Clinical chemistry最新文献

{"title":"B-241 AUTOMATING REPORTS TO MONITOR LABORATORY STABILITY AND DEFECTS","authors":"Bernard Cook, Pratik Shrestha, Shreya Ramesh Kothari, Omar Baba, Timothy Ellacott, Kyle Veasey, Hanan Aldahan, Ajdin Bilalovic, Daisy Unsihuay Vila","doi":"10.1093/clinchem/hvag086.534","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.534","url":null,"abstract":"Background Comprehensive understanding of clinical laboratory operations requires timely access to critical performance metrics. Our core laboratory has used lean management tools since 2013 to standardize performance reporting and defect monitoring and to identify process improvement opportunities. Key performance indicators (KPIs) include turnaround times (TATs) for critical analytes as measures of overall operations, defects affecting TATs or workflow productivity and incident details documented through shift reports. Historically, TAT, defect and incident data resided in separate operational platforms. Staff were required to manually log into multiple systems to retrieve daily metrics, record observations, update paper KPI boards and archive results. We sought to leverage modern data integration and visualization tools to consolidate these data sources into a single, centralized digital dashboard, enabling automated reporting, standardized defect tracking, and improved accessibility for staff and leadership. Our goal was to enable automated reporting of KPIs, improving data accuracy and consistency, reducing manual effort and increasing accessibility for all. Methods We developed a Microsoft Power BI-based KPI dashboard that integrates data from multiple operational sources within our clinical laboratory system analytics environment. Representative high-volume assays (CBC, PT/PTT, BMP, troponin) were selected to assess process stability. TAT data are automatically extracted from the laboratory information system (LIS) daily at 06:00. Extracted metrics were cross validated over several weeks against existing operational reports to ensure concordance prior to deployment. For defect tracking, a large and heterogeneous defect repository was consolidated into a discrete defect list to support uniform documentation and enable automated incident trending. Shift reports completed by lab staff were embedded directly into the dashboard, allowing automated documentation of workflow disruptions, operational observations and countermeasures, all viewable within the same platform. Results Three essential KPIs – TAT, defects and shift reports – were transformed from manual workflows into an automated, data-driven dashboard. Daily %TAT reporting is visualized using goal-based color indicator (green = met; red = not met) and can be stratified by assay, patient location, and order priority. The primary view displays month-to-date %TAT alongside the prior three months and provides drill-down hourly analytics by assay and result date. Orders added to in-lab specimens are identified by a unique LIS code and excluded from calculations. Additional visualizations display defect types and incident counts across laboratory workstations with direct access to shift report narratives for contextual review. The dashboard is hosted on the health system analytics platform and accessed via shared link, eliminating logins to multiple disparate applications. Direct observation","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"7 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"B-310 Haplotypic Heterogeneity of the Glucose-6-Phosphate Dehydrogenase Gene in Brazilian Children","authors":"Gustavo Barra, Beatriz Lobo, Daniel Cardoso, Rosenelle Benício, Silvana Fonseca, Juliana Gonçalves, Thais Sena, Giovanna Bortolini, Miguel Andrade, Aline Cabral, Aline Locca, Anderson Santos, Rafael Jácomo, Lidia Nery","doi":"10.1093/clinchem/hvag086.592","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.592","url":null,"abstract":"Background Glucose-6-phosphate dehydrogenase (G6PD) deficiency is the most common enzymopathy worldwide and a clinically relevant condition in neonatal and pediatric laboratory medicine due to its association with hemolysis risk and neonatal hyperbilirubinemia. In Brazil, historical admixture and regional demographic differences can influence the spectrum of G6PD variants, which directly affects clinical laboratory test design (variant coverage), expected diagnostic yield, and interpretive reporting. However, regional patterns of G6PD haplotypes and the structure of pathogenic haplotypes remain insufficiently characterized. We aimed to characterize G6PD haplotype diversity across Brazil’s five macro-regions and to quantify the prevalence and type-complexity of pathogenic haplotypes to support region-aware laboratory