Clinica Chimica Acta最新文献

{"title":"Untargeted metabolomics analysis of the urinary metabolic signature of acute and chronic gout","authors":"Qiangqiang Jia ,&nbsp;Qiuxia Dong ,&nbsp;Jie Zhang ,&nbsp;Qing Zhao ,&nbsp;Yanhong Li ,&nbsp;Zhu Chao ,&nbsp;Ju Liu","doi":"10.1016/j.cca.2024.119968","DOIUrl":"10.1016/j.cca.2024.119968","url":null,"abstract":"<div><h3>Background</h3><p>Gout is a common kind of inflammatory arthritis with metabolic disorders. However, the detailed pathogenesis of gout is complex and not fully clear. We investigated the urine metabolic profiling of gout patients by ultra-performance liquid chromatograph quadrupole time-of-flight mass spectrometry (UPLC-Q-TOF-MS).</p></div><div><h3>Method</h3><p>Urine metabolites were extracted from 26 acute gout patients, 31 chronic gout patients, and 32 healthy controls. Metabolite extracts were analyzed by UPLC-Q-TOF-MS for untargeted metabolomics. The peak area of creatinine was used to correct the content variations of urine samples for the semi-quantitative analysis. The value of variable importance in the projection (VIP) was obtained through the orthogonal partial least squares-discrimination analysis (OPLS-DA), and several differential metabolites were screened out.</p></div><div><h3>Results</h3><p>The potential metabolic markers of gout in different stages were found based on the <em>t</em>-test. Finally, 18 different metabolites were identified through Human Metabolome Database (HMDB) and Targeted-MS/MS. The receiver operating characteristic (ROC) curve results revealed that all the screened biomarkers exerted high accuracy and diagnostic value. Pathway analysis indicated that the significantly different metabolites were mainly involved in purine metabolism and amino acid metabolism.</p></div><div><h3>Conclusion</h3><p>The identified potential biomarkers are mainly involved in purine metabolism and amino acid metabolism, which leads us to further explore the pathogenesis of gout. This will lead us to further explore the pathogenesis of gout and provide the basis and ideas for the prevention and treatment of gout.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142229915","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 for renal cell carcinoma","authors":"Retnagowri Rajandram ,&nbsp;Tulsi Laxmi Suren Raj ,&nbsp;Glenda Carolyn Gobe ,&nbsp;Shanggar Kuppusamy","doi":"10.1016/j.cca.2024.119964","DOIUrl":"10.1016/j.cca.2024.119964","url":null,"abstract":"<div><p>Liquid biopsies offer a less invasive alternative to tissue biopsies for diagnosis, prognosis, and determining therapeutic potential in renal cell carcinoma (RCC). Unfortunately, clinical studies using liquid biopsy biomarkers in RCC are limited. Accordingly, we examine RCC biomarkers, derived from urine, plasma, serum and feces of potential impact and clinical outcome in these patients. A PRISMA checklist was used to identify valuable liquid biopsy biomarkers for diagnosis (plasma cfDNA, serum- or urine-derived circulating RNAs, exosomes and proteins), prognosis (plasma cfDNA, plasma- or serum-derived RNAs, and proteins), and therapeutic response (plasma- and serum-derived proteins). Although other analytes have been identified, their application for routine clinical use remains unclear. In general, panels appear more effective than single biomarkers. Important considerations included proof of reproducibility. Unfortunately, many of the examined studies were insufficiently large and lacked multi-center rigor. Cost-effectiveness was also not available. Accordingly, it is clear that more standardized protocols need to be developed before liquid biopsies can be successfully integrated into clinical practice in RCC.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142239488","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":"Comparative assessment of trough and peak levels and AUC24 for amikacin in nontuberculous mycobacterial infection","authors":"Jiyeon Kim ,&nbsp;John Hoon Rim ,&nbsp;Jaehyeok Jang,&nbsp;Hanmil Jang,&nbsp;Jong-Baeck Lim","doi":"10.1016/j.cca.2024.119963","DOIUrl":"10.1016/j.cca.2024.119963","url":null,"abstract":"<div><h3>Background</h3><p>Amikacin, an aminoglycoside antibiotic, is widely used for the treatment of nontuberculous mycobacterial (NTM) infections. To date, therapeutic drug monitoring (TDM) of amikacin has primarily relied on the measurement of peak and trough levels as indicators rather than the 24-hr area under the concentration–time curve (AUC24).