Journal of Clinical Laboratory Analysis最新文献

{"title":"Quantitative Analysis of DNA Double-Strand Breaks in Genomic DNA Using Standard Curve Method.","authors":"Lihuang Guo, Hanying Dai, Jiancheng Li, Chenwei Li, Yue Huang, Keqian Xu","doi":"10.1002/jcla.70123","DOIUrl":"https://doi.org/10.1002/jcla.70123","url":null,"abstract":"<p><strong>Background: </strong>DNA double-strand breaks (DSBs) are the most lethal and dangerous type of lesions with significant implications for both cellular function and organismal health. The number of DSBs (N_DSBs) across the genome reflects DNA damage severity. However, current quantification methods mainly rely on next-generation sequencing, which is laborious and expensive. This study aims to provide a simple, low-cost, and high-throughput standard curve-based method for quantifying genome-wide DSBs.</p><p><strong>Method: </strong>Genomic DNA from human, mouse, Arabidopsis, Saccharomyces cerevisiae, and Escherichia coli was digested by seven blunt-end restriction enzymes to generate DSB standards. Theoretical N_DSBs for each standard were calculated based on restriction site frequency. Ligation-mediated quantitative PCR (LM-qPCR) was performed to obtain the Ct values, which were plotted against log-transformed N_DSBs to construct standard curves. Method reliability was assessed by comparing results with neutral single-cell gel electrophoresis and γ-H2AX flow cytometry.</p><p><strong>Results: </strong>All genomes were successfully digested by seven blunt-end restriction enzymes to produce standard DSB fragments. Standard curves demonstrated high linearity (R² > 0.95), with intra- and inter-assay coefficients of variation of 1.101% and 2.528%, respectively. The detection limit was below 100 DSBs. Quantification results strongly correlated with traditional DSB detection methods (|r| > 0.9).</p><p><strong>Conclusion: </strong>This standard curve-based method enables accurate, reproducible quantification of genome-wide DSBs in various organisms. It is simple, low-cost, and easily standardized, offering a promising tool for applications in genotoxicity testing, environmental exposure monitoring, and DNA damage research.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70123"},"PeriodicalIF":2.9,"publicationDate":"2025-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145312165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Detection of bla_NDM-1 and bla_IMP-1 Metallo-β-Lactamases in Meropenem-Resistant Clinical Escherichia coli Isolates Using Modified Carbapenem Inactivation Method (mCIM) and PCR Techniques.","authors":"Mehdi Roshdi Maleki","doi":"10.1002/jcla.70100","DOIUrl":"https://doi.org/10.1002/jcla.70100","url":null,"abstract":"<p><strong>Introduction: </strong>Escherichia coli, a member of the Enterobacteriaceae family, is a leading cause of various infections. Carbapenems, a potent class of β-lactam antibiotics, serve as the last line of defense against multidrug-resistant bacteria. However, the global rise of carbapenemase-producing E. coli (CP-Ec), particularly metallo-β-lactamases (MBLs), poses a significant public health concern. This study aimed to determine the prevalence of bla_NDM-1 and bla_IMP-1 genes in E. coli strains isolated from clinical samples.</p><p><strong>Methods: </strong>A cross-sectional study was conducted on 80 meropenem-resistant E. coli strains isolated from clinical samples. Bacterial identification was performed using biochemical tests, including IMViC. Carbapenemase production was assessed using the modified carbapenem inactivation method (mCIM). Genotypic analysis of carbapenem-resistant strains was conducted via polymerase chain reaction (PCR) to detect bla_NDM-1 and bla_IMP-1 genes.</p><p><strong>Results: </strong>The mCIM phenotypic test identified 46.25% (37/80) of isolates as carbapenemase producers. PCR analysis revealed that bla_NDM-1 was more prevalent than bla_IMP-1 (48.65% vs. 16.22%). Four isolates (10.81%) carried both genes. Notably, 35.14% (13/37) of meropenem-resistant E. coli isolates tested negative for both bla_NDM-1 and bla_IMP-1, indicating the possible involvement of other carbapenemase genes such as bla_VIM or non-carbapenemase mechanisms.</p><p><strong>Conclusion: </strong>The detection of bla_NDM-1 and bla_IMP-1 genes in E. coli highlights the alarming spread of carbapenem resistance. The presence of resistant strains lacking these genes suggests additional resistance mechanisms, warranting further investigation.