Clinical chemistry最新文献

{"title":"A-393 Can anyone do it? Measuring lay user success when using a home capillary blood collection, separation, and temperature controlled shipping kit","authors":"Gabriella Iacovetti, Nicolas Tokunaga, Mitchell Peevler, Jason Ragar, Greg Sommer, Ulrich Schaff","doi":"10.1093/clinchem/hvag086.320","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.320","url":null,"abstract":"Background Home capillary blood collection faces challenges with sample volume and quality. Without the ability for venous draws, timely separation, and temperature control, self-collection of blood at home has had limited test menus and availability. Here we show a study evaluating usability and specimen quality using the Labcorp Comfort Draw ™ Home Collection Kit for lay user home blood collection, separation, and temperature-controlled shipping. Methods N=44 subjects were consented to participate in this study. These subjects were mailed kits including the following: a Labcorp Comfort Draw device for capillary blood collection and accessories, a TrueSpin™ Centrifuge, and a TrueTherm™ flask for sample shipment. Instructions, a usability survey, and a link to a recommended instructional video were also included. Subjects independently followed the instructions to complete blood collection and separation using kit components and mailed the sample back in the provided TrueTherm flask for temperature protection using overnight shipping. Returned kits were evaluated for correct return, volume of blood collected, volume of serum, visual hemolysis, cell contamination of serum, and temperature stability below 30 °C during shipment. Results Of the n=44 consented subjects, 40 subjects returned the kits. 91.9% of measurable samples contained at least 200 µL of blood and 97.1% of those samples contained at least 80 µL of serum. A mean blood volume of 539.9 µL and a mean cell concentration of 4.65 M/mL were found in returned serum and 94.4% of samples were graded “-“ on hemolysis. 100.0% of the samples were kept below 30 °C during shipping. The total collection success rate of the study was found to be 87.5% defined as separated samples received with at least 80 µL serum out of subjects who returned kits. Conclusion Subjects were able to collect their own capillary blood samples, separate them, and ship them under thermal protection using the Labcorp Comfort Draw Home Collection Kit. Utilizing this kit provided adequate protection from hemolysis and the vast majority of subjects were able to return a testable sample. These results indicate that the Comfort Draw is a viable option for home capillary self-collection and that when combined with the TrueSpin and TrueTherm flask, testable samples can be shipped by untrained users and may increase test menu availability for home collected samples.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"80 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086542","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-399 Analytical performance of enzymatic amperometric glucose and creatinine sensors for the Fluxergy multimodal point-of-care platform","authors":"Dmitriy Ruckodanov, Matthew Soto, Peter Lamberg, Esmeralda Ruiz-Garcia, Qinyi Yan, Cesar Gomez, Sahir Gandhi, Mariusz Banaszczyk, Roy Heltsley, Tej Patel","doi":"10.1093/clinchem/hvag086.324","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.324","url":null,"abstract":"Background Point-of-care (POC) metabolic testing requires robust amperometric sensors capable of accurately quantifying clinically relevant analytes across wide concentration ranges while maintaining manufacturability and scalability. Enzymatic amperometric sensing of glucose and creatinine presents challenges related to non-ideal electrode behavior, enzyme kinetics, and matrix effects. This study evaluates the analytical performance of enzymatic glucose and creatinine sensors integrated into a multimodal POC platform with respect to FDA-cleared benchtop reference systems, with an emphasis on calibration, accuracy, and robustness across clinically relevant concentration ranges. Methods Amperometric glucose and creatinine sensors were evaluated using aqueous and biological samples spanning concentrations relevant to intended clinical use (glucose: 20–450 mg/dL; creatinine: 0.3–12 mg/dL). Sensors employed enzyme-based reaction cascades and were tested under controlled assay conditions. Sensor responses were compared against measurements obtained from a Nova Stat Prime Plus reference analyzer. Calibration approaches incorporated data-driven correction methods to account for nonlinear sensor response and electrode-specific variability. Analytical performance was assessed using correlation analysis, bias evaluation, and agreement with established clinical accuracy criteria. Manufacturing reproducibility was evaluated by testing sensors from multiple production batches. Results Both glucose and creatinine sensors demonstrated strong correlation with the reference analyzer across the evaluated concentration ranges