</p></div><div><h3>Methods</h3><p>NTM patients referred for amikacin TDM from March 2021 to May 2023 were assessed for the AUC24 values based on administered dose. We investigated re-admission rates, all-cause mortality and AFB smear results to evaluate clinical outcome based on the actual AUC24 values. Ototoxicity and nephrotoxicity were also investigated as adverse effects in correlation with TDM parameters.</p></div><div><h3>Results</h3><p>Among 65 patients, the mean and median values of AUC24 were 234 and 249 mg·hr/L, respectively. In a group of patients with AUC24 values less than 250 mg·hr/L, 42.4 % of patients were re-admitted for pulmonary symptoms. On the contrary, another group with AUC24 values equal to or more than 250 mg·hr/L, had lower re-admission rates (25.0 %). They also showed lower all-cause mortality rates and more improvement on acid-fast bacilli smear results. Moderate to poor correlation between AUC24 values and peak/trough levels were observed. Ototoxicity and nephrotoxicity were revealed to be associated with drug exposure duration rather than AUC24 values.</p></div><div><h3>Conclusion</h3><p>In this study, we performed comparative assessment of trough/peak level, traditional clinical marker for amikacin TDM, and AUC24 value. Although AUC24 values showed poor to moderate correlation to trough/peak levels, higher AUC24 correlated with favorable clinical outcomes without additional risk of toxicity.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0009898124022162/pdfft?md5=071acdcb8e357d395879cffb783ae927&pid=1-s2.0-S0009898124022162-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142229926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Free thyroid hormone: Methods and standardization","authors":"Zijia Ma ,&nbsp;Zhenni Liu ,&nbsp;Yuhang Deng ,&nbsp;Xuanchang Bai ,&nbsp;Weiyan Zhou ,&nbsp;Chuanbao Zhang","doi":"10.1016/j.cca.2024.119944","DOIUrl":"10.1016/j.cca.2024.119944","url":null,"abstract":"<div><p>Free thyroid hormone (FTH) serves as the preferred indicator for the clinical assessment of thyroid function, mainly encompassing free thyroxine and free triiodothyronine. The immunoassay commonly employed in the clinical setting exhibits certain unresolvable deficiencies. The results of over 5,500 clinical laboratories for FTH from China in 2024 demonstrated that the outcomes of immunoassay were not comparable, with robust CVs calculated in accordance with ISO 13528 ranging from 13.82% to 21.42%. Establishing reference methods is an important tool to achieve accurate and comparable results of free hormones. Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) holds a distinct advantage in the precise detection of small molecules, and two reference methods for free thyroxine based on LC-MS/MS are included in the JCTLM list. This article conducts a comprehensive review of the detection methods and standardization of FTH. It presents the metabolism of thyroid hormones, the significance of detection, the techniques, and application examples of free thyroid hormone assays, and deliberates on the current status, prospects, and recommendations for the standardization of FTH assays. Immunoassay and LC-MS/MS, as significant techniques for FTH detection, are predominantly emphasized in the case references. Ultrafiltration and equilibrium dialysis, which are utilized to separate FTH, are also addressed. This article aims to discuss the status quo of FTH detection and clarify the advantages of LC-MS/MS in FTH detection, propose that LC-MS/MS can be utilized as an auxiliary validation method or alternative method in clinical applications, and offer suggestions for the standardization of testing results.