Clinical chemistry最新文献

{"title":"A-321 Performance evaluation of a rapid, universal and automation amenable sepsis diagnostic workflow that identifies pathogens and determines their antimicrobial resistance directly from whole blood","authors":"Ramya VM, Divya Khandige Sharma, Rangarajan Sampath, Megan Carpenter, Ishita Chakraborty, Thomas A Hall, Michael Mosel, James Hannis, Lisa Risen, Christine Marzan, Robert Bonomo","doi":"10.1093/clinchem/hvaf086.309","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.309","url":null,"abstract":"Background Fast and accurate diagnosis of bloodstream infections (BSIs) is critical for administering an appropriate treatment regimen in patients, who face hourly-increasing mortality risk due to sepsis. The current gold standard technique is blood culture, and it takes 15 to 72 hours for pathogen identification (ID) and an additional 8 to 15 hours for antimicrobial susceptibility (AST). Apart from the long turnaround time, blood culture is prone to false positives and negatives. Most of the nucleic acid-based methods in the market also require blood culture as a starting sample and/or are limited in identifying pre-defined set of pathogens and antimicrobial resistance (AMR) genes. Hence, the availability of a rapid, agnostic pathogen diagnostic for sepsis which detects pathogens and associated AMR directly from whole blood in a clinically actionable turnaround time, remains a major unmet need in managing critically ill patients. Towards advancing the field of sepsis diagnostics, we have developed a cutting-edge approach called ASPIRE: Agnostic Sepsis Pathogen Identification and REsistance determination. This workflow is rapid, agnostic, quantitative, automation amenable and based on nanopore sequencing that can report pathogen ID and AMR determinants, directly from whole blood, within 6 to 8 hours. The workflow is illustrated in figure 1. Methods We evaluated the performance of ASPIRE workflow using 3 to 5 mL contrived blood samples (n=50) spiked with typical BSI bacteria and fungi at 10 to 100 CFU/mL. We also tested =1.0 mL clinical samples (n=50 confirmed positives and 10 confirmed negatives, tested as blinded samples) to evaluate the clinical concordance of the ASPIRE workflow with blood culture outcomes. Results The ASPIRE workflow can detect 10-100 CFU/mL of spiked bacteria and fungi in 6 to 8 hours turnaround time. We have achieved removal of 95 to 99% human genomic DNA from 3 mL blood samples. Multiple AMR determinants were also detected within blinded clinical samples. We observed significant concordance with clinical samples. Conclusion ASPIRE is a novel, cutting-edge, rapid, and universal Sepsis diagnostic workflow that can identify pathogens and characterize their AMR, directly from whole blood. Clinical studies showed significant concordance between blood cultures and ASPIRE workflows. This work has been supported by NIH-NIAID funding under the contract 75N93023C00025","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"11 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203212","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-003 Assessing the role of KMT2D in muscle regeneration to understand hypotonia symptoms associated with Kabuki Syndrome","authors":"Sarah Hachmer, F Dilworth","doi":"10.1093/clinchem/hvaf086.403","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.403","url":null,"abstract":"Background Kabuki syndrome (KS) is a rare multi-systemic genetic condition affecting 1 in 32,000 individuals globally. It is characterized by symptoms such as dysmorphic facial features, developmental delays, intellectual disabilities, and hypotonia. Muscle weakness as a result of hypotonia is a concern among patients and their families, causing significant impact on their quality of life. Genetic testing has shown that 80% of KS cases are caused by pathogenic mutations in the histone methyltransferase KMT2D. KMT2D is an epigenetic factor responsible for commissioning enhancer regions through the mono-methylation of histone 3 lysine 4 (H3K4me1). The muscle regeneration pathway requires the expression of tissue-specific genes that are tightly regulated to control cell fate transitions, which likely occurs through the commissioning of enhancer regions. Thus, it is our goal to identify the function of KMT2D in muscle stem cells (MuSCs) and explore whether KMT2D mutations in MuSCs contribute to the hypotonia phenotype that is observed in KS patients. Methods We used a mouse model with a MuSC-specific inducible deletion