Clinica Chimica Acta最新文献

{"title":"Measurement of AST and ALT with Pyridoxal-5′-Phosphate according to IFCC: A decades-long gap seems to be filled","authors":"Ilaria Talli ,&nbsp;Lucio Marchioro ,&nbsp;Martina Zaninotto ,&nbsp;Chiara Cosma ,&nbsp;Elisa Pangrazzi ,&nbsp;Carlo Artusi ,&nbsp;Andrea Padoan ,&nbsp;Mario Plebani","doi":"10.1016/j.cca.2025.120158","DOIUrl":"10.1016/j.cca.2025.120158","url":null,"abstract":"<div><div>Pyridoxal-5′-Phosphate (PLP) is not always added to the reagents for the measurement of Aspartate Amino Transferase (AST) and Alanine Amino Transferase (ALT), although the International Federation of Clinical Chemistry recommends using it as a cofactor. This is true for patients with lower Vitamin B6, precursor of PLP. The aim of this study is to compare the methods for transaminase measurement with or without the presence of PLP.</div><div>102 leftover LiHe samples were collected after transaminase measurement with the reagent already including PLP (R). The residual plasma was analyzed on the ILab Taurus instrumentation (Werfen, Spain) using Werfen reagents with (WP) and without (W) PLP. Vitamin B6 results were obtained on the respective residual K₂-EDTA whole blood. Qualitative and quantitative statistical analyses were performed.</div><div>Optimal agreement and comparability were found between R and WP. Addition of PLP to the reagents shows an average percentage increase in ALT concentrations of 12 %. Patients were categorized for Vitamin B6: the median value of WP-W for patients with lower Vitamin B6 is 34, 18 for patients with higher Vitamin B6 (p = 0.006), demonstrating that ALT values are higher when measured with WP for patients with low Vitamin B6.</div><div>The addition of PLP to reagents has greater accuracy in transaminase determination, promoting optimal comparability of the results between different methods, particularly in patients’ samples with reduced Vitamin B6. Users should adapt their procedures to overcome the difficulties related to the lower stability of transaminase reagents containing PLP, respecting also the recommendations of international scientific societies.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"569 ","pages":"Article 120158"},"PeriodicalIF":3.2,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143074073","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":"Redefining vitamin D status: Establishing population-based indirect reference intervals through big data analysis","authors":"Aleix B. Fabregat-Bolufer ,&nbsp;Alba Escolà-Rodríguez ,&nbsp;José Luís Bedini-Chesa ,&nbsp;Gregori Casals ,&nbsp;Manuel Morales-Ruiz ,&nbsp;Xavier Filella","doi":"10.1016/j.cca.2025.120155","DOIUrl":"10.1016/j.cca.2025.120155","url":null,"abstract":"<div><h3>Objectives</h3><div>To establish accurate population-based reference intervals (RIs) for serum 25-hydroxyvitamin D [25(OH)D] using the <em>refineR</em> indirect method and real-world data (RWD), accounting for demographic, methodological, and seasonal factors.</div></div><div><h3>Methods</h3><div>A retrospective analysis of 130,030 serum 25(OH)D samples collected from 2018 to 2022 at a tertiary hospital in Barcelona was performed. Samples were measured using VDSP-certified Liaison and Atellica immunoassays. The <em>refineR</em> algorithm was employed to establish RIs, utilizing Box-Cox transformations to adjust for data distribution. Demographic variables (sex and age), assay differences, medical department and seasonal variations were analysed. RIs were verified using a subset of healthy individuals.</div></div><div><h3>Results</h3><div>The median serum 25(OH)D level was 25 ng/mL (62.5 nmol/L). Vitamin D deficiency (≤20 ng/mL, ≤50 nmol/L) was observed in 34.2% of samples, and severe deficiency (≤12 ng/mL, ≤30 nmol/L) in 12.6%. The default Box-Cox transformation estimated RIs of 11.5–64.5 ng/mL (28.7-161.2 nmol/L), while the modified Box-Cox transformation yielded RIs of 14.2–65.9 ng/mL (35.5-164.7 nmol/L). Women exhibited wider RIs (14.5–68.6 ng/mL, 36.2-171.5 nmol/L) compared to men (11.6–57.3 ng/mL, 29-143.2 nmol/L). Method-specific RIs were 10.2–58.6 ng/mL (25.5-146.5 nmol/L) for the Liaison assay and 9.9–59.3 ng/mL (24.7-133.2 nmol/L) for the Atellica assay. The lowest RIs were observed in outpatients (4.3–46.4 ng/mL, 10.7-116 nmol/L) and endocrinology patients (5.5–43.9 ng/mL, 13.7-109.7 nmol/L). Seasonal variation significantly impacted RIs, with higher levels during summer months.</div></div><div><h3>Conclusions</h3><div>The <em>refineR</em> algorithm effectively established population-based RIs for serum 25(OH)D in Barcelona, revealing significant demographic and seasonal variations. Redefining 25-hydroxyvitamin D thresholds based on population-specific data may reduce unnecessary screening and supplementation, minimizing associated risks. This study highlights the need for population-, seasonal-, and method-specific RIs to improve vitamin D assessment and management.