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70100"},"PeriodicalIF":2.9,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145308201","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Severe Malnutrition Identified by the Controlling Nutritional Status (CONUT) Score Is Associated With Prolonged Intensive Care Unit (ICU) Stay in Pneumonia Complicated With Respiratory Failure Patients Who Underwent Invasive Mechanical Ventilation.","authors":"Zhijuan Zheng, Guixia Peng, Yue Xiao","doi":"10.1002/jcla.70109","DOIUrl":"https://doi.org/10.1002/jcla.70109","url":null,"abstract":"<p><strong>Background: </strong>Mechanical ventilation is an effective method to improve the ventilation of patients with severe pneumonia and respiratory failure. The length of intensive care unit (ICU) stay reflects the treatment effectiveness of patients. This study was to evaluate the relationship between Controlled Nutritional Status (CONUT) score and prolonged ICU stay in patients with pneumonia complicated by respiratory failure who underwent invasive mechanical ventilation.</p><p><strong>Methods: </strong>1994 patients who underwent invasive mechanical ventilation were retrospectively analyzed. Medical records (age, gender, body mass index, smoking, drinking, hypertension, diabetes mellitus, lung diseases, blood transfusion, and serum albumin, lymphocyte, cholesterol levels) were collected. The threshold for prolonged ICU stay was defined based on the third quartile (75th percentile) of length of ICU stay. The relationship between CONUT and prolonged ICU stay was analyzed.</p><p><strong>Results: </strong>The mean ICU stay of patients was 6.6 (3.9, 11.6) days; there were 1495 (75.0%) patients without prolonged ICU stay (< 11.6 days) and 499 (25.0%) with prolonged ICU stay (≥ 11.6 days). The proportion of CONUT severe grade in patients with prolonged ICU stay was higher than that in patients without prolonged ICU stay. Logistic regression analysis showed that CONUT severe grade (odds ratio (OR): 1.298, 95% confidence interval (CI): 1.024-1.646, p = 0.031), smoking (OR: 1.475, 95% CI: 1.105-1.968, p = 0.008), and blood transfusion (OR: 2.981, 95% CI: 2.406-3.694, p < 0.001) were independently associated with prolonged ICU stay.</p><p><strong>Conclusions: </strong>CONUT severe grade, smoking, and blood transfusion were independently associated with prolonged ICU stay in pneumonia with respiratory failure patients who underwent invasive mechanical ventilation.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70109"},"PeriodicalIF":2.9,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145286184","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characterization of PIVKA-II Molecular Forms via Size Exclusion Chromatography and Hydrophobic Interaction Chromatography in HCC Patients.","authors":"Yoshiyuki Kitamura, Katsumi Aoyagi","doi":"10.1002/jcla.70114","DOIUrl":"https://doi.org/10.1002/jcla.70114","url":null,"abstract":"<p><strong>Background: </strong>Protein induced by the absence of vitamin K or antagonist-II (PIVKA-II) is an important serological biomarker for the diagnosis of hepatocellular carcinoma (HCC). The crucial epitope of PIVKA-II comprises a series of Glu residues located in the Glu-Gla domain. The other antibody required for the PIVKA-II sandwich immunoassay recognizes prothrombin fragments 1 and 2. However, the molecular diversity of these regions has not been well documented.</p><p><strong>Methods: </strong>PIVKA-II immuno-reactivities in blood taken from HCC patients were analyzed by size exclusion chromatography (SEC) and hydrophobic interaction chromatography (HIC). Obtained fractions were subsequently tested using MU-3 monoclonal antibody (mAb) and a polyclonal anti-prothrombin antibody (pAb). Immuno-reactivity in each fraction was analyzed by an inhibition assay using prothrombin fragments and by a sandwich immunoassay.</p><p><strong>Results: </strong>SEC analysis of three paired serum and plasma samples gave a single peak of PIVKA-II immuno-reactivity corresponding to the expected molecular mass. However, HIC analysis using three paired sets and 14 HCC specimens revealed immuno-reactivity present in two distinct peaks of either low (peak-L: an elution position of 300-500 mM ammonium sulfate) or high (peak-H: an elution position of 100-300 mM ammonium sulfate) hydrophobicity or both peaks together. Immuno-reactivity of peak-L was inhibited by human prothrombin fragment-1 and detected by mAbs that recognize prothrombin-1. Immuno-reactivity of peak-H was inhibited by human prothrombin fragment-2 and detected by mAbs for prothrombin-2.</p><p><strong>Conclusions: </strong>These results demonstrate PIVKA-II exhibits molecular diversity, suggesting its potential as a diagnostic tool. This finding will contribute to further understanding of HCC and improve diagnostic accuracy.