Clinical chemistry最新文献

{"title":"A-218 Ensuring Deionized Water Availability for Clinical Analyzers: A Clinical Engineering Strategy for Operational Continuity in a Laboratory Network","authors":"Cyra Araujo, Ronaldo Silva, Patricia Costa, Jonas Oliveira, Rafael Jacomo, Lidia Nery, Vitor Domingos, João Oliveira, Wesley Silva, Hilton Borges, Ramoniele Silva, Jéssica Sena, Mariana Oliveira, Valter Vieira","doi":"10.1093/clinchem/hvag086.175","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.175","url":null,"abstract":"Background Treated/deionized water systems are critical infrastructures for the operation of automated clinical analyzers. Continuous water quality and availability directly affect analytical performance, reagent stability, internal system integrity, and ultimately the reliability of laboratory results. Interruptions in water supply or degradation of physicochemical parameters may lead to immediate analyzer shutdown, test repetition, delayed result reporting, and potential clinical risk. In geographically distributed laboratory networks, variability in water supply quality — influenced by regional characteristics — makes standardized consumable management a significant technical challenge. This study describes a Clinical Engineering strategy designed to ensure continuous deionized water availability for 27 systems supporting laboratory analyzers across 12 Technical Operational Centers. Methods An individualized technical assessment was conducted for each water system, considering: historical analyzer downtime associated with water system failures; identification of critical consumables (deionization cartridges, filters, UV lamps, and filtration elements); observed practical lifespan of each component; manufacturer recommendations; and local incoming water characteristics (conductivity, organic load, and particulates), which vary by region. Clinical Engineering correlated historical consumption data with real operational parameters, adjusting consumable sizing according to the specific conditions of each system. The analysis recognized that practical consumable lifespan may be shorter than the manufacturer’s nominal expectation, particularly in regions with greater variability in the water supply quality. A preventive planning model was implemented with strategic inventory and scheduled replenishment, prioritizing elimination of stock-out risk for critical consumables. Monitored indicators included: downtime events due to lack of consumables, stability of water quality parameters (conductivity, resistivity, and Total Organic Carbon (TOC), and impact on analyzer availability. Results During the analyzed period, none of the 27 systems experienced operational interruption due to lack of consumables. Consequently, no clinical analyzer downtime was attributed to deionized water unavailability. The individualized approach improved predictability of component replacement and reduced technical alarms related to water quality deviations. Stability of physicochemical parameters mitigated analytical failure risk and minimized test repetition. Although the primary objective was operational continuity, the model also generated an estimated financial optimization of approximately USD 116,000 per year. These savings resulted from precise technical planning, elimination of emergency purchases, and avoidance of premature component replacement. More significant than the economic impact was the consolidation of a stable operational environment, ensuring uninterrupte","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"28 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086422","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-122 ANXA6 as a Potential Biomarker for Immunotherapy in Nasopharyngeal Carcinoma and Preliminary Exploration of Its Underlying Mechanisms","authors":"Kun Wang, Ya Tao, Bin Yi","doi":"10.1093/clinchem/hvag086.434","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.434","url":null,"abstract":"Background Nasopharyngeal carcinoma (NPC) is one of the most common head and neck malignancies in southern China and Southeast Asia, posing a serious threat to public health. Currently, NPC is mainly treated with a combination of radiotherapy and chemotherapy. The integration of immunotherapy with conventional treatment modalities has emerged as an important strategy to further improve therapeutic efficacy and establish novel comprehensive treatment models for NPC. Although immunotherapy has become a new treatment