The 99th percentile upper reference limit for the 5th generation cardiac troponin T assay in the United States.
Date
2020-05
Journal Title
Journal ISSN
Volume Title
Repository Usage Stats
views
downloads
Citation Stats
Abstract
BACKGROUND:Determining diagnostic thresholds for cardiac troponin assays is key to interpreting their clinical performance. We describe the calculation of 99th percentile upper reference limits (URLs) for the Elecsys® Troponin T Gen 5 (TnT Gen 5) assay. METHODS:Plasma and serum samples from healthy US participants were prospectively evaluated using TnT Gen 5 Short Turn Around Time and 18-min assays on cobas e 411 and cobas e 601 analyzers (Roche Diagnostics); with, up to 8 TnT Gen 5 results per participant. RESULTS:A total of 10,402 TnT Gen 5 results from 1301 participants were included (50.4% female). Across 9 calculation methods, overall 99th percentile URL was 19.2 ng/l (females, 13.5-13.6 ng/l; males, 21.4-22.2 ng/l). Across different sample/assay/analyzer combinations, overall 99th percentile URLs ranged from 18.4-20.2 ng/l. Median TnT Gen 5 results increased with age, were higher in males, and ranged from 3.0-3.7 ng/l across races/ethnicities and from 3.0-3.6 ng/l across body mass index (BMI) classes. Applying additional exclusion criteria (N-terminal pro-brain natriuretic peptide, BMI and estimated glomerular filtration rate) resulted in lower 99th percentile URLs (overall, 16.9 ng/l; females, 11.8 ng/l; males, 18.5 ng/l). CONCLUSION:Our findings facilitate the interpretation of TnT Gen 5 results in US clinical practice.
Type
Department
Description
Provenance
Citation
Permalink
Published Version (Please cite this version)
Publication Info
Fitzgerald, Robert L, Judd E Hollander, W Frank Peacock, Alexander T Limkakeng, Nancy Breitenbeck, E Joy Rivers, André Ziegler, Michael Laimighofer, et al. (2020). The 99th percentile upper reference limit for the 5th generation cardiac troponin T assay in the United States. Clinica chimica acta; international journal of clinical chemistry, 504. pp. 172–179. 10.1016/j.cca.2020.01.027 Retrieved from https://hdl.handle.net/10161/21626.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
Collections
Scholars@Duke
Alexander Tan Limkakeng
Dr. Alexander T. Limkakeng, Jr., MD, MHSc, FACEP is a Professor of Emergency Medicine, Vice Chair of Clinical Research, Director of the Acute Care Research Team, and Director of the Resident Research Fellowship for the Department of Emergency Medicine in the Duke University School of Medicine in Durham, North Carolina.
Dr. Limkakeng has served as chair of the American College of Emergency Physicians (ACEP) Research Committee, and been the Course Director of the ACEP Research Forum from 2016-2018, the largest emergency medical research platform in the nation. He is also the Assistant Director of ACEP’s Emergency Medicine Basic Research Skills course. He was elected to the Nominating Committee of the Society of Academic Emergency Medicine.
As a researcher, Dr. Limkakeng has led multiple clinical trials and interdepartmental sponsored projects and is author on over 100 peer-reviewed manuscripts. These include studies in emergency conditions such as COVID-19, traumatic brain injury, hypertension, heart failure, thrombosis, stroke, envenomations, and septic shock. His research has been funded by grants and contracts totaling over $9 million dollars. He has lectured internationally on acute coronary syndrome, responsible conduct of research, design of clinical trials, and precision medicine in emergency care. He has led Duke’s involvement in NIH-funded research networks and in industry-funded work that led to FDA approval for multiple high-sensitivity cardiac troponin assays and point-of-care COVID-19 diagnostic tests. He has servesd as Co-PI for the Duke U24 Hub in the NIH Early Phase Pain Investigation Clinical Network (EPPIC-Net) (1U24NS114416) and now serves as a co-PI on the Duke U24 Hub award (1U24NS129498) in the NIH Strategies to Innovate Emergency Care Clinical Trials (SIREN) Network and in the NIH NINDS Strokenet network (1U24NS135250)
His personal research interest is finding new ways to diagnose acute coronary syndrome. In particular, he is interested in novel biomarkers and precision medicine approaches to this problem. The common element throughout this work is a focus on time-sensitive health conditions.
Unless otherwise indicated, scholarly articles published by Duke faculty members are made available here with a CC-BY-NC (Creative Commons Attribution Non-Commercial) license, as enabled by the Duke Open Access Policy. If you wish to use the materials in ways not already permitted under CC-BY-NC, please consult the copyright owner. Other materials are made available here through the author’s grant of a non-exclusive license to make their work openly accessible.