Determination of high-sensitivity cardiac troponin T upper reference limits under the improved selection criteria in
Xin Zhang1,2, Xiaoxu Han1,2, Min Zhao1,2
1Department of Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.
Insights
Establishing accurate reference limits for high-sensitivity cardiac troponin T (hs-cTnT) is crucial. Improved selection criteria for healthy populations significantly reduce hs-cTnT upper reference limits, avoiding overestimation.
Area of Science:
- Clinical Chemistry
- Cardiovascular Diagnostics
- Biomarker Reference Limits
Background:
- Lack of consensus exists on defining reference populations for high-sensitivity cardiac troponin (hs-cTn) upper reference limits (URL).
- Accurate determination of hs-cTn URLs is essential for reliable clinical interpretation.
- Previous criteria may not adequately exclude individuals with subclinical cardiovascular risk factors.
Purpose of the Study:
- To establish the 99th percentile upper reference limits (URLs) for high-sensitivity cardiac troponin T (hs-cTnT).
- To compare URLs derived from 2018 AACC/IFCC criteria versus improved selection criteria.
- To evaluate the impact of excluding hypertension, overweight/obesity, and dyslipidemia on hs-cTnT URLs.
Main Methods:
- Stratified cluster sampling of 1848 apparently healthy individuals in Shenyang, China.
- Application of 2018 AACC/IFCC criteria using surrogate biomarkers.
- Implementation of improved selection criteria including physical examination and laboratory screening to exclude hypertension, overweight/obesity, and dyslipidemia.
Main Results:
- Using 2018 AACC/IFCC criteria, the 99th percentile URLs for hs-cTnT were 19 ng/L (male), 16 ng/L (female), and 18 ng/L (total).
- Improved selection criteria resulted in lower 99th percentile URLs: 18 ng/L (male), 13 ng/L (female), and 16 ng/L (total).
- Male hs-cTnT URLs were consistently higher than female URLs across all age groups.
Conclusions:
- Improved selection criteria, incorporating questionnaire, physical examination, and laboratory screening, are effective in refining the reference population.
- These enhanced criteria help to avoid overestimation of the 99th percentile upper reference limit for hs-cTnT.
- The findings underscore the importance of rigorous population selection for accurate hs-cTnT biomarker interpretation.
Background:
There is no common consensus on how to define the reference population for determination of high-sensitivity cardiac troponin (hs-cTn) upper reference limit (URL). This study aimed to establish 99th percentile URLs of hs-cTnT under both 2018 AACC/IFCC criteria and improved selection criteria for further judging whether two URLs are different.
Methods:
Applying the stratified cluster sampling protocol, this study took 1848 apparently healthy subjects in communities of Shenyang China as the screening objects. We first followed 2018 AACC/IFCC criteria using surrogate biomarker for diabetes, myocardial dysfunction, renal dysfunction, and electrocardiogram. Then, we followed improved selection criteria to exclude hypertension, overweight and obesity, and dyslipidemia by physical examination and laboratory screening. Accordingly, 99th percentile URLs of hs-cTnT were established.
Results:
If the 2018 AACC/IFCC criteria were applied, 99th percentile URLs (90% confidence interval) of hs-cTnT male, female, and total were 19 (17-20) ng/L, 16 (15-17) ng/L, and 18 (16-19) ng/L, respectively. If added a single supplementary selection criteria, 99th percentile URLs of hs-cTnT total reduced to 16 ng/L, 17 ng/L, and 16 ng/L, respectively. If the improved selection criteria were applied, 99th percentile URLs (90% confidence interval) of hs-cTnT male, female, and total were 18 (14-24) ng/L, 13 (11-16) ng/L, and 16 (13-17) ng/L, respectively. The 99th percentile URLs of hs-cTnT male were higher than those of female in every age group.
Conclusions:
Improved selection criteria through questionnaire survey, physical examination, and laboratory screening to further exclude hypertension, overweight and obesity, and dyslipidemia can avoid overestimation of the 99th percentile URL of hs-cTnT.
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