option for NPC, immune-related molecular biomarkers predictive of therapeutic response remain insufficiently explored. In our preliminary studies, annexin A6 (ANXA6) was found to be detectable in the serum of NPC patients, suggesting its potential as a biomarker associated with NPC. Methods Serum samples collected at initial diagnosis from 40 matched NPC patients receiving immunotherapy were analyzed. Serum ANXA6 levels were measured using an enzyme-linked immunosorbent assay (ELISA), and their associations with immunotherapy efficacy were evaluated. Correlations between ANXA6 and commonly used clinical indicators were further analyzed to provide a basis for the future development of a multimodal model for immunotherapy response assessment. To explore the potential mechanisms underlying differential ANXA6 expression in NPC, immunoprecipitation combined with mass spectrometry was performed to identify potential ANXA6-interacting proteins, followed by preliminary bioinformatic analyses. Results Patients with high serum ANXA6 levels at initial diagnosis achieved complete or partial responses after immunotherapy, whereas those with low ANXA6 levels exhibited stable or progressive disease. In addition, baseline serum HDL/TC levels were significantly higher in the response group than in the stable and progressive disease groups (P < 0.05). Serum ANXA6 levels at diagnosis were significantly correlated with TC, LDL, white blood cell count (WBC), and monocyte count, with Spearman correlation coefficients of -0.614, -0.644, -0.665, and -0.536, respectively (P = 0.000). Analysis of ANXA6-interacting proteins revealed that these proteins were mainly enriched in processes related to monocyte and lymphocyte differentiation, leukocyte adhesion, membrane-associated molecular events, and nucleotide receptor activity. These proteins were primarily involved in lymphocyte receptor signaling, chemokine pathways, the NF-?B signaling pathway, and other immune-related signaling pathways. Conclusion This study demonstrates that serum ANXA6 levels at initial diagnosis are closely associated with immunotherapy efficacy in NPC patients, with higher serum ANXA6 expression at diagnosis are more likely to benefit from immunotherapy. ANXA6 may be involved in tumor-associated immunometabolic regulation and may influence immunotherapeutic responses by modulating immune cell function and immune signaling networks. Serum ANXA6 shows promise as a potential biomarker","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"148 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086427","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-277 Analytical Comparison of ANA Screening by BioPlex® 2200 and the Sebia dIFine® IFA Platform","authors":"Isabel Espinosa, Mark Pool, Merih Tesfazghi","doi":"10.1093/clinchem/hvag086.561","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.561","url":null,"abstract":"Background Autoimmune connective tissue diseases (CTDs) are common and often present with heterogeneous or overlapping clinical manifestations, making early and analytically robust laboratory detection essential to prevent irreversible organ damage. Many patients exhibit polyautoimmunity or evolving autoantibody profiles, with sequential development of additional specificities over time. This evolution increases the risk that restricted screening strategies may fail to detect concurrent or emerging autoimmune conditions, potentially delaying appropriate management. Indirect immunofluorescence assay (IFA) on HEp-2 cells remains the reference method for antinuclear antibody (ANA) screening because of its broad antigenic substrate and ability to detect antibodies against a wide spectrum of nuclear and cytoplasmic targets. In this study, we evaluated the diagnostic performance of ANA screening using the Sebia automated IFA platforms (dIFine and P30 with Sebia HEp-2 slides), with the in-house BioPlex 2200 multiplex assay serving as the predicate method. Methods Serum samples (n = 101) submitted to the core laboratory for ANA screening as part of routine patient care were sequentially analyzed using the Bio-Rad BioPlex 2200 and the Sebia dIFine® IFA platforms according to the manufacturers’ instructions. The dIFine automated imaging software was used to capture and classify IFA images, while manual IFA was performed to titer positive results identified by the Bio-Rad BioPlex 2200. When sufficient sample volume was available, discrepant results were further evaluated by