Biochemia medica最新文献

{"title":"Proteomics in myelodysplastic syndromes: towards novel prognostic and diagnostic biomarkers.","authors":"Ruđer Novak, Inga Mandac Smoljanović, Lovorka Grgurević","doi":"10.11613/BM.2026.020504","DOIUrl":"10.11613/BM.2026.020504","url":null,"abstract":"<p><p>Myelodysplastic neoplasms (MDS) are clonal hematopoietic disorders defined by ineffective hematopoiesis, cytopenias, and variable risk of progression to acute myeloid leukemia. Although genomic and epigenomic studies have provided insight into disease pathogenesis, reliable biomarkers for diagnosis and prognosis remain limited. Proteomics offers an important advantage because it reflects the functional protein state and captures post-translational modifications, making it highly relevant for risk assessment and therapy guidance. Recent studies have identified several groups of candidate biomarkers. Kinases and signal transduction proteins such as CAMK1D, PRKCZ, KIT, MAST4, PAK6, PTK7, and NTRK1 are dysregulated in MDS and associated with poor outcomes, immune evasion, and aberrant stem cell signaling. Oncofetal proteins like IGF2BP3 and signaling regulators such as RBP4 further highlight proteomic signatures linked to chemoresistance and subtype specificity. In the transplant setting, immune regulators including CSK, FGR, CRTAM, GP1BA, UBE2N, and STAT1 may serve as predictors of graft rejection and relapse. Cytoskeletal and extracellular matrix proteins such as CEP55, Talin-1, Kindlin-3, Vinculin, THBS1, LRG1, SPARC, SAA1, Clusterin, and PRDM16 underscore the role of bone marrow microenvironmental remodeling and adhesion defects in disease progression. Finally, metabolic enzymes such as LDHA reflect altered energy metabolism and correlate with more aggressive disease biology. Collectively, these proteomic candidates illustrate the complex interplay of signaling, immune regulation, bone microenvironment, and metabolism in MDS. Their validation in clinical cohorts could enable early detection, refined risk stratification, and new therapeutic avenues, positioning proteomics as a central tool in the future management of MDS.</p>","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"36 2","pages":"020504"},"PeriodicalIF":1.8,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13262759/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148261221","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Factors associated with Gla-rich protein serum concentrations in healthy adults.","authors":"Catarina Marreiros, Carla Viegas, Selene Nunes, Ana Paula Silva, Marília Faísca, Leon Schurgers, Dina Costa Simes","doi":"10.11613/BM.2026.020709","DOIUrl":"10.11613/BM.2026.020709","url":null,"abstract":"<p><strong>Introduction: </strong>Gla-rich protein (GRP) is a vitamin K-dependent protein involved in the regulation of ectopic calcification and inflammatory processes. However, data on circulating GRP concentrations in healthy adults remain limited.</p><p><strong>Materials and methods: </strong>This cross-sectional observational study evaluated serum total GRP (tGRP) concentrations in 254 healthy adult blood donors (48% male), aged 18-65 years, using a sandwich enzyme-linked immunosorbent assay (ELISA) (GenoGla Diagnostics, Faro, Portugal). Participants were stratified by age tertiles, and associations between serum tGRP concentrations and demographic and laboratory parameters were assessed using non-parametric statistical tests, Spearman correlation, and stepwise linear regression.</p><p><strong>Results: </strong>The median serum tGRP concentration in the overall population was 1809.5 pg/mL (interquartile range: 1197.4-2476.0 pg/mL). Serum tGRP concentrations differed significantly across age tertiles (P = 0.038), with higher concentrations observed in younger adults. Serum tGRP concentrations showed a weak but statistically significant inverse correlation with age (r = - 0.30, P = 0.001), while no significant differences were observed between sexes (P = 0.420). In multivariable analysis, age and serum calcium concentration remained independently associated with serum tGRP concentrations, jointly explaining approximately 7% of their variability.</p><p><strong>Conclusion: </strong>This study establishes robust reference data for circulating tGRP concentrations in healthy adults, providing a foundation for the interpretation of GRP measurements in future clinical and epidemiological research.