of KMT2D. Heterozygous deletion mice (KMT2DscKO/wt) represent a KS-like state and are compared to homozygous deletion mice (KMT2DscKO/scKO) and wildtype mice (KMT2Dwt/wt). To specifically investigate the enzymatic function of KMT2D, we used a knock-in mutant KMT2D (KMT2DKI) that is catalytically dead. We have performed in vivo and in vitro studies to characterize the muscle regeneration capabilities of MuSCs, looking at overall regeneration and the effects on distinct pathway stages. Additionally, we have performed RNAseq and CUT&Tag analyses to identify and characterize genes directly regulated by KMT2D. Results Using the outlined mouse models, we ablated KMT2D expression in MuSCs and tested muscle regeneration capabilities. Following acute cardiotoxin-induced injury, the KMT2DscKO/wt, KMT2DscKO/scKO, and KMT2DKI mice had impaired muscle regeneration with phenotypic defects observed in a protein concentration dependent manner. In vitro analysis of the distinct stages of muscle regeneration showed that both deletion of KMT2D and expression of enzyme mutant KMT2D resulted in impaired differentiation capabilities. RNA-seq analysis at the differentiation time point identified ∼1200 dysregulated genes, the majority being downregulated. Integration of KMT2D binding results from CUT&Tag identified direct targets including essential fusion genes. Comparing KMT2DscKO to KMT2DKI, we show that regulation of KMT2D target genes occurs in either an enzyme-dependent or enzyme-independent manner. Conclusion Our results show KMT2D to be important for the expression of genes involved in muscle cell fate changes, with gene dysregulation leading to impaired regenerative capabilities. We find that KMT2D functions in an enzyme-dependent and enzyme-independent manner. Together, these results provide the first mechanistic insight into the role of KMT","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"101 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203316","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-015 Verification of the ESC hs-cTnT guidelines for suspected acute coronary syndromes: real world data","authors":"C S Lau, L F Yew, S K Phua, T C Aw","doi":"10.1093/clinchem/hvaf086.015","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.015","url":null,"abstract":"Background High-sensitivity cardiac troponin T (Hs-cTnT) remains indispensable in the management of acute coronary syndromes (ACS). The European Society for Cardiology (ESC) 0/1- and 0/2-hour hs-cTnT algorithms are used to rule out ACS. Where serial testing is performed, the number of cases in the observed zone can be reduced in patients with moderately raised initial hs-cTnT values. We describe the distribution of rule-in/out subjects in our institution, using the ESC 0/2-hour hs-cTnT (Roche) algorithm. Methods We reviewed the hs-cTnT results of subjects with serial hs-cTnT testing between 2023 to 2024 (n = 868) and evaluated their results according to established ESC Roche hs-cTnT guidelines for ACS diagnostic categories. Subjects with an initial hs-cTnT of <5.0/>52 ng/L are immediately ruled-out/in for ACS. For subjects with initial hs-cTnT 5.0-14 ng/L, and a 0/2H delta of <4.0/>10 ng/L are ruled-out/in respectively; all other cases remained in the observation zone. For subjects with initial hs-cTnT >14 to 52 ng/L, a second sample delta <4.0 or 4.0-10 ng/L remains in observation while a delta >10 ng/L is ruled-in for ACS. Results The first hs-cTnT sample ruled out/in 40/355 subjects (4.6/40.9%), with 473 subjects (54.5%) requiring further observation. Only 1 of the 40 subjects ruled out for ACS had elevated 0/2H delta hs-cTnT (suspected early presenter, first and second sample 4.0 and 28 ng/L respectively). In the observation cohort, 147 subjects had an initial hs-cTnT between 5.0-14 ng/L, of which 129 had a delta <4.0 ng/L after a second sample, 9 had a delta of 4.0-10.0 ng/L, and 9 had a delta of >10.0 ng/L. 326 subjects had an initial hs-cTnT of >14-52 ng/L, of which 204 had a delta of <4.0 ng/L, 54 had a delta of 4.0-10.0 ng/L, and 68 had a delta of >10 ng/L. In total, this resulted in an additional 129/77 subjects being ruled-out/in for ACS after the second sample, with only 267 subjects (30.8%) remaining for further observation (see Figure 1), resulting in a total of 169 subjects being ruled out for ACS (4.6% to 19.5%), and a total of 432 subjects being ruled in (40.9% to 49.8%). Conclusion A single cut-off of an initial hs-cTnT of <5.0 ng/L resulted in 1 early presenter being ruled out for ACS (2.5%). Serial sampling is valuable to reduce the cases in the observation zone as well as increasing the number of rule-out/in cases. The 0/2-hour ESC algorithm performed well in our hospital.