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"569 ","pages":"Article 120155"},"PeriodicalIF":3.2,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143073180","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 mature microRNA panel: A novel approach for primary prostate cancer diagnosis","authors":"Pengwu Zhang ,&nbsp;Chen Sun ,&nbsp;Shengjie Lin ,&nbsp;Chong Lu ,&nbsp;Zhenyu Wen ,&nbsp;Zhenjian Ge ,&nbsp;Wenkang Chen ,&nbsp;Yingqi Li ,&nbsp;Yutong Wu ,&nbsp;Xutai Li ,&nbsp;Huimei Zhou ,&nbsp;Siwei Chen ,&nbsp;Wuping Wang ,&nbsp;Hang Li ,&nbsp;Yongqing Lai","doi":"10.1016/j.cca.2025.120150","DOIUrl":"10.1016/j.cca.2025.120150","url":null,"abstract":"<div><h3>Background</h3><div>Prostate cancer (PC) is the second most common malignant tumor in males and a leading cause of cancer-related morbidity and mortality among men. Early detection is essential for improving outcomes. Although prostate-specific antigen (PSA) is widely used for PC screening, it suffers from high false positive and false negative rates. Our study aimed to identify a panel of serum mature microRNAs (miRNAs) for PC diagnosis.</div></div><div><h3>Methods</h3><div>We conducted a PubMed search to identify candidate mature miRNAs associated with PC. We then used quantitative reverse transcription-polymerase chain reaction (RT-qPCR) to assess the expression profiles of these mature miRNAs in serum samples from 112 PC patients and 112 healthy controls (HCs). We selected mature miRNAs with favorable diagnostic potential by analyzing receiver operating characteristic (ROC) curves and calculating the area under the curve (AUC). Subsequently, we developed a highly diagnostically efficient panel of three mature miRNAs using stepwise logistic regression based on their expression levels.</div></div><div><h3>Results</h3><div>We identified three mature miRNAs (hsa-miR-143-5p, hsa-miR-23b-3p, and hsa-miR-148b-3p) with significant diagnostic value, constructing a panel with an AUC of 0.891, sensitivity of 84.15%, and specificity of 80.49%. Bioinformatics analysis also revealed LDB3 and RBMS3 as potential therapeutic targets for PC.</div></div><div><h3>Conclusions</h3><div>Our study introduces a novel diagnostic approach by identifying a panel of three mature miRNAs (hsa-miR-143-5p, hsa-miR-23b-3p, and hsa-miR-148b-3p) as novel and non-intrusive biomarkers for PC.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"569 ","pages":"Article 120150"},"PeriodicalIF":3.2,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143073517","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":"“Whole genome bisulfite sequencing of serum extracellular vesicle DNA identifies alterations in mitochondrial DNA methylation in early onset preeclampsia”","authors":"Uma Shinde ,&nbsp;Kushaan Khambata ,&nbsp;Sanketa Raut ,&nbsp;Aishwarya Rao ,&nbsp;Vandana Bansal ,&nbsp;Niranjan Mayadeo ,&nbsp;Dhanjit Kumar Das ,&nbsp;Taruna Madan ,&nbsp;Vinoth Prasanna Gunasekaran ,&nbsp;Nafisa Huseni Balasinor","doi":"10.1016/j.cca.2025.120168","DOIUrl":"10.1016/j.cca.2025.120168","url":null,"abstract":"<div><div>Early-onset preeclampsia (EOPE) is a serious pregnancy complication. Understanding its underlying mechanisms could lead to improved diagnosis and management. Genome-wide DNA methylation changes in circulating Extracellular Vesicle DNA (EV-DNA) from women with EOPE could serve as a non-invasive approach to identify key regions and genes that could serve as biomarkers to understand placental pathophysiology. In this case-control study, serum extracellular vesicles were isolated from 3rd trimester pregnant women and characterized using Nanoparticle Tracking Analysis and Transmission Electron Microscopy. The circulating EV-DNA samples were subjected to Whole Genome Bisulfite Sequencing analysis (WGBS) to identify differentially methylated CpGs (DMCs) sites in EOPE cases compared to control.</div><div>A total of 154 DMCs were identified in EV-DNA, of which 131 were hypomethylated and 23 were hypermethylated. Majority of DMCs were of mitochondrial origin. Previously, it has been reported that oxidative stress, decreased trophoblast differentiation, and invasion are linked to preeclampsia pathogenesis and are related to mitochondrial dysfunction. Therefore, DMCs of the mitochondrial genes like <em>MT-ND1, MT-ND4, MT-CO2, MT-CO3</em>, and <em>MT-RNR1</em> were selected for validation and showed a similar trend by pyrosequencing. The expression of these genes were also altered in circulating extracellular vesicles. Our study shows changes in the DNA methylation patterns of circulating EV-DNA in women with EOPE. These changes, especially in mitochondrial genes, could lead to mitochondrial dysfunction and contribute EOPE pathogenesis. These findings suggest that these alterations could be explored as non-invasive approach to better understand placental health and improve disease management.