99th Percentile of High-Sensitivity Cardiac Troponin I in a Representative Sample of Healthy Individuals from the Russian Population: Data from the ESSE-RF Study

Aim. To determine the 99th percentile value of hs-cTnI in a sample of apparently healthy individuals from the Russian population, considering sex and age, based on standardized IFCC criteria.

Material and methods. Data from the ESSE-RF1 and ESSE-RF2 studies (n=14,035, age 25-64 years) were used. After excluding participants with cardiovascular and chronic diseases, diabetes mellitus, renal dysfunction, and those taking antihypertensive or lipid-lowering medications, 4,356 individuals (1,588 men and 2,768 women) were included in the analysis. Hs-cTnI levels were measured using the Architect i2000sr analyzer (Abbott). Statistical analysis was performed using nonparametric methods; the 99th percentile was estimated using the Harrell-Davis method with bootstrap.

Results. Hs-cTnI concentrations were above the limit of detection in 67.9% of participants. The median hs-cTnI level in the overall sample was 1.5 ng/L [Q1-Q3: 0.9-2.5], with significantly higher levels in men (1.9 [1.2-3.0] ng/L) compared to women (1.3 [0.7-2.2] ng/L) (p<0.001). The 99th percentile values (upper reference limits) were: overall — 16.5 ng/L (95% CI 14.7-19.4); men — 17.1 ng/L (14.6–20.9); women — 16.2 ng/L (13.7-21.5). No significant age dependence of the 99th percentile was observed (p>0.05). Compared to the manufacturer’s reference limits, the obtained values for men were significantly lower (17.1 vs. 34.2 ng/L), while for women they were slightly higher (16.2 vs. 15.6 ng/L).

Conclusion. The 99th percentile values of hs-cTnI in the healthy Russian population differ from the reference levels proposed by the manufacturer, demonstrate sex-specific differences, but do not depend on age. These findings emphasize the necessity of sex-specific stratification of hs-cTnI in the diagnosis of myocardial injury and infarction.

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