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Noninvasive surrogate endpoints of adverse outcomes, disease progression, and treatment efficacy in metabolic dysfunction–associated steatohepatitis (MASH)
Sanyal, Arun J., Abdelmalek, Manal F. , Loomba, Rohit, Sanyal, Arun J. , Sanyal, A J , Loomba, Rohit , Abdelmalek, Manal , Loomba, Rohit

Hepatology | March 30, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1097/hep.0000000000001734 | PMID 41911560 Get It

Background and Aims: Metabolic dysfunction–associated steatohepatitis (MASH) is a progressive liver disease that poses significant public health challenges. Although liver biopsy remains the gold standard for diagnostic and prognostic use in patients with MASH, its invasiveness limits its practical application in routine care and large-scale trials. This narrative review explores the growing role of noninvasive tests in the assessment of disease progression and treatment efficacy in MASH. Approach and Results: This review represents expert opinion synthesizing current literature on the most widely used noninvasive tests being assessed as frontline biomarkers for identification of patients with metabolic dysfunction–associated steatotic liver disease at risk of outcomes and/or in need of pharmacological intervention, and that are being used to assess treatment response in the context of clinical trials, and how they may be translated into clinical practice. Among these, elastography and the enhanced liver fibrosis test are highlighted for their potential to replace liver biopsy in clinical settings and trials. These methods are analyzed for their accuracy and ability to monitor therapeutic response, emphasizing their growing importance in providing reliable measures of clinical improvement as drug development efforts for MASH intensify. Conclusions: This synthetic review aims to provide a roadmap for federal regulators updating and potentially revising the requirements for demonstrating histologic improvement in MASH clinical trials, and for practitioners to translate this information into clinical practice. The ultimate goal is to reduce the reliance on liver biopsy while maintaining the rigor necessary to evaluate therapeutic efficacy, thus accelerating the path to approval for new MASH treatments.
Enhancement of Drying Performance of Biologic Paint Using Cellulose Nanocrystals and Chitosan
Duggirala, Rathan , Mikkilineni, Prasamsi, Kondragunta, Venkateswarlu

Coatings | March 30, 2026 | Volume: 16 | Issue: 4 | Pages: 412

10.3390/coatings16040412 Get It

Conventional paints pose major environmental and health concerns due to their reliance on heavy-metal pigments and volatile organic compound (VOC)-emitting binders, emphasizing the need for sustainable alternatives. Previous formulations of biologic paints that combined bacteria-derived dsRED pigment protein and casein-based binders, while devoid of toxic components, suffered from prolonged drying times (~16 min), limiting their practical applicability. The present study addresses this key limitation by incorporating cellulose nanocrystals (CNC) and chitosan as biologic additives to enhance drying kinetics. Paint formulations containing 2%, 5%, and 10% of each additive were tested under controlled environmental conditions (20 °C, 60% relative humidity) following the GB/T 1728–2020 standard. Both CNC and chitosan significantly reduced drying time in a concentration-dependent manner (p < 0.001). The 10% CNC and 10% chitosan formulations achieved 61% and 44% reductions in drying time, respectively, relative to the unmodified biologic paint (12.96 ± 1.07 min at baseline). Regression analyses indicated that each 1% increase in CNC or chitosan concentration reduced drying time by 0.77 min and 0.58 min, respectively. The optimized paints exhibited acceptable drying times (5–7 min). These findings demonstrate an advancement in the development of biologically derived coatings, providing a feasible pathway toward safe and sustainable alternatives to conventional synthetic paints.
Clinical, Genetic, and Pathologic Variability in Myelodysplastic Syndromes and Precursor Conditions Across Race, Ethnicity, and Sex
Colin‐Leitzinger, Christelle, Tang, Yi-Han , Sherman, Seth, Zhang, Ling, Walker, Mary Ellen, Painter, Jeffrey S. , Abel, Gregory A., Baghdadi, Tareq Al, Deeg, H. Joachim, Foran, James M., Gore, Steven D., Harrington, Alexandra M., Kroft, Steven H. , Liu, Jane Jijun, Saber, Wael, Virani, Shamsuddin, Bejar, Rafael, Padron, Eric , Komrokji, Rami, DeZern, Amy E., Sekeres, Mikkael A., Colin, Christelle , Foran, James M , Gillis, Nancy , Otterstatter, Michael , Zhang, Ling , Moscinski, Lynn C. , Walker, Mary E. , Abel, Gregory A. , Deeg, H. Joachim , Foran, James M. , Gore, Steven D. , Saber, Wael , Bejar, Rafael , Lindsley, R Coleman , Walter, Matthew J , Komrokji, Rami, Dezern, Amy Elizabeth , Sekeres, Mikkael A.