manual IFA using Sebia HEp-2 slides and interpreted by an experienced technologist. Positive and negative percent agreement, as well as Cohen’s kappa (MedCalc online), were calculated to assess method concordance. Results Overall concordance between the two methods was 75% (76/101), with a Cohen’s kappa of 0.42 (95% CI, 0.23–0.61), indicating moderate agreement. Negative percent agreement was 80.3% (57/71), while positive percent agreement was 63.3% (19/30). Fourteen discrepant samples were negative by the Bio-Rad BioPlex 2200 but positive by the Sebia dIFine system; 10 of these were confirmed by manual IFA, with titers ranging from 1:40 to 1:640. Conclusion Given the limited sample size, the two methods demonstrated overall moderate agreement, with high negative percent agreement. Additional studies are ongoing to expand the sample size and incorporate a third method to aid in discrepancy resolution and more accurately characterize diagnostic performance.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"17 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086480","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-299 Analytical performance, variant detection and result reportability of the CAPILLARYS 3 TERA HbA1c assay relative to the Siemens Atellica CH930","authors":"Imad Tarhoni, Kelsey Reschly, Mackenzie Edward, Margaret Gearhart, Nichole Korpi-Steiner, Steven Cotten","doi":"10.1093/clinchem/hvag086.582","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.582","url":null,"abstract":"Background Accurate hemoglobin A1c (HbA1c) measurement is key for diabetes diagnosis and monitoring. Many methods exist; however, immunoassay methods may be limited in detection of hemoglobin variants, abnormal fractions, and hemoglobin concentrations that impact result measurement. This study evaluated the analytical performance, variant detection, and result reportability of HbA1c measurement using the CAPILLARYS 3 TERA and Siemens Atellica CH930. Methods Studies included precision, accuracy, method comparisons, retesting of flagged samples, variant prevalence analysis, and precision of variant samples. CAPILLARYS 3 TERA within-run precision was evaluated using three residual samples (low, medium, high) analyzed in eight replicates per level and between-run precision was assessed in triplicate over three days. Accuracy was evaluated using 10 NGSP samples with assigned values. Six hundred and thirty-three residual EDTA samples with HbA1c values using the Atellica CH930 sent to McLendon Laboratory as part of routine care were tested using the CAPILLARYS 3 TERA within 24 hours of collection. Retesting of unreportable samples on the Atellica included specimens comprising flagged samples (n=64) and samples (n=65) with total hemoglobin concentrations of 7-12 g/dL. Results were compared to the Abbott Afinion 2 HbA1c diagnostic cartridge when HbA1c values were not generated by the Atellica. An enriched cohort (n=32) was used to challenge hemoglobin variant detection on both platforms. Variant precision was assessed in triplicate for nine specimens. Results CAPILLARYS 3 within-run, and between-run precision demonstrated CVs =1.5% across all levels. All measurements of NGSP samples on both platforms were within 6% relative bias. Slope, intercept, and mean absolute bias were 1.090, -0.373, 0.37% for CAPILLARYS 3 and 1.036, -0.12, and 0.18% for the Atellica compared to NGSP. Method comparison of the CAPILLARYS 3 versus Atellica using residual samples demonstrated a slope of 1.029, intercept of -0.05, correlation of 0.987 and mean bias of 0.12%. The CAPILLARYS 3 generated results for 96.9% (62/64) of Atellica flagged samples. These results showed good agreement (slope 1.025, bias -0.16) compared to the Afinion 2. The two remaining unreportable samples were flagged by the CAPILLARYS 3 as atypical and were previously known hemoglobin variants. For the variant enriched cohort, the CAPILLARYS 3 had a sensitivity of 100% versus 81% for the Atellica in flagging samples with possible interferences. The CAPILLARYS 3 correctly identified variant interferences despite calculating HbA1c values for 13 specimens collected from transfused patients. Six variant samples were not identified by the Atellica yet generated results; five were ß-globin related hemoglobinopathies, with Atellica values systematically lower than CAPILLARYS 3, showing 15-20% underestimation. Additionally, flagged and variant samples showed CV <1%, supporting the stability of HbA1c