in aqueous and biological matrices. Data-driven calibration and correction approaches improved linearity and reduced bias without introducing instability or increased variability. Most tested samples met applicable clinical accuracy expectations (as defined by the 2025 CLIA limits) across the reportable range for both analytes. Sensor performance remained consistent across production batches, indicating acceptable manufacturing reproducibility. Conclusion These results demonstrate that enzymatic amperometric glucose and creatinine sensors can achieve clinically relevant analytical performance on a scalable POC platform when paired with appropriate calibration and correction strategies. The findings support the feasibility of integrating multiple enzymatic assays into a single multimodal POC system and highlight the importance of data-driven approaches for characterizing and mitigating non-ideal electrochemical behavior in practical sensor implementation for 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":"149086543","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-404 Accidental Acetaminophen Overdose: A Pediatric Case Study","authors":"Shaimaa Maher, Claudia Wang, Imir Metushi","doi":"10.1093/clinchem/hvag086.671","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.671","url":null,"abstract":"Background Acetaminophen is a widely used antipyretic/analgesic and remains a leading cause of toxic ingestions in children. Although most pediatric exposures are unintentional, severe toxicity in infants is uncommon. Clinical decision-making often relies on the reported time and amount of ingestion; however, these estimates may be unreliable, particularly when the history is uncertain. Enteric-coated formulations can further complicate assessment by delaying absorption and causing unexpectedly high serum acetaminophen concentrations. Methods We report an 11-month-old male with no significant past medical history who presented to the ED after suspected accidental ingestion of adult, enteric-coated generic acetaminophen 500-mg red coated tablets. The amount ingested was estimated to be around 15 tablets, dried red residue was noted around the mouth. On admission, the patient presented with hypothermia, hypotension, high anion gap metabolic acidosis, altered mental status with posturing, and elevated mixed venous oxygen saturation, raising concern for acetaminophen-associated mitochondrial dysfunction. He underwent rapid sequence intubation (etomidate 3 mg; rocuronium 10 mg), followed by sedation/analgesia. A nasogastric tube was placed and activated charcoal was administered. Initial laboratory studies (BMP, hepatic panel, salicylate, and serum acetaminophen concentration) were obtained at day 1 approximately 13:35, with serial acetaminophen and methemoglobin/ABG measurements thereafter. Results Initial laboratory evaluation demonstrated a high anion gap metabolic acidosis (22 mmol/L) and severe hypokalemia (K 2.9 mmol/L at day 1, 13:35). The initial serum acetaminophen concentration was markedly elevated at 735 µg/mL (day 1,13:35) and increased to 835 µg/mL (day 1, 15:40) consistent with delayed or ongoing absorption, before steadily declining with therapy. Arterial blood gas showed acidemia with low bicarbonate (pH 7.25, HCO3- 14.1 mmol/L, pCO2 32 mm Hg at day 1, 15:41), with subsequent improvement (pH 7.45–7.46 with HCO3- ∼24 mmol/L later in the day). Methemoglobin was elevated, peaking at 6.8% (day1, 20:50) with subsequent downtrending to 1.0% (day 2, 06:08). The patient was put on dialysis and continuous renal replacement therapy was initiated on admission for severe metabolic acidosis and discontinued after correction of acidosis. The patient also received an IV N-acetylcysteine (NAC) loading dose in the ED and was continued on a maintenance infusion (12.5 mg/kg/hr) on admission; fomepizole was also initiated (15 mg/kg, then 10 mg/kg every 12 hours). NAC was discontinued on following clinical improvement. Hepatic function panel, ammonia, coagulation studies, electrolytes, and phosphorus were closely monitored, and phosphate was repleted to maintain a goal >4.5 mg/dL to support hepatic regeneration. Notably, liver markers did not show a critical rise during hospitalization (AST 35–60 U/L; ALT 19–28 U/L across measured timepoints, Figur","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":"149086547","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-068 Functional inhibition of target YB1 via rationally designed ligand library for mechanistic biomarker validation in triple negative breast cancer models","authors":"Ruchitha Korem","doi":"10.1093/clinchem/hvag086.392","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.392","url":null,"abstract":"Background Breast cancer is one of the leading causes of death worldwide. Triple negative breast cancer accounts for 10-15% of all the breast cancer cases, and it is the most aggressive form. YB1 is a multifunctional protein that plays a major role in tumor progression, drug resistance, and metastasis in