Robert L Fitzgerald1, Judd E Hollander2, W Frank Peacock3, Alexander T Limkakeng4, Nancy Breitenbeck5, E Joy Rivers6, André Ziegler7, Michael Laimighofer8, Christopher deFilippi9. 1. Department of Pathology, UC San Diego Health, San Diego, CA, USA. Electronic address: rfitzgerald@ucsd.edu. 2. Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA, USA. 3. Department of Emergency Medicine, Baylor College of Medicine, Houston, TX, USA. 4. Division of Emergency Medicine, Duke University, Durham, NC, USA. 5. NB Research Inc, Indianapolis, IN, USA. 6. Agent Representing Roche Professional Diagnostics, Indianapolis, IN, USA. 7. Roche Diagnostics International Ltd, Rotkreuz, Switzerland. 8. Roche Diagnostics GmbH, Penzberg, Germany. 9. Inova Heart and Vascular Institute, Falls Church, VA, USA.
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.
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.
Authors: Nathan Kong; Rhys F M Chua; Stephanie A Besser; Louise Heelan; Sandeep Nathan; Thomas F Spiegel; Xander M R van Wijk; Corey E Tabit Journal: BMC Cardiovasc Disord Date: 2021-06-07 Impact factor: 2.298