Journal of Clinical Laboratory Analysis最新文献

{"title":"Development and Analytical Validation of a Smartphone-Based Quantitative Lateral Flow Immunoassay for Serum Cystatin-C.","authors":"Ye Lian, Ruiying Zheng, Chenqi Yang, Yueyang Luo, Na Zhang, Guojun Lian, Baoqing Li","doi":"10.1002/jcla.70372","DOIUrl":"10.1002/jcla.70372","url":null,"abstract":"<p><strong>Background: </strong>Cystatin-C is an important renal function biomarker, but conventional quantification requires centralized laboratory analyzers, limiting timely testing in primary care and resource-limited settings.</p><p><strong>Methods: </strong>We developed and validated a quantitative smartphone-based lateral flow immunoassay (SP-LFIA) comprising a colorimetric strip, a Redmi Note 12R smartphone, a fixed-geometry macro-lens module with integrated LED illumination, and an Android application. The application directly converted background-corrected test/control-line (T/C) ratios into concentrations using a batch-specific third-order polynomial calibration model. Analytical validation followed relevant Clinical and Laboratory Standards Institute guidelines.</p><p><strong>Results: </strong>The assay showed a quantitative range of 0.32-8.00 mg/L and a limit of detection of 0.15 mg/L. Intra- and inter-assay coefficients of variation were below 10%. No significant interference was observed from bilirubin, triglycerides, hemoglobin, rheumatoid factor, gentamicin sulfate, norvancomycin hydrochloride, or cisplatin at the tested concentrations. Accelerated testing supported strip performance after storage at 50°C for 28 days. In 120 clinical serum samples, SP-LFIA agreed closely with the commercial particle-enhanced turbidimetric immunoassay reference method (R² = 0.9946), with a mean bias of -0.01 mg/L.</p><p><strong>Conclusion: </strong>The smartphone-based LFIA provides a reliable, rapid, low-cost, and practical approach to quantitative Cystatin-C testing in point-of-care settings where serum preparation is available.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70372"},"PeriodicalIF":2.5,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13639760/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110267","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Establishment and Application of a Quantitative Lipemia Index as a Novel Indicator for Assessing Lipemic Interference in Clinical Chemistry.","authors":"Haifeng Xie, Shuhua Bao, Pengcheng Tong, Peng Li, Zhe Shen, Jinlong Wei","doi":"10.1002/jcla.70378","DOIUrl":"10.1002/jcla.70378","url":null,"abstract":"<p><strong>Background: </strong>Lipemia is a common pre-analytical interference in clinical chemistry. Triglyceride (TG) concentration is commonly used as a surrogate indicator for lipemic interference, but its predictive reliability is limited by heterogeneity in lipoprotein particle composition. This study aimed to establish and validate a quantitative Lipemia index (LI) assay for direct measurement of serum turbidity, compare its predictive value with TG, and evaluate its clinical applicability through reference interval estimation and correlation with interference deviations in native patient samples.</p><p><strong>Methods: </strong>The LI assay was developed on a Beckman Coulter AU5800 analyzer by measuring ΔA (A₆₆₀-A_{800 nm}). Performance was validated per CLSI guidelines: precision (EP05-A3), detection capability (EP17-A2), linearity (EP06-ED2), method comparison (Passing-Bablok regression, Bland-Altman analysis), reference interval (EP28-A3c), and dilution recovery (EP07-A2). LI's predictive value for lipemic interference was compared to TG using deviations in total protein assays (single- vs. double-reagent methods).</p><p><strong>Results: </strong>The LI assay demonstrated precision with CV ≤ 2.23% and linearity (0.05-30.87 mmol/L TG-equivalent). It correlated strongly with the reference TG method (ρ = 0.998, p < 0.0001). In predicting assay interference, LI showed a closer correlation with total protein deviations than did TG (r_s = 0.822 vs. 0.770). A reference interval of 0.093-0.240 was established for healthy adults. Dilution recovery (90%-110%) confirmed accuracy.</p><p><strong>Conclusions: </strong>The quantitative LI assay provides a standardized, clinically validated measure of lipemic interference aligning more directly with the optical nature of clinical chemistry testing than TG measurement. These findings support its analytical validity, utility as a predictor of turbidity interference, and clinical applicability.