Ultra-highly sensitive cardiac troponin I: Age and sex differences in healthy individuals

Mitra Mastali, Anum Asif, Qin Fu, Janet Wei, Frederick K. Korley, W. Frank Peacock, Kimia Sobhani, Galen Cook-Wiens, Marcio A. Diniz, C. Noel Bairey Merz, Jennifer E. Van Eyk

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Associations between elevated circulating cardiac troponin I (cTnI) levels and adverse cardiac outcomes were established prior to the ability to measure extremely low levels of cTnI. Immunoassays that achieve precise ultra-highly sensitive quantification of cTnI (u-hs-cTnI) will allow accurate measurement in healthy subjects. We aimed to evaluate the distribution of u-hs-cTnI values measured by (Simoa HD-1 Analyzer, Quanterix Corporation, Lexington, MA) in healthy subjects and characterize relations to sex and age. Methods: Two independent, healthy cohorts (total of 200 women, 200 men) aged 18–86 years were analyzed in duplicate using the u-hs-cTnI Immunoassay. The u-hs-cTnI 99th percentiles were calculated as the upper limits considering a robust estimation against outliers with 90% confidence intervals. The Quanterix immunoassay analytical performance was established and compared to an existing clinical assay (ARCHITECT STAT High Sensitivity Troponin I, Abbott Laboratories, Wiesbaden, Germany). Results: The lower limit of detection of the u-hs-cTnI assay was calculated to be 0.005 ng/L; we accurately quantified u-hs-cTnI in 95% of healthy individuals. The Quanterix immunoassay within overlapping concentrations correlated with the Abbott assay (R2 = 0.932). The calculated combined 99th percentile was 7.94 ng/L (90% Confidence Interval [CI], 5.47–10.52). Women had lower mean u-hs-cTnI concentrations than men under the age of 40 years. The sex-specific 99th percentile for female vs. male individuals was 4.89 ng/L (90%CI, 3.71–6.25) and 10.49 ng/L (90%CI, 5.19–15.06), respectively. Conclusion: The Quanterix immunoassay provides precise quantification in 95% of healthy individuals. Women under the age of 40 years have significantly lower levels of u-hs-cTnI than men.

Original languageEnglish
Article number100110
JournalAmerican Heart Journal Plus: Cardiology Research and Practice
Volume13
DOIs
StatePublished - Jan 2022
Externally publishedYes

Keywords

  • Age
  • Cardiac troponin
  • Quanterix
  • Sex
  • Simoa immunoassay

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