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70114"},"PeriodicalIF":2.9,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative Evaluation of Centrifugation Speed and Its Impact on Diagnostic Accuracy.","authors":"Mohammed A Jeraiby, Jobran M Moshi, Sajad A Dar, Mahmoud M Habibullah, Mjery Yahia, Saif Elden B Abdalla, Raheem M Balkhtab, Renad A Saigh, Nahlah S Burayk","doi":"10.1002/jcla.70120","DOIUrl":"https://doi.org/10.1002/jcla.70120","url":null,"abstract":"<p><strong>Introduction: </strong>Timely laboratory results are essential for effective clinical decision-making, with turnaround time (TAT) serving as a key performance indicator. Pre-analytical steps like centrifugation significantly impact TAT. This study investigates whether a shorter, high-speed centrifugation can reduce TAT while maintaining the analytical accuracy required for routine diagnostic testing.</p><p><strong>Methodology: </strong>This comparative experimental study analyzed blood samples from patients using plasma and serum tubes. Two centrifugation methods (A: (routine) 10 min at 3200 g; B: (faster) 5 min at 4000 g) were compared across chemistry, immunochemistry, coagulation, and interference indices.</p><p><strong>Results: </strong>Most analytes showed no significant difference between the two methods, indicating strong analytical agreement. However, significant differences were observed in sodium (p = 0.003), CKMB (p = 0.044), ALP (p = 0.001), ALT (p = 0.011), FRT4 (p < 0.001), PT (p = 0.008), and INR (p = 0.003). Despite these differences, all values remained within clinically acceptable ranges. Hemolysis rates decreased notably under the high-speed method, dropping from 10.4% to 5.1%. Bias analysis across tube types revealed greater variability for CKMB and ALT under the high-speed method (bias = 2.76 and -2.92; CVs = 68.8% and 84.16%, respectively).</p><p><strong>Conclusion: </strong>High-speed centrifugation significantly reduces processing time without compromising clinical reliability. Despite minor analyte differences, all values ramined within acceptable clinical ranges. Furthermore, the observed reduction in hemolysis rates strengthens the case for adopting the high-speed method as a reliable, efficient, and clinically safe alternative for routine laboratory workflows.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70120"},"PeriodicalIF":2.9,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145251426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Prevalence of Abnormal Glucose Metabolism and Its Correlates in the Zhuang Nationality, Nanning, Guangxi Province.","authors":"Qin Yuanyuan, Liao Lin, Chen Qingyun, Huang Yunhua, Lin Faquan","doi":"10.1002/jcla.70117","DOIUrl":"https://doi.org/10.1002/jcla.70117","url":null,"abstract":"<p><strong>Background: </strong>The prevalence of diabetes prevalence has surged in China, becoming a severe public health issue. However, data on abnormal glucose metabolism among ethnic minorities, particularly the Zhuang population, remains limited. This study aims to fill this gap by analyzing the prevalence and risk factors of glucose abnormalities in the Zhuang population.</p><p><strong>Methods: </strong>In 2017, data were gathered from a sample of 1957 Zhuang adults, aged 18 and older, who underwent a comprehensive physical examination at the First Affiliated Hospital of Guangxi Medical University. Variables included demographic information, lifestyle habits, anthropometric measurements, and biochemical indicators. Abnormal glucose metabolism was diagnosed based on fasting blood glucose (GLU) and 2-h postprandial glucose (2hPG) levels. Statistical analysis was performed using SPSS 24.0.</p><p><strong>Results: </strong>This study shows reveals a 37.52% prevalence of abnormal glucose metabolism among the Zhuang population in Nanning, with Type 2 diabetes mellitus (T2DM) and pre-diabetes (PDM) rates of 9.7% and 23.17%, respectively. Risk factors identified include age, high BMI, hypertension, dyslipidemia, and alcohol consumption.</p><p><strong>Conclusion: </strong>This study highlights that the prevalence of abnormal glucose metabolism is very high in Nanning, Guangxi. Targeted intervention measures, such as enhanced health education, should be implemented for high-risk populations to effectively implement diabetes prevention policies and interventions.</p><p><strong>Trial registration: </strong>This study is not a clinical trial, so there is no clinical trial registry.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70117"},"PeriodicalIF":2.9,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145251439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimizing Markers for Chronic Lymphocytic Leukemia Diagnosis by Flow Cytometry: Results From the Nationwide Thai Lymphoma Study Group.","authors":"Ornnicha Sathitakorn, Sirorat Kobbuaklee, Chantiya Chanswangphuwana, Thanawat Rattanathammethee, Nisa Makruasi, Anothai Chintabanyat, Suporn Chuncharunee, Pisa Phiphitaporn, Archrob Khuhapinant, Peerapon Wong, Jakrawadee Julamanee, Chayapa Thookhamme, Lalita Norasetthada, Udomsak Bunworasate, Kitsada Wudhikarn, Tanin Intragumtornchai, Chantana Polprasert","doi":"10.1002/jcla.70116","DOIUrl":"https://doi.org/10.1002/jcla.70116","url":null,"abstract":"<p><strong>Introduction: </strong>Accurate diagnosis of chronic lymphocytic leukemia (CLL) is crucial for effective management. Although recent advancements in flow cytometry have significantly improved diagnostic accuracy, distinguishing atypical cases of CLL remains challenging. This study aimed to identify specific markers to enhance CLL diagnosis and prognostic assessment.