American Journal of Hematology | March 30, 2026 | Volume: 101 | Issue: 6 | Pages: 1407-1420

10.1002/ajh.70279 | PMID 41906220 Get It

ABSTRACT The epidemiology of myelodysplastic syndromes/neoplasms (MDS) is challenging to define due to inconsistent reporting, complex diagnostic procedures, and evolving diagnostic criteria. Using the National MDS Natural History Study—a prospective cohort with centrally adjudicated histopathology and genetic variant review—we characterized the landscape of MDS across the United States and identified differences across demographics. Among 2115 participants, 64% (1346) had an MDS spectrum condition, including MDS (24%), MDS/myeloproliferative neoplasm (5%) and precursor conditions—clonal cytopenia of undetermined significance (22%) and idiopathic cytopenia/dysplasia of undetermined significance (13%). The median age was 74 years, and participants were predominantly male (66%), White (91%), and Non‐Hispanic (92%). Myeloid‐associated variants were detected in 68% of participants, most commonly in TET2, DNMT3A, ASXL1, SF3B1, and SRSF2 . Black, compared to White, participants were younger at diagnosis (69 vs. 74 years, p = 0.01), had equal or increased prevalence of higher‐risk MDS, lower hemoglobin, and higher peripheral blood blasts, yet were less likely to receive MDS‐directed therapy (14% vs. 42%, p = 0.008). Black and Hispanic participants had fewer detectable gene mutations than White participants. Females had lower variant allele frequencies and fewer RNA splicing gene mutations than males. After multivariable adjustment, TP53 mutations, MDS diagnosis, and higher‐risk disease were associated with worse progression‐free and overall survival; age was also associated with overall survival. Black race trended toward improved progression‐free survival. These findings highlight the need for enhanced understanding of MDS pathogenesis across patient groups and refined prognostic tools to improve personalized management of MDS spectrum conditions. Trial Registration: ClinicalTrials.gov identifier: NCT02775383
Molecular-Based Ecosystem to Improve Personalized Medicine in Chronic Myelomonocytic Leukemia
Lanino, Luca , Hunter, Anthony M. , Gagelmann, Nico, Robin, M., Dall'Olio, Daniele , Flamigni, Alice, Gurnari, Carmelo, Wang, Yu‐Hung , Pleyer, Lisa , Xicoy, B., Montalban-Bravo, Guillermo, Shih, Lee-Yung, Alsugair, Ali, Gregorio, Caterina, Platzbecker, Anne Sophie, Sallman, David A., Fariselli, Piero, Garcia-Manero, Guillermo, Platzbecker, U, Solé, Francesc Gessé, Díez-Campelo, María, Maciejewski, Jaroslaw, Bejar, Rafael, Thol, Felicitas, Kroger, N., Fenaux, Pierre, Sanz, G. F., Kordasti, S., Santini, Valeria, Zeidan, Amer M., Komrokji, Rami S., Haferlach, Torsten, Germing, Ulrich, Castellani, Gastone, D'Amico, Saverio, Patnaik, M., Ieva, F., Tefferi, Ayalew, Padron, Eric , Porta, Matteo Giovanni Della, Alliance, for the iCPSS, Haque, Tamanna, Abdel-Wahab, Omar, Geissler, Klaus, Bataller, Alex, Bazinet, Alexandre , Meggendorfer, Manja , Quintavalla, Mirco, Bruseghini, Alessandro , Carota, Luciana , Dall'Olio, Lorenzo, Travaglino, Erica , Zamora, Lurdes López, Quintela, David, Jerez, Andrés , Cornejo, Elena, Martín, Paloma García, Díaz-Beyá, Marina, Pita, Alejandro Avendano, Roldán, Verónica , Suarez, Dolly Viviana Fiallo, Velasco, Estefania Cerezo, Calabuig, Marisa , Such, Esperanza, Castilla-Llorente, Cristina, Bulabois, Claude Eric, Souchet, Laëtitia, Bernardi, Massimo, Chiusolo, Patrizia, Borin, Lorenza, Follo, Matilde Yung, Consagra, Angela , Passamonti, Francesco, Diral, Elisa , Vucinic, Vladan, Bergonzi, Gregorio Maria , Hou, Hsin-An, Russo, Antonio, Tentori, Cristina Astrid , Buizza, Alessandro , Ferrari, Ivan, Matteo, Maria Di, Crespi, Alessandra, Figini, Giulia , Delponte, Camilla, Zampini, Matteo, Riva, Elena, Delleani, Mattia , Iascone, Eleonora, Ficara, Francesca , Ventura, Denise, Pinocchio, Nicole, Santoro, Armando, Kiwan, Ahmad , Ali, Najla H. Al, Zeidan, Amer M. , Robin, Marie , Dall’Olio, Daniele , Riva, Elena , Gagelmann, Nico , Robin, Marie , Sala, Claudia , Gurnari, Carmelo , Wang, Yu-Hung , Shih, Lee‐Yung , Alsugair, Ali , Fathima, Saubia , Gregorio, Caterina , Rollo, Cesare , Platzbecker, Anne Sophie , Asti, Gianluca , Itzykson, Raphael , Sallman, David A , Fariselli, Piero , Kern, Wolfgang , Garcia-Manero, Guillermo , Platzbecker, Uwe , Solé, Francesc , Diez-Campelo, Maria , Maciejewski, Jaroslaw P , Bejar, Rafael , Thol, Felicitas , Savona, Michael R , Sanz, Guillermo F , Kordasti, Shahram , Santini, Valeria , Zeidan, Amer M , Komrokji, Rami S , Castellani, Gastone , D'Amico, Saverio , Patnaik, Mrinal , Ieva, Francesca , Solary, Eric , Padron, Eric , Della Porta, Matteo Giovanni , Buizza, Alessandro , Ficara, Francesca , Lanino, Luca , Gagelmann, Nico , Gurnari, Carmelo , Xicoy, Blanca , Montalban‐Bravo, Guillermo , Fathima, Saubia , Gregorio, Caterina , Palomo, Laura , Itzykson, Raphaël , Sallman, David A. , Kern, Wolfgang , Garcia‐Manero, Guillermo , Platzbecker, Uwe , Solé, Françesc , Díez‐Campelo, María , Thol, Felicitas , Kröger, Nicolaus , Savona, Michael R. , Fenaux, Pierre , Sanz, Guillermo , Santini, Valeria , Fontenay, Michaëla , Komrokji, Rami S. , Haferlach, Torsten , Germing, Ulrich , Solary, Éric , Tefferi, Ayalew , Haque, Tamanna , Bataller, Alex , Sauta, Elisabetta , Sanavia, Tiziana , Dall'Olio, Lorenzo, Díaz‐Beyá, Marina , Roldan, Veronica, Fiallo, Dolly Viviana , Such, Esperanza , Castilla‐Llorente, Cristina , Bulabois, Claude‐Eric , Awada, Hussein , Chiusolo, Patrizia , Curti, Antonio , Giaccone, Luisa , Finelli, Carlo , Casetti, Ilaria Carola , Onida, Francesco , Passamonti, Francesco , Vučinić, Vladan , Voso, Maria Teresa , Hou, Hsin-An, Chou, Wen‐Chien , Yao, Chi‐Yuan , Lin, Chien‐Chin , Tien, Hwei‐Fang , Campagna, Alessia , Ubezio, Marta , Todisco, Gabriele , Maggioni, Giulia , Matteo, Maria Di, Pesce, Francesco , Zampini, Matteo , Crisafulli, Laura , Ventura, Denise , Pinocchio, Nicole , Brindisi, Matteo , VanOudenhove, Jennifer , Ali, Najla H. Al, Graubert, Timothy Aaron , Thota, Swapna , Griffiths, Elizabeth A.