screening and result interpretation. Methods We conducted a retrospective observational study using an anonymized laboratory database of neonatal screening performed by next-generation sequencing (NGS) between January 2021 and January 2024. Genetic material was obtained from oral mucosa samples collected during routine screening workflows. The dataset included 915 children (456 females, 459 males), generating 1,371 haplotypes for analysis. Variants within the G6PD genomic region were retrieved alongside demographic variables (sex and address-based geographic information). Individuals were assigned to Brazilian macro-regions (North, Northeast, Central-West, Southeast, and South) according to recorded location data. Haplotype inference was performed using 20 variants within the G6PD region; phasing and haplotype reconstruction were conducted with BEAGLE v5.5 using statistical inference to estimate the most probable haplotype pairs. Haplotypes were classified as pathogenic or non-pathogenic based on the presence of clinically established pathogenic variants. For each macro-region, we summarized haplotype diversity (h), number of haplotype types, absolute and relative haplotype frequencies, and the number/proportion and type-complexity of pathogenic haplotypes. The protocol was approved by the institutional ethics committee (CAAE No. 79180324.7.0000.0368). Results Haplotype counts by macro-region were: Central-West (n=475), North (n=389), Southeast (n=273), Northeast (n=122), and South (n=112). Among 22 unique haplotypes, nine were classified as pathogenic. Haplotype diversity was highest in the North (h=0.450; 14 types), followed by the Northeast (h=0.390; 6 types), Central-West (h=0.386; 13 types), South (h=0.357; 8 types), and Southeast (h=0.308; 7 types). The combined prevalence of pathogenic haplotypes showed a regional gradient: Northeast (4.10%), North (2.57%), Southeast (2.20%), Central-West (2.11%), and South (1.79%). The North and Central-West demonstrated greater pathogenic haplotype type-complexity (five pathogenic haplotype types each), whereas the Southeast and South had two types each; the Northeast concentrated pathogenic ","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"16 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086498","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-200 Advancing Parvovirus B19 Detection: A Fully Automated Solution for Today’s Clinical Demands","authors":"Dat Vo, Greg Feitl, Daniela Santtelia, Jennifer Cheeseman, Ashli Rode","doi":"10.1093/clinchem/hvag086.161","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.161","url":null,"abstract":"Background Recent increases in confirmed parvovirus B19 activity in the United States—including a multi state outbreak reported between late 2024 and early 2025—have heightened clinical demand for rapid, reliable serologic testing to distinguish acute from past infection. This need is especially critical for pregnant individuals and immunocompromised patients, where timely identification of acute parvovirus B19 infection directly informs clinical management. Despite this increased disease burden, currently FDA cleared diagnostic options for parvovirus B19 IgM rely on historical, manually performed ELISA methods. These legacy methods require substantial hands on time, manual pipetting steps, batch dependent workflow constraints, and extended turnaround times that strain laboratory operations during periods of elevated test volume. Methods To address these challenges, the LIAISON® Biotrin Parvovirus B19 IgM Plus assay was clinically evaluated as a fully automated chemiluminescent immunoassay (CLIA) for use on the LIAISON® XL analyzer, complementing the FDA cleared LIAISON® Parvovirus B19 IgG assay. The U.S. clinical validation study included 1,247 serum specimens: 356 from pregnant individuals representing all trimesters, and 891 from patients for whom a physician ordered parvovirus B19 IgM testing during the confirmed outbreak period. Results Across both cohorts, the automated IgM assay demonstrated strong agreement with the predicate ELISA method, achieving a positive percent agreement of 96.3% and a negative percent agreement of 99.7%). In addition, the assay exhibits excellent intra-site reproducibility, supporting its robustness across routine clinical laboratory conditions. Conclusion These data underscore the value of transitioning parvovirus B19 serologic testing from manual ELISA workflows to a fully automated IgG + IgM testing solution. Automation reduces hands on labor, improves standardization, and provides on demand scalability during outbreak surges. The LIAISON® Parvovirus B19 IgM Plus assay offers clinical laboratories a reliable, operationally efficient method for detecting acute parvovirus B19 infection in both routine and high demand settings.