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142145262","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":"Serum neuron-specific enolase can predict the severity and outcome of anti-N-methyl-D-aspartate receptor encephalitis","authors":"Yinyao Lin ,&nbsp;Haiyan Li ,&nbsp;Enpeng Song ,&nbsp;Zhengqi Lu ,&nbsp;Yongqiang Dai ,&nbsp;Bingjun Zhang","doi":"10.1016/j.cca.2024.119962","DOIUrl":"10.1016/j.cca.2024.119962","url":null,"abstract":"<div><h3>Background</h3><p>Little is known about the association between serum neuron-specific enolase (NSE) concentration and anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis. This study aims to investigate if serum NSE concentration is related to the clinical features of anti-NMDAR encephalitis.</p></div><div><h3>Methods</h3><p>Serum NSE levels were detected in 58 anti-NMDAR encephalitis cases, 58 matched healthy controls and 58 matched disease controls. Demographic features, clinical symptoms, cerebrospinal fluid parameters and brain MRI indexes of the cases were evaluated.</p></div><div><h3>Results</h3><p>Serum NSE concentrations were significant higher in case group than those in healthy controls and disease controls (both p &lt; 0.001). Serum NSE concentrations in patients with mRS≥3 one year after onset were obviously higher than in those with mRS&lt;3 (p &lt; 0.001). Patients with status epilepticus or central hypoventilation had higher serum NSE levels than those without (p = 0.003 and p = 0.006). Serum NSE concentrations in cases with brain lesions or brain atrophy were significant higher than in those without (p = 0.001 and p &lt; 0.001, respectively). Serum NSE concentrations were found to be significant higher in cases with limited response to treatment compared to those with favourable therapy outcomes (p &lt; 0.001). Spearman’s correlation analysis showed a significant positive association between serum NSE concentration and mRS score at the most critical time (max mRS) (r = 0.575, p &lt; 0.001) and one year after onset (r = 0.705, p &lt; 0.001). Cox regression results reflected that high serum NSE level was an independent predictor of poor prognosis in anti-NMDAR encephalitis group (p = 0.001), and the ROC curve threshold value was 15.72 ng/ml.</p></div><div><h3>Conclusions</h3><p>Serum NSE concentrations in anti-NMDAR encephalitis cases are higher than those in controls. It can be used to predict the brain damage degree and prognosis of anti-NMDAR encephalitis cases.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142145263","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 performance evaluation of an HIV Duo assay: From HIV screening to acute and non-acute HIV infection detection","authors":"Xin Liu ,&nbsp;Chongyang Wu ,&nbsp;Yulin Yuan ,&nbsp;Dongdong Li ,&nbsp;Jinli Lou ,&nbsp;Xia Feng ,&nbsp;Qiuwei Lu ,&nbsp;Rongcai Wu ,&nbsp;An-Jou Chen ,&nbsp;Chuanmin Tao","doi":"10.1016/j.cca.2024.119949","DOIUrl":"10.1016/j.cca.2024.119949","url":null,"abstract":"<div><h3>Background</h3><p>Evaluating the clinical performance of Elecsys HIV Duo assay for primary human immunodeficiency virus (HIV) screening and acute HIV infection detection.</p></div><div><h3>Methods</h3><p>This study was conducted from April 2022 to April 2023 and involved two distinct populations. For the HIV screening population, three HIV Duo results [HIV Duo, HIV antigen (Ag), and HIV antibody (Ab)] in primary screening were obtained (January 2021 to June 2021). In the diagnosed HIV population, retrospective samples from November 2016 to March 2023 were measured.</p></div><div><h3>Results</h3><p>The HIV screening population included 111,383 samples from a real-world screening program. The assay demonstrated a specificity of 99.91 % (95 % CI: 99.89 %, 99.93 %) and a PPV of 0.8516 (95 % CI: 0.8225, 0.8776). Regarding the diagnosed HIV population, 836 HIV patients were enrolled, including 14 acute HIV infectious patients with only HIV Ag + and a Western Blot (WB) confirmation rate of 0 %. The median (IQR) of the numeric cut-off index (COI) ratios of HIV Duo Ab and Ag significantly differed among the Ag + Ab-, Ag-Ab+, and Ag + Ab + subgroups.</p></div><div><h3>Conclusion</h3><p>The Elecsys HIV Duo assay is suitable for primary HIV screening and can be integrated into a novel laboratory HIV testing algorithm to improve acute HIV detection in Chinese clinical practice.