Journal of Clinical Oncology | March 27, 2026 | Volume: 44 | Issue: 17 | Pages: 1608-1623

10.1200/jco-25-02116 | PMID 41894646 Get It

PURPOSE Chronic myelomonocytic leukemia (CMML) is a rare myeloid neoplasm characterized by clinical heterogeneity and is associated with poor outcomes. To date, limited molecular information has been incorporated into disease classification and risk stratification. We aimed to integrate genomic features into the clinical decision-making process for CMML. PATIENTS AND METHODS We analyzed a retrospective cohort of 3013 patients with CMML (training set) and a prospective population of 516 patients (validation set). Using an innovative framework for multimodal data analysis, we developed molecular-based disease taxonomy and prognostication. RESULTS Unsupervised clustering identified nine entities with distinct genomic features and outcomes ( P < .001), including splicing machinery, transcription factors, signal transduction and tyrosine kinase pathways aberrations, and high-risk molecular signatures. Notably, 15% of patients showed molecular/clinical overlap with other myeloid neoplasms. We integrated molecular and clinical information to build the international CMML Prognostic Scoring System (iCPSS), incorporating mutations in nine genes together with hematologic parameters and cytogenetic abnormalities. The iCPSS identified five groups with distinct probability of overall and leukemia-free survival in both training and validation cohorts ( P < .001), outperforming existing prognostic models. Importantly, 55% of patients were reassigned to higher or lower risk groups by the iCPSS. Decision analysis demonstrated that iCPSS could refine the optimal timing of allogeneic transplantation at the individual level; compared with conventional prognostic tools, iCPSS-based decision modeling changed transplantation strategy in 31% of cases, resulting in a significant gain-in-life expectancy for eligible patient population ( P < .001). A federated learning platform was implemented to enable continuous, privacy-preserving model update across multiple centers. CONCLUSION Molecular information improves CMML classification and prognostication, supports more effective clinical decision making, and potentially refines the design of clinical trials.
The landscape of dementia research, diagnosis, treatment, and care in Latin America
Suemoto, Claudia K., Custodio, Nilton, Avila‐Funes, José A., Baez, Sandra, Bagnati, Pablo , Barnes, Lisa Laverne, D., Brucki Sonia M., Calandri, Ismael L., Cornejo‐Olivas, Mario, Derio, Carolina Delgado, García, Adolfo M., Grinberg, Lea T., Ibanez, Agustin M., Isasi, Rosario, Josephy‐Hernandez, Sylvia , Porras, Maria Lazo, Llibre‐Guerra, Jorge J., Llibre‐Rodriguez, Juan J., Meza, B. Marcela Mar, Migeot, Joaquin, Miranda, J. Jaime, Miranda‐Castillo, Claudia, Mummery, Catherine J., Parodi, José F., Castro, Natalia Pozo, Contreras, Rosa María Salinas, Slachevsky, Andrea, Souza‐Talarico, Juliana Nery, Takada, Leonel T., Tsoy, Elena, Pilalumbo, Martha Unaucho, Zimmer, Eduardo R., Fontana, Igor C. , Snyder, Heather M. , Carrillo, Marı́a C., Carrillo, María C. , Takada, Leonel Tadao , Custodio, Nilton , Ibáñez, Agustín , Suemoto, Cláudia Kimie , Delgado, Carolina , Mahinrad, Simin , Ibañez, Agustín , Suemoto, Claudia Kimie , Aguilar, Diego, Ávila‐Funes, José Alberto , Báez, Sandra , Barnes, Lisa L. , Brucki, Sônia Maria Dozzi , Caramelli, Paulo , Cornejo-Olivas, Mario , Ferreira, Sérgio T. , García, A.R. , Grinberg, Lea T. , Llibre‐Guerra, Jorge J. , Rodríguez, Juan J. Llibre , Lourenco, Mychael V. , Migeot, Joaquín , Miranda, J. Jaime , Miranda‐Castillo, Claudia , Mummery, Catherine J. , Parodi, Jose Francisco , Salinas‐Contreras, Rosa Maria, Santamaría‐García, Hernando A , Slachevsky, Andrea , Souza‐Talarico, Juliana Nery , Surace, Ezequiel , Tsoy, Elena , Unaucho‐Pilalumbo, Martha , Zimmer, Eduardo Rigon , Mahinrad, Simin