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"11 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145202934","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-008 Unveiling Molecular Mechanisms and Biomarkers of Eosinophilic Myocarditis: Insights from a Mouse Model and Single-Cell RNA Sequencing","authors":"Usman Sunusi, Ben Ziegelmeyer, Immaculeta Osuji, Mario Medvedovic, Haley Todd, Joe Abou-Khalil, Nives Zimmermann","doi":"10.1093/clinchem/hvaf086.408","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.408","url":null,"abstract":"Background Hypereosinophilic syndromes (HES) are rare disorders characterized by unexplained, persistent eosinophilia (>1,500 eosinophils/mm³) and evidence of eosinophil-mediated end-organ damage. Among the most severe complications is eosinophilic myocarditis (EM), which contributes to significant morbidity and mortality in approximately 60% of HES patients. Diagnosing EM remains challenging as patients often present without cardiac symptoms, and traditional diagnostic tools, including electrocardiography and echocardiography, frequently yield unremarkable results. While advanced imaging modalities such as cardiac magnetic resonance imaging and endomyocardial biopsy can aid diagnosis, they are effective primarily in advanced disease stages. Despite these clinical challenges, the molecular drivers of EM and early diagnostic biomarkers remain largely unexplored. This study aims to develop and characterize models of EM, explore its intricacies, and identify early diagnostic markers and therapeutic targets. Methods We developed and characterized a mouse model of eosinophilic experimental autoimmune myocarditis (eoEAM) using hypereosinophilic (CD2-IL5 transgenic) mice immunized with cardiac myosin peptide. This model replicates key features of human EM. Disease progression was assessed using heart histology, flow cytometry, complete blood counts, RT-PCR, and circulating biomarkers including cell-free DNA (cfDNA) and cardiac troponin. Single-cell RNA sequencing (RNA-Seq) was also performed to map inflammatory and resident cardiac cell populations, identifying gene signatures and enriched pathways associated with disease. Results After three weeks, the eoEAM model exhibited eosinophil-predominant cardiac inflammation. Peripheral blood analysis revealed elevated cardiac troponin and cfDNA, indicating systemic markers of myocardial damage and cell death. However, these markers lacked specificity for EM. scRNAseq of the heart uncovered distinct populations of inflammatory cells, including eosinophils, and resident cardiac cells driving the disease process. Novel gene signatures and enriched pathways critical to the pathogenesis of EM were identified, offering potential avenues for biomarker discovery and therapeutic intervention. Conclusion We successfully established a reproducible mouse model of eoEAM that mimics human eosinophilic myocarditis. While serum troponin and cfDNA serve as systemic markers of cardiac injury, they are nonspecific. In contrast, single-cell transcriptomics revealed unique gene signatures and pathways that provide a foundation for developing noninvasive and disease-specific biomarkers. This study highlights the potential of advanced molecular approaches in elucidating the pathophysiology of EM and improving diagnostic accuracy. This work emphasizes the integration of molecular diagnostics into clinical practice, advancing precision medicine for eosinophilic myocarditis and related diseases.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"39 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203149","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-206 Instilling Diagnostic Stewardship through Pathology Resident Triage of Referral Testing","authors":"Maitri Mehta, Andreas Kontosis, Kristen Krum, Anastasia Gant Kanegusuku, Amanda Harrington, Jack Maggiore","doi":"10.1093/clinchem/hvaf086.200","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.200","url":null,"abstract":"Background Formal laboratory directorship education varies amongst institutions. Typically lecture-based curriculum highlights core competencies including: scientific knowledge, management and leadership skills, quality assurance and regulatory compliance, ethics, safety, and budgeting and financial management. Our institution has implemented