The 99th percentile upper reference limit for the 5th generation cardiac troponin T assay in the United States.

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Fitzgerald, RL; Hollander, JE; Peacock, WF; Limkakeng, AT; Breitenbeck, N; Rivers, EJ; Ziegler, A; Laimighofer, M; deFilippi, C

Published Date

  • May 2020

Published In

Volume / Issue

  • 504 /

Start / End Page

  • 172 - 179

PubMed ID

  • 32001233

Electronic International Standard Serial Number (EISSN)

  • 1873-3492

Digital Object Identifier (DOI)

  • 10.1016/j.cca.2020.01.027

Language

  • eng

Conference Location

  • Netherlands