency: Unleashing the truth.","authors":"Hikmet Can Çubukçu","doi":"10.1016/j.cca.2024.120068","DOIUrl":"10.1016/j.cca.2024.120068","url":null,"abstract":"<p><strong>Objectives: </strong>This study investigates the optimal number of quality control (QC) events per day in two scenarios: high-sensitive troponin, requiring three levels of QC materials, and creatinine, with two levels. The aim is to explore how different QC rules and sigma metric values affect the frequency of QC events, considering both analytical performance and the clinical impact of potential measurement errors as severity of harm.</p><p><strong>Methods: </strong>Risk-based QC calculations were performed using the QC Constellation tool. Four QC rule schemes (1-3 s, 1-3 s/2-2 s, 1-3 s/2-2 s/R-4 s, 1-3 s/2-2 s/R-4 s/4-1 s) were tested for high-sensitive troponin (catastrophic harm) and creatinine (serious harm). Sigma metric values from 3 to 6 were evaluated to determine maximum run sizes. QC event frequency was estimated for a hypothetical laboratory processing 1,000 samples daily.</p><p><strong>Results: </strong>Maximum run sizes decreased as sigma metric values declined. Correspondingly, the number of QC events per day increased as sigma metric values decreased. For high-sensitive troponin, with its catastrophic severity of harm related to potantial error, more frequent QC was necessary compared to creatinine.</p><p><strong>Conclusions: </strong>Analytical performance and severity of harm significantly influence the required frequency of QC events. Laboratories must consider both factors when designing QC strategies to balance patient safety with operational efficiency. For analytes with high severity of harm, achieving higher sigma metrics is critical to maintain feasible and cost-effective QC practices. A hybrid QC approach combining risk-based and patient-based methods may optimize QC strategies, but standardization of sigma metric calculations is still needed.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120068"},"PeriodicalIF":3.2,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142791279","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":"Biosensors for early stroke detection.","authors":"Firoozeh Alavian, Fatemeh Khodabakhshi, Fatemeh Heidary Chenary","doi":"10.1016/j.cca.2024.120079","DOIUrl":"10.1016/j.cca.2024.120079","url":null,"abstract":"<p><p>This article aims to provide a comprehensive review of the latest advances in biosensor technology for early stroke diagnosis. Analyzing current research from authoritative databases highlights the significance of biosensors in improving stroke detection and treatment outcomes, discusses their diagnostic capabilities, and addresses the challenges that must be overcome for broader clinical application. This review utilizes updated information and valid research from ISI, Google Scholar, Science Direct, Scopus, and PubMed to examine recent developments in biosensors applicable to early stroke diagnosis. The results indicate that biosensors are crucial for the early detection of strokes, and enhance treatment efficacy. The biosensors studied in this research serve as rapid and non-intrusive diagnostic instruments with exceptional precision and detection capabilities. Cutting-edge biosensors can identify distinct stroke-related biomarkers, offering rapid and non-invasive diagnostic solutions to improve stroke care outcomes. Despite these advancements, significant challenges remain regarding the sensitivity, specificity, and reliability of biosensors. These issues must be resolved to facilitate their widespread implementation in clinical settings.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120079"},"PeriodicalIF":3.2,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142791275","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":"Crispr-cas biosensing for rapid detection of viral infection.","authors":"Yuting Qiu, Shiyu Chen, Juezhuo Li, Dong-Ang Liu, Ruiyao Hu, Yue Xu, Keyi Chen, Jinghua Yuan, Xinling Zhang, Xiaoping Li","doi":"10.1016/j.cca.2024.120071","DOIUrl":"10.1016/j.cca.2024.120071","url":null,"abstract":"<p><p>With the frequent outbreaks of viral diseases globally, accurate and rapid diagnosis of viral infections is of significant importance for disease prevention and control. The CRISPR-Cas combined biosensing strategy, as an emergent nucleic acid detection technology, exhibits notable advantages including high specificity, elevated sensitivity, operational simplicity, and cost-effectiveness, thereby demonstrating significant potential in the domain of rapid viral diagnostics. This paper summarizes the principles of the CRISPR-Cas system, the novel biotechnologies, and the latest research progress in virus detection using the combined biosensing strategy. Additionally, this paper discusses the challenges faced by CRISPR-Cas biosensing strategies and outlines future development directions, which provides a reference for further research and clinical applications in the rapid diagnosis of viral infections.