clinical pathology call (“Keeper of the Beeper” or “KOB call”) to prepare pathology residents to investigate transfusion reactions, positive meningitis panels, critical lab values, as well as referral testing triage. The referral testing triage emphasizes the budgeting and financial management competency by learning how to manage lab resources and help ensure that the lab continues to operate within their financial means while maintaining a high level of patient care and providing direct experiences in clinical consultation to other medical services. Methods Referral tests, which cost greater than $1000, are evaluated to assess the utility and medical necessity. This evaluation process includes review of the patient’s chart to find the clinical indication for the test ordered, and in some cases, discussion with the clinical team and ordering physician if the indication was not clear from initial chart review. Information regarding the patient’s status of inpatient or outpatient was documented. After complete evaluation, the test was either approved, rejected, and/or provision of alternate testing options were provided. Tests greater than $1000 and on the Department of Pathology referral testing formulary are eliminated from evaluation and automatically approved. Results Over an 8-month period, 8 tests were rejected for send out referral testing through our triaging protocol. The reasons for rejections included: redundancy (n=2), incorrect order (n=1), non-contributory (n=2), deviation from standard of care (n=2), or research purposes (n=1). Of note, 5 of the 8 rejected tests were ordered in the inpatient setting, for which institutional billing of these non-indicated tests would have directly affected our department budget. The rejected tests resulted in total direct savings of $21,175. Conclusion Lab triage of send out tests is a crucial aspect of laboratory management to ensure both efficiency and diagnostic stewardship in providing patient care. While our data are somewhat limited, we are observing trends in a positive direction that demonstrates the value that Pathology Residents are able to provide while gaining firsthand exposure to the roles of a laboratory director. The implementation of this protocol has yielded valuable insight into frequently ordered tests, allowing us to expand the pre-approved list in our formulary. These data also serve as a critical resource should the decision be made to bring these tests in-house. We believe this is a model that could be easily replicated at other academic medical centers and should be considered as a tool for teaching aspects of diagnostic stewardship in Pa","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"2 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203313","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-225 Translating GWAS into Clinical Practice: Real-World Utility of a Polygenic Risk Score for Diabetes Risk Stratification","authors":"Inhwa Jeong","doi":"10.1093/clinchem/hvaf086.613","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.613","url":null,"abstract":"Background Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder which arises from a complex interplay of genetic, environmental and behavioral factors. We evaluated the clinical utility of polygenic risk score (PRS)-based multigene panel test for predicting diabetes mellitus (DM) in a healthy population. Methods Overall, 302 individuals underwent genetic testing using the HelloGene™ DM panel, which comprises four DM-related SNPs (CDKAL1, HHEX, KCNQ1, TCF7L2). Each genotype was analyzed using a PRS algorithm based on a dataset of 70,000 Koreans, classifying participants into four risk groups (low, moderate, high, and very high). Fasting blood glucose (FBG), glycated hemoglobin (HbA1c), and body mass index were measured at baseline and after at least 3 years of follow-up. Smoking status, alcohol use, and exercise status were recorded. Results No significant differences in age, sex, or lifestyle habits were observed among the PRS groups. The ‘very high risk’ group had significantly higher 3-year follow-up FBG (p=0.001) and baseline/3-year follow-up HbA1c (p=0.025 and 0.001, respectively) levels (Table 1). The ‘very high risk’ group had a 4.5-fold higher risk of developing DM compared to other groups (Table 2A). Smoking was a significant modifier of genetic risk; smokers in the ‘very high-risk’ group had a 25% greater likelihood of developing DM. CDKAL1, HHEX, and TCF7L2 genotype carriers were prevalent in the individuals diagnosed with DM, while HHEX carriers in the ‘high risk’ group showed the greatest susceptibility, especially among current smokers (Table 2B). Conclusion PRS-based genetic testing demonstrated clinical utility in DM risk prediction. Elevated FBG and HbA1c levels in the high PRS group emphasize the importance of early identification. Smoking significantly increases genetic risk, underscoring the need for targeted interventions in genetically susceptible individuals.