measurement","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"12 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086507","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-112 New generation of p24-specific antibodies and HIV proteins for reliable HIV diagnostics.","authors":"Natalia Tamm, Evgenia Mikhailuk, Anfisa Popova, Qiang Han, Chengxiong Zhan, Alexander Kogan, Iuliia Abdulina, Elizaveta Sokolova, Sergei Kotlov, Natalia Gruzdeva, Stanislav Kozlovsky, Fedor Rozov, Kristina Gainova, Tatiana Balaneva, Anna Trufanova, Alexander Mishin","doi":"10.1093/clinchem/hvag086.086","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.086","url":null,"abstract":"Background Accurate diagnosis of human immunodeficiency virus (HIV) infection depends on the efficiency of detecting diverse HIV strains of the HIV-1 group M, including subgroups and circulating recombinant forms, group O, and HIV-2. For reliable HIV detection HIV combo assays, targeting both p24 antigen and HIV-specific antibodies are recommended. Diagnostic performance is predominantly determined by the specificity and sensitivity of p24-specific antibodies and the selection of proper HIV antigens. This study aimed to develop high-performance HIV combo assay prototypes for accurate detection of HIV infection across global HIV strains. Methods Recombinant p24 proteins of HIV-1 M and O groups, and HIV-2 were expressed in E. coli and used for animals’ immunization as well as for monoclonal antibody screening. Recombinant gp41, gp36, gp120 proteins and their fragments (for HIV-1/2 antibody detection) were expressed in a mammalian cell line; a gp41-gp120 fusion protein was produced in both mammalian cell line and E. coli. All p24-specific antibodies and recombinant HIV proteins were evaluated via sandwich chemiluminescent particle-based immunoassays. Results Antibodies that recognize three recombinant p24 proteins with equal efficiency were selected for the development of HIV antigen assay prototypes. Selected antigen assay prototypes recognized three p24 variants and viral p24 in the blood of infected patients; detected p24 with LoDs of 0.5-0.65 IU/ml (WHO International Standard, NIBSC code: 90/636); recognized HIV-1 M/O p24 genotypes and HIV-2 p26 (WHO Reference panels, NIBSC codes: 16/210 and 16/236, respectively), and demonstrated high specificity (>99.5%) with patient samples. Therefore, newly developed HIV antigen assay prototypes enabled the detection of HIV infection with high sensitivity and specificity. Recombinant HIV proteins were tested with clinical blood samples and confirmed to be reactive with corresponding HIV-positive samples of a specific type or group. For HIV-1 and HIV-2 antibody detection in the blood of patients, optimized two-site antigen combinations were evaluated in testing with clinical samples, containing common interfering substances. For HIV-1 antibody detection, two two-site antigen combinations were screened. Both combinations showed 100% sensitivity, with specificities of 99.83% (n=5901) and 99.86% (n=2957), respectively. For HIV-2 antibody detection, another two two-site antigen combinations were evaluated. Both achieved 100% sensitivity and 100% specificity (n=1638 and n=6683). Using recombinant HIV proteins expressed in mammalian cells and E. coli, unique combinations of antigens and their forms were developed to cover the diversity of measured antibodies while ensuring a minimal level of false-positive results. Using the above-described combinations of antigen and antibody assays, two HIV combo assay prototypes were constructed and demonstrated 100% sensitivity with specificities of 99.93% (n=4272) and 9","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"79 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086508","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-180 Performance of Anti-14-3-3eta Multiplex Autoantibody Assay in Differentiating Axial Spondyloarthritis from Diseases with Overlapping Symptoms","authors":"Anthony Marotta, Stephen Bleakley, Yuan Gui, Stephanie Wichuk, Walter Maksymowych","doi":"10.1093/clinchem/hvag086.482","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.482","url":null,"abstract":"Background Axial Spondyloarthritis (axSpA) is a chronic autoimmune disease often resulting in spinal fusion and significant disability if left untreated. A major challenge in early intervention is the prolonged diagnostic delay, typically 7-10 years, driven by symptom overlap with chronic lower backpain and