Clinica Chimica Acta最新文献

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Early serum PreS1 levels are predictive of HBsAg loss in interferon-alpha treated children with HBeAg-positive chronic hepatitis B 早期血清PreS1水平可预测干扰素治疗的hbeag阳性慢性乙型肝炎患儿的HBsAg损失。
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2025-10-16 DOI: 10.1016/j.cca.2025.120661
Peiyao Fan , Fuchuan Wang , Yi Dong , Jianguo Yan , Lili Cao , Yinjie Gao , Zhiqiang Xu , Yanwei Zhong , Min Zhang
{"title":"Early serum PreS1 levels are predictive of HBsAg loss in interferon-alpha treated children with HBeAg-positive chronic hepatitis B","authors":"Peiyao Fan ,&nbsp;Fuchuan Wang ,&nbsp;Yi Dong ,&nbsp;Jianguo Yan ,&nbsp;Lili Cao ,&nbsp;Yinjie Gao ,&nbsp;Zhiqiang Xu ,&nbsp;Yanwei Zhong ,&nbsp;Min Zhang","doi":"10.1016/j.cca.2025.120661","DOIUrl":"10.1016/j.cca.2025.120661","url":null,"abstract":"<div><h3>Background and Aim(s)</h3><div>The PreS1 surface antigen of large surface proteins (LHBs) plays an important role in predicting clinical outcomes in adults with chronic hepatitis B (CHB). This study aimed to determine whether PreS1 levels can predict HBsAg loss in children with HBeAg-positive CHB undergoing a 48-week interferon-alpha (IFN-α) therapy protocol.</div></div><div><h3>Methods</h3><div>We conducted a retrospective analysis of 133 children with CHB. Biomarkers and clinical outcomes were assessed every three months. The area under the receiver operating characteristic (AUROC) curve was calculated to evaluate the predictive value of different biomarkers for HBsAg loss at the 48-week end-point.</div></div><div><h3>Results</h3><div>At the end of the 48-week IFN-α therapy, HBsAg loss was achieved in 16.5 % (22/133) of patients. PreS1 levels were positively correlated with serum quantitative HBsAg (qHBsAg) and hepatitis B virus (HBV) DNA levels. At baseline, only the PreS1/qHBsAg ratio predicted HBsAg loss at week 48 (AUROC = 0.661, <em>p</em> = 0.015). At week 12, PreS1 levels also predicted HBsAg loss at week 48 (AUROC = 0.875, <em>p</em> &lt; 0.001).</div></div><div><h3>Conclusions</h3><div>Early serum PreS1 levels and the PreS1/qHBsAg ratio may serve as useful predictors of HBsAg loss in children with CHB receiving IFN-α therapy, providing potential guidance for clinical decision-making.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"579 ","pages":"Article 120661"},"PeriodicalIF":2.9,"publicationDate":"2025-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145318283","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}
引用次数: 0
Corrigendum to "Sex based profiles in serum and urine levels of major VEGF-A isoforms, VEGF-A121 and VEGF-A165" [Clin. Chim. Acta. 578 (2026) 120576]. “主要VEGF-A亚型,VEGF-A121和VEGF-A165的血清和尿液中基于性别的特征”[临床]的更正。詹。学报,578(2026):120576]。
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2025-10-16 DOI: 10.1016/j.cca.2025.120652
Ryosuke Kikuchi, Shingo Yamada, Hidekazu Ishida, Masahiro Nakatochi, Yumiko Kobayashi, Yuki Ohashi, Kazuhiko Kotani, Atsuo Suzuki, Yohei Shirakami, Takatomo Watanabe, Hiroyuki Okura
{"title":"Corrigendum to \"Sex based profiles in serum and urine levels of major VEGF-A isoforms, VEGF-A<sub>121</sub> and VEGF-A<sub>165</sub>\" [Clin. Chim. Acta. 578 (2026) 120576].","authors":"Ryosuke Kikuchi, Shingo Yamada, Hidekazu Ishida, Masahiro Nakatochi, Yumiko Kobayashi, Yuki Ohashi, Kazuhiko Kotani, Atsuo Suzuki, Yohei Shirakami, Takatomo Watanabe, Hiroyuki Okura","doi":"10.1016/j.cca.2025.120652","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120652","url":null,"abstract":"","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120652"},"PeriodicalIF":2.9,"publicationDate":"2025-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145312374","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}
引用次数: 0
Analytical validation of a novel capillary finger-stick blood sampling device for clinical chemistry, complete blood count, and hemoglobin A1c testing 一种用于临床化学、全血细胞计数和血红蛋白A1c检测的新型毛细管指棒采血装置的分析验证。