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"62 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203315","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-392 Breaking barriers in blood testing with a phlebotomy-free approach to near-patient diagnostics with Truvian’s multi-modal platform using microneedle capillary collection","authors":"Florence Lee, Renee Higgins, Nicholas Haase, Thomas Briggs, Michael Mina, Dena Marrinucci","doi":"10.1093/clinchem/hvaf086.376","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.376","url":null,"abstract":"Background Blood testing is the backbone of modern medicine, yet traditional lab-based testing remains inconvenient, costly, and often inaccessible—especially for those without easy access to phlebotomy services. Delays owing to phlebotomy appointments, specimen transport or fear of needles means that many healthcare decisions are made without up-to-date labs. Truvian’s novel multi-modal benchtop platform is designed to change that by bringing high-quality, comprehensive blood testing directly to the patient at the point of care for real-time lab results of the most commonly ordered tests. This fully automated benchtop device has been independently validated to deliver results concordant with central laboratory analyzers in previous studies. Capable of simultaneously running chemistry, immunoassay, and hematology panels from a single small-volume blood sample, the platform eliminates the need for large-volume venous draws and specially trained operators. However, venous draws remain standard-of-care for routine blood testing due to conventional capillary blood collection methods still struggling with sample integrity, volume, and reliability—particularly for tests like complete blood counts (CBC). To overcome these limitations and enhance test accessibility in settings where trained phlebotomists are unavailable, we developed a novel phlebotomy-free capillary self-collection device (TAP) designed to work seamlessly with the Truvian Platform and the TruWellness Panel™—a 34-test panel covering key biomarkers, including metabolic markers, lipids, HbA1c, TSH, and CBC. This study demonstrates the feasibility of using TAP to generate high-quality capillary blood samples compatible with comprehensive lab-grade near-patient real-time testing using the Truvian platform. Methods Paired venous and capillary whole blood samples were collected from consented donors (N = 50). Licensed phlebotomists performed venous draws, while participants self-collected capillary blood using different TAP device configurations. Samples were analyzed on the Truvian Platform to assess performance, accuracy, and concordance. Results Capillary samples self-collected with the primary TAP device yielded >350 µL of high-quality blood in under 75 seconds and showed low hemolysis (< 50 mg/dL plasma free hemoglobin) in 90% of samples. These samples demonstrated strong agreement for 21 of 23 measured analytes (mean bias within ± 10%) on the TruWellness Panel™ relative to venous samples. Initial capillary collections showed negative biases for white blood cell (WBC) and platelet (PLT) counts, primarily due to cell clumping. However, modified TAP device configurations designed to minimize and delay the blood clotting cascade significantly reduced clotting and improved WBC and PLT accuracy. Conclusion This study demonstrates the feasibility of using a blood sample collected from a phlebotomy-free capillary collection method to support high-quality, comprehensive blood testin","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"9 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203694","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-345 Evaluating the Clinical Utility of Urine hCG testing in Community Laboratory Service","authors":"Sisu Han","doi":"10.1093/clinchem/hvaf086.330","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.330","url":null,"abstract":"Background Accurate and sensitive pregnancy detection is needed to identify patients that require timely access to prenatal care and to