Determination of high-sensitivity cardiac troponin I 99th percentile upper reference limits in a healthy Korean
Misuk Ji1, Hee-Won Moon1, Mina Hur1
1Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, South Korea.
Insights
This study established the 99th percentile upper reference limit for cardiac troponin I (cTnI) in a Korean population. Results show lower cTnI levels compared to other ethnicities, influenced by age and selection criteria.
Area of Science:
- Cardiology
- Clinical Chemistry
- Population Health
Background:
- Establishing accurate reference ranges for cardiac troponin I (cTnI) is crucial for diagnosing myocardial infarction.
- High-sensitivity assays have improved detection limits, necessitating updated reference values.
- Population-specific reference limits are important due to potential ethnic and demographic variations.
Purpose of the Study:
- To determine the 99th percentile upper reference limit (URL) for cardiac troponin I (cTnI) using a high-sensitivity assay in a healthy Korean population.
- To investigate the influence of age and sex on cTnI levels within this reference population.
Main Methods:
- Enrolled 854 healthy Korean males and females (mean age 49.8 years).
- Excluded participants with subclinical conditions based on estimated glomerular filtration rate, glycated hemoglobin, and B-type natriuretic peptide levels.
- Measured serum cTnI using the ARCHITECT STAT High-Sensitive Troponin-I Assay.
Main Results:
- The 99th percentile URL for cTnI in the Korean population was 18 ng/L (90% CI, 14-35 ng/L).
- Specific 99th percentile URLs were 20 ng/L for males and 19 ng/L for females.
- Median cTnI concentrations were higher in participants aged 50 years and older compared to younger individuals.
Conclusions:
- The Korean reference population exhibited lower 99th percentile URLs for cTnI compared to other ethnic groups.
- Factors such as ethnicity, age distribution, and health selection criteria significantly influence cTnI reference limits.
- These findings underscore the importance of population-specific reference ranges for cTnI assays.
Objectives:
This study aimed to determine the 99th percentile upper reference limit (URL) concentration of cardiac troponin I (cTnI) with a high-sensitivity assay in a Korean population.
Design And Methods:
Cardio-healthy males and females were enrolled between March 2014 and March 2015. Participants with possible subclinical conditions were excluded on the basis of laboratory measures (primary: estimated glomerular filtration rate and glycated hemoglobin; secondary: B-type natriuretic peptide). Serum cTnI was measured using ARCHITECT STAT High-Sensitive Troponin-I Assay (Abbott Diagnostics, USA).
Results:
A total of 1204 participants completed a self-reporting questionnaire for inclusion in the study. Of these, we excluded 349 (29.0%) participants on the basis of primary (n=283) and secondary (n=66) laboratory measures. Ultimately, we included 854 participants (mean age, 49.8±10.2years) in the final analysis. The 99th percentiles of cTnI concentrations were 18 (90% confidence interval [CI], 14-35) ng/L for all participants, 20 (90% CI, 15-69) ng/L for males and 19 (90% CI, 11-41) ng/L for females. In both males and females, the median cTnI concentrations were significantly higher in participants aged 50years and older than in those younger than 50years old.
Conclusions:
In this study, the reference population with Korean ethnicity had lower overall and male 99th percentile URLs than other reference populations. Our data suggest that 99th percentile URLs may be influenced by factors such as ethnicity, age distribution of participants, and selection criteria used to define a healthy reference population.
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