</p>","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"36 2","pages":"020709"},"PeriodicalIF":1.8,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13262751/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148261171","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preanalytical study concerning the influence of tube type and centrifugation conditions on the concentration of calprotectin in ascites.","authors":"Adrijana Dorotić, Marija Siter-Kuprešanin, Helena Čičak, Andrea Saračević, Dora Vuljanić, Rosana Troskot Perić, Igor Alfirević","doi":"10.11613/BM.2026.020703","DOIUrl":"10.11613/BM.2026.020703","url":null,"abstract":"<p><strong>Introduction: </strong>Concentration of calprotectin in ascitic fluid has been proposed as the possible diagnostic marker for spontaneous bacterial peritonitis. This study aimed to choose the optimal preanalytical conditions for the determination of the concentration of calprotectin in ascitic fluid.</p><p><strong>Materials and methods: </strong>Study was performed using 20 samples of ascitic fluid of inflammatory etiology. Number of total nucleated (TNC) and polymorphonuclear cells (PMN) were determined on Advia 2120i (Siemens Healthineers). Ascitic samples were collected into three tube types (K2EDTA, tubes with clot activator and Li-heparin tubes) and centrifuged under three different conditions (400xg, 1500xg and 3000xg 15 minutes). Concentration of calprotectin was determined using Bühlmann's turbidimetric assay and potassium and lactate dehydrogenase using standard laboratory methods on Atellica Solution (Siemens Healthineers). Data was evaluated by Friedman test and Spearman's correlation coefficient.</p><p><strong>Results: </strong>The highest concentration of calprotectin was observed in red tubes with clot activator (centrifuged 1500xg 15 minutes; median 0.349 mg/L, IQR 0.094-1.129 mg/L) and the lowest in lavender tubes (centrifuged 3000xg 15 minutes; median 0.109 mg/L, IQR: 0.037-0.850 mg/L). Friedman test showed statistically significant difference between concentration of calprotectin in different preanalytical conditions (P < 0.001). According to the desirable biological variation criteria, differences in calprotectin concentration were clinically significantly different for different preanalytical conditions.</p><p><strong>Conclusions: </strong>To determine the concentration of calprotectin in ascites, we suggest using a test tube with a red cap and centrifugation conditions of 1500xg 15 minutes which is consistent with the relevant national and international guidelines.</p>","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"36 2","pages":"020703"},"PeriodicalIF":1.8,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13067892/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147679111","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"EvalTest: a web-based tool for the assessment of diagnostic test performance.","authors":"Nassim Ayad","doi":"10.11613/BM.2026.020101","DOIUrl":"10.11613/BM.2026.020101","url":null,"abstract":"<p><strong>Introduction: </strong>Accurate diagnostic tests are essential in clinical and laboratory medicine. Evaluation of diagnostic test performance requires advanced statistical expertise and the use of specialized or proprietary software. The aim of this work is to develop an open-source R Shiny application for facilitating diagnostic test evaluation by integrating statistical rigor with user-friendly interactivity.</p><p><strong>Materials and methods: </strong>The EvalTest application was developed in the R programming language using the Shiny framework and released as an open-source package on the Comprehensive R Archive Network, with the full source code available on GitHub. In addition, the application is available on a cloud platform and accessible <i>via</i> web browser. Statistical formulas used to compute diagnostic performance indicators and their confidence intervals were implemented within the R environment to ensure transparency and reproducibility.</p><p><strong>Results: </strong>The developed application provides an interactive interface for importing Excel datasets, setting test variable type, selecting test and reference variables, and specifying disease prevalence. It automatically computes key diagnostic performance indicators, including sensitivity, specificity, predictive values, likelihood ratios, accuracy, the Youden index, and the area under the curve (AUC), along with their 95% confidence intervals. EvalTest also generates confusion matrices, receiver operating characteristic (ROC) curves with confidence bands, and identifies the optimal cutoff for quantitative tests. All numerical and graphical outputs can be exported in suitable formats to facilitate reporting and documentation.