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"569 ","pages":"Article 120168"},"PeriodicalIF":3.2,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143074069","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":"Performance and efficiency of machine learning models in analyzing capillary serum protein electrophoresis.","authors":"Xia Wang, Mei Zhang, Chuan Li, Chengyao Jia, Xijie Yu, He He","doi":"10.1016/j.cca.2025.120165","DOIUrl":"10.1016/j.cca.2025.120165","url":null,"abstract":"<p><strong>Background and objective: </strong>Serum protein electrophoresis (SPEP) plays a critical role in diagnosing diseases associated with M-proteins. However, its clinical application is limited by a heavy reliance on experienced experts.</p><p><strong>Methods: </strong>A dataset comprising 85,026 SPEP outcomes was utilized to develop artificial intelligence diagnostic models for the classification and localization of M-proteins. These models were trained and validated using three data features, and their performance was evaluated using comprehensive metrics, including sensitivity, positive predictive value (PPV), specificity, negative predictive value (NPV), F1 score, accuracy, area under the receiver operating characteristic curve (AUC), Matthews correlation coefficient (MCC), and Intersection over Union (IoU). The best-performing machine learning (ML) and deep learning (DL) models were further tested on a separate dataset of 1,079 samples. The localization ability of the DL model was compared against three clinical experts.</p><p><strong>Results: </strong>Among the four ML models, the extreme gradient boosting (XGB) model achieved the best performance, with MCC, AUC, F1 score, sensitivity, specificity, accuracy, PPV, and NPV of 0.847, 0.903, 0.875, 0.822, 0.985, 0.951, 0.934, and 0.955, respectively. Different feature extraction methods significantly influenced model performance. The DL models outperformed the ML models in comprehensive performance. The U-Net combined with Transformer model demonstrated localization ability comparable to that of clinical experts, achieving sensitivity, specificity, accuracy, PPV, NPV, F1 score, AUC, MCC, and IoU of 0.947, 0.984, 0.976, 0.938, 0.986, 0.942, 0.966, 0.927, and 0.877, respectively.</p><p><strong>Conclusion: </strong>The U-Net combined with the Transformer model demonstrated expert-level performance in M-protein classification and localization, achieving an accuracy of 0.976 and an IoU of 0.877. This exceptional performance highlights the potential of this combined model for automating clinical SPEP workflows.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120165"},"PeriodicalIF":3.2,"publicationDate":"2025-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143058033","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":"Non-invasive diagnosis for urothelial carcinoma using a dual-target DNA methylation biomarker panel","authors":"Juanjuan Hou ,&nbsp;Yaqian Niu ,&nbsp;Jiamin Yan ,&nbsp;Junqiang Tian ,&nbsp;Weitao Yu ,&nbsp;Guoping Zhang ,&nbsp;Tingting Li ,&nbsp;Zhenyun Wang","doi":"10.1016/j.cca.2025.120164","DOIUrl":"10.1016/j.cca.2025.120164","url":null,"abstract":"<div><h3>Background</h3><div>Urothelial carcinoma (UC) is a common malignancy worldwide. Aberrant DNA methylation is implicated in UC carcinogenesis. This study sought to delineate the DNA methylation landscape in UC and identify DNA methylation-based biomarkers for early detection of UC.</div></div><div><h3>Methods</h3><div>Whole genome bisulfite sequencing (WGBS) was conducted on bladder cancer tissues and paired normal tissues. By integrating WGBS data with The Cancer Genome Atlas (TCGA) UBC data, a DNA methylation-based biomarker was identified. When combined with a known UC biomarker <em>AL021918.2</em>, the performance of the dual-target test was evaluated in voided urine samples from 224 UC patients and 419 controls.