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2025-10-14 DOI: 10.1016/j.cca.2025.120664
Yasuhiro Sakai , Taku Kato , Midori Saito , Michiko Osawa , Kazuya Shinmura , Koichi Seto , Kuniaki Saito , Hiroyasu Ito
{"title":"Analytical validation of a novel capillary finger-stick blood sampling device for clinical chemistry, complete blood count, and hemoglobin A1c testing","authors":"Yasuhiro Sakai ,&nbsp;Taku Kato ,&nbsp;Midori Saito ,&nbsp;Michiko Osawa ,&nbsp;Kazuya Shinmura ,&nbsp;Koichi Seto ,&nbsp;Kuniaki Saito ,&nbsp;Hiroyasu Ito","doi":"10.1016/j.cca.2025.120664","DOIUrl":"10.1016/j.cca.2025.120664","url":null,"abstract":"<div><h3>Background and aims</h3><div>Capillary Cup® is a novel finger-stick blood collection device equipped with separation float technology to effectively isolate plasma and blood cell layers. This study aimed to evaluate its analytical equivalence compared to venipuncture sampling in clinical chemistry, complete blood count, and hemoglobin A1c testing.</div></div><div><h3>Methods</h3><div>Blood samples were collected from 63 healthy participants for clinical chemistry and hemoglobin A1c tests and 67 for complete blood count tests. Discrepancies between the Capillary Cup® and venipuncture sampling results were analyzed using the 2025 Clinical Laboratory Improvement Amendments (CLIA) acceptance limits and total allowable error (TE<sub>A</sub>) thresholds.</div></div><div><h3>Results</h3><div>The Capillary Cup® samples showed strong linear correlations with venipuncture samples across proteins, transaminases, kidney function markers, lipids, C-reactive protein, blood cell and platelet counts, white blood cell differentials, hemoglobin, hematocrit, and Wintrobe's indices (<em>r</em> = 0.740–0.999, <em>P</em> &lt; 0.0001). Hemoglobin A1c was accurately measured alongside other clinical chemistry markers in a single kit (<em>r</em> = 0.976, <em>P</em> &lt; 0.0001). All values met the 2025 CLIA acceptance limits, and most also met the TE<sub>A</sub> thresholds. Minor deviations were observed for creatinine, triglycerides, and C-reactive protein, as well as for platelet counts—potentially affected by activation and aggregation—but all remained within acceptance limits and demonstrated preserved linearity.</div></div><div><h3>Conclusions</h3><div>The Capillary Cup® provides analytically equivalent results to venipuncture for all tested parameters. It is easy to use, reduces waste, and is a potential alternative for at-home health monitoring, addressing challenges in venous access, and reducing iatrogenic blood loss risk in clinical practice.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"579 ","pages":"Article 120664"},"PeriodicalIF":2.9,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145307081","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}
引用次数: 0
Discrimination of urine infrared spectral biomarkers for early-stage chronic kidney disease patients using attenuated total reflectance fourier transform infrared spectrometry 衰减全反射傅里叶变换红外光谱法鉴别早期慢性肾病患者尿液红外光谱生物标志物
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2025-10-14 DOI: 10.1016/j.cca.2025.120665
Patipat Rachawangmuang , Patutong Chatchawal , Patcharaporn Tippayawat , Apinya Jusakul , Ratthapol Kraiklang , Worachart Lert-itthiporn , Anuchin Najermploy , Molin Wongwattanakul
