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Published on: December 13, 2017
Defining the serum 99th percentile in a normal reference population measured by a high-sensitivity cardiac troponin I
Fred S Apple1, Peter A Simpson, Maryann M Murakami
1Hennepin County Medical Center and the University of Minnesota, Department of Laboratory Medicine and Pathology, Minneapolis, MN, USA. apple004@umn.edu
Insights
This study established the 99th percentile reference value for cardiac troponin I (cTnI) using a high-sensitivity assay in healthy adults. These findings aid in diagnosing cardiac conditions and assessing patient risk.
Area of Science:
- Biochemistry
- Cardiology
- Clinical Diagnostics
Background:
- Cardiac troponin I (cTnI) is a critical biomarker for myocardial injury.
- High-sensitivity assays have improved the detection limits for cTnI.
- Establishing accurate reference values is essential for clinical interpretation.
Purpose of the Study:
- To determine the serum 99th percentile reference value for cTnI.
- To utilize the high-sensitivity Erenna cTnI assay for this determination.
- To provide a basis for diagnostic and risk assessment studies.
Main Methods:
- Serum samples were collected from 348 healthy adults (18-76 years; 147 males, 201 females).
- Nonparametric statistical analysis was employed.
- The 99th percentile was calculated for the overall cohort and by gender.
Main Results:
- The overall 99th percentile for cTnI was 10.19 ng/L (mean 1.45 ng/L).
- Gender-specific 99th percentiles were 16.58 ng/L for males (mean 1.72 ng/L) and 9.36 ng/L for females (mean 1.25 ng/L).
- No statistically significant difference was observed between genders (p=0.108).
Conclusions:
- The high-sensitivity Erenna cTnI assay detects cTnI in 100% of normal subjects.
- These reference values facilitate prospective diagnostic studies.
- The findings support early cardiac disease detection and patient risk stratification.
Objectives:
This study determined the serum 99th percentile reference value for cTnI measured using the high sensitivity Erenna cTnI assay.
Design And Methods:
Serum was obtained from healthy adults (n=348); aged 18-76 years of which 147 were males and 201 were females. Nonparametric analysis was performed to determine the 99th percentiles.
Results:
For all subjects, the 99th percentile was 10.19 ng/L; mean concentration=1.45 ng/L, range=0.2 to 34.56 ng/L. By gender, the male and female 99th percentile values were as follows: male=16.58 ng/L, mean concentration=1.72 ng/L, and female=9.36 ng/L, mean concentration=1.25 ng/L, respectively (p=0.108).
Conclusion:
cTnI measured by the high-sensitivity Erenna cTnI assay measured 100% of normal subjects, allowing prospective diagnostic and risk assessment studies to be performed, which are essential for the early detection of cardiac disease and for the management of patients presenting with symptoms suggestive of acute coronary syndrome.
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