multiple cancers. Yb1 overexpression correlates with aggressive oncologic phenotypes, but its translation to functional biomarkers is constrained by lack of small molecule inhibitors for mechanistic perturbation studies. So, it is important to synthesize small molecule YB1 inhibitors to understand the functional role of YB1 as a biomarker. Methods A curated library of 40 novel compounds is obtained from a multi-step synthetic process by incorporating chemically diverse compounds that yield potential YB1 inhibitors. All the compounds’ structures are characterized by hydrogen and carbon NMR, HPLC, and LC-MS. Later, functional screening is performed through the MTT cell viability assay in human and murine cell lines with YB1 overexpression and in the breast cancer cell line in which the YB1 is not overexpressed to evaluate the selectivity. Dose-response curves are generated, and IC50 values are obtained through non-linear regression models. Biological assay is performed thrice to ensure experimental robustness. Results Out of all the forty compounds, only a subset of compounds showed increased dose-dependent antiproliferative activity along with elevated selectivity towards YB1 protein. IC50 values for the drugs that have increased activity are valued below 5 µM and have a selectivity of greater than 100. The structure optimization revealed that the fluorine groups on the compounds contribute to increased activity. These results and future experiments help us understand the mechanistic target evaluation. Conclusion This work provides the synthetic platform of YB1 inhibitory molecules that help with the mechanistic evaluation of YB1. These small molecules aid in assay development, mechanistic validation, and translational biomarker studies. In the future, we would like to explore more of the YB1 mechanism of action through these compounds.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"04 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086548","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-025 The continued value of CKMB in the era of High Sensitivity cardiac Troponins","authors":"Alagarraju Muthukumar","doi":"10.1093/clinchem/hvag086.020","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.020","url":null,"abstract":"Background High-sensitivity cardiac troponin (hs-cTn) is the definitive biomarker for diagnosing acute myocardial infarction, rendering creatine kinase-MB (CKMB) clinically redundant. Despite ADLM/ACC/AHA guidelines and CMS reimbursement cuts for co-ordered tests, CKMB utilization persists in many hospital systems. This continued reliance on an obsolete marker suggests a significant gap between evidence-based standards and real-world clinical practice. Our study quantifies these ordering patterns and investigates the departmental rationales for maintaining CKMB within the modern hs-cTn era. Methods We conducted a 10-year retrospective analysis (2014–2024) of cardiac biomarker orders across a large multicenter healthcare system to quantify concurrent hs-cTn and CKMB utilization. To investigate clinical drivers of guideline non-adherence, we developed and distributed a targeted qualitative survey to caregivers including cardiothoracic surgeons identified as CKMB ordering providers. Statistical trends in ordering frequency were analyzed by department and year, while survey responses were evaluated to identify specific clinical scenarios such as post-CABG monitoring where CKMB is perceived to offer incremental value. Graphpad prism was used in data analysis. Results Between 2014 and 2024, CKMB utilization in the Emergency Department declined to near-zero by 2017, aligning with ADLMAHA/ACC hs-cTn guidelines. Conversely, ICU and CVICU volumes remained high, with CKMB orders nearly equaling hs-cTn. Survey data showed 71% of providers, primarily cardiothoracic surgeons, opposed removing CK-MB from the test menu due to clinical utility. Notably, hs-cTnI levels post-surgery frequently exceeded 60,000 ng/L, reaching a diagnostic \"ceiling\" that limited trend interpretation. In these cases, the shorter half-life of CK-MB provided clearer kinetic patterns, allowing clinicians to distinguish perioperative myocardial injury from baseline surgical elevation to guide treatment and discharge. Conclusion We find that while hs-cTn has replaced CKMB in the Emergency Department, CKMB remains as a complementary marker in ICU and CVICU settings. Its continued use is driven by the clinical familiarity of the marker and the need for an additional interpretable cardiac marker when hs-cTn is markedly elevated. These findings highlight the importance of recognizing the unique perioperative context in which CKMB may still provide actionable clinical value and the opportunity for targeted educational initiatives to align test utilization with evidence-based guidelines.","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":"149086561","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-262 Push, Chat, Loop Me In: Evaluating the Performance of a Tiered Closed-Loop