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"8 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086504","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"B-103 Implementation of an Automated Critical Value Module in a Latin American Oncology Institute Laboratory: Process Optimization and Clinical Impact Analysis","authors":"Laura Noro, Melanie Cassarino, Giuliana Colussi, Ximena Varela, Fernando Diaz Couselo, Carla Noro","doi":"10.1093/clinchem/hvag086.420","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.420","url":null,"abstract":"Background In high-complexity oncology, rapid communication of laboratory critical values (CV) is essential to ensure patient safety and enable timely therapeutic interventions. Prior to implementation, the laboratory at Instituto Alexander Fleming (IAF), located in Argentina and recognized as the first private oncology center in Latin America, relied on manual identification of critical values (CV) using Excel spreadsheets. This process was prone to errors, lacked traceability, and caused delays. This study aims to assess the impact of implementing an automated CV alert module within the Laboratory Information System (LIS) on reporting efficiency and downstream clinical intervention. Methods A dual-phase study was conducted. First, a quasi-experimental pre-post implementation analysis compared a manual recording period (Nov 2022–Apr 2023) with an automated period (Nov 2023–Apr 2024). Variables included the number of communicated CV and reporting time, defined as detection-to-notification. Statistical analysis was performed to compare pre- and post-implementation periods. Laboratory analyzers (Abbott Diagnostics) were interfaced with the LIS (Kern LIS, Argentina), enabling automated alerts to be triggered when a critical value result was transmitted from the analyzer to the LIS. Second, a retrospective observational study (Nov 2023–Apr 2024) assessed clinical impact in emergency department patients and outpatients for the three most frequently reported CV analytes: Hemoglobin (HGB), white blood cells (WBC), and potassium (K). Medical response times (notification-to-action), types of clinical interventions, and hospitalization rates were evaluated. Results The implementation of the automated critical value module significantly increased the number of communicated CVs from 336 to 881 (p < 0.0001). The median reporting time was reduced from 26 to 10 minutes (p < 0.0001). Regarding clinical impact, 94.1% of outpatients and 98.8% of emergency department patients received documented medical intervention following CV notification. Specific therapeutic actions were more frequent in the emergency department (94.2%) compared with outpatients (76.5%). Emergency department settings showed faster clinical response times (median 64 minutes) and higher hospitalization rates (75.6%) compared with the outpatient setting, which had a median response time of 88 minutes and a hospitalization rate of 22.4%. Conclusion The implementation of the automated module optimized CV management by drastically reducing reporting times and enhancing data traceability. Beyond technical efficiency, the system proved to be a vital clinical support tool, ensuring high rates of timely medical interventions in more than 94% of cases. In the context of high-complexity oncologic care, where patients are particularly vulnerable to rapid clinical deterioration, these findings confirm that automation effectively supports timely, and potentially life-saving, clinical decision-m","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"39 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086527","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-351 Experience and outcomes of cfDNA testing in the midst of ethnic and demographic variability at a large SafetyNet teaching hospital","authors":"Ibrahim Hashim, Phuong Draeger, Shelly Lopez-Gray, Elizabeth Eklund, Kristian Faulk","doi":"10.1093/clinchem/hvag086.286","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.286","url":null,"abstract":"Background Biochemical assessment of risk of foetal aneuploidy, Trisomy’s T21, 18 and 13 are widely performed and have evolved over time from using a combination of maternal circulating biomarkers namely alpha-fetoprotein, chorionic gonadotropin, unconjugated esteriol, and dimeric inhibin A at about 21 weeks of gestation to recent development using cfDNA thought to exhibit much lower false positive rates and thus reduces unnecessary follow up invasive amniocentesis procedures. This study examined the impact of implementing a cfDNA testing program at a large SafetyNet hospital. Methods Retrospective review