Department of Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.
National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.
J Clin Lab Anal. 2020 Jan;34(1):e23007. doi: 10.1002/jcla.23007. Epub 2019 Aug 16.
There is no common consensus on how to define the reference population for determination of high-sensitivity cardiac troponin (hs-cTn) upper reference limit (URL). This study aimed to establish 99th percentile URLs of hs-cTnT under both 2018 AACC/IFCC criteria and improved selection criteria for further judging whether two URLs are different.
Applying the stratified cluster sampling protocol, this study took 1848 apparently healthy subjects in communities of Shenyang China as the screening objects. We first followed 2018 AACC/IFCC criteria using surrogate biomarker for diabetes, myocardial dysfunction, renal dysfunction, and electrocardiogram. Then, we followed improved selection criteria to exclude hypertension, overweight and obesity, and dyslipidemia by physical examination and laboratory screening. Accordingly, 99th percentile URLs of hs-cTnT were established.
If the 2018 AACC/IFCC criteria were applied, 99th percentile URLs (90% confidence interval) of hs-cTnT male, female, and total were 19 (17-20) ng/L, 16 (15-17) ng/L, and 18 (16-19) ng/L, respectively. If added a single supplementary selection criteria, 99th percentile URLs of hs-cTnT total reduced to 16 ng/L, 17 ng/L, and 16 ng/L, respectively. If the improved selection criteria were applied, 99th percentile URLs (90% confidence interval) of hs-cTnT male, female, and total were 18 (14-24) ng/L, 13 (11-16) ng/L, and 16 (13-17) ng/L, respectively. The 99th percentile URLs of hs-cTnT male were higher than those of female in every age group.
Improved selection criteria through questionnaire survey, physical examination, and laboratory screening to further exclude hypertension, overweight and obesity, and dyslipidemia can avoid overestimation of the 99th percentile URL of hs-cTnT.
目前对于如何确定高敏心肌肌钙蛋白(hs-cTn)上参考限(URL)的参考人群尚无共识。本研究旨在根据 2018 年 AACC/IFCC 标准和改良的选择标准确定 hs-cTnT 的 99 百分位 URL,并进一步判断两个 URL 是否不同。
应用分层聚类抽样方案,本研究以中国沈阳社区的 1848 名貌似健康的受试者为筛查对象。我们首先根据替代生物标志物(糖尿病、心肌功能障碍、肾功能障碍和心电图)遵循 2018 年 AACC/IFCC 标准。然后,我们通过体检和实验室筛查,根据改良的选择标准排除高血压、超重和肥胖以及血脂异常,从而建立 hs-cTnT 的 99 百分位 URL。
如果应用 2018 年 AACC/IFCC 标准,男性、女性和总 hs-cTnT 的 99 百分位 URL(90%置信区间)分别为 19(17-20)ng/L、16(15-17)ng/L 和 18(16-19)ng/L。如果添加单一补充选择标准,总 hs-cTnT 的 99 百分位 URL 降低至 16 ng/L、17 ng/L 和 16 ng/L。如果应用改良的选择标准,男性、女性和总 hs-cTnT 的 99 百分位 URL(90%置信区间)分别为 18(14-24)ng/L、13(11-16)ng/L 和 16(13-17)ng/L。各年龄段男性 hs-cTnT 的 99 百分位 URL 均高于女性。
通过问卷调查、体检和实验室筛查进一步排除高血压、超重和肥胖以及血脂异常的改良选择标准,可以避免 hs-cTnT 的 99 百分位 URL 过高估计。