Critical Result Notification System","authors":"Erika Vargas, Kyana Garza, Ming Jin, Abraham Qavi, Haik Mkhikian","doi":"10.1093/clinchem/hvag086.551","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.551","url":null,"abstract":"Background Timely communication of critical laboratory results is essential for patient safety and regulatory compliance. Although traditional phone-call based notification workflows are common, they can be labor intensive for laboratory staff and prone to delays related to paging, call back, and provider availability. Closed-loop notification systems can modernize these workflows through automated push alerts and secure messaging, reducing communication barriers while maintaining timely acknowledgement of critical results. At our institution, a closed-loop notification system using automated push alerts was implemented to replace traditional phone-call based reporting as the primary communication method. One year later, the escalation pathway was further enhanced by incorporating secure chat messaging as a secondary step for unacknowledged push alerts, with phone-call notification reserved only for results not acknowledged electronically. Here, we evaluate the performance of our closed-loop notification system to effectively communicate critical results while improving workflow efficiency and reliability. Methods All chemistry critical values occurring in inpatient and emergency department (ED) settings from November 2024-January 2026 at UC Irvine Medical Center were analyzed retrospectively. Three notification pathways were evaluated, each with an expected turnaround time (TAT) =30 min: (1) verbal phone communication, (2) automated push notification with follow-up phone call if no response within 15 minutes, and (3) tiered closed-loop system including automated push notification followed by secure chat message if no response after 15 minutes, and phone call if no response after 20 minutes. Notification TAT was defined as the interval from result verification to clinician acknowledgement. Critical value data were extracted monthly from Epic Beaker using a customized report. Median TAT, 95th percentile TAT, and electronic acknowledgement patterns were calculated using Microsoft Excel. Results Historically, all critical results at our institution were communicated exclusively via telephone. Prior to November 2024, the median TAT for chemistry results was consistently 2 minutes; however, the percentage of critical values communicated within 30 minutes ranged from 94 to 96%. Following implementation of a closed-loop system, approximately 80% of inpatient and ED chemistry critical results qualified for an automatic push alert. During the initial implementation period from November to December 2024, less than 50% of push notifications were acknowledged by clinicians, requiring phone calls for the remaining critical results, likely reflecting limited provider and lab staff familiarity with the new notification workflow. Over time, push notification acknowledgement rates improved, reaching a peak of 70%, with a reduction in median TAT from 6 minutes to 2 minutes. Overall, approximately 96% of critical chemistry results were acknowledged within 30 minute","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"60 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086563","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-093 Molecular Detection of Rabies Using the LN34 Pan-Lyssavirus Real-Time RT-PCR Assay","authors":"Bryan Nguyen, Mariam Zhowandai, Mihyun Kim, Megan Crumpler, Radhika Patel","doi":"10.1093/clinchem/hvag086.069","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.069","url":null,"abstract":"Background Orange County Public Health Laboratory (OCPHL) routinely performs diagnostic rabies virus testing on animal brain material using the CDC Protocol for Postmortem Diagnosis of Rabies in Animals by Direct Fluorescent Antibody (DFA). The objective of this study was to validate the CDC LN34 qRT-PCR assay, which detects rabies virus RNA, using the Applied BiosystemsTM ABI 7500 Fast Dx. Implementing the LN34 assay included the validation and optimization of a safe Rabies virus RNA extraction method with the Qiagen TissueLyser II and the Qiagen EZ1 Advanced XL instrument. Methods Forty animal brain tissue specimens, previously tested for rabies virus by DFA, were tested on the Fusion LN34 assay. Results were compared with DFA as the gold standard. The CDC LN34 qRT-PCR assay was validated using the EZ1 instrument for viral RNA extraction. An inactivation study was performed to test the viability of rabies virus in Hologic Specimen Transport Media using cell cultures of serial ten-fold dilutions. The inactivation study was performed by Wadsworth Center’s Griffin Laboratory at New York State Department of Health. Results The validation of the LN34 had a 100% accuracy and 100% precision with the qualitative data in comparison with rabies DFA. Inactivation study in progress. Conclusion With the validation of the LN34 assay, rabies diagnostics can become more sensitive, specific, and economical. Currently, the LN34 assay serves to be an additional confirmatory test following the gold standard, direct fluorescence antibody (DFA) microscopy.