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Direct comparison of clinical decision limits for cardiac troponin T and I

Dorien M Kimenai1, Ronald M A Henry2, Carla J H van der Kallen2

  • 1Department of Clinical Chemistry, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands.

Heart (British Cardiac Society)
|January 23, 2016
PubMed

Insights

High-sensitivity cardiac troponin (hs-cTn) thresholds for diagnosing heart attacks are similar between assays, despite current differences. Adjusting hs-cTnI limits for sex could prevent underdiagnosis, especially in women.

Area of Science:

  • Cardiology
  • Biomarker analysis
  • Clinical diagnostics

Background:

  • Current diagnostic thresholds for high-sensitivity cardiac troponin T (hs-cTnT) and troponin I (hs-cTnI) assays differ (14 ng/L and 26 ng/L, respectively).
  • These thresholds were established using separate reference populations, raising questions about their biological equivalence.
  • Understanding assay-specific reference limits is crucial for accurate acute myocardial infarction (AMI) diagnosis.

Purpose of the Study:

  • To directly compare sex- and age-specific 99th percentile upper reference limits for hs-cTnT and hs-cTnI within a single reference cohort.
  • To investigate whether current divergent hs-cTnT and hs-cTnI thresholds are due to intrinsic assay differences or cohort variations.
  • To inform potential adjustments in diagnostic criteria for AMI.

Main Methods:

  • A healthy reference population (n=1540) was selected from the Maastricht Study (n=3451), aged 40-75 years.
  • Exclusion criteria included diabetes, cardiovascular disease history, ECG abnormalities, elevated NT-proBNP, or reduced estimated glomerular filtration rate.
  • Non-parametric statistical methods were used to determine 99th percentile upper reference limits.

Main Results:

  • Overall 99th percentile upper reference limits were 15 ng/L for hs-cTnT and 13 ng/L for hs-cTnI.
  • Reference limits were higher in men than women for both assays (hs-cTnT: 16 vs 12 ng/L; hs-cTnI: 20 vs 11 ng/L).
  • Upper reference limits demonstrated an increasing trend with age for both hs-cTnT and hs-cTnI.

Conclusions:

  • Numerically similar thresholds for hs-cTnT and hs-cTnI assays were observed upon direct comparison.
  • The current hs-cTnI threshold of 26 ng/L may lead to underdiagnosis of AMI, particularly in women.
  • Sex-differentiated downward adjustment of the hs-cTnI threshold could align clinical decision limits and improve AMI detection.
Abstract

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