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120071"},"PeriodicalIF":3.2,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142784310","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":"Osteocalcin: A bone protein with multiple endocrine functions.","authors":"Determe William, Hauge Sabina Chaudhary, Demeuse Justine, Massonnet Philippe, Grifnée Elodie, Huyghebaert Loreen, Dubrowski Thomas, Schoumacher Matthieu, Peeters Stéphanie, Le Goff Caroline, Evenepoel Pieter, Hansen Ditte, Cavalier Etienne","doi":"10.1016/j.cca.2024.120067","DOIUrl":"https://doi.org/10.1016/j.cca.2024.120067","url":null,"abstract":"<p><p>Bones are now recognised as endocrine organs with diverse functions. Osteocalcin, a protein primarily produced by osteoblasts, has garnered significant attention. Research into osteocalcin has revealed its impact on glucose metabolism and its unexpected endocrine role, particularly in its undercarboxylated form (ucOC). This form influences organs, affecting insulin sensitivity and even showing correlations with conditions like type 2 diabetes and cardiovascular diseases. However, analytical challenges are impeding advances in clinical research. Various immunoassays like RIA, EIA, ECLIA, IRMA, and ELISA have been developed to analyse osteocalcin. Recent innovations include techniques like OS-ELISA and OS phage Immuno-PCR, enabling fragment analysis. Advancements also encompass porous silicon for detection and ECLIA for rapid measurements. The limitations of immunoassays lead to ucOC measurement discrepancies, prompting the development of mass spectrometry-based techniques. Mass spectrometry increasingly quantifies carboxylated, undercarboxylated, and fragmented forms of osteocalcin. Mass spectrometry improves routine and clinical analysis accuracy. With heightened specificity, it identifies carboxylation status and serum fragmentations, boosting measurement reliability as a reference method. This approach augments analytical precision, advancing disease understanding, enabling personalised medicine, and ultimately benefiting clinical outcomes. In this review, the different techniques for the analysis of osteocalcin will be explored and compared, and their clinical implications will be discussed.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120067"},"PeriodicalIF":3.2,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142779475","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":"Clinicopathological characteristics of patients with low titer anti-phospholipase A2 receptor antibodies verified by indirect immunofluorescence assay.","authors":"Hao-Yuan Cui, Chao Li, Yu-Bing Wen, Wei Ye, Wen-Ling Ye, Hang Li, Li-Meng Chen","doi":"10.1016/j.cca.2024.120070","DOIUrl":"10.1016/j.cca.2024.120070","url":null,"abstract":"<p><strong>Objective: </strong>Laboratory extensively applied enzyme-linked immunosorbent assay (ELISA) to measure anti-phospholipase A2 receptor antibodies (PLA2R-abs) since its diagnostic significance on PLA2R related primary membranous nephropathy (PLA2R-related pMN) was discovered. However, PLA2R-abs determined by ELISA (PLA2R-ELISA) could infrequently yield inconclusive results, specifically a grey-zone defined as PLA2R-abs ranging from 2 to 20 RU/mL. Recently, researchers suggested that double-check grey-zone PLA2R-abs by indirect immunofluorescence (IIF) could improve diagnostic accuracy. We evaluated the diagnostic performance of PLA2R-IIF in assessing PLA2R-related pMN and summarized clinicopathological characteristics of grey-zone population to provide more evidence for clinical practice.</p><p><strong>Methods: </strong>Data on demographics, serology and pathology of patients with PLA2R-ELISA grey-zone results and a native kidney biopsy at Peking Union Medical College Hospital from September 2020 to April 2023 were reviewed. Grey-zone samples were analyzed using PLA2R-IIF. Negative results were defined as no fluorescence and positive results were graded according to fluorescence intensity.</p><p><strong>Results: </strong>This study included a total of 52 grey-zone patients divided into pMN group (n = 36, 69 %) and non-pMN group (n = 16, 31 %) according to renal pathology reports. The pMN patients had higher PLA2R-abs and lower serum creatinine compared to the non-pMN patients (P = 0.003, P < 0.001). No statistically significant differences were observed in 24-hour urine protein and albumin between the two groups. Multiple pathological types were identified in the non-pMN group. The sensitivity and specificity of PLA2R-IIF in PLA2R-ELISA grey-zone population were 72 % and 88 %, respectively, with a total consistent rate of 77 % and a positive predictive value of 93 %.</p><p><strong>Conclusion: </strong>Both pMN and non-pMN patients presented grey-zone PLA2R-ELISA results. It was necessary to perform PLA2R-IIF to assist in the diagnosis of patients with PLA2R-ELISA grey-zone results.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120070"},"PeriodicalIF":3.2,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142779471","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":"MiR-363: A potential biomarker of kidney diseases.","authors":"Yiqi Huang, Jiazhen Zhou, Yaotang Deng, Guoliang Li, Shuirong He, Hecheng Li, Lili Liu","doi":"10.1016/j.cca.2024.120049","DOIUrl":"10.1016/j.cca.2024.120049","url":null,"abstract":"<p><p>MicroRNAs (miRNAs), a class of endogenous small RNAs with lengths of approximately 19-24 nucleotides, play important regulatory roles in cells. In recent years, miR-363 has emerged as a prominent member of the miR-92a family, participating in various biological functions, including cellular proliferation, cycle, migration, and apoptosis. In particular, miR-363 plays a critical role in acute kidney injury, renal fibrosis, and diabetic nephropathy and can serve as a biomarker for the diagnosis of renal cell carcinoma. Ongoing research is exploring its potential as a biomarker of other kidney diseases. This review focuses on the role of miR-363 in kidney diseases, elucidating its regulatory mechanisms and exploring its possible value as a biomarker of kidney diseases.