</p><p><strong>Conclusions: </strong>EvalTest provides an open and reproducible solution for diagnostic test evaluation by computing and visualizing key performance measures with their confidence intervals, supporting its use in clinical and research settings.</p>","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"36 2","pages":"020101"},"PeriodicalIF":1.8,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13067893/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147680100","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to: Refining quality control strategies in highly automated laboratories: experience in the integration of multistage statistical designs and risk management.","authors":"Maria Costa-Pallaruelo, Alvaro Garcia-Osuna, Marina Canyelles, Cecilia Martinez-Bru, Nicoleta Nan, Rosa Ferrer-Perez, Francisco Blanco-Vaca, Leonor Guinon","doi":"10.11613/BM.2026.021201","DOIUrl":"10.11613/BM.2026.021201","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.11613/BM.2025.030704.].</p>","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"36 2","pages":"021201"},"PeriodicalIF":1.8,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13067895/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147680132","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and validation of a HPLC method for therapeutic monitoring of brivaracetam.","authors":"Sven Komljenović, Sara Zovko, Andreja Bujan Kovač, Željka Petelin Gadže, Miranda Sertić, Mila Lovrić","doi":"10.11613/BM.2026.020702","DOIUrl":"10.11613/BM.2026.020702","url":null,"abstract":"<p><strong>Introduction: </strong>Brivaracetam belongs to antiepileptic drugs and due to the interindividual variability, therapeutic drug monitoring is recommended, especially when used in polytherapy and in patients with altered pharmacokinetics. The aim of this study is to develop and validate a high-performance liquid chromatography (HPLC) method with a diode array detector (HPLC-DAD) that is suitable for therapeutic monitoring of brivaracetam and assess method's greenness.</p><p><strong>Materials and methods: </strong>High-performance liquid chromatography method was validated according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Clinical and Laboratory Standards Institute (CLSI) guidelines. Preparation of serum samples was performed by liquid-liquid extraction using ethyl acetate:hexane (1:1) with chloramphenicol as internal standard. Separation was achieved using a 5 µm 4.6 x 250 mm C18 Shim-pack GIST column with the mobile phase consisting of a 50 mM phosphate buffer (pH = 4.5) and organic mixture of acetonitrile and methanol (8/3; v/v). Brivaracetam is quantified at 210 nm. AGREEprep was utilized for the method's greenness scoring.</p><p><strong>Results: </strong>The developed HPLC-DAD method is linear over a concentration range of 0.25-20.00 µmol/L. Repeatability was lower than 7.20%, intermediate precision was lower than 8.30%, and within-laboratory precision was lower than 10.50%, except for the values at the lower limit of quantification (0.25 µmol/L) which were still below 20.00%. Bias was lower than ± 10.60%. The method displays very high specificity at 210 nm. The result for method greenness was 0.4.</p><p><strong>Conclusions: </strong>The validation parameters were within the acceptance criteria of the ICH and CLSI guidelines. The developed method is simple, selective, reproducible, more sensitive than other published HPLC methods and suitable for the therapeutic drug monitoring of brivaracetam.</p>","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"36 2","pages":"020702"},"PeriodicalIF":1.8,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13067899/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147680125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Urinary placental growth factor stability as a critical factor in the reliability of preeclampsia diagnosis.","authors":"Eva Martinez-Marzo, Maria Peran, Juan Lerma-Irureta, Ana Medel-Martinez, Cristina Paules, Daniel Oros, Marta Fabre","doi":"10.11613/BM.2026.020701","DOIUrl":"10.11613/BM.2026.020701","url":null,"abstract":"<p><strong>Introduction: </strong>Placental growth factor (PlGF) is a key biomarker for diagnosing and predicting preeclampsia (PE). While serum-based PlGF assays are well established, urine has emerged as a promising non-invasive alternative matrix. However, the absence of urinary PlGF stability data remains a major preanalytical limitation. This study aimed to assess urinary PlGF stability under common preanalytical conditions, including refrigerated storage and a double freeze-thaw cycle.