</p><p>Abbreviations: HIV, Human immunodeficiency virus; AIDS, acquired immunodeficiency syndrome; Ag, antigen; Ab, antibody; WB, Western Blot; COI, numeric cut-off index; CI, confidence interval; NAT, nucleic acid tests; EDC, electronic data capture systems; CDC, Chinese Centers for Disease Control and Prevention; IQR, interquartile range; PPV, positive predictive value; HCV, hepatitis C virus; HBV, hepatitis B virus; CI, confidence interval; ND, not able to define; F, female; M, male;</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0009898124022022/pdfft?md5=bc22993ab543cae54638a163b83759ba&pid=1-s2.0-S0009898124022022-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142145261","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The optimal cut-off value","authors":"Arne Åsberg ,&nbsp;Bjørn Johan Bolann","doi":"10.1016/j.cca.2024.119953","DOIUrl":"10.1016/j.cca.2024.119953","url":null,"abstract":"","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104870","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":"Excreted albumin of diabetic microalbuminuria cases exhibits pseudo esterase activity: A new way to explore microalbuminuria, perhaps with more information","authors":"Deepak Kumar ,&nbsp;Pinaki Dutta ,&nbsp;Raja Ramachandran ,&nbsp;Rajasri Bhattacharyya ,&nbsp;Dibyajyoti Banerjee","doi":"10.1016/j.cca.2024.119947","DOIUrl":"10.1016/j.cca.2024.119947","url":null,"abstract":"<div><h3>Background</h3><p>Microalbuminuria is associated with several clinical conditions of public health concern. Particularly in diabetic patients, there is routine microalbuminuria screening to understand whether the renal complication has progressed to the microalbuminuria stage or not. Therefore, microalbuminuria detection is a matter of considerable interest. For such detection, the clinical labs rely on immunochemical methods. Nevertheless, the immunochemical methods are believed to be less sensitive for the purpose. So, the need arises for continuous research in the field. We believe that pseudoesterase activity of the excreted albumin in microalbuminuria cases is a potential target. This aspect is investigated here and it is shown that the excreted albumin in diabetic microalbuminuria cases retains its pseudoesterase activity, unlike the overt albuminuria cases.</p></div><div><h3>Methods</h3><p>The cases of diabetic nephropathy and healthy controls were included in the study. The patients were divided into diabetic controls microalbuminuria, and overt albuminuria group considering the albumin to creatinine ratio (ACR). The urinary proteins of the cases were isolated by centrifugation. The obtained protein pellet was then checked for pseudoesterase activity by electrophoretic and fluorescence-based methods. The CD spectroscopy and LC-MS study was carried out to show the suitability of the substrate for the detection of albumin pseudoesterase activity. To further, understand the structure–function relation, molecular docking studies were carried out.</p></div><div><h3>Results</h3><p>From the CD and LC-MS study the suitability of the used substrate was confirmed. The electrophoretic and fluorescence study showed that the protein of the microalbuminuria group retained the pseudoesterase activity whereas the same is lost in the overt albuminuria group. The molecular docking studies indicated that a change in albumin structure may result in a change in its pseudoesterase activity.</p></div><div><h3>Conclusion</h3><p>The urinary protein of diabetic microalbuminuria cases exhibits pseudoesterase activity. It distinguishes the excreted protein in the diabetic albuminuria group and the overt albuminuria group. This is the first study that showed the retention of pseudoesterase property in excreted albumin. Further, in this study a simple test is developed that distinguishes the excreted albumin in the microalbuminuria group and overt albuminuria group.