of all cfDNA results reported as well as electronic medical chart review for amniocentesis testing findings (if performed), ultrasound findings, and birth (pregnancy) outcomes were reviewed for final diagnosis. cfDNA testing was performed using Revvity chemagic cfDNA isolation kits, dedicated chemagic instruments using M-PVA Magnetic beads. Results A total of 19,328 patients had cfDNA screens during the study period where 156 (0.811%) patients had positive results. OF the positive screens, 41 were positive for T21, 56 were positive for T18, and 59 patients were positive for T13. Patients’ outcomes (true positives) were confirmed by reviewing medical charts for birth outcomes and results of secondary confirmatory testing (amniocentesis, ultrasound). Of the T21 positive patients, 6 were true positives (14.6%), and 19 were false positives (46.3%), the remainder outcomes were unknown, as for T18, 15 (2.8%) patients were true positives, 17 patients were false positives (30.4%), and the remainder outcomes were unknown, and for T13, 9 patients (15.3%) were true positives, 27 patients (45.8%) were false positives, and the rest were unknown or had other congenital anomalies. T 21 positive samples Z-scores ranged from 12.07 to 23.34 (median 19.69), T18 positive samples Z scores ranged from 4.74 to 45.31 (median 12.17), and T13 positive samples Z scores ranged from 8.65 to 33.33 (median 17.46). Z-scores exhibited marked imprecision and variability when patients BMI exceeded 40. Significant association between screen results and BMI was only observed for T18. Patients with true positive T18 had significantly lower BMI compared to patients with false positive results (p=0.02). Although T21 samples Z-scores were significantly higher among African American patients compared with White patients (p=0.007), no significant differences were observed for T18 or T13 (p= 0.3 and 0.2 respectively). Conclusion cfDNA in addition to offering low false positive results, it facilitated earlier detection at 10 weeks. Interestingly, samples from patients with high BMI (>40.0) exhibited variable Z-scores for T21, T18, and T13. The pathophysiology is not known but likely to be secondary to dilutional effects. The cause of false positive results and whether additional interventions are required remains under debate. Placental mosaicism and intra-uterine fetal demise were ","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"9 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-271 Standardization of a Single Sterile Urine Collection Tube: Diagnostic Stewardship Applied to the Pre-Analytical Phase","authors":"Sergio Brasil Tufik, Stephanie Cunha, Caio Filipe Souza, Géssica Silva, Priscila Pereira, Ruana Helena Wenceslau, Leandro Reis, Sergio Tufik, Jussimara Nurmberger, Soraya Andrade","doi":"10.1093/clinchem/hvag086.220","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.220","url":null,"abstract":"Background Urine tests, including routine urinalysis and culture, are widely used in the diagnosis and monitoring of urinary tract infections. Pre-analytical factors, including specimen collection and container adequacy, play a pivotal role in ensuring analytical accuracy. Since we receive samples already collected, recurrent pre-analytical errors were observed when urine cultures are mistakely collected in non-sterile containers. This workflow failure generates negative consequences, such as pre-analytical waste, additional financial costs, delays in diagnosis and treatment, postponed medical appointments and impact on patient safety. The aim of this study was to evaluate the impact of standardized urine specimen collection by adopting a single sterile tube suitable for both urinalysis and culture in urinary samples received at a clinical laboratory in the city of São Paulo, Brazil. Methods A total of three outpatient units were selected for the study. As part of a strategy to improve the laboratory process through the replacement of supplies, a standardized sterile collection system was introduced for both routine urinalysis and urine culture. Recollection rates for these tests were compared for each unit located in São Paulo over three distinct periods: (i) Pre-implementation (January-March 2025): two tubes were used—one for routine urinalysis and a separate sterile tube for urine culture. (ii) Implementation (April 2025): the two-tube system was replaced by a single sterile tube. (iii) Post-implementation (May-July 2025): the single tube system was consistently used in all scenarios. Results During the implementation phase, improvements in the process were already noticeable, with reductions in recollection rates associated with the adoption of a single tube. Recollections decreased by 40.6%, 39.2%, and 11.5% in