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

R. Zhong, Hao Wang, Zhihua Tao, Qingfeng Chen, Zheng Zhang, X. Pu, L. Wang, Wei Chen, Hui Yuan, Ying Cao, Xing Gao, Yijie Zheng, P. Yin
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引用次数: 3

Abstract

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 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.
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中国正常健康人群高敏感肌钙蛋白I第99百分位值的多中心研究
背景:本研究的目的是建立中国正常健康人群高敏感肌钙蛋白I的第99百分位值,并分析不同年龄、性别和地区之间的差异。方法与结果:本研究纳入1537例正常健康受试者,入选标准严格。他们来自中国不同的地区,被分为不同的年龄组。所有患者都仔细扫描了可能影响心脏肌钙蛋白水平的疾病或因素。标准化了高灵敏度心肌肌钙蛋白的测量,重复测试多次,并记录所有结果。我们使用ARCHITECT-i2000 (Abbott Laboratories, Lake Bluff, Illinois, USA)测量所有高灵敏度心肌肌钙蛋白。第99百分位值为26.42 pg/ml。男性组第99百分位值为29.40 pg/ml,女性组第99百分位值为19.46 pg/ml。男性与女性正常组心肌肌钙蛋白第99百分位值差异有统计学意义(P 65岁高敏感心肌肌钙蛋白水平较高,与其他组比较差异有统计学意义。第99个百分位值对应的不精度小于10%。结论:我们建立了中国人群中心肌肌钙蛋白的第99百分位值和男性和女性的正常范围,我们评估了ARCHITECT高灵敏度肌钙蛋白I检测的分析性能。
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