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104868","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":"Salivaomics in head and neck cancer","authors":"Chandrarohini Saravanan ,&nbsp;Rabiatul Basria S. M. N. Mydin ,&nbsp;Nur Rizikin Mohamed Sheriff ,&nbsp;Gurjeet Kaur ,&nbsp;Satvinder Singh Dhaliwal ,&nbsp;Muhamad Yusri Musa","doi":"10.1016/j.cca.2024.119952","DOIUrl":"10.1016/j.cca.2024.119952","url":null,"abstract":"<div><p>Salivaomics is a promising method for the early detection and monitoring of head and neck cancer (HNC). By analyzing salivary proteomics, RNA, and DNA, it identifies biomarkers that distinguish HNC patients from healthy individuals. Saliva’s non-invasive, easily collectible nature and affordability make it an advantageous screening tool. Multiomics approaches, which explore genetic mutations, gene expression patterns, protein profiles, and metabolite levels, provide a comprehensive molecular perspective that enhances clinical applicability. The approaches enhance the precision of diagnoses, enable the development and application of targeted therapies, and contribute to the overall advancement of personalized medicine. Despite its potential, larger-scale studies are essential for validating biomarkers, and assessing sensitivity, accuracy, and specificity in detecting HNC. This review highlights salivaomics’ potential as a non-invasive, accessible biological sample for early disease detection in HNC and underscores the value of multiomics in advancing this research. Salivaomics offers significant insights into the underlying mechanisms of HNC, enabling the discovery of robust, non-invasive biomarkers for improved disease management.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104873","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":"Utility of plasma nucleocapsid protein in predicting severity and prognosis in severe COVID-19 patients with comorbidities","authors":"Di Wang ,&nbsp;Yutao Shen ,&nbsp;Jianbo Wu ,&nbsp;Yaju Li ,&nbsp;Ke Ma ,&nbsp;Guangjie Jiang ,&nbsp;Xiangyu Li ,&nbsp;Huanhuan Qin ,&nbsp;Kun Chen ,&nbsp;Zhiyuan Wu ,&nbsp;Ming Guan","doi":"10.1016/j.cca.2024.119951","DOIUrl":"10.1016/j.cca.2024.119951","url":null,"abstract":"<div><h3>Objectives</h3><p>The COVID-19 pandemic poses ongoing challenges to global public health systems, emphasizing the critical necessity for efficient diagnostic and prognostic markers. This study evaluates the MAGLUMI® SARS-CoV-2 Ag N protein chemiluminescent immunoassay (MAG-CLIA) for its analytical performance and its role in predicting disease severity and prognosis among severe COVID-19 patients with comorbidities.</p></div><div><h3>Methods</h3><p>Analytical validation of plasma MAG-CLIA SARS-CoV-2 Ag N protein encompassed precision, interference, LoQ and linearity. Plasma N protein concentrations and other biomarkers were measured within 48 h of admission, tracked until discharge or death. The Mann-Whitney <em>U</em> test explored the association between plasma N protein and COVID-19 severity or prognosis. Longitudinal monitoring of plasma N protein dynamics was conducted in representative patients.</p></div><div><h3>Results</h3><p>MAG-CLIA demonstrated precise quantification of plasma N protein with a CV below 10 % and minimal interference. The LoQ was 0.88 ng/L, with a broad linear range. Plasma N protein showed high diagnostic accuracy for COVID-19, achieving 95.42 % specificity and 78.32 % sensitivity at 2.388 ng/L. Plasma N protein emerged as a valuable prognostic indicator, correlating with mechanical ventilation need and patient survival. Plasma N protein concentrations ≥ 424.3 ng/L (AUC 0.8102, sensitivity 78.38 %, specificity 85.48 %) were associated with poor prognosis in severe COVID-19 patients with comorbidities.</p></div><div><h3>Conclusions</h3><p>MAG-CLIA’s SARS-CoV-2 N protein detection in plasma demonstrates both analytical reliability and clinical relevance in our inaugural evaluation. As a promising prognostic biomarker for severe COVID-19 patients, it offers crucial insights into disease severity and progression, emphasizing the significance of early monitoring and intervention, especially for patients with comorbidities.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104871","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}