</p><p><strong>Materials and methods: </strong>A prospective study was conducted using urine samples from ten pregnant women. Each sample was processed under standard laboratory conditions and aliquoted into five tubes. One aliquot was immediately frozen at - 80 °C (T0), three were stored at 2-8 °C for 48, 96, and 168 hours before freezing, and one underwent a double freeze-thaw cycle. Urinary PlGF concentrations were measured using the Elecsys PlGF immunoassay on Roche Cobas e801 analyzer. Percent degradation (PD%) was calculated relative to baseline. A linear regression model was applied to estimate the time to exceed a maximum permissible instability (MPI) of ± 10%.</p><p><strong>Results: </strong>Urinary PlGF remained stable at 2-8 °C for up to 48 hours, with a mean PD% of - 6% (95% confidence interval (CI): - 9.1 to - 2.8). The regression model (PD% = - 0.0834 x Time (h)) estimated the - 10% threshold at approximately 120 hours. After a double freeze-thaw cycle, the mean PD% was - 1.5% (95% CI: - 3.4 to 0.4%).</p><p><strong>Conclusions: </strong>Urinary PlGF shows acceptable stability for up to 48 hours under refrigeration and is stable over two freeze-thaw cycles. These findings provide essential preanalytical data supporting its potential use in clinical and research settings.</p>","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"36 2","pages":"020701"},"PeriodicalIF":1.8,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13067898/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147679951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimization of icterus interference thresholds for 45 parameters on the Atellica analyzers CH930 and IM1300.","authors":"Damien Leleu, Damien Denimal, Laurence Duvillard","doi":"10.11613/BM.2026.020707","DOIUrl":"10.11613/BM.2026.020707","url":null,"abstract":"<p><strong>Introduction: </strong>The data provided by the manufacturer regarding icterus interference on the various parameters measured on Atellica analyzers are very incomplete, potentially leading to erroneous result interpretation. We aimed to evaluate icterus interference on Atellica CH930 and IM1300 for 45 parameters and to suggest revised icterus indexes for a better interpretation of results.</p><p><strong>Materials and methods: </strong>Pools of serum or plasma were spiked with various concentrations of either conjugated or unconjugated bilirubin. Analytes were measured in triplicate on bilirubin-spiked and native samples. Biases were calculated as the difference between the mean results of both samples. We compared the observed biases to the threshold of 10% similar to the manufacturer, and also to the total allowable errors recommended by the European Biological Variation Study (EuBIVAS).</p><p><strong>Results: </strong>Based on significant bias above 10%, revised icterus index thresholds were higher than manufacturer recommendations for 33 parameters, and lower for 3 parameters. Based on the EuBIVAS criteria, the thresholds were higher than manufacturer recommendations for 33 parameters, and lower for 5 parameters. The revised thresholds differed between the 2 evaluation methods in 13 cases, being less strict for some parameters with the EuBIVAS criteria, and stricter for other ones. For some parameters, the magnitude of interference differed for conjugated and unconjugated bilirubin, or depended on the concentration of the analyte.</p><p><strong>Conclusions: </strong>This work provides important data that can be used to improve the interpretation of results for 45 parameters on Atellica analyzers CH930 and IM1300 in patients with hyperbilirubinemia.</p>","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"36 2","pages":"020707"},"PeriodicalIF":1.8,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13262758/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148261213","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of different blood storage conditions on leukocytes cell population data using the Sysmex XN hematological analyzer.","authors":"Vincenzo Roccaforte, Rossella Panella, Massimo Daves, Antonella De Martino, Erika Jani, Giovanni Sabbatini, Pierfrancesco Agostini, Floriana De Filippi, Paolo Formenti, Giuseppe Lippi, Matteo Vidali, Angelo Pezzi, Stefano Pastori","doi":"10.11613/BM.2026.020704","DOIUrl":"10.11613/BM.2026.020704","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this study was to investigate the stability of leukocyte cell population data (CPD) assessed on Sysmex XN-3000 hematological analyzer in samples stored for up to 24 h at different temperatures.