</p><p><strong>Methods: </strong>Blood or bone marrow from patients presenting with persistent lymphocytosis (> 5 × 10³/μL) was collected. Flow cytometric analysis was performed using a customized CLL panel to evaluate the expression of CD markers for the diagnosis of CLL. Clinical and laboratory data were reviewed to support the CLL diagnosis.</p><p><strong>Results: </strong>A total of 228 patients were included in the study, including 206 patients (90.4%) in the CLL group and 22 patients (9.6%) in the non-CLL group. The use of CD5, CD19, and CD200 in combination for diagnosing CLL demonstrated a sensitivity of 82.5% (95% CI, 76.6-87.4) and a specificity of 90.9% (95% CI, 70.8-98.9). In the final predictive model, which incorporated five markers (CD5, CD19, CD200, CD31, and CD11c), both specificity and positive predictive value for CLL diagnosis were close to 100% (95% CI, 84.6-100 and 95.5-100, respectively). CD38 was identified as an independent predictor of increased relapse risk, while LAIR expression was associated with a reduced relapse rate.</p><p><strong>Conclusion: </strong>Expression of CD5, CD19, and CD200 by flow cytometry demonstrated a highly sensitive and accurate diagnostic utility for CLL. Adding both CD31 and CD11c to the predictive model further improved diagnostic specificity, reaching as high as 100%. The identification of relapse-associated markers provides valuable insights for personalized treatment strategies.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70116"},"PeriodicalIF":2.9,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145251432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advances in Isothermal Amplification for the Diagnosis of Tuberculosis.","authors":"Nuttapon Jirakittiwut, Panan Ratthawongjirakul","doi":"10.1002/jcla.70113","DOIUrl":"https://doi.org/10.1002/jcla.70113","url":null,"abstract":"<p><strong>Background: </strong>Detecting tuberculosis (TB) remains challenging in low-resource settings due to limited access to advanced diagnostic tools. The emergence of isothermal amplification techniques, such as loop-mediated isothermal amplification (LAMP), presents a promising solution for TB detection. Several isothermal amplification techniques, e.g., strand displacement amplification (SDA), helicase-dependent amplification (HDA), recombinase polymerase amplification (RPA), and rolling cycle amplification (RCA), have been attracting attention for development as point-of-care testing (POCT) in many diagnostic fields. The present review summarizes the most common isothermal amplification techniques for the detection of TB.</p><p><strong>Methods: </strong>To collect the necessary information, we searched PubMed and Scopus for scientific evidence published from 2000 to September 2024, using the keywords loop-mediated isothermal amplification tuberculosis, strand displacement amplification tuberculosis, helicase-dependent amplification tuberculosis, recombinase polymerase amplification tuberculosis, rolling circle amplification tuberculosis, polymerase spiral reaction tuberculosis, cross-priming amplification tuberculosis, and multiple cross displacement amplification tuberculosis.</p><p><strong>Results: </strong>The methodologies of the most usual isothermal amplification techniques are addressed, as well as the advantages and limitations of the technique, highlighting applications in TB diagnosis. Exploring these advances addresses the principles of innovation in isothermal amplification, including their performance and applicability across diverse sample types. Some techniques have already been launched into routine TB diagnosis, while other promising tests are still being researched or evaluated. These techniques are easy to perform and provide results rapidly, enabling prompt treatment within a few hours. Isothermal amplification techniques may be one of the key molecular tools to fight TB in pursuit of the goals of the End TB strategy.