In healthy US adults, the 99th percentile URLs for Abbott, Ortho, and Siemens hs-troponin-I assays were substantially lower (13, 5, and 37 ng/L, respectively) than manufacturer-reported URLs.
Cross-Sectional (n=12,545)
Yes
What are the 99th percentile upper reference limits for four high-sensitivity troponin assays in a healthy US adult population?
High-sensitivity troponin-I upper reference limits in a healthy US population are substantially lower than currently listed manufacturer thresholds, with significant variations by age and sex.
Background: Myocardial injury is defined as a cardiac troponin above the sex-specific 99th percentile (upper reference limit, URL) of a healthy reference population. Objectives: To estimate high-sensitivity (hs) troponin URLs that are representative of the US adult population; overall and by sex, race/ethnicity, and age group. Methods: Among adults participating in the 1999–2004 National Health and Nutrition Examination Survey (NHANES), we measured hs-troponin-T using one assay (Roche) and hs-troponin-I using three assays (Abbott, Siemens, and Ortho). In a strictly defined healthy reference subgroup, we estimated 99th percentile URLs for each assay using the recommended non-parametric method. Results: Of 12,545 participants, 2,746 met criteria for the healthy subgroup (mean age 37 years, 50% male). The NHANES 99th percentile URL for hs-troponin-T (19 ng/L) matched the manufacturer-reported URL (19 ng/L). NHANES URLs were 13 ng/L (95% CI 10, 15) for Abbott hs-troponin-I (manufacturer: 28 ng/L), 5 ng/L (95% CI 4, 7) for Ortho hs-troponin-I (manufacturer: 11 ng/L), and 37 ng/L (95% CI 27, 66) for Siemens hs-troponin-I (manufacturer: 46.5 ng/L). There were significant differences in URLs by sex, but none by race/ethnicity. Furthermore, the 99th percentile URLs for all four hs-troponin assays were statistically significantly lower in healthy adults aged <40 years compared to ≥60 years (all p<0.001 by rank sum testing). Conclusions: We found URLs for hs-troponin-I assays that were substantially lower than currently listed 99th percentile URLs. There were significant differences in hs-troponin-T and hs-troponin-I URLs by sex and by age group in healthy US adults but none by race/ethnicity.
“What I believe our data have clarified and now [should] motivate a serious conversation about is the use of age-specific cut points for high-sensitivity troponin in the diagnosis of myocardial injury.”
McEvoy et al. (2023) conducted a cross-sectional in Healthy adults (n=12,545). High-sensitivity troponin assays vs. Manufacturer-reported URLs was evaluated on 99th percentile upper reference limits (URLs) for hs-troponin assays. In healthy US adults, the 99th percentile URLs for Abbott, Ortho, and Siemens hs-troponin-I assays were substantially lower (13, 5, and 37 ng/L, respectively) than manufacturer-reported URLs.