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Multi-Center Study of the 99th Percentile Value of High-Sensitivity Troponin I in A Normal Healthy Chinese Population

Renqian Zhong, Hao Wang, Zhihua Tao, Qingfeng Chen, Zheng Zhang, Xiaoyun Pu, Lianming Wang, Wei Chen, Hui Yuan, Yingping Cao, Xing Gao, Yijie Zheng, Peng Yin

Background: The aim of this study was to establish the 99th percentile value for high sensitivity troponin I in a normal healthy Chinese population and to analyze the differences between different age groups and sex and regions. Methods and Findings: The study included 1,537 cases of normal healthy subjects who were chosen according to a strict inclusion criterion. They were recruited from different regions of China and separated in different age groups. All patients were carefully scanned for any diseases or factors that might influence cardiac troponin levels. The measurement of high-sensitivity cardiac troponin was standardized and tests were repeated several times and all results recorded. We used ARCHITECT-i2000 (Abbott Laboratories, Lake Bluff, Illinois, USA) for measurement of all high sensitivity cardiac troponins. The overall value of the 99th percentile value was 26.42 pg/ml. For the male group 99th percentile value was 29.40 pg/ml and for the female group 99th percentile value was 19.46 pg/ml. The difference in cardiac troponin 99th percentile value for the male and female normal group was statistically significant (P<0.01). The age group >65 years old had a higher level of high sensitivity cardiac troponin and the difference was statistically significant when compared with other groups. The 99th percentile value corresponded to an imprecision of less than 10%. Conclusions: We established the 99th percentile value for cardiac troponin in the Chinese population and the normal range for males and females and we evaluated the analytical performance of ARCHITECT high sensitivity troponin I assays.