Alzheimer's & Dementia | March 27, 2026 | Volume: 22 | Issue: 3 | Pages: No page available

10.1002/alz.71309 | PMID 41894159 Get It

Abstract Latin America is undergoing rapid population aging alongside a rising burden of dementia. While the region holds substantial potential for dementia risk reduction, challenges remain, such as delayed diagnoses, limited access to specialized care and biomarker testing, persistent stigma, and deep‐rooted structural inequities. To address these gaps and foster regionally informed solutions, the Alzheimer's Association convened the 2025 Alzheimer's Association International Conference (AAIC) Satellite Symposium in Lima, Peru, on May 14–15, in collaboration with the Global Brain Health Institute (GBHI) and the Atlantic Fellows for Equity in Brain Health. The meeting aimed to bring core elements of the global AAIC meeting to regional Latin American settings, recognizing that national and cultural contexts demand tailored approaches to dementia prevention, risk reduction, treatment and care all aimed at promoting brain health in the region. This manuscript synthesizes the symposium's key discussions, scientific advances, and opportunities for collaboration across the region.
BASECAMP-1 screening study: a model for efficient enrolment in precision oncology clinical trials
Hecht, J Randolph , Molina, Julian R , Liechty, Kirstin B., Welling, Theodore H., Grierson, Patrick , Patel, Sandip Pravin , Kirtane, Kedar , Morelli, M Pia, Locke, Frederick L, Maloney, David G. , Nikiforow, Sarah, Lin, Yi, Ulrickson, Matthew, Specht, J. M., Lozac’hmeur, Ariane, Garde, Ryan J., Rangel, Gena A, Ng, Eric W, Welch, John S. , Tebbets, Jessica , Go, William Y., Specht, Jennifer M. , Tebbets, Jessica C , Specht, Jennifer , Molina, Julian R. , Morelli, Maria Pia , Locke, Frederick L. , Punekar, Salman R. , Nikiforow, Sarah , Ulrickson, Matthew L. , Osterman, Chelsea Kendall , Ng, Eric W., Simeone, Diane M.