units 1, 2, and 3, respectively. After full consolidation of the new process, recollection rates decreased even further by 97.9%, 78.3%, and 71.6%, respectively, representing a substantial reduction across the evaluated units and overall reduction of 83%. The few inappropriate recollections were possibly related to residual use of non-sterile containers distributed before the change in supplies. Conclusion In healthcare systems where specimen collection is decentralized and frequently performed outside the laboratory, pre-analytical errors represent a major source of diagnostic delay. Standardizing the use of a single sterile container for both routine urinalysis and urine culture aligns with Lean principles and proved to be an effective strategy for reducing recollection rates. Overall, the strategy enhanced laboratory workflow efficiency, increased patient and user satisfaction, and strengthened diagnostic practices with a clear focus on patient safety.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"6 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-149 Reduction of Unnecessary Free and Bioavailable Testosterone Orders Using a Reflex Strategy","authors":"Christopher Koch, Dennis Orton, Victoria Higgins, Michael Reid, Ashley Newbigging, Evan Hagen, Joshua Raizman","doi":"10.1093/clinchem/hvag086.120","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.120","url":null,"abstract":"Background Evaluation of testosterone concentration is central to the diagnosis of male hypogonadism, with total testosterone (TT) recommended as the first-line screen in most clinical guidelines. Measurement or calculation of free (FT) or bioavailable testosterone (BAT) are only recommended in select circumstances, particularly when abnormalities in sex hormone binding globulin (SHBG) concentration or function are suspected. Nonetheless, FT and BAT are frequently ordered alongside TT in routine practice, raising concerns regarding overutilization. In this study we optimized calculated FT (cFT) and calculated BAT (cBAT) reference intervals, evaluated cFT/cBAT utilization and clinical utility relative to TT, and defined TT thresholds at which reflexing to cFT/cBAT is most likely to provide further value. Methods TT/SHBG (immunoassay, Roche) and albumin (various platforms) data from adult male patients was extracted from the laboratory information system (N=81,023). Reference intervals for cFT/cBAT were established using RefineR after excluding duplicates, inpatients, non-morning collections, and patients with abnormal diabetes, sex hormone, or prostate markers (N=22,101). Logistic regression was used to model the probability of low cFT/cBAT as a function of continuous TT after excluding duplicates (N=45,977). Results cFT RIs decreased with age with optimal partitioning in 10-year bins. Logistic regression showed a strong inverse association between TT and odds of low cFT (slope = -1.14, odds ratio = 0.32 per 1 nmol/L (∼29 ng/dL) TT increase, p<2×10?¹6), where 1 nmol/L (∼29 ng/dL) decrease in TT approximately tripled the odds of low FT. TT results of =2.5 nmol/L (72 ng/dL) predicted low cFT with 95% probability, while >7.6 nmol/L (219 ng/dL) predicted normal FT, defining a reflex range of 2.5-7.5 nmol/L (∼72-218 ng/dL). In unfiltered data, 10.9% of FT results fell within this interval. cBAT showed similar patterns. Conclusion TT by immunoassay strongly predicted cFT and cBAT, indicating limited incremental diagnostic value from routine FT/BAT testing. By quantifying the probability of low cFT or cBAT when TT exceeds the lower reference limit, reflex algorithms can be derived to substantially reduce unnecessary testing.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"120 3 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086567","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-378 Performance Evaluation of the Roche Cobas® Pulse Point-of-Care Glucometer","authors":"Pit Hung Lim, Sian Foong Lim, Kelly Lim, Lizhen Ong","doi":"10.1093/clinchem/hvag086.308","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.308","url":null,"abstract":"Background Point-of-care testing (POCT) for glucose monitoring plays a crucial role in enabling timely clinical decisions within healthcare settings. The Roche cobas® pulse is a POCT device for glucose measurement and is compatible with cobas® GLU test strips and cobas® GLU QC kit for internal quality control (Roche Diagnostics GmbH). This new generation glucometer utilises FAD-dependent glucose dehydrogenase (GDH) enzyme technology and is intended to replace the current Roche Inform II system. This study provided a real-world analytical and clinical accuracy evaluation of the Roche cobas® pulse glucometer compared to its predecessor Roche Inform