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70113"},"PeriodicalIF":2.9,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145238629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Soluble C5b-9 (sC5b-9) in Pediatrics-A Clinical Assessment.","authors":"Ridwan B Ibrahim, Radwa Almamoun, Sarah E Sartain, Sridevi Devaraj","doi":"10.1002/jcla.70122","DOIUrl":"https://doi.org/10.1002/jcla.70122","url":null,"abstract":"<p><strong>Background: </strong>The soluble C5b-9 (sC5b-9) is a soluble form of the Terminal Complement Complex (TCC) that is released into the circulation with elevated levels, associated with increased morbidity and mortality in patients with complement-mediated inflammatory conditions. With the advent of eculizumab and ravulizumab, proper testing for diagnoses and therapeutic monitoring is warranted.</p><p><strong>Methods: </strong>We evaluated both the analytical and clinical performance of the Quidel Microvue sC5b-9 Plus enzyme immunoassay. Analytical performance was evaluated with precision, linearity, interference studies, and correlation with a reference laboratory. Reference intervals were established using control donor samples [n = 26; median age 18.5 years (range 2-59)]. Clinical performance of the assay was assessed using plasma samples of patients who (i) developed transplant-associated thrombotic microangiopathy [n = 10; median age 14 years (range 3-19)], (ii) had reduced ADAMTS13 activity [n = 6; median age 16 years (range 9-18)], and (iii) developed acquired Von-Willebrand disease [n = 10; median age 18.5 years (range 0.5-18)].</p><p><strong>Results: </strong>The assay showed acceptable intra and inter-precision at both low and high levels. Linearity ranged from 12.6 to 160.66 ng/mL, while accuracy and method correlation studies with a reference laboratory yielded a correlation coefficient (R) of 0.96. The reference range in control donors was established at ≤ 268.0 ng/mL. Clinical performance of the assay in patients' plasma revealed elevated sC5b-9 levels suggesting complement activation in these patient cohorts compared with control levels.</p><p><strong>Conclusion: </strong>The Quidel Microvue sC5b-9 plus EIA assay demonstrated acceptable analytical performance and clinical utility for monitoring complement activation in patients. Further studies are needed to correlate sC5b-9 levels with existing markers of complement activation.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70122"},"PeriodicalIF":2.9,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145232754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Application of Using Diffusion-Based Wasserstein Generative Adversarial Network for Morphologic Analysis of Blood Cells.","authors":"Hyun-Young Kim, Emmanuel Edward Ngasa, Hee-Jin Kim, Boram Kim, Gyujin Lim, Chang-Hun Park, Hyeon Jeong Kwon, Mi-Ae Jang, Jiyoung Woo","doi":"10.1002/jcla.70118","DOIUrl":"https://doi.org/10.1002/jcla.70118","url":null,"abstract":"<p><strong>Background: </strong>Morphologic analysis of peripheral blood smears is essential for diagnosing hematologic diseases and patient management. Although manual microscopy is the traditional gold standard, it is time-consuming and subjective. Digital morphology analyzers have improved automation and accuracy; however, challenges remain, particularly in classifying certain cell types. Recently, the diffusion-based Wasserstein generative adversarial network with gradient penalty (DWGAN-GP) showed potential by enhancing image quality and addressing data imbalance. We aim to investigate the accuracy of blood cell classification using the DWGAN-GP model.</p><p><strong>Methods: </strong>In this study, the DWGAN-GP model in conjunction with the EfficientNetB3 classification model was evaluated using 78,494 peripheral blood cell images. Samples were collected from patients with normal and abnormal hematologic conditions. Data were balanced by augmenting underrepresented classes with synthetic images, resulting in equal representation across 13 cell classes. Performance was compared with PBIA (ANI Co., Suwon, Korea), a commercial digital morphology analyzer.</p><p><strong>Results: </strong>DWGAN-GP augmentation significantly improved classification accuracy of the EfficientNetB3 model to 97.74% with an F1-score of 91.13%. This result surpassed both the unbalanced dataset (accuracy 95.68%, F1-score 82.12%) and PBIA system (accuracy 95%). Notably, improvements were significant in minority classes such as blasts and myelocytes, which are critical in diagnosing leukemia.</p><p><strong>Conclusion: </strong>Incorporating synthetic data using DWGAN-GP significantly enhanced model performance and addressed class imbalance. This method shows promise for more accurate and consistent blood cell classification, offering potential improvements in clinical diagnostics for hematologic disorders.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70118"},"PeriodicalIF":2.9,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145232788","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}