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.
Abstract

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