</p><p><strong>Materials and methods: </strong>Whole-blood samples from 25 donors were analyzed for 18 CPD parameters at baseline and after storage at room temperature (RT), 4 °C, or 37 °C for 3, 6, 12, and 24 h. Stability was assessed using three complementary approaches: paired Wilcoxon tests with Bonferroni correction, percent difference between medians > 10%, and <i>per</i>-sample percent change > 10% in ≥ 2 samples. In addition, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) stability protocol was applied, modelling percent differences over time using linear regression through the origin to estimate the rate of change and the stability limit (SL), defined as the time required to exceed a maximum permissible error of 10%.</p><p><strong>Results: </strong>According to predefined stability criteria, several CPD parameters exceeded stability limits within 24 h, particularly under storage at 37 °C. Parameters related to neutrophil, lymphocyte and monocyte complexity and size (<i>e.g.</i>, neutrophils complexity (NE-SSC), neutrophils size (NE-FSC), monocytes complexity (MO-X), lymphocytes complexity (LY-X); where SSC = side scatter, FSC = forward scatter) showed slow rates of change with estimated stability limits beyond 24 h across storage conditions. In contrast, fluorescence- and dispersion-related parameters (<i>e.g</i>., neutrophils fluorescence intensity (NE-SFL), width of dispersion of neutrophils complexity (NE-WX), width of dispersion of lymphocytes fluorescence (LY-WY), width of dispersion of monocytes size (MO-WZ); where SFL = side fluorescence, W = width of dispersion) reached the stability limit within 24 h, most frequently at 37 °C. Lymphocyte size (LY-Z) exceeded the stability limit at 17 h also under storage at 4 °C.</p><p><strong>Conclusions: </strong>Leukocyte CPD stability is strongly temperature- and parameter-dependent. Exposure to elevated temperature (37 °C) leads to early exceedance of predefined stability limits for several CPD parameters, whereas storage at RT preserves stability for longer time intervals. Avoiding prolonged exposure to high temperatures is therefore essential for reliable CPD assessment in routine laboratory practice.</p>","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"36 2","pages":"020704"},"PeriodicalIF":1.8,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13067896/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147680109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of analytical performance and clinical applicability of the UriSed Mini, a semi-automated urine analyzer for cell counting in cerebrospinal fluid.","authors":"Oana Roxana Oprea, Ana-Maria Fotache, Ion Bogdan Mănescu, Minodora Dobreanu","doi":"10.11613/BM.2026.020705","DOIUrl":"10.11613/BM.2026.020705","url":null,"abstract":"<p><strong>Introduction: </strong>Cerebrospinal fluid (CSF) analysis is essential in diagnosing central nervous system pathologies. While manual cell counting by optical microscopy is the gold standard, it is labor-intensive and time-consuming, posing challenges particularly in urgent cases, automated hematology analyzers offer alternatives but come with limitations. The aim of the study was to evaluate the performance of the UriSed Mini instrument for CSF in accordance with ICSH guidelines.</p><p><strong>Materials and methods: </strong>A total of 77 CSF patient samples were analyzed by both methods from September 2023 to September 2024. Following the International Council for Standardization in Hematology guidelines, the UriSed Mini was evaluated for short- and long-term imprecision, limit of blank, limit of detection and analytical measurement range. Quantitative comparison between the two methods was conducted using Bland-Altman and Passing-Bablok analyses. Qualitative agreement was assessed through inter-rater agreement testing.</p><p><strong>Results: </strong>The UriSed Mini successfully met all performance criteria, both in comparison to the manufacturer's claims and in the context of practical clinical requirements. While statistically significant differences were observed in the quantitative comparison (0.6 cells/µL), these discrepancies are unlikely to have clinical significance at the medical decision-making level. The qualitative comparison demonstrated excellent agreement, with a weighted kappa coefficient of 0.96 (95% confidence interval: 0.89-1.00).</p><p><strong>Conclusions: </strong>This study demonstrates that the UriSed Mini meets analytical standards for CSF cell counting and aligns closely with optical microscopy at clinically relevant thresholds.</p>","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"36 2","pages":"020705"},"PeriodicalIF":1.8,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13067900/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147680145","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}