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70378"},"PeriodicalIF":2.5,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13639763/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110353","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Discrepant Urinary Findings Between Dipstick Protein and Sulfosalicylic Acid Test in a Patient With Hyaline Casts: A Case Report.","authors":"Yifei Jia, Binquan Chu, Fengjun Chen, Xiangyu Zhu, Chen Hang, Xiaoling Yu, Jinpiao Lin","doi":"10.1002/jcla.70376","DOIUrl":"https://doi.org/10.1002/jcla.70376","url":null,"abstract":"<p><strong>Background: </strong>Routine urinalysis is a foundational screening tool; however, increased hyaline casts accompanied by a negative dipstick protein result may complicate laboratory interpretation. In patients at high risk of acute kidney injury (AKI), this discordant pattern may warrant confirmatory protein testing and correlation with renal-function trends.</p><p><strong>Case presentation: </strong>A 31-year-old female with hemophagocytic lymphohistiocytosis (HLH) underwent routine urinalysis after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Automated sediment analysis detected elevated hyaline casts (5.8/μL), whereas the concurrent dipstick protein result was negative. Protocol-based sulfosalicylic acid (SSA) verification yielded a visually graded positive (++) reaction. Serial renal-function monitoring showed that serum creatinine (SCr) increased from 53 μmol/L on December 10 to 62 μmol/L on December 12, followed by progressive deterioration and a peak SCr of 132 μmol/L with an estimated glomerular filtration rate (eGFR) nadir of 46.3 mL/min/1.73 m² on December 24. Follow-up urinalysis on December 26 showed normalization of this urinary phenotype, with negative dipstick protein, negative SSA testing, and a decrease in hyaline casts to 0.5/μL. These findings were consistent with a transient urinary abnormality occurring during evolving AKI rather than persistent kidney disease.</p><p><strong>Conclusion: </strong>In this high-risk post-transplant patient, increased hyaline casts with negative dipstick protein and positive SSA testing occurred during evolving AKI and resolved as renal function improved. The finding may indicate acid-precipitable non-albumin urinary material, but its molecular basis and relationship to tubular injury remain uncertain.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70376"},"PeriodicalIF":2.5,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13635927/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Flow Cytometry-Guided Diagnosis of Cortical T-Lymphoblastic Lymphoma Presenting With a Massive Mediastinal Mass and Borderline Bone Marrow Involvement.","authors":"Chen Glait-Santar, Yakir Moshe, Itzhaki-Alfia Ayelet, Ben-Zion Katz","doi":"10.1002/jcla.70369","DOIUrl":"10.1002/jcla.70369","url":null,"abstract":"<p><strong>Background: </strong>T-cell lymphoblastic lymphoma (T-LBL) and T-cell acute lymphoblastic leukemia (T-ALL) are considered a single biological entity, distinguished primarily by the extent of bone marrow infiltration. This distinction becomes diagnostically challenging in patients with borderline marrow blast counts and predominantly extramedullary disease, risking overclassification as leukemia.</p><p><strong>Methods: </strong>We describe a 57-year-old man who presented with dyspnea and a large mediastinal mass causing superior vena cava syndrome, with pleural and pericardial effusions. Diagnostic workup included complete blood count and biochemistry, imaging, fine-needle aspiration, core biopsy, pleural fluid cytology, multiparameter flow cytometry of pleural fluid and bone marrow, immunohistochemistry, and cerebrospinal fluid analysis.</p><p><strong>Results: </strong>CBC and biochemistry were largely unremarkable aside from elevated LDH and CRP. Cytology and biopsy showed a diffuse blastoid lymphoid infiltrate. Pleural fluid flow cytometry identified an aberrant immature T-cell population (cytoplasmic CD3+, CD1a+, CD2+, CD4+, CD5(dim)+, CD7+, CD8+, CD10+, TdT+; surface CD3-, CD34-, MPO-), confirming cortical T-ALL/LBL and excluding B- and myeloid-lineage differentiation. Bone marrow morphology suggested ~10% blasts, but flow cytometry detected only 3.8% CD34+ cells with a myeloid-skewed, non-T-lymphoblastic phenotype, arguing against significant marrow involvement. The patient was classified as T-LBL and treated per the GMALL protocol, achieving complete remission.</p><p><strong>Conclusion: </strong>Flow cytometry resolved a discrepancy between morphologic and immunophenotypic assessment of bone marrow involvement, preventing overclassification as T-ALL. Multiparameter flow cytometry is essential for accurate lineage assignment and staging of precursor T-lymphoid neoplasms in cytologic specimens and borderline marrow samples.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70369"},"PeriodicalIF":2.5,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13624735/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149081048","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"METTL7B Expression in Sepsis: Association With Disease Severity and 28-Day Mortality.","authors":"Yuxuan Zhang, Yonghua Wang, Mengjiao Yang, Dan Huang","doi":"10.1002/jcla.70366","DOIUrl":"10.1002/jcla.70366","url":null,"abstract":"<p><strong>Background: </strong>Sepsis is a life-threatening condition associated with high mortality, and current biomarkers remain suboptimal in prognostic evaluation. This study aimed to explore the associations of whole blood methyltransferase-like 7B (METTL7B) expression with disease severity and 28-day mortality in sepsis patients.