Cai Qinzhen, Liu Mei, Xie Zhen, Wu Mo, Zhao Lun, Tuo Wenbin, Xie Si, Xiang Yun, Sun Hong, Yuan Chunhui, Yao Cong, Wang Jun
Department of Laboratory Medicine, Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Hospital), Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China.
Department of Laboratory Medicine, Wuhan Hankou Hospital, Wuhan, China.
Transl Pediatr. 2024 Jun 30;13(6):908-920. doi: 10.21037/tp-24-98. Epub 2024 Jun 24.
Troponin (Tn) is of an important biomarker for the diagnosis and prognosis of myocardial injury and for evaluating the severity of cardiac involvement due to other systemic diseases in children. Unfortunately, high-sensitivity cardiac troponin I (hs-cTnI) specific reference intervals (RIs) are extremely limited. This study aimed to establish a preliminary pediatric hs-cTnI RI for newborns, children, and adolescents in Wuhan, China.
A total of 1,355 healthy participants (1 day to 19 years