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韩国健康人群高敏心肌肌钙蛋白I第99百分位数上限参考值的测定

Determination of high-sensitivity cardiac troponin I 99th percentile upper reference limits in a healthy Korean population.

作者信息

Ji Misuk, Moon Hee-Won, Hur Mina, Yun Yeo-Min

机构信息

Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, South Korea.

Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, South Korea.

出版信息

Clin Biochem. 2016 Jul;49(10-11):756-61. doi: 10.1016/j.clinbiochem.2016.01.027. Epub 2016 Apr 9.

Abstract

OBJECTIVES

This study aimed to determine the 99th percentile upper reference limit (URL) concentration of cardiac troponin I (cTnI) with a high-sensitivity assay in a Korean population.

DESIGN AND METHODS

Cardio-healthy males and females were enrolled between March 2014 and March 2015. Participants with possible subclinical conditions were excluded on the basis of laboratory measures (primary: estimated glomerular filtration rate and glycated hemoglobin; secondary: B-type natriuretic peptide). Serum cTnI was measured using ARCHITECT STAT High-Sensitive Troponin-I Assay (Abbott Diagnostics, USA).

RESULTS

A total of 1204 participants completed a self-reporting questionnaire for inclusion in the study. Of these, we excluded 349 (29.0%) participants on the basis of primary (n=283) and secondary (n=66) laboratory measures. Ultimately, we included 854 participants (mean age, 49.8±10.2years) in the final analysis. The 99th percentiles of cTnI concentrations were 18 (90% confidence interval [CI], 14-35) ng/L for all participants, 20 (90% CI, 15-69) ng/L for males and 19 (90% CI, 11-41) ng/L for females. In both males and females, the median cTnI concentrations were significantly higher in participants aged 50years and older than in those younger than 50years old.

CONCLUSIONS

In this study, the reference population with Korean ethnicity had lower overall and male 99th percentile URLs than other reference populations. Our data suggest that 99th percentile URLs may be influenced by factors such as ethnicity, age distribution of participants, and selection criteria used to define a healthy reference population.

摘要

目的

本研究旨在确定韩国人群中采用高敏检测法检测心肌肌钙蛋白I(cTnI)的第99百分位数上限参考值(URL)浓度。

设计与方法

2014年3月至2015年3月招募了心脏健康的男性和女性。根据实验室检测指标(主要指标:估算肾小球滤过率和糖化血红蛋白;次要指标:B型利钠肽)排除可能存在亚临床疾病的参与者。采用ARCHITECT STAT高敏肌钙蛋白I检测法(美国雅培诊断公司)检测血清cTnI。

结果

共有1204名参与者完成了用于纳入本研究的自我报告问卷。其中,我们根据主要(n = 283)和次要(n = 66)实验室检测指标排除了349名(29.0%)参与者。最终,854名参与者(平均年龄49.8±10.2岁)纳入最终分析。所有参与者cTnI浓度的第99百分位数为18(90%置信区间[CI],14 - 35)ng/L,男性为20(90% CI,15 - 69)ng/L,女性为19(90% CI,11 - 41)ng/L。在男性和女性中,50岁及以上参与者的cTnI浓度中位数均显著高于50岁以下参与者。

结论

在本研究中,韩国种族的参考人群总体和男性第99百分位数URL低于其他参考人群。我们的数据表明,第99百分位数URL可能受到种族、参与者年龄分布以及用于定义健康参考人群的选择标准等因素的影响。

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