frequent misdiagnosis in primary care as presentation can mimic other inflammatory diseases. Anti 14-3-3eta autoantibodies have been identified as a biomarker candidate capable of differentiating axSpA from inflammatory back pain. A validated serologic marker capable of discriminating axSpA from clinically overlapping autoimmune and inflammatory diseases could streamline differential diagnosis and accelerate referral. This study evaluates whether anti-14-3-3eta autoantibodies can distinguish axSpA from the broad range of inflammatory and arthritic diseases that commonly delay and complicate diagnosis. Methods Anti-14-3-3eta autoantibody levels incorporating five non-overlapping peptide regions of the 14-3-3eta protein were measured in a total of 151 serum samples using a Luminex multiplex immunoassay. Cohorts included patients diagnosed with axSpA (n=30) according to modified New York criteria, healthy controls (n=60), and disease controls representing conditions with overlapping symptomatology: rheumatoid arthritis (n=19), psoriatic arthritis (n=19), psoriasis (n=4), Crohn’s disease (n=4), ulcerative colitis (n=2), osteoarthritis (n=12), and gout (n=1), for a total of 151 samples. Anti-14-3-3eta autoantibody values were log10-transformed and analyzed using nominal logistic regression (JMP v18). For each peptide, a univariate model was fitted to assess its ability to classify axSpA versus controls. Model performance was summarized using likelihood-ratio, AICc/BIC, and ROC AUC. Optimal classification thresholds were determined using Youden’s index, and diagnostic odds ratios (DxOR) were calculated at these cut points. Statistical significance was set at p<0.05. Results As demonstrated in Figures 1A-E, anti-14-3-3eta autoantibody levels were significantly higher in axSpA when compared to healthy and disease controls across all peptides. ROC analysis (Figure 1F) demonstrated that all five peptides produced statistically significant discrimination. Peptide 2 demonstrated the strongest performance (AUC=0.657, p=0.0080), followed by Peptide 1 (AUC=0.637, p=0.0203), Peptide 3 (AUC=0.634, p=0.0307), Peptide 4 (AUC=0.628, p=0.0229), and Peptide 5 (AUC=0.598, p=0.0969). Univariate logistic regression confirmed significant associations for all peptides (4.49–6.30, p = 0.034–0.012; RSquare(U) = 0.030–0.042). At Youden’s optimal thresholds, diagnostic odds ratios ranged from 3.09 to 47.1, with Peptide 2 demonstrating the strongest discrimination (DxOR=47.1), followed by Peptide 4 (DxOR=20.4), Peptide 1 (DxOR=19.9), Peptide 3 (DxOR=15.7), and Peptide 5 (DxOR=3.09). Conclusion This study demonstrates that anti-14-3-3eta autoantibody responses provide ","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"14 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086509","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-369 Ensuring Quality of Free Hormone Measurements Through Detection of Membrane Leakage in Equilibrium Dialysis","authors":"Li Zhang, David Spector, William Perry, John Goodwin, Chui Tse, Ashley Ribera, Otoe Sugahara, Norma Vazquez, Uliana Danilenko, Hubert Vesper","doi":"10.1093/clinchem/hvag086.638","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.638","url":null,"abstract":"Background Hormones circulate in the body either bound to carrier proteins or unbound (free). The unbound fraction is considered the biologically active form and of greater clinical relevance for disease diagnosis than total hormone levels. Equilibrium dialysis (ED) of serum samples is considered the gold standard procedure for separating free hormones from their bound counterparts. However, membrane leakage during ED can lead to misleadingly elevated free hormone values due to contamination of free hormone in dialysate by bound ones, thereby compromising the diagnostic utility of free hormone biomarkers. In the current study, we used a free serum thyroxine (FT4) assay based on ED coupled with liquid chromatography-tandem mass spectrometry (LC-MS/MS) as an example to explore practical approaches for detecting membrane leakage, with the aim of enhancing the assay quality for free hormone measurement. Methods A commercially available micro-ED plate with dialysis membrane of 8 kDa molecular weight cut-off was employed to separate FT4 from bound T4. FT4 extraction from the dialysate was performed using a 96-well C18 solid-phase extraction (SPE) plate, followed by quantification via LC-MS/MS in positive ion mode. Certified primary reference material was