</p><p><strong>Methods: </strong>In this prospective cohort study (93 sepsis patients, 22 non-septic ICU controls), whole blood METTL7B (RT-qPCR) and conventional biomarkers (SOFA, PCT, CRP, IL-6) were measured. Dynamic SOFA changes (ΔSOFA from admission to Day 7) were assessed. ROC curves, logistic regression, and a combined model were used.</p><p><strong>Results: </strong>METTL7B levels were significantly elevated in sepsis patients compared to non-septic controls (5.6 ± 1.33 vs. 2.44 ± 0.54, p < 0.001), with higher levels observed in non-survivors. Baseline METTL7B levels were significantly higher in patients with a deteriorating SOFA trajectory (ΔSOFA ≥ +2) compared to those with stable or improving courses (p < 0.05). The AUC for METTL7B alone in predicting 28-day mortality was 0.779, outperforming CRP and IL-6. The combination of METTL7B with SOFA and PCT achieved the highest predictive accuracy (AUC = 0.854). Multivariate logistic regression identified METTL7B as associated with disease severity and 28-day mortality risk in patients with sepsis (OR = 1.928, p = 0.017).</p><p><strong>Conclusion: </strong>Elevated whole blood METTL7B expression is associated with disease severity and unfavorable outcomes in septic patients. When combined with dynamic SOFA and PCT, it improves prognostic stratification. These findings suggest its potential value as a severity-associated complementary marker warranting multi-center validation.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70366"},"PeriodicalIF":2.5,"publicationDate":"2026-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13620335/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149074895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"First-Trimester CBC-Derived Inflammatory Indices for Prediction of Miscarriage: A Retrospective Cohort Study.","authors":"Suchada Wattanaploy, Suchaya Luewan, Theera Tongsong","doi":"10.1002/jcla.70365","DOIUrl":"10.1002/jcla.70365","url":null,"abstract":"<p><strong>Objective: </strong>To develop and internally validate a predictive model for miscarriage using clinical factors combined with CBC-derived inflammatory indices, including the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), systemic immune-inflammation index (SII), and systemic inflammation response index (SIRI).</p><p><strong>Methods: </strong>This retrospective cohort study included Thai women with singleton pregnancies who attended their first antenatal visit during the first trimester between January 2020 and December 2025. Eligible participants had available CBC results and pregnancy outcomes. Associations between CBC-derived indices and subsequent miscarriage were evaluated, and predictive models were developed. Model discrimination was assessed using the area under the curve (AUC).</p><p><strong>Results: </strong>A total of 796 women were included, comprising 118 with subsequent miscarriage and 678 with ongoing pregnancies. Gestational age was significantly lower among the study group (7.32 ± 1.61 vs. 8.69 ± 2.07 weeks, p < 0.001). Women who miscarried had significantly higher lymphocyte counts but lower neutrophil counts and NLR than controls. A clinical model based on maternal age and gestational age demonstrated modest discrimination (AUC, 0.741). A penalized model incorporating maternal age, gestational age, NLR, and SII significantly improved predictive performance (AUC, 0.781; p = 0.001). At a predicted probability threshold of 0.15, the model achieved a sensitivity of 77.1% and a specificity of 70.0%.</p><p><strong>Conclusion: </strong>Maternal age and gestational age were significant predictors of miscarriage, and the first-trimester combination model provided significant improvement in discrimination. Because these indices are routinely derived from standard CBC testing without additional cost, they may potentially serve as practical adjuncts to clinical risk factors for early miscarriage risk stratification after validation.