II. Methods Between June to October 2025, we evaluated Roche cobas® pulse glucometer (FAD-GDH electrochemical method) against its predecessor Roche Inform II (mutant quinoprotein GDH electrochemical method) and referencing to central laboratory platform testing on Abbott CI hexokinase glucose method for method comparison, imprecision, linearity and accuracy. Within-day and between-day imprecision were assessed using two QC levels (Low level: 3.3 mmol/L; High level: 17.7 mmol/L). Linearity was verified using commercial linearity material ranging from 1.5 to 29.7 mmol/L. Method correlation studies were performed using 77 patient samples for each comparison (Alinity CI and Inform II) across the reportable range of 0.6 to 33.3 mmol/L. Accuracy was verified using CAP WBGQ-B 2025 EQA samples. Performance was evaluated using Royal College of Pathologists of Australasia (RCPA) allowable performance specifications (±0.4 mmol/L for glucose =5.0 mmol/L or ±8% for glucose >5.0 mmol/L) and Food and Drug Administration (FDA) recommendations of 98% accuracy within ±15% for glucose = 4.2 mmol/L or ±0.83 mmol/L for glucose < 4.2 mmol/L. Results The Roche cobas® pulse showed excellent precision with within-day CV of 1.0% and 0.5% and between-day CV of 1.3% and 0.4% for low and high levels respectively, fulfilling manufacturer claims. Linearity was verified across the tested range (R²=0.9998). Correlation with Abbott Alinity CI showed strong agreement (cobas® pulse = 0.9291[Alinity CI] + 0.2634, R²=0.9979, n=76), with 71 of 76 samples (93.4%) meeting RCPA allowable performance specifications (APS) after excluding 1 outlier. Comparison with Roche Inform II showed excellent correlation (cobas® pulse = 0.9693[Inform II] + 0.013, R²=0.9940, n=77), with 73 of 77 samples (94.8%) meeting RCPA APS. Both comparisons achieved 100% compliance with FDA hospital-use accuracy criteria, exceeding the 98% requirement. Accuracy verification using CAP EQA samples showed all results within ±2 SDI and CAP evaluation criteria (peer group mean ±12.5%). The Roche cobas® pulse glucometer demonstrated analytical equivalence to Inform II, with improved precision, equivalent linearity across the clinical range and comparable accuracy. Conclusion The Roche cobas® pulse glucometer demonstrated excellent analytical performance, meeting al","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"49 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086568","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-257 Monocyte Subset Repartitioning by Flow Cytometry: A Three-Year Retrospective Study Differentiating Chronic Myelomonocytic Leukemia from Other Causes of Monocytosis","authors":"Jussimara Nurmberger, Ana Cecilia Silva, Perla Vicari, Andressa Vaz, Karina Lacerda, Julia Oliveira, Sergio Tufik, Vitor Queiroz","doi":"10.1093/clinchem/hvag086.208","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.208","url":null,"abstract":"Background Chronic myelomonocytic leukemia (CMML) is a rare, non-classical chronic myeloproliferative neoplasm whose diagnostic criteria were updated by the World Health Organization (WHO) in 2022 incorporating peripheral blood (PB) monocyte subset analysis by flow cytometry (FCM) into the diagnostic framework. An increased proportion of classical monocytes (MO1; CD14++/ CD16-) =94% facilitates the differential diagnosis among causes of monocytosis, particularly in settings with limited access to molecular testing. The aim of this study was to describe the experience of a Brazilian diagnostic laboratory applying monocyte subset analysis by FCM in patients presenting with monocytosis. Methods This retrospective study included 25 patients with suspected CMML evaluated between January 2022 and March 2025. Complete blood counts, karyotyping, and BCR-ABL testing (when available) were reviewed, along with FCM performed on PB (n=14) or bone marrow (n=11) samples. FCM acquisition was performed using a 13-color DxFLEX Flow Cytometer (Beckman Coulter). Daily instrument performance and fluorescence stability were monitored according to manufacturer recommendations and internal quality control procedures. The antibody panel included CD3, CD4, CD8, CD11b, CD13,CD14, CD16, CD19, CD33, CD34, CD36, CD45, CD56, CD64, IREM, and HLA-DR, and was internally validated according to the 2022 WHO classification. Up to 100,000 leukocyte events were acquired, depending on sample quality. Doublets were excluded using forward scatter height versus area parameters, and debris was removed based on FSC/SSC properties. Leukocytes were identified by CD45 expression and SSC characteristics. Monocyte subsets were defined by CD14 and CD16 expression as MO1 (CD14++/CD16-), MO2 (CD14+/CD16+), and MO3 (CD14low/-/CD16+). Patients were classified