{"title":"Discrimination of urine infrared spectral biomarkers for early-stage chronic kidney disease patients using attenuated total reflectance fourier transform infrared spectrometry","authors":"Patipat Rachawangmuang ,&nbsp;Patutong Chatchawal ,&nbsp;Patcharaporn Tippayawat ,&nbsp;Apinya Jusakul ,&nbsp;Ratthapol Kraiklang ,&nbsp;Worachart Lert-itthiporn ,&nbsp;Anuchin Najermploy ,&nbsp;Molin Wongwattanakul","doi":"10.1016/j.cca.2025.120665","DOIUrl":"10.1016/j.cca.2025.120665","url":null,"abstract":"<div><div>Chronic Kidney Disease (CKD) is a highly prevalent non-communicable disorder lacking a gold standard method for diagnosis. Early-stage CKD remains undiagnosed and untreated leading to the disease progression. The study aimed to discriminate urine samples from CKD patients and healthy groups using an ATR-FTIR spectrometer. Forty-five healthy and a hundred CKD urine samples were included. Five replicates of three microliters of urine were dropped onto a crystal and air-dried as a film on a portable ATR-FTIR spectrometer. Spectra were analyzed using multivariate analysis combined with machine learning. The PCA scores plot showed the discrimination of the CKD group, both early and late stage, from healthy in the C<img>H and fingerprint regions. For a screening approach, machine learning were introduced to the healthy and early-stage CKD samples. Prediction models were generated using six machine learning models. The neural networks (NN) model demonstrating the best performance, achieving 85 % sensitivity, 73 % specificity and 77 % accuracy on test dataset. Thus, ATR-FTIR data combined with machine learning shows potential as a medical tool with high performance for screening minimal urine volumes of CKD patients.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"579 ","pages":"Article 120665"},"PeriodicalIF":2.9,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145307112","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}
引用次数: 0
Liquid chromatography-tandem mass spectrometry-based recalibration reduces inter-platform variability in aldosterone detection across chemiluminescence immunoassay platforms 基于液相色谱-串联质谱的再校准减少了化学发光免疫分析平台间醛固酮检测的平台间变异性。
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2025-10-14 DOI: 10.1016/j.cca.2025.120604
Jing Zhang, Baobin Luo, Zifu Fan, Xiaoyu Ma, Yungang Pu, Xiangyi Liu
{"title":"Liquid chromatography-tandem mass spectrometry-based recalibration reduces inter-platform variability in aldosterone detection across chemiluminescence immunoassay platforms","authors":"Jing Zhang,&nbsp;Baobin Luo,&nbsp;Zifu Fan,&nbsp;Xiaoyu Ma,&nbsp;Yungang Pu,&nbsp;Xiangyi Liu","doi":"10.1016/j.cca.2025.120604","DOIUrl":"10.1016/j.cca.2025.120604","url":null,"abstract":"<div><h3>Background</h3><div>Accurate aldosterone (ALD) measurement is vital in managing diseases such as primary aldosteronism (PA). However, inter-platform inconsistency across chemiluminescence immunoassay (CLIA) platforms complicates clinical decisions. This study conducted the largest comparison of CLIA platforms (six CLIA platforms) and one liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay for ALD detection to date, systematically evaluated inter-platform consistency and explored the role of recalibration strategy based on LC-MS/MS in improving consistency among CLIA platforms.</div></div><div><h3>Methods</h3><div>Fifty pooled clinical plasma samples were used to evaluate ALD levels across six different CLIA platforms and one LC-MS/MS assay. Friedman’s test, Spearman correlation, Passing-Bablok regression, and Bland-Altman analysis were used to evaluate the consistency among assays. In addition, CLIA platforms were recalibrated against LC-MS/MS using regression equations with five pooled clinical plasma samples as calibration materials, and consistency was evaluated before and after recalibration.</div></div><div><h3>Results</h3><div>LC-MS/MS yielded significantly lower ALD levels than six CLIA platforms (median: 120.75 vs<em>.</em> 129.29 to 216.25 pg/mL, <em>P</em> &lt; 0.05). All assays correlated strongly (R ≥ 0.955), yet regression parameters revealed most slopes deviated from 1 (0.909 to 1.444) and intercepts ranged from −31.424 to 52.272 pg/mL. Bland-Altman plots demonstrated large relative mean differences (−2.396 % to 55.876 %) between assays. The recalibration process significantly reduced relative mean differences, whereas it showed limited improvement in addressing both proportional and systematic biases.