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Establishing Reference Values in Healthy Participants for the Cardiac Troponin T High-Sensitivity Gen 6 Assay:

Lori B Daniels1, Christian Mueller2, Evangelos Giannitsis3

  • 1Division of Cardiovascular Medicine, Department of Medicine, University of California, San Diego, La Jolla, CA, United States.

Clinical Chemistry
|January 21, 2026
PubMed

Insights

This study established new reference limits for cardiac troponin (cTn) using a high-sensitivity assay in a global population. These findings aid in the accurate diagnosis of myocardial infarction by providing sex-specific and uniform upper reference limits (URLs).

Area of Science:

  • Clinical Chemistry
  • Cardiology
  • Biomarker Discovery

Background:

  • High-sensitivity cardiac troponin (cTn) assays are crucial for diagnosing myocardial infarction.
  • Establishing accurate reference limits is essential for reliable diagnostic interpretation.

Purpose of the Study:

  • To determine sex-specific and uniform 99th percentile upper reference limits (URLs) for the Elecsys® Troponin T high-sensitivity Gen 6 assay.
  • To validate these URLs in a diverse, global cohort of healthy individuals.

Main Methods:

  • Collected plasma and serum samples from over 4000 healthy adults across 34 global sites.
  • Measured cardiac troponin T (cTnT) using the Elecsys® Troponin T high-sensitivity Gen 6 assay.
  • Determined 99th percentile URLs and 95% confidence intervals (CI) for sex-specific and uniform values.

Main Results:

  • The study included 4147 healthy participants of diverse ethnicities and ages.
  • Sex-specific 99th percentile URLs were 18 ng/L for females and 32 ng/L for males.
  • A uniform 99th percentile URL of 27 ng/L was established, with comparable results across plasma and serum matrices.

Conclusions:

  • Established sex-specific and uniform 99th percentile URLs for the Troponin T high-sensitivity Gen 6 assay.
  • The determined URLs are comparable across different sample matrices (plasma and serum).
  • These reference limits are based on a large, global, healthy population, supporting accurate myocardial infarction diagnosis.
Abstract

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