ensure medications or treatments that may be harmful to the pregnant patient and/or their fetus are avoided. Human chorionic gonadotropin (hCG), detectable in urine and blood, is a reliable biomarker of pregnancy due to its rapid rise post-implantation. Qualitative urine hCG testing is non-invasive but has drawbacks, such as lower analytical sensitivity and the need for manual processing that can lead to patient misidentification. Conversely, quantitative serum hCG offers higher analytical sensitivity, can be fully automated, detects conditions such as ectopic and molar pregnancies via serial measurements, and is commonly performed on the primary specimen preventing aliquoting errors. Despite these benefits, the invasive nature of blood collection may deter some patients from serum hCG testing. In our health system, both urine and serum hCG testing is offered to community patients, presenting an opportunity to optimize resource use. When a blood specimen with the appropriate container type has been concurrently collected to facilitate other laboratory testing (ie. TSH, serum creatinine), replacing a urine hCG order with a serum hCG order can improve diagnostic accuracy for the patient and provide workflow efficiencies for the laboratory without an additional venipuncture. However, the feasibility of replacing urine hCG with serum hCG testing in a community setting remains unclear. This study assessed urine hCG test utilization and identified opportunities to transition to serum hCG testing without an additional blood collection. Methods Data between April 2022 and March 2024 were extracted from the laboratory information system for urine hCG tests performed at the two large community testing laboratories in Alberta, Canada (catchment population 4.8 million). Urine hCG samples that also had a serum or plasma collected within two hours were identified. For these samples, we assessed the number of urine collections that could be avoided if urine hCG was the sole test ordered on the urine specimen. Cost savings were estimated by comparing the costs of urine and serum hCG testing, factoring in the elimination of the urine collection. Results Between April 2022 and March 2024, 20,090 urine hCG tests were performed at two community reference laboratory sites. 72.0% and 72.9 % of urine hCG tests at Site 1 and Site 2 respectively, had concurrent blood draws with specimen types suitable for serum hCG testing. Urine hCG was the sole urine test ordered in 42.7% and 44.8% of the tests performed at Site 1 and Site 2, respectively. Shifting from urine to serum hCG testing when there is a concurrent draw of an appropriate blood specimen would lead to 19.7% and 20.6% reduction in the cost for hCG testing at Site 1 and Site 2, respectively. Conclusion In a community setting, as many patients have suitable blood specimens collected","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"63 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203005","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-028 Absorbance vs. Chemiluminescent: A Comparison of Two Different Enzyme-Immunoassay Methods of Digoxin Measurement","authors":"S M Touhidul Islam","doi":"10.1093/clinchem/hvaf086.426","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.426","url":null,"abstract":"Background Digoxin is a cardiac glycoside which is commonly used for the treatment of congestive heart failure as well as some cardiac arrhythmias. Treatment with digoxin increases intracellular calcium ions and cardiac contraction and slows down the heart rate. Therapeutic range of digoxin is narrow. Excess administration of Digoxin could result in toxicity undistinguishable from original cardiac symptoms. Although the therapeutic and toxic concentration overlaps, measurement of digoxin helps to maintain effective concentration and prevent overdose. Enzyme-immunoassays are widely used to measure the concentration of digoxin. Absorbance and chemiluminescent Enzyme-immunoassays are two common methods used to measure digoxin. This study reports a detailed comparison of these two methods which could assist in choosing a more appropriate one for digoxin measurement. Methods This retrospective study was a part of the validation study of Beckman AU680 and AU5800 chemistry analyzers performed at Albany Medical Center. Absorbance and chemiluminescent Enzyme-immunoassays for digoxin measurement were performed on Beckman AU5800 and AU680 analyzers, respectively. Linearity data was used to determine the average percent recovery. Quantitative