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"140 1 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086397","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-035 Validation of Neurofilament Light Chain as laboratory developed test using electrochemiluminescence assay in serum and plasma","authors":"Ashwini Kumar Nepal, Kabiru Ayodele, Michele Durham, Bradley Collier, Satya Narla","doi":"10.1093/clinchem/hvag086.365","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.365","url":null,"abstract":"Background Neurofilament light chain (NfL) is a 68 kDa type IV intermediate filament mainly found in axons and has structural functions mainly in the neuronal cytoskeleton. During axonal damage, NfL is released into the cerebrospinal fluid, resulting in increased concentrations in the blood as well. Increased NfL concentrations in both CSF and blood have been reported among individuals with traumatic brain injury, amyotrophic lateral sclerosis, multiple sclerosis, alzheimer disease and other neurodegenerative diseases. The objective of this validation was to evaluate the performance of Roche Elecsys NfL research use only (RUO) kits in serum and plasma as a laboratory developed test (LDT) for clinical trials testing per Clinical and Laboratory Standards Institute (CLSI) guidelines. Methods NfL was measured quantitatively by two-incubation step assay using sandwich assay principle method on the Roche Cobas 8000 (Roche Diagnostics, USA) using Roche Elecsys RUO immunoassay kits. Results Intra-assay precision (3 levels, 20 replicates each) average CV was 2.9%. Inter-assay precision (3 levels, 1 replicate per day, 10 days) average CV was 4.7%. Accuracy was tested in 3 levels of kit controls and 3 different concentrations of NfL reference material (Roche NFLCore, 168 µg/mL) measured in replicates of 4. All samples were within manufacturer range, and average recovery for kit controls was 97.3%. Recoveries for NfL reference material ranged from 97.4 to 108.1%. Inter-lab comparison performed between two sites (N=58) resulted in a slope of 0.970, intercept 1.5, and correlation coefficient, (r=0.9997). Serum versus plasma correlation (N=31) resulted in a slope of 1.043, intercept 0.01, and correlation coefficient (r=0.9910). Analytical Measurement Range (0.3 to 5000 pg/mL) was verified using 5 levels of serum spiked with linearity material, 3 replicates each (slope = 0.991). Sensitivity (LLOQ) of 0.3 pg/mL was verified using 5 levels of serum spiked with linearity material, 8 replicates each per day, 5 days total 40 replicates per level (CV = 8.4%). Age specific reference ranges were established as: 4 years or younger= 1.56, 5 to 9 years= 1.30,10 to 14 years = 1.13, 15 to 19 years = 1.26, 20 to 29 years = 1.30, 30 to 39 years = 1.49, 40 to 49 years= 1.69, 50 to 59 years = 2.99, 60 to 69 years = 3.65, 70 to 79 years = 6.04, and 80 years or older = 9.13. Stability was evaluated at room temperature (20–25°C):14 days, refrigerated (2–8°C):14 days, frozen (< –10°C): 14 days, freeze/thaw cycles: up to 3 cycles, deep frozen (< –70°C): 199 days. Analytical interferences were evaluated for hemoglobin 1000 mg/dL, triglycerides 1500 mg/dL, conjugated bilirubin 40 mg/dL, unconjugated bilirubin 40 mg/dL. The observed bias for analytical interference parameters was =±10.0%. Conclusion The laboratory developed test for NfL provides a robust quantitative method for determination of serum NfL and meets the Clinical and Laboratory Standards Institute (CLSI) requ","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"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":"149086407","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-161 Correlation of Cardiovascular Disease and Diabetes to the Enhanced Liver Fibrosis Score","authors":"Cody Orahoske, Shirley Li, Alan Wu","doi":"10.1093/clinchem/hvag086.130","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.130","url":null,"abstract":"Background Roughly 90% of patients with Metabolic dysfunction-associated steatotic liver disease (MASLD) have at least one feature of metabolic syndrome, a disease characterized by insulin resistance, obesity, hypertension and hyperlipidemia. MASLD can be accessed by the Enhanced Liver Fibrosis test (ELF, Siemens Healthineers), a noninvasive estimate of liver fibrosis, which is a calculated score that includes measurement of hyaluronic acid, amino-terminal pro-peptide of type III procollagen (PIIINP), and tissue inhibitor of matrix metalloproteinase 1 (TIMP-1). We evaluated whether the presence of diabetes mellitus (DM) and/or cardiovascular disease (CVD) is associated with differences in ELF score. Methods 203 remnant serum samples were retrieved from the Zuckerberg San Francisco General Hospital and 221 serum and plasma samples were retrieved from the Wexner Medical Center, Ohio State University (OSU). This