as “suspected CMML” when MO1 =94% was observed in association with absolute monocytosis =1,000/µL and =10% monocytes in PB. Results Among the 25 patients (age range: 15–87 years), four (16%) demonstrated a PB immunophenotypic profile suggestive of CMML, with MO1 =94% and monocytosis =1,000/µL and =10%. Among these patients, one had negative BCR-ABL result and another presented a normal karyotype (46,XY); the remaining two lacked molecular and cytogenetic data. Four patients (16%) exhibited a pattern compatible with reactive monocytosis, characterized by proportional increases in MO2 and MO3 subsets. The remaining 17 patients (68%) were classified as indeterminate based solely on monocyte subset distribution. Conclusion Monocyte subset repartitioning by FCM, particularly a classical monocyte proportion =94% in PB, is highly suggestive of CMML and effectively distinguishes clonal from reactive monocytosis, with high reported sensitivity and specificity. In our cohort, the identifying of 16% of patients as suggestive of CMML and 16% as probable reactive monocytosis supports the applicability of this method in a real-world Brazilian laboratory setti","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"396 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086654","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"B-383 Development and Validation of a High-throughput LC-MS/MS Method for Routine Monitoring of Benzodiazepines in Serum","authors":"Michael Smith, Thomas Gorewich, Taylor Hunt, Sarah Bartock","doi":"10.1093/clinchem/hvag086.651","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.651","url":null,"abstract":"Background Benzodiazepines are medications prescribed to target the central nervous system and enhance the neurotransmitter gamma-aminobutyric acid (GABA). Alprazolam, clonazepam, and lorazepam are used for short term treatment of severe anxiety, insomnia, panic disorders, and seizures. Clobazam and its metabolite norclobazam are used to treat childhood seizure disorders. Due to their risk of abuse and severe side effects, benzodiazepine concentrations are routinely monitored when prescribed. LC-MS/MS is the preferred testing method for therapeutic drug monitoring of benzodiazepines in serum due to its analytical sensitivity and specificity. For clinical laboratories, high-throughput specimen processing and analysis are also essential. Our objective was to develop and validate a high-throughput LC-MS/MS method using automated crash-and-shoot extraction of specimens after room-temperature enzymatic hydrolysis. Methods De-identified pooled serum was fortified with the 5 analytes of interest, alprazolam, lorazepam, clobazam, and norclobazam provided as reference standards from commercial sources. Automated sample preparation utilized the Hamilton Microlab STAR (Reno, NV). After serum specimens were hydrolyzed at room temperature using B-One enzyme (Kura Biotech, Los Angeles, CA) and fortified with an acetonitrile solution containing 4 internal standards (IS), they were diluted with a mix of mobile phase A (0.1% formic acid in water) and acetonitrile. Analytes were chromatically resolved using a 2.5-minute gradient on a Kinetex 2.6 µm C18 100 Å 50×3 mm column (Phenomenex, Torrance, CA). A SCIEX 4500 MS (Framingham, MA) paired with a Shimadzu Nexera LC-20AD (Columbia, MD) was used for analysis. High throughput was achieved by multiplexing 2 LC columns in staggered parallel configuration. All analytes were monitored using 2 transitions and 1 ion ratio for acceptance. Analytes were coupled with a matched IS, except for clonazepam, which used lorazepam-13C2-d4. Automated data processing was performed using Indigo Ascent software (Indigo Bioautomation, Carmel, IN). Validation studies were performed per ANSI/ASB standards and CLIA guidelines. Results are reported quantitatively for each analyte of interest. Results A quadratic 7-point calibration model was used to establish analytical measurement ranges (AMRs) of 2 to 2,000 ng/mL for alprazolam, and lorazepam and 10 to 10,000 ng/mL for clobazam and norclobazam. Within run precision ranged from 1.5% to 2.8% (n=5), and between run precision from 1.8% to 4.4% (n=25). No matrix effect was observed for dilutions at 2-, 4-, or 5-times the upper AMR limit. No carryover was observed at the upper AMR limit. Hydrolysis efficiency was 98% based B-one enzyme hydrolysis of lorazepam glucuronide at a free target concentration of 1,550 ng/mL under the same conditions used for sample preparation. Within panel and related interferences were tested at commonly observed concentrations. Except for a 51% decrease in clonazepam","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"7 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}