</div></div><div><h3>Conclusions</h3><div>These findings demonstrate that the consistency among CLIA platforms and LC-MS/MS assays is suboptimal. Actionable design strategies for developing recalibration coefficients, which reduce relative mean differences, are provided for CLIA platforms, emphasizing the necessity for standardized calibration to reduce inter-platform variability in clinical ALD measurement. The persistent proportional and systematic biases underscore the urgency for optimization in calibration strategy and detection methodology.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"579 ","pages":"Article 120604"},"PeriodicalIF":2.9,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145307124","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}
引用次数: 0
Nanoparticle-based liquid biopsy 纳米颗粒液体活检。
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2025-10-13 DOI: 10.1016/j.cca.2025.120658
Saja S. Falih , Ahmed Mahdi Rheima , Fatin Fadhel Al-Kazazz , Zaid Nsaif Abbas
{"title":"Nanoparticle-based liquid biopsy","authors":"Saja S. Falih ,&nbsp;Ahmed Mahdi Rheima ,&nbsp;Fatin Fadhel Al-Kazazz ,&nbsp;Zaid Nsaif Abbas","doi":"10.1016/j.cca.2025.120658","DOIUrl":"10.1016/j.cca.2025.120658","url":null,"abstract":"<div><div>Liquid biopsy has emerged as a revolutionary diagnostic strategy in oncology, providing a minimally invasive means for real-time monitoring of tumor dynamics through the analysis of circulating tumor-derived biomarkers in biological fluids. The incorporation of nanotechnology into liquid biopsy platforms has significantly enhanced analytical sensitivity and specificity by improving the detection and isolation of circulating tumor cells (CTCs), cell-free DNA (cfDNA), extracellular vesicles (EVs), and exosomal non-coding RNAs. This review provides a detailed overview of recent advancements in nanoparticle-enabled liquid biopsy, focusing on essential nanomaterials, including gold nanoparticles (AuNPs), magnetic nanoparticles (MNPs), and silica nanoparticles, and their mechanistic contributions to enhancing assay performance through targeted biomarker capture, signal amplification, and multiplexed detection. The clinical translation of these technologies is exemplified by emerging platforms such as an exosome-based AuNPs-SERS–AI assay, which achieved an AUC of 0.97, with 90.2 % sensitivity and 94.4 % specificity in the detection of early-stage multi-cancer. Lastly, we outline future directions for the clinical integration of nanoparticle-assisted liquid biopsy, highlighting their potential to advance precision oncology through real-time, non-invasive, and personalized diagnostics.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"579 ","pages":"Article 120658"},"PeriodicalIF":2.9,"publicationDate":"2025-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145299044","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}
引用次数: 0
The diagnostic performance of a novel flow cytometry-based assay for the diagnosis of systemic lupus erythematosus 一种新的基于流式细胞术的系统性红斑狼疮诊断方法的诊断性能。
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2025-10-13 DOI: 10.1016/j.cca.2025.120662
Yanling Zhao , Minghua Zhan , Jianing Chen , Honglin Xu , Futai Feng , Zhou Bai , Fang Wang , Yongjing Cheng , Xuan Zhang , Yudong Liu
{"title":"The diagnostic performance of a novel flow cytometry-based assay for the diagnosis of systemic lupus erythematosus","authors":"Yanling Zhao ,&nbsp;Minghua Zhan ,&nbsp;Jianing Chen ,&nbsp;Honglin Xu ,&nbsp;Futai Feng ,&nbsp;Zhou Bai ,&nbsp;Fang Wang ,&nbsp;Yongjing Cheng ,&nbsp;Xuan Zhang ,&nbsp;Yudong Liu","doi":"10.1016/j.cca.2025.120662","DOIUrl":"10.1016/j.cca.2025.120662","url":null,"abstract":"<div><h3>Objectives</h3><div>There is continuous need to identify novel biomarkers that can provide early and accurate diagnosis of systemic lupus erythematosus (SLE) due to its highly heterogenous nature and lack of specific clinical manifestations.