study was approved by the IRB at the University of California San Francisco, and OSU, who deemed that informed consent was not required. Among the combined cohort, 129 samples had a confirmed diagnosis of DM, 58 with CVD, 60 with both, and 177 with neither disorder. Serum and plasma samples were tested for the following analytes: ELF, B-type natriuretic peptide (NT-proBNP), and high-sensitivity cardiac troponin (hs-TnI) using the Siemens Atellica IM analyzer. An ELF score of <9.80 indicates a low risk for disease progression (cirrhosis and liver-related events), = 9.80 to < 11.30 indicates a indicates an intermediate risk, and =11.30 suggests a higher risk. As some of the results exhibited a non-parametric distribution, the Wilcoxon test was used to determine statistical significance given the non-parametric data of the data. Categorical comparisons were evaluated using the chi-square test. Results A comparison of serum to plasma samples collected simultaneously showed a positive bias for PIIINP and a negative bias for TIMP-1, but no significant difference in the ELF score, therefore results for the two sample types were combined. An ELF score <9.80 was observed in 74% of patients without diabetes or CVD and 51% of patients with DM, CVD, or both. A score (9.80 – <11.30) was observed in 19.8% and 40.1% of patients, respectively. Finally, A ELF score (=11.30) was observed in 6.2% and 8.9% of patients, respectively (p < 0.001). Regarding the ELF score, patients with DM, or both also had higher median ELF scores (9.70, 9.70, and 9.80, respectively) than patients without either disorder (median 9.20, p<0.001, p<0.005 and p<0.001, respectively). As expected, hs-cTnI and NT-proBNP were significantly higher in CVD and combined groups. Conclusion In this pilot cohort, the presence of DM and/or CVD was associated with modest but statistically significant increases in ELF score compared with individuals without these conditions. These findings suggest that ELF may reflect the broader metabolic and","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":"149086428","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-394 Advancing Rapid Clinical Toxicology Through DART-MS Detection of Emerging Drug Threats","authors":"Jill Kodger, Joe El-Khoury","doi":"10.1093/clinchem/hvag086.661","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.661","url":null,"abstract":"Background Novel psychoactive substances (NPS) are synthetic compounds engineered to mimic the effects of commonly misused illicit drugs. This study aims to develop a rapid and robust analytical method for detecting a novel benzodiazepine (bromazepam), as well as veterinary anesthetics such as xylazine and medetomidine. Interest in these substances has increased because of their growing involvement in polydrug exposures. At the same time, the continued spread of synthetic opioids, particularly fentanyl, has contributed to what is described as the “fourth wave” of the opioid epidemic. These evolving trends highlight the need for analytical platforms that can keep pace with rapidly changing drug use patterns. Current clinical laboratory technologies have not adapted quickly enough to address the emergence of these compounds. Immunoassays are slow to develop, and although liquid chromatography–tandem mass spectrometry (LC-MS/MS) offers high sensitivity, it is not widely accessible and often suffers from long turnaround times due to technical complexity. Direct analysis in real time (DART) tandem mass spectrometry (MS/MS) presents a promising alternative. DART is an ambient ionization technique that requires minimal sample preparation and eliminates the need for chromatographic separation, enabling near-instantaneous acquisition of mass spectral data. Methods Urine (50 µL) was combined with hydrolysis mix (50 µL) and left at room temperature for 5 minutes. Methanol (50 µL) was then added. Samples were vortexed for 10 seconds and centrifuged for 5 minutes at 15,000 × g at room temperature. A 5-µL aliquot of the supernatant was spotted onto the mesh of an Ion Sense DART QuickStrip and allowed to dry at room temperature before analysis. Results A 10-second jumpshot acquisition was used with a cone temperature of 250 °C and a DART gas temperature of 225 °C. The cone gas pressure was 23 psi. The analytical measureable range (AMR) was within %CV <12% for 1.3 to 2000 ng/mL for xylazine. The lower limit of quantitation was 5 ng/mL for xylazine and medetomidine, and 20 ng/mL for bromazepam. Conclusion We developed a rapid DART-MS/MS method capable of detecting xylazine, medetomidine, and bromazepam in 10 seconds per sample. With CLIA validation and application to clinical specimens, this approach could reduce turnaround times from days to seconds. Given the sensitivity and specificity of mass spectrometry, DART-MS/MS has the potential to serve as an alternative to traditional immunoassay-based drug screening.","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":"149086436","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}