utilized for FT4 assay calibration. To verify ED membrane leakage, each serum sample was measured in duplicate. Leakage was determined using two different approaches: First, if two FT4 replicate measurements differed by more than 25%, the dialysate was classified as contaminated. Second, the contaminated dialysates were crystallized with a-Cyano-4-hydroxycinnamic acid (CHCA) and subsequently analyzed using matrix-assisted laser desorption time-of-flight mass spectrometry (MALDI-MS) to identify macromolecule biomarkers present in the contaminated samples. Results By comparing duplicate measurements of the same samples, we identified approximately 4% of dialysate samples exhibiting membrane leakage. MALDI-MS analysis indicated that human albumin (molecular weight: 66.5 kDa) was the predominant protein present in samples with leakage during ED, while it was absent in the non-contaminated samples. The sensitivity of MALDI-MS is adequate to detect 1:50,000 (v/v) serum contamination in the dialysate. Conclusion MALDI-MS offers a sensitive, high-throughput, and cost-effective method for detecting ED membrane leakage, thereby improving the quality of free hormone assays, including FT4 assay. Disclaimer: The findings and conclusions in this report are those of the author(s) and do not necessarily represent the official position of the Centers for Disease Control and Prevention/the Agency for Toxic Substances and Disease Registry. Use of trade names is for identification only and does not imply endorsement by the Centers for Disease Control and Prevention, the Public Health Service, and the US Department of Health and Human Services.","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":"149086511","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-415 Agreement Between Colorimetric Roche Cobas PRO and ICP-MS Zinc Assays in Blood Samples","authors":"Waleed Tamimi, Khaled Ahmad, Monzer Elsafdi, Ahmad Kamaleddine, Mohammed Alabdullatif, Majd Alharbi, Khalid Sumaily, Khalid Al-Qahtani, Ahmed Alakedi, Osamah khojah, Omar Almugren, Mohamed Babiker, Sara Zubair, Kareem Shehata, Duaa BinKhalaf","doi":"10.1093/clinchem/hvag086.682","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.682","url":null,"abstract":"Background Accurate measurement of zinc concentrations in blood is essential for assessing nutritional status and diagnosing deficiency. This study compared zinc results obtained using the Roche Cobas Pro colorimetric assay with those generated by inductively coupled plasma mass spectrometry (ICP-MS), the analytical reference method. Methods A total of 22 patient serum blood samples collected in royal-blue top tubes, spanning a concentration range of 55–97?µg/dL, were analyzed by both techniques. This study was conducted on January 2026 between the laboratory of King Abdelaziz Medical City and Medical Diagnostic laboratory of Dr Suliman Al-Habib Sahafah Hospital, both in Riyadh of Saudi Arabia. Direct colorimetric test without deproteinization of the sample. At pH 8.6, in a buffered media, zinc reacts with the specific compound (5-Br-PAPS): Bromo-pyridylazo propyl-N-(3-sulfopropyl) amino] phenol, forms a stable-colored complex and measured at wavelength 560nm. The color intensity is proportional to the amount of zinc present in the sample. The results of CAP proficiency samples were also compared for the two assays. Results Method comparison demonstrated strong agreement, with a correlation coefficient of ??= 0.9269, indicating a high degree of linear association across the tested range. There were 6 samples (27%) with zinc deficiency by colorimetric method with 83% agreement with ICP-MS method. On the other hand, a 100% agreement was found in the normal samples between the two assays. The reference interval was verified for the colorimetric Roche Cobas and found to be between 68 to 107 ug/dL. The CAP proficiency of 3 samples (R-01, R-02, R-03) for years 2024 and 2025 have shown a good agreement between the two assays. Conclusion While minor proportional differences were observed, the overall performance of the Cobas colorimetric method showed good concordance with ICP-MS, supporting its suitability for routine clinical zinc measurement when rapid, high-throughput analysis is required.