BMJ Oncology | March 27, 2026 | Volume: 5 | Issue: 1 | Pages: e001033

10.1136/bmjonc-2025-001033 | PMID 41918932 Get It

Objective Identifying eligible patients for precision oncology clinical trials is challenging, particularly for rare molecular subpopulations. To address this challenge, A2 Biotherapeutics developed BASECAMP-1 ( NCT04981119 ), a non-interventional master screening study to identify patients eligible for interventional studies of logic-gated Tmod chimeric antigen receptor T-cell therapies. Eligible patients for these interventional trials have an advanced solid malignancy and are germline human leucocyte antigen (HLA)-A*02 heterozygous, with tumour-associated HLA-A loss of heterozygosity (LOH). HLA-A LOH occurs in ~16% of advanced solid malignancies; therefore, an efficient screening strategy is required. This report describes BASECAMP-1; compares the efficiency of two screening methods; and discusses the broader advantages of BASECAMP-1 beyond efficient enrolment. Methods and analysis Patients are identified for BASECAMP-1 using two approaches. In the traditional approach, common for clinical trials, investigators consent and screen all patients who might be good candidates for cell therapy trials, with no prior knowledge of patient HLA-A type or LOH status. To further optimise our approach, we co-developed with Tempus AI (Tempus) the bioinformatic programme Aware, which identifies potentially eligible patients with tumour-associated HLA-A*02 LOH within a clinico-genomic database that includes linked genomic and transcriptomic sequencing and clinical data collected during routine care. Results Over 42 months of using a traditional approach to identify eligible patients, 1918 patients at 13 study sites were consented and screened for BASECAMP-1; of these, 30 patients with tumour-associated HLA-A*02 LOH were enrolled (~0.7 participants per month). Over the last 30 months of that same period, Tempus Aware screening was implemented and 55 patients with tumour-associated HLA-A*02 LOH were enrolled (~1.8 participants per month). The bioinformatic approach identified more patients than the traditional approach and used sequencing results produced as part of the standard clinical tumour sequencing workflow, reducing resource use and study staff burden. Additional advantages of using a screening study, such as BASECAMP-1, include manufacturing efficiencies and collection of a large dataset of molecular and clinical parameters that can be used to supplement trial analyses. Conclusions The BASECAMP-1 study demonstrates a clinico-genomic screening approach can more efficiently identify patients for precision oncology trials. Furthermore, precision oncology can be enhanced through collaborative data-sharing. Trial registration number NCT04981119 .
Empowering Neurosurgical Leadership: Training the Next Generation of Neurosurgical Leaders
Razak, Shahaan S. , Veeravagu, Anand , Stiehl, Emily, Sharan, Ashwini , Levy, Elad, Khalessi, A, Kalkanis, Steven N. , Asmussen, Brian, Langer, David, Chambless, Lola B. , Hilgart, Michele, Ratliff, John K. , Scarrow, Alan M., Scarrow, Alan, Ratliff, John , Stiehl, Emily , Khalessi, Alexander A., Langer, David J., Haydu, Lauren E. , Air, Ellen L. , Nahed, Brian V.

Neurosurgery | March 26, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1227/neu.0000000000003996 | PMID 41885450 Get It