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70365"},"PeriodicalIF":2.5,"publicationDate":"2026-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13617317/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149069667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"COL1A1+ Epithelial Cells Orchestrate VEGFA-VEGFR Signaling in Endometritis Revealed by Single-Cell Analysis","authors":"Chengzi Tian,&nbsp;Zaiyi Li","doi":"10.1002/jcla.70221","DOIUrl":"10.1002/jcla.70221","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Endometritis is linked to adverse reproductive outcomes, but epithelial programs in disease initiation and persistence remain unclear. We aimed to systematically define inflammation-associated epithelial states and regulation in endometritis using single-cell analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Method</h3>\u0000 \u0000 <p>The single-cell RNA sequencing (scRNA-seq) data from Gene Expression Omnibus (GEO) were processed using Seurat. After quality control, data were normalized with SCTransform and batch-corrected using the Harmony package. Cell types were annotated based on canonical markers. Differential expression analysis was performed to identify genes altered in endometritis. Epithelial cells were subsetted for reclustering and trajectory inference using Monocle2. Cell–cell communication was inferred with CellChat, and transcriptional regulon activity was assessed using SCENIC and AUCell methods.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 153,877 cells formed 14 clusters across seven lineages, with lower epithelial proportion in endometritis. Epithelial cells included four subpopulations (SPDEF⁺, MT1H⁺, Ciliated, COL1A1⁺), with SPDEF⁺ and COL1A1⁺ expanded in disease. Upregulated epithelial genes enriched in ribosome, antigen processing/presentation, and estrogen-related pathways. Pseudotime showed a continuous trajectory splitting into two fates: one ferroptosis-related with glutathione metabolism and mineral absorption, the other ribosome and antigen presentation. Communication networks were denser in endometritis, with COL1A1⁺ epithelium as a hub and enhanced VEGFA–VEGFR signaling. SCENIC revealed elevated regulon activity in disease, especially AP-1 (JUN/FOS) modules.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>This epithelial-centric single-cell atlas delineates disease-associated states, fate decisions, signaling axes, and regulatory programs in endometritis. The data support a model of epithelial fate remodeling coupled to angiogenic signaling and AP-1–driven transcription, nominating testable targets for mechanistic validation and potential translation.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":"40 18","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13399849/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147941660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Molecular Functions and Drug Prediction of MMP1 and TGFBR2 in Nasopharyngeal Carcinoma","authors":"Feng Wang,&nbsp;Binbin Ge,&nbsp;Ming Li,&nbsp;Xiaochun Xia,&nbsp;Fuming Zhang,&nbsp;Pengqin Xu","doi":"10.1002/jcla.70222","DOIUrl":"10.1002/jcla.70222","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Nasopharyngeal carcinoma (NPC) is partially driven by epithelial–mesenchymal transition (EMT). We identified potential EMT-related biomarkers and targeted drugs for NPC via computational and machine learning approaches.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Based on the NPC patient dataset derived from the public database, differentially expressed genes (DEGs) were screened using the limma package and intersected with the EMT gene set from the database of Epithelial–Mesenchymal Transition-associated genes (dbEMT). Subsequently, GO and KEGG enrichment analyses were performed, and a protein–protein interaction (PPI) network was constructed via the STRING database. Core genes were identified through LASSO regression and SVM-RFE algorithms. Immune cell infiltration was assessed using CIBERSORT; pathway enrichment was analyzed with GSEA software; targeted drugs were predicted via Enrichr; and molecular docking validation was performed using AutoDock. Finally, the selected genes were functionally validated using NPC cell lines.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Among 131 EMT genes, 18 were filtered via PPI. Machine learning algorithms combined with external dataset validation further pinpointed <i>MMP1</i> and <i>TGFBR2</i> as hub genes. <i>MMP1</i> was correlated with M0/M1 macrophages and activated NK cells, whereas <i>TGFBR2</i> was correlated with resting NK cells and memory B cells. Both genes were linked to EMT, angiogenesis, hypoxia, and MYC targets. Dexamethasone showed strong binding affinity to <i>MMP1</i> (−7.72 kcal/mol) and <i>TGFBR2</i> (−7.27 kcal/mol). Cellular assays revealed upregulated <i>MMP1</i> and downregulated <i>TGFBR2</i> in NPC cells; MMP1 knockdown suppressed NPC malignant phenotypes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p><i>MMP1</i> and <i>TGFBR2</i> were identified as EMT-related biomarkers that mediated immune evasion and metastasis in NPC. Dexamethasone may target these genes, offering a novel therapeutic strategy for NPC.