method correlation was performed by applying Deming, Passing-Bablok, and Regular regression analyses and used to determine the bias with reference method. Comparison of method specifications were based on published literature investigation. Results While both absorbance and chemiluminescence methods are immunoassay-based, they have some differentiating and similar criteria as well. Although they are similarly impacted by endogenous and exogenous interferents, chemiluminescence method have a favorable calibration frequency, analytical measurement range, and reportable range. While mean percent recovery was comparable for both absorbance and chemiluminescence methods, chemiluminescence method displayed a reduced systematic bias and imprecisions as compared to absorbance method. Slopes of Deming and regular regression analyses of chemiluminescence method displayed proportional biases. On the other hand, intercepts of Deming, Passing-Bablok, and regular regression analyses of absorbance method displayed constant biases (Table 1). Statistical analyses were performed by using EP evaluator and GraphPad Prism. Conclusion Given Beckman chemistry analyzers are standardized, difference of immunoassay methods could result in variation of validation specifications. In this study, chemiluminescence immunoassay exhibited lesser bias and imprecision as compared to absorbance immunoassay.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"28 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203113","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-359 The prevalence of multiple myeloma and types among age groups and gender as well as M-component correlation with biochemical parameters","authors":"Bibek Poudel, Ibrahim Hashim","doi":"10.1093/clinchem/hvaf086.744","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf086.744","url":null,"abstract":"Background Multiple Myeloma (MM) is often characterized by laboratory detection of a monoclonal band on protein electrophoresis and the finding of elevated free light chains (FLC) ratio. Although several risk factors for MM have been reported, the association of monoclonal type and extent of FLC production with the patient’s gender and age are far less pronounced. This study investigated the relative distribution of monoclonal isotype and FLC ratio among patients with MM, their age, and the various MM-associated comorbidities. Methods This is a retrospective study from a large county hospital. Laboratory and clinical findings among patients presenting to a large public safety count hospital between January 2021 and December 2024 were reviewed. Protein electrophoresis and immunofixation were performed using the Seibia system, whereas FLC measurements were performed at a reference laboratory using an immunoturbidimetry-based methodology. Results A Total number of 269 patients with protein electrophoresis results were entered into the study. Among the study patients, 71(26.4%), 57(21.2%), 24(8.9%), 60(22.3%), and 92 (34.2%) had a clinical presentation of bone disorder, chronic kidney disease, anemia, neuropathy, and hematological bone malignancy respectively. 91(34%) patients expressed monoclonal bands on electrophoresis. There were no gender differences (male= 45 (16.7%) and female 46 (17.1%)). The prevalence of MM among the 30-39, 40-49, 50-59, 60-69, and >70 years age groups had 1%, 9.9%, 16.5%, 45%, and 27.5% respectively. The monoclonal bands frequence among study patients were typed as IgG-kappa in 50 (54.9%), IgG-lambda in 21(23.1%), IgA-kappa in 6(6.6%), IgA-lambda in 9(9.9), IgM-kappa in 3(3.3%) and IgM-lambda in 2(2.2%) patients. Patients with MM had a significantly higher level of total protein (p-value 0.04), globulin (p-value 0.029), and FLC-ratio (p-value 0.022) compared to patients without an M-component. The level of the respective M-component positively correlated with FLC-kappa (p-value<0.0001) and FLC-ratio (kappa/lambda) (p-value<0.0001) whereas the level significantly but negatively correlated with hemoglobin levels (P< 0.006). However, we did not observe a significant correlation between the respective M-component and FLC-lambda (P 0.6319). Conclusion Although there was no apparent gender association, this study showed that the prevalence of multiple myeloma increases with age and that IgG-kappa is the predominant type followed by IgG-lambda.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"59 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203116","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}