Myocardial Injury Thresholds for 4 High-Sensitivity Troponin Assays in U.S. Adults
John W McEvoy1, Olive Tang2, Dan Wang3
1Division of Cardiology and National Institute for Prevention and Cardiovascular Health, University of Galway, Galway, Ireland; Johns Hopkins School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA; Department of Epidemiology and the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Insights
This study found lower-than-expected upper reference limits (URLs) for high-sensitivity troponin assays in healthy US adults. These troponin levels varied significantly by sex and age, impacting myocardial injury definitions.
Area of Science:
- Cardiovascular diagnostics and biomarkers
- Clinical chemistry and laboratory medicine
- Population health and epidemiology
Background:
- Myocardial injury is defined by cardiac troponin levels exceeding the sex-specific 99th percentile of a healthy reference population (upper reference limit [URL]).
- Accurate troponin URLs are crucial for diagnosing myocardial injury.
- Existing troponin assay URLs may not reflect contemporary US adult populations.
Purpose of the Study:
- To estimate high-sensitivity (hs) troponin T and I upper reference limits (URLs) in a representative US adult sample.
- To analyze these URLs stratified by sex, race/ethnicity, and age group.
- To compare assay-specific URLs with manufacturer-reported values.
Main Methods:
- Utilized data from the National Health and Nutrition Examination Survey (NHANES) 1999-2004.
- Measured hs-troponin T (Roche) and hs-troponin I (Abbott, Siemens, Ortho) in a strictly defined healthy reference subgroup (n=2,746).
- Estimated 99th percentile URLs using the nonparametric method.
Main Results:
- NHANES-derived URLs for hs-troponin I assays were substantially lower than manufacturer-reported values.
- Significant differences in URLs were observed between sexes and across age groups (<40 vs. ≥60 years).
- No significant differences in URLs were found based on race/ethnicity.
Conclusions:
- Established new, lower upper reference limits for hs-troponin I assays in healthy US adults.
- Highlighted significant sex and age-related variations in troponin URLs, necessitating assay and population-specific considerations.
- Findings suggest a need to re-evaluate current diagnostic thresholds for myocardial injury.
Background:
Myocardial injury is currently defined as a cardiac troponin above the sex-specific 99th percentile of a healthy reference population (upper reference limit [URL]).
Objectives:
The purpose of this study was to estimate high-sensitivity (hs) troponin URLs in a representative sample of the U.S. 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 1 assay (Roche) and hs-troponin I using 3 assays (Abbott, Siemens, and Ortho). In a strictly defined healthy reference subgroup, we estimated 99th percentile URLs for each assay using the recommended nonparametric method.
Results:
Of 12,545 participants, 2,746 met criteria for the healthy subgroup (mean age 37 years, 50% men). 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 ng/L) for Abbott hs-troponin I (manufacturer: 28 ng/L), 5 ng/L (95% CI: 4-7 ng/L) for Ortho hs-troponin I (manufacturer: 11 ng/L), and 37 ng/L (95% CI: 27-66 ng/L) 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 4 hs-troponin assays were statistically significantly lower in healthy adults aged <40 years compared with healthy adults ≥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 I URLs by sex and by age group in healthy U.S. adults but none by race/ethnicity.
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