</div></div><div><h3>Results</h3><div>Notable hypomethylation was observed in UC samples compared to normal samples. Through differential methylation analysis, differential methylation CpG sites, regions, and genes were identified. Of these, Transmembrane protein 106A gene (<em>TMEM106A</em>) was screened as a new UC biomarker. In a dual-target test, using triplex quantitative methylation-specific PCR (qMSP) to examine <em>TMEM106A</em> and <em>AL021918.2</em> methylation levels, the training set showed a sensitivity of 89.0 %, a specificity of 92.9 %, and an area under the curve (AUC) value of 0.941 (95 % confidence interval [CI]: 0.913–0.969). Similarly, the validation set showed a sensitivity of 90.0 %, a specificity of 91.1 %, and an AUC value of 0.922 (95 % CI: 0.881–0.962). In addition, our dual-target test demonstrated outstanding detection rates for low-grade or early-stage tumors.</div></div><div><h3>Conclusions</h3><div>We provide a comprehensive analysis of DNA methylation profiles in UC, and highlight the promising clinical potential of dual-target urine tests for UC detection.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"569 ","pages":"Article 120164"},"PeriodicalIF":3.2,"publicationDate":"2025-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143058010","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":"Diagnostic value of three urine miRNAs composite score in BK virus nephropathy.","authors":"Zhoufan Zhang, Changling Cao, Cuello Garcia Haider, Yinfeng Wang, Yiying Zhu, Ouzaouit Abdelhak, Haitao Liu, Chenzhen Yu, Sheng Chang, Weijie Zhang, Tingya Jiang, Yang Zhou","doi":"10.1016/j.cca.2025.120162","DOIUrl":"10.1016/j.cca.2025.120162","url":null,"abstract":"<p><p>Noninvasive detection of BK virus, for early detection of BK polyomavirus-associated nephropathy post-renal transplantation, is currently an active subject of investigation. In this study, we developed and validated a novel risk score diagnostic assay (PymiR Score) based on measurements of three urine miRNAs, including BKV-related miRNA (bkv-miR-B1-5p), polyomavirus-related miRNA (bkv-miR-B1-3p) and renal tubular injury-related miRNA (miR-21-5p), by quantitative polymerase chain reaction. The limit of detection of the three miRNAs was 2 × 10³ copies/mL, while the intra- and inter-assay coefficients of variation were in the ranges of 2.13 %-3.59 % and 2.30 %-3.35 %, respectively. In the training set, we identified that at a PymiR Score of 71.78, the maximum sensitivity and specificity for the detection of BKVAN were 76.9 % and 100 % respectively, with the receiver-operator characteristic (ROC) analysis showing an area under the curve of 0.8681. In the validation set, we observed a significant difference in the PymiR Score between BKV infection and biopsy-proven BKVAN (P ＜ 0.05), with the ROC analysis showing a sensitivity of 72.73 %, specificity of 100 %, and an AUC of 0.8571. Compared with the area under the ROC curve of plasma BK virus DNA load (AUC = 0.7266), the PymiR Score exhibited higher discrimination capacity (P＜0.05) between BKV infection and biopsy-proven BKVAN. Overall, this non-invasive approach offers a robust and convenient alternative for the diagnosis of BK polyomavirus-associated nephropathy.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120162"},"PeriodicalIF":3.2,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143051834","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":"Comparability of the LDH measurement and analysis based on external quality assessment.","authors":"Guanfei Zhao, Ning Wang, Rui Zhang, Shunli Zhang","doi":"10.1016/j.cca.2025.120157","DOIUrl":"10.1016/j.cca.2025.120157","url":null,"abstract":"<p><strong>Background: </strong>Lactate dehydrogenase (LDH) is a critical enzyme widely used in clinical diagnostics. However, variations in measurement systems can lead to inconsistent results, potentially impacting clinical decision-making. This study aimed to evaluate the comparability of lactate dehydrogenase measurements by comparing routine methods with the IFCC reference method, and to analyze the standardization status of LDH testing through external quality assessment (EQA).</p><p><strong>Methods: </strong>We analyzed 40 individual serum samples using four routine LD measurement systems: Siemens ADVIA 2400, Hitachi 7600/BioSino, Beckman AU5800, and Roche Cobas C501, alongside the IFCC reference method. The analytical quality specification (±6.4 %) was based on biological variation. Our study also included a comprehensive external quality assessment (EQA) program conducted by the Beijing Center for Clinical Laboratory (BCCL) over three years (2020, 2021, and 2023) to evaluate the consistency and reliability of LD measurements across different reagents. The acceptance limit is based on the requirement of desirable biological variability (±11.4 %).</p><p><strong>Results: </strong>All four measurement systems showed strong correlations with the IFCC reference method (r ≥ 0.98). Relative average deviations ranged from -5.23 % to 3.71 %, within the acceptable biological variation limit. External quality assessment revealed high pass rates (94.9 %-98.7 %) across reagent groups, with significant improvements observed in some reagent groups from 2020 to 2023..