</div></div><div><h3>Methods</h3><div>A total of 316 subjects comprising 127 patients with SLE, 129 patients with other autoimmune diseases as disease controls (DCs) and 60 healthy controls (HCs) were enrolled to determine the clinical relevance of the surface expression levels of CD169 on monocytes, CD317 on B cells and CD177 on neutrophils by flow cytometry for the diagnosis of SLE.</div></div><div><h3>Results</h3><div>The flow cytometric assay based on the combination of three molecules displayed a favorable diagnostic performance with an area under curve (AUC) of 0.9243. The sensitivities and specificities for this assay were 79.2 % and 96.2 % in the training cohort, and 82.1 % and 97.3 % in the validation cohort, respectively. Importantly, the diagnostic performance of this assay was independent of anti-double stranded DNA (dsDNA) antibodies with an AUC of 0.9329. The clinical performance of this assay was validated in an independent test cohort with a sensitivity and a specificity of 88.9 % and 95.9 %, respectively.</div></div><div><h3>Conclusion</h3><div>Our findings may have important clinical relevance in the diagnosis of SLE, especially when the suspects were tested negative for anti-dsDNA antibodies. Our study may shed light on a new direction other than detection of autoantibodies for the diagnosis of SLE in clinical settings.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"579 ","pages":"Article 120662"},"PeriodicalIF":2.9,"publicationDate":"2025-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145299059","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}
引用次数: 0
Quantification of plasma APOE4 with a novel automated Lumipulse immunoassay enables the identification of homozygous and heterozygous APOE ε4 carrier status 用一种新型的自动Lumipulse免疫分析法定量血浆APOE4,可以识别纯合子和杂合子APOE ε4载体状态。
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2025-10-12 DOI: 10.1016/j.cca.2025.120659
G. Musso , C. Cosma , S. Moz , C. Gabelli , F. Navaglia , A. Codemo , C.F. Zambon , A. Cagnin , A. Antonini , M. Corbetta , M. Montagnana
{"title":"Quantification of plasma APOE4 with a novel automated Lumipulse immunoassay enables the identification of homozygous and heterozygous APOE ε4 carrier status","authors":"G. Musso ,&nbsp;C. Cosma ,&nbsp;S. Moz ,&nbsp;C. Gabelli ,&nbsp;F. Navaglia ,&nbsp;A. Codemo ,&nbsp;C.F. Zambon ,&nbsp;A. Cagnin ,&nbsp;A. Antonini ,&nbsp;M. Corbetta ,&nbsp;M. Montagnana","doi":"10.1016/j.cca.2025.120659","DOIUrl":"10.1016/j.cca.2025.120659","url":null,"abstract":"<div><h3>Introduction</h3><div>The Apolipoprotein E (APOE) ε4 allele is a significant risk factor for Alzheimer's disease (AD). While genetic testing remains the gold standard for determining <em>APOE</em> status, protein-level quantification could offer advantages in clinical practice. This study evaluates a novel, fully automated immunoassay for quantifying APOE4 and total APOE (Pan-APOE) in plasma samples, assessing its accuracy and clinical utility compared to traditional genetic testing.</div></div><div><h3>Materials and methods</h3><div>Plasma samples from 65 patients (39 ε4 non-carriers, 21 ε4 heterozygous, 5 ε4 homozygous) were analyzed using the Lumipulse 1200 G APOE4 &amp; Pan-APOE immunoassays. The APOE4/Pan-APOE ratio (Ratio%) was calculated to determine ε4 carrier status. Results were compared to genetic testing. Assay repeatability was evaluated using triplicate measurements from three patients with different genotypes.</div></div><div><h3>Results</h3><div>APOE4 and Pan-APOE protein levels and Ratio% differed significantly across ε4 status groups (<em>p</em> &lt; 0.0001). The Ratio% showed no overlap between groups. ROC curve analysis for ε4 carrier identification showed an AUC of 1.00, with 100 % sensitivity and specificity at a 14 % cut-off. Perfect agreement was observed between the immunoassay and genetic testing (Cohen's kappa = 1.00, <em>p</em> &lt; 0.0001). Intra-assay CV was &lt;5 % for APOE4 and &lt;8 % for Ratio%.