Department of Laboratory Medicine, Health Promotion Research Institute, Korea Association of Health Promotion, Seoul, Korea.
MEDIcheck LAB, Korea Association of Health Promotion, Cheongju, Korea.
J Clin Lab Anal. 2020 Nov;34(11):e23461. doi: 10.1002/jcla.23461. Epub 2020 Jul 7.
Soluble ST2 (sST2) is known to predict adverse outcomes and death in individuals with established heart failure. However, the role of sST2 testing in the general population has not been established. The aims of this study were to determine the reference interval (RI) and the clinical utility of sST2 in subclinical cardiac dysfunction in general population.
This cross-sectional study consecutively selected 41,806 general subjects at health checkups who underwent echocardiography and sST2 testing at 16 health promotion centers in 13 Korean cities. The reference subjects were obtained among those with normal findings in echocardiography. Sex-specific RIs were established according to the CLSI C28-A3 guidelines. sST2 was measured using immunoassay with the Presage ST2 assay (Critical Diagnostics).
In the general subjects, age, sex, BMI, systolic blood pressure, blood glucose, creatinine, liver function, and triglycerides were associated with the sST2 levels. The RI for sST2 was higher in males (≤49.6 ng/mL, 95% CI = 48.5-51.5) than in females (≤44.5 ng/mL, 95% CI = 43.5-45.6) and higher in subjects aged < 40 years than ≥ 40 years in both sexes. The sST2 levels were 29.1 ± 10.7 (mean ± SD) and 29.1 ± 14.4 ng/mL in the groups with normal cardiac function and subclinical cardiac dysfunction, respectively. The sST2 level was not associated with subclinical cardiac dysfunction (odd ratio = 1.002, P = .13).
RIs obtained from a large and echocardiography-proven healthy community-based sample are presented. Subclinical cardiac dysfunction was associated with older age, male sex, and metabolic factors but not with the sST2 level.
可溶性 ST2(sST2)已被证实可预测心力衰竭患者的不良预后和死亡。然而,sST2 检测在普通人群中的作用尚未确定。本研究旨在确定一般人群亚临床心功能障碍患者的 sST2 参考区间(RI)和临床应用价值。
本横断面研究连续选取了在韩国 13 个城市的 16 个健康促进中心接受超声心动图和 sST2 检测的 41806 名健康体检者。参考人群为超声心动图检查结果正常者。根据 CLSI C28-A3 指南建立了基于性别的 RI。sST2 采用 Presage ST2 检测法(Critical Diagnostics)进行免疫测定。
在一般人群中,年龄、性别、BMI、收缩压、血糖、肌酐、肝功能和甘油三酯与 sST2 水平相关。sST2 的 RI 在男性(≤49.6ng/mL,95%CI=48.5-51.5)中高于女性(≤44.5ng/mL,95%CI=43.5-45.6),且在两性中均小于 40 岁组高于≥40 岁组。心功能正常和亚临床心功能障碍组的 sST2 水平分别为 29.1±10.7(均值±标准差)和 29.1±14.4ng/mL。sST2 水平与亚临床心功能障碍无关(比值比=1.002,P=0.13)。
本研究提供了基于大样本和超声心动图证实的健康社区人群的 RI。亚临床心功能障碍与年龄较大、男性和代谢因素相关,与 sST2 水平无关。