BACKGROUND AND OBJECTIVES: The Congress of Neurological Surgeons (CNS) Leadership Institute developed the first structured leadership program designed specifically for neurosurgeons. Led by the experts in neurosurgery, health care administration, and business, the program provides formal leadership training and mentorship aimed at advancing neurosurgeons' professional development at local, regional, national, and international levels. METHODS: The CNS Leadership Institute offers 2 curricula tailored for junior and senior faculty. Training begins with assigned readings, webinars, and online lectures that establish essential leadership principles. Core learning occurs during 2 in-person courses featuring interactive lectures, feedback sessions, and a longitudinal leadership project guided by national mentors. Program outcomes were assessed through a 40-question survey of alumni evaluating training effectiveness, skill application, and career advancement. RESULTS: Since 2016, 195 neurosurgeons have completed the CNS Leadership Institute. Among the 77 survey respondents, 70.1% reported significant professional advancement (new leadership role or job transition), and 64.8% directly attributed their advancement in skills and insights acquired through the program. Overall program effectiveness was rated 4.4 of 5, and the mean likelihood-to-recommend was 8.95 (95% CI: 8.70-9.20), yielding a Net Promoter Score of +63 (95% CI: +49 to +77). Alumni have assumed prominent roles including 16 Residency Program Directors, 3 Department Chairs, 1 Vice Dean, 4 Service Line Leaders, 13 CNS Executive Committee members, and over 100 committee or editorial board appointments critical to the specialty. CONCLUSION: The CNS Leadership Institute equips neurosurgeons with structured leadership training, mentorship, and practical tools to enhance their effectiveness as leaders. Survey results confirm that the program has a measurable impact on participants' career trajectories and professional growth. This initiative provides a reproducible model for cultivating the next generation of neurosurgical leaders and advancing the specialty's capacity for strategic, transformational leadership.
Analytical Performance Evaluation of the Cardiac Troponin T High Sensitivity Gen 6 Assay
Knoll, Marko, Daniels, Lori B. , Mueller, Christian, Mills, Nicholas L, Giannitsis, Evangelos, Rösser, Alisa F A, Kurtoic, Dunja, Wahl, Annika , BODY, R. A. F., Christenson, R H, Cobbaert, Christa, deFilippi, Christopher R, Inoue, Kenji, Jaffe, A. S., McCarthy, C. F., McCord, James, Neumann, Johannes T, Omland, Torbjørn, Papendick, Cynthia , Sandoval, Yader, Than, Martin P, Twerenbold, Raphael, Peacock, W Frank, Meex, Steven J. R., Giannitsis, Evangelos , Body, Richard , Neumann, Franz–Josef , Müller, Christian , Mills, Nicholas L. , Mueller, Christian , Mills, Nicholas L , Giannitsis, Evangelos , Body, Rick , Eggers, Kai M. , Jaffe, Allan S. , Neumann, Johannes T , Sandoval, Yader , Tan, Jack Wei Chieh , Than, Martin , Twerenbold, Raphael , Daniels, Lori B , Cobbaert, Christa M. , deFilippi, Christopher R. , McCarthy, Cian P, McCord, James , Omland, Torbjørn , Sandoval, Yader , Tan, Jack Wei Chieh , Than, Martin , Twerenbold, Raphael , Meex, Steven J.R.

The Journal of Applied Laboratory Medicine | March 26, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1093/jalm/jfag031 | PMID 41885135 Get It

Abstract Background High-sensitivity cardiac troponin (hs-cTn) assays are recommended for the diagnosis of acute myocardial infarction. Here, we characterize the analytical performance of a next-generation hs-cTn assay, Elecsys® Troponin T hs Gen 6 (Roche Diagnostics International). Methods Surplus lithium-heparin plasma or serum samples from patients or healthy volunteers were run on Cobas® e 801, e 402, and Pro analyzers. Limits of blank (LoB), limits of detection (LoD), and limits of quantitation (LoQ) were determined according to CLSI EP17-A2, with target values of 1.0 and 1.5 ng/L for LoB/LoD and 3.0 ng/L (10% CV) and 1.5 ng/L (20% CV) for LoQ, respectively. Precision was measured, per CLSI EP17-A2, using 3 QC samples (approximately 4, 30, and 220 ng/L), 12 native samples, and 3 reagent lots. Linearity, per CLSI EP06-Ed2, was determined by diluting samples with cardiac troponin T (cTnT) concentration above the measuring range with a low/blank sample. Interference (per Glick) with endogenous and assay components at 5 cTnT concentrations was assessed. Results Measured values for LoB, LoD, and LoQ at 10% and 20% CV were 0.1 to 0.7 ng/L, 0.3 to 1.4 ng/L, 1.0 to 2.9 ng/L, and 0.4 to 1.2 ng/L, respectively. Repeatability CVs were 1.0 to 5.8% for mean cTnT concentrations of 2.6 to 9230 ng/L in lithium-heparin plasma. High precision was shown across lots, and linearity was observed across the measuring range (1.5 to 9500 ng/L, all Pearson's r = 1.00). No interferences were observed, specified up to ≤1000 mg/dL hemoglobin, ≤50 mg/dL [≤855 µmol/L] icterus/bilirubin, and ≤1200 ng/mL biotin. Conclusions The analytical performance characterization of the assay demonstrated high sensitivity, high precision at the low end and across the measuring range, and resistance to interference.