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"35 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086532","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-248 From Static to Dynamic: Establishing Next-Generation Reference Intervals for Cerebrospinal Fluid Biomarkers Using a SOM+refineR Framework","authors":"Lihua Guan, Chaochao Ma, Ermu Xu, Lian Hou, Liu Qiam, Liangyu Xia, Ling Qiu","doi":"10.1093/clinchem/hvag086.538","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.538","url":null,"abstract":"Background Cerebrospinal fluid (CSF) biomarkers, including chloride (Cl), glucose (Glu), and total protein (Pro), play a vital role in diagnosing and monitoring central nervous system (CNS) disorders. However, ethical and practical challenges limit the direct establishment of reference intervals (RIs) from healthy populations. Methods Using real-world data from the Laboratory Information System of Peking Union Medical College Hospital, this study applied a combined self-organizing map (SOM) and refineR framework to identify presumptively healthy individuals. Age-overlapping subgrouping and penalized spline modeling were used to construct continuous, age-dependent next-generation RIs (NGRIs) for CSF Cl, Glu, and Pro. Sex- and age-related variations were assessed by standard deviation ratio (SDR) and visual analyses. Results The SOM?+?refineR approach effectively reduced abnormal data influence and generated robust, population-specific RIs. CSF-Cl remained stable across age and sex. CSF-Glu exhibited a mild, age-related increase consistent with systemic glucose trends. CSF-Pro concentrations were higher in males than in females and showed a progressive rise with aging, likely reflecting physiological changes in blood–brain barrier permeability and protein metabolism. Conclusion This study provides the first comprehensive, data-driven NGRIs for major CSF analytes using an integrated SOM + refineR approach. The resulting age- and sex-specific continuous RIs offer improved precision and clinical applicability, supporting individualized laboratory interpretation in neurological diagnostics.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"12 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086536","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-313 Environmental impact of electronic test ordering and reduced specimen recollection in a hospital laboratory","authors":"Carolina Prieto, Haydee Gallardo, Karen Castillo","doi":"10.1093/clinchem/hvag086.255","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.255","url":null,"abstract":"Background Clinical laboratories generate significant paper consumption and single-use plastic waste. Digital transformation and process optimization may reduce environmental impact while improving quality of care. This study quantified the environmental benefits associated with implementation of electronic laboratory test ordering and reduction of specimen recollection in a hospital laboratory. Methods A quality improvement initiative implemented electronic test ordering for hospitalized patients, reaching 82% adoption in 2025 (33,013 electronic requests). Paper savings were estimated based on avoided printed request forms. In parallel, reductions in identification-related specimen rejection were analyzed (2024 vs 2025). Avoided repeat venipunctures were estimated assuming 80% of rejected identification cases require recollection. Plastic mass avoided was calculated based on average weights of PET blood collection tubes (3.4 g) and nitrile gloves (3.5 g per glove). Carbon dioxide equivalents (CO2e) were estimated using cradle-to-gate emission factors for paper and plastic. Results Electronic ordering avoided 33,013 printed request forms, corresponding to approximately 165 kg of paper and an estimated 180 kg CO2e avoided in 2025. Reduction in identification-related errors (28.4% to 8.6%) prevented 392 rejection events and an estimated 314 repeat venipunctures. Depending on 1–2 tubes per recollection, 314–628 blood collection tubes were avoided. Total plastic reduction (tubes plus gloves) was estimated at 3.3–4.3 kg, corresponding to an additional 10–14 kg CO2e avoided from plastic manufacturing. Total combined CO2e reduction associated with the initiative was approximately 190–194 kg CO2e in 2025. Conclusion Electronic test ordering and improved specimen identification reduced both clinical errors and environmental impact. Digitalization in laboratory medicine can support measurable sustainability gains while reinforcing patient safety, supporting environmentally responsible quality improvement in healthcare.","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":"149086657","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}