</div></div><div><h3>Discussion</h3><div>This novel immunoassay demonstrates excellent and potential for faster results could offer advantages in clinical practice, particularly for AD therapy eligibility evaluation. However, further validation in larger, diverse cohorts is necessary before considering widespread clinical implementation.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"579 ","pages":"Article 120659"},"PeriodicalIF":2.9,"publicationDate":"2025-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145291320","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}
引用次数: 0
Improving self-collected dried blood spot specimens for phenylketonuria monitoring: a 10-year computer vision review of dried blood spot specimen quality 改进自行采集的干血斑标本用于苯丙酮尿监测:干血斑标本质量的10年计算机视觉回顾。
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2025-10-11 DOI: 10.1016/j.cca.2025.120656
Nick Flynn , Stuart J. Moat , Sarah L. Hogg
{"title":"Improving self-collected dried blood spot specimens for phenylketonuria monitoring: a 10-year computer vision review of dried blood spot specimen quality","authors":"Nick Flynn ,&nbsp;Stuart J. Moat ,&nbsp;Sarah L. Hogg","doi":"10.1016/j.cca.2025.120656","DOIUrl":"10.1016/j.cca.2025.120656","url":null,"abstract":"<div><h3>Background</h3><div>Biochemical monitoring of phenylketonuria (PKU) is performed using dried blood spot (DBS) specimens, usually collected by the patient or carer. DBS quality affects DBS phenylalanine results and self-collected specimen quality may often be sub-optimal. However, it is unclear how often specimen quality affects clinical interpretation of PKU monitoring results, or whether sustained improvements in DBS quality are achievable in this setting.</div></div><div><h3>Methods</h3><div>We used a computer vision algorithm to objectively assess DBS quality in 8472 DBS specimens collected from 111 PKU patients over a 10-year period. Trends in specimen quality were analysed over time, by patient, and by frequency of specimen collection. We modelled the effect of sub-optimal DBS size on phenylalanine result classification against European PKU treatment guidelines.</div></div><div><h3>Results</h3><div>The proportion of poor-quality DBS decreased from 66.5 % to 3.2 % over a 10-year period. The median proportion of acceptable specimens returned by each patient each year improved from 28.6 % in 2015/16 to 100 %. Patients returning specimens more frequently showed better DBS quality performance, with acceptability rates of 96.3 % in patients who returned ≥10 specimens in 2024–25, compared to 78.3 % in patients who returned &lt;5 specimens. Improvement in DBS quality reduced potential misclassification against PKU treatment guidelines due to DBS size from 3.1 % to 0.6 %.</div></div><div><h3>Conclusions</h3><div>Without training and education, DBS quality in self-collected specimens may be very poor. However, substantial improvements are achievable for PKU monitoring specimens, reducing total measurement error and the risk of incorrect clinical interpretation of results.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"579 ","pages":"Article 120656"},"PeriodicalIF":2.9,"publicationDate":"2025-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145285646","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}
引用次数: 0
Electrochemical biosensors for inflammatory bowel disease 用于炎性肠病的电化学生物传感器。
IF 2.9 3区 医学
Clinica Chimica Acta Pub Date : 2025-10-11 DOI: 10.1016/j.cca.2025.120651
Mukhabbat Saidova , Nargiza Xamrakulova , Nodira Mirzayeva , Ilnur Аbitov , Firuza Turayeva , Barno Shagazatova , Gulchekhra Bekenova , Maxmudjon Butaboyev , Islom Kadirov , Bunyod Kendjaev , Bakhtiyor Khasanov , Nigora Dustova , Kurbaniyazova Madina Zafajanovna
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