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120049"},"PeriodicalIF":3.2,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142779473","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":"Methylated cell-free DNA as a novel biomarker in Alzheimer’s disease","authors":"Mengyang Zhen ,&nbsp;Miao Dang ,&nbsp;Zexiang Cao ,&nbsp;Xiaoying Xia ,&nbsp;Fan Peng ,&nbsp;Siyuan Wang ,&nbsp;Yang Liu","doi":"10.1016/j.cca.2024.120069","DOIUrl":"10.1016/j.cca.2024.120069","url":null,"abstract":"<div><div>Due to an aging population, Alzheimer’s disease (AD), a neurodegenerative disorder, has affected more than 40 million people worldwide, a figure predicted to significantly increase in the coming decades. Despite much effort to understand AD pathogenesis, effective diagnosis and treatment remain a challenge. However, the development of liquid biopsy including the analysis of cell-free DNA (cfDNA) and methylation thereof has provided an alternative source of investigation to further explore the pathophysiology of AD. Herein, we discuss the research progress to date and highlight clinical applications of methylated cfDNA in AD.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"566 ","pages":"Article 120069"},"PeriodicalIF":3.2,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142758807","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":"Liquid biopsy biomarkers in breast cancer: An overview of systematic reviews","authors":"Bizhar Ahmed Tayeb ,&nbsp;Alaa AM Osman ,&nbsp;Isaac Kinyua Njangiru","doi":"10.1016/j.cca.2024.120063","DOIUrl":"10.1016/j.cca.2024.120063","url":null,"abstract":"<div><div>Breast cancer (BC) is the leading type of cancer affecting women globally and remains a significant cause of death. The diagnostic accuracy of liquid biopsy (LB) in the diagnosis of BC has not been well established. This overview synthesizes and critically evaluates the diagnostic test accuracy (DTA) of LB biomarkers in individuals with BC. Of 433 systematic reviews, eleven were included, assessing Fourier transform infrared (FTIR) spectroscopy, circulating tumor cells (CTCs), cell-free DNA (cfDNA), and microRNAs (miRNAs). The overall methodological quality of most of the reviews included was rated as critically low (n = 9, 81.8 %), and the remaining reviews were ranked as low and moderate. Key findings include CTCs with moderate sensitivity (0.50, 95 % confidence interval (CI) 0.48–0.52) and high specificity (0.93, 95 % CI: 0.92–0.95) with moderate certainty; cfDNA assays with high sensitivity (0.71–0.86) and specificity (0.88) with high certainty; FTIR assays with high sensitivity (0.97, 95 % CI: 0.94–0.96) and specificity (0.92, 95 % CI: 0.88–0.95) but low certainty. The miRNAs showed moderate to high sensitivity, while miR-21 had high specificity. Our overview indicates that identified liquid biopsies could serve as valuable tools for the diagnosis of breast cancer.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"566 ","pages":"Article 120063"},"PeriodicalIF":3.2,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142759314","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":"Study of the impact of ClinGen Revisions on ACMG/AMP variant semi-automatic classification for Rare Diseases diagnosis","authors":"Ana Rius ,&nbsp;Nicolas Aguirre ,&nbsp;Lorenzo Erra ,&nbsp;Franco Gino Brunello ,&nbsp;German Biagioli ,&nbsp;Jonathan Zaiat ,&nbsp;Marcelo A. Marti","doi":"10.1016/j.cca.2024.120065","DOIUrl":"10.1016/j.cca.2024.120065","url":null,"abstract":"<div><div>With the rapid development of massive sequencing technologies, the analysis of genetic variants for clinical diagnosis has exponentially escalated, particularly in the context of Rare Diseases (RDs). Diagnosing them involves identifying the genetic variants responsible for the underlying pathology development.</div><div>In 2015, the American College of Medical Genetics (ACMG) established a set of recommendations to assess the evidence associated with each variant, aiming to achieve a standardized five tier classification. Over the past 5 years, ClinGen, the NIH-funded Clinical Genome Resource, has reviewed these criteria in order to make variant classification a more reproducible and rigorous process.</div><div>This paper examines the impact of ClinGen-Rev modifications on variant classification, comparing them with the ACMG-2015 original recommendations. After analyzing sets of genetic variants, extracted from VCFs samples, using both criteria, we observed a change in 8.0 % of the clinical verdicts for these variants. ClinGen-Rev modifications correctly categorized 89.2 % of the curated variants, representing a significant improvement compared to the 65.6 % achieved by ACMG-2015. We also analyzed the modifications impact in a real like clinical setting, showing a significant overall reduction of VUS variants and thus potential reduction in analysis time. Finally, we discuss the underlying reasons for the most relevant changes in terms of specific labels and present their implications on the prioritization and selection process of variants, identifying some recommendations of key significant importance.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"566 ","pages":"Article 120065"},"PeriodicalIF":3.2,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142745881","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}