</p><p><strong>Conclusions: </strong>While the four LD measurement systems demonstrated good correlation with the IFCC reference method, some systems require further standardization. The study provides valuable insights into LD measurement accuracy and supports ongoing efforts to enhance laboratory testing comparability.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120157"},"PeriodicalIF":3.2,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143051826","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":"Number of patient samples affected before error detection: Strategic implications for internal quality control and patient-based quality control practices.","authors":"Hui Qi Low, Corey Markus, Tze Ping Loh, Chun Yee Lim","doi":"10.1016/j.cca.2025.120166","DOIUrl":"10.1016/j.cca.2025.120166","url":null,"abstract":"<p><strong>Introduction: </strong>There is a general impression that patient-based quality control (PBQC) requires a high volume of laboratory results to detect errors effectively. However, internal quality control (IQC) performed infrequently may be associated with increased risk of missed error (i.e. low power of error detection).</p><p><strong>Methods: </strong>Using simulations and routine sodium and aspartate aminotransferase (AST) as examples, this study examined how the \"average number of patient samples affected before error detection' (ANPed) metrics can provide linkage to compare relative performance of QC practices in various IQC and PBQC settings.</p><p><strong>Results: </strong>Smaller numbers of IQC samples tested per IQC run or larger average number of patient samples measured between IQC runs are associated with higher ANPed. The ANPed for sodium and AST PBQC models were smaller than IQC performed once every 100 patient samples, except when the systematic error was small for AST.</p><p><strong>Discussion: </strong>Use of ANPed clearly illustrate the relative impact of different IQC frequencies and number of IQC levels tested. Patient-based quality control can outperform IQC even for laboratories with small testing volume. Laboratory practitioners can use this metric to design a QC strategy that suit their desired risk profile.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120166"},"PeriodicalIF":3.2,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143051842","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":"Annual biological variation and personalized reference intervals of 8 serum liver enzymes and 3 noninvasive tests in fatty liver patients.","authors":"Shuo Wang, Min Zhao, Zihan Su, Dan Yang, Runqing Mu","doi":"10.1016/j.cca.2025.120156","DOIUrl":"10.1016/j.cca.2025.120156","url":null,"abstract":"<p><strong>Background: </strong>The liver function tests and noninvasive tests (NITs) play important roles in the follow-up and monitoring of fatty liver disease (FLD). Our aim is to establish annual biological variation (BV) and personalized reference intervals (prRIs) of liver function tests for the first time in order to accurately assess the status and progress of FLD.</p><p><strong>Methods: </strong>67 fatty liver patients who participated in regular physical examination once a year for six consecutive years, were enrolled. Based on these patients, we calculated annual BV and derived parameters, including reference change value (RCV), index of individuality (II), and total variation around the true homeostatic set point (TV_set) which could further be used to derive prRI.</p><p><strong>Results: </strong>We calculated the annual within-subject BV (CV_I), within-person BV (CV_P), RCV, II, TV_set of 8 liver function tests and 3 NITs for fatty liver patients. CV_I estimates of fatty liver patients for half of liver function tests were significantly lower than those of healthy people and these could lead to a lower RCV. IIs of all measurands were < 1.4 except for total bile acids (TBA). The mean of CV_P is similar to the CV_I; however, there is a significant heterogeneity in CV_P among different subjects. Annual TV_set estimates for 7 measurands were lower and prRI was also narrower in fatty liver patients than that of healthy people.</p><p><strong>Conclusion: </strong>Annual BV and their derived parameters based on fatty liver patients can provide an objective basis for the monitoring and follow-up of FLD, a global epidemic disease.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120156"},"PeriodicalIF":3.2,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143051821","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}