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":"40 18","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13399821/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147874063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Organ-Specific Human Microbiomes and Dysbiosis: Mechanistic Links to Disease and Emerging Therapeutic Strategies","authors":"Awadh Alanazi","doi":"10.1002/jcla.70307","DOIUrl":"10.1002/jcla.70307","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The human microbiome is a dynamic and diverse community of microorganisms that affects susceptibility to illness and promotes wellness. Dysbiosis, or disruption of this delicately regulated microbial ecology, has been identified as a major factor in the emergence and development of systemic and organ-specific disorders.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>With an emphasis on dysbiosis-driven illness processes and therapeutic intervention implications, this study attempts to critically analyze host–microbiome interactions across key human organ systems.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Using predetermined microbiome-related keywords, a systematic literature search (2001–2025) was carried out in PubMed, Scopus, Web of Science, and Google Scholar. To assess microbiome formation, organ-specific distribution, disease correlations, and therapeutic implications, English-language peer-reviewed original papers, meta-analyses, and clinical or validated animal studies were chosen and methodically compiled.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Microbiome dysbiosis is linked to cardiovascular, metabolic, inflammatory, neurological, hepatic, renal, and cancer-related illnesses by interfering with immune modulation, metabolic balance, and epithelial barrier integrity, according to evidence from human and verified animal research. Modified production of short-chain fatty acids, immunological signaling imbalance, chronic inflammation, and communication between the gut–organ axis are examples of mechanistic linkages. Immune and metabolic indicators improved condition-specifically with interventions such as probiotics, fecal microbiota transplantation, and diet-based regulation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Collectively, current evidence supports the microbiome as a modifiable determinant of disease risk and therapeutic response, underscoring its translational potential for precision medicine.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":"40 18","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13399894/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148396443","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prospective Head-To-Head Comparison of a 10-Color Single-Tube Flow Cytometry and EuroFlow Next-Generation Flow in Multiple Myeloma Minimal Residual Disease","authors":"Go Eun Bae,&nbsp;Dae Jin Lim,&nbsp;Sung Hoan Bang,&nbsp;Suhng-Wook Kim,&nbsp;Ari Ahn,&nbsp;Hee-Jin Kim,&nbsp;Jun Ho Yi,&nbsp;Kihyun Kim,&nbsp;Duck Cho,&nbsp;Hyun-Young Kim","doi":"10.1002/jcla.70332","DOIUrl":"10.1002/jcla.70332","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Minimal residual disease (MRD) assessment by next-generation flow cytometry (NGF) is an important prognostic tool in multiple myeloma (MM). Although the EuroFlow NGF assay provides highly standardized and sensitive MRD detection, its dual-tube workflow requires larger sample volumes and longer processing time, potentially limiting efficiency in routine clinical practice. This prospective study evaluated a 10-color single-tube (ST-10C) MRD assay by directly comparing its analytical and clinical performance with the EuroFlow NGF assay.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>MRD analysis was performed in 40 patients with MM, of whom 39 who achieved very good partial response or complete response were included in the final analysis. Each sample was analyzed in parallel using both assays. Analytical sensitivity, qualitative and quantitative agreement, and progression-free survival (PFS) were assessed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Both assays achieved analytical sensitivity below 10⁻⁵. MRD was detected in 48.7% of samples by the ST-10C assay and in 38.5% by the EuroFlow NGF assay, with substantial agreement (κ = 0.79). Concordance remained high using the clinical MRD cutoff (≥ 0.001%) (κ = 0.84). Quantitative MRD levels showed strong correlation between the assays (ρ = 0.964) without significant systematic bias. MRD-positive patients showed a trend toward inferior PFS compared with MRD-negative patients by both assays.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The ST-10C assay demonstrated analytical performance comparable to the EuroFlow NGF assay, supporting its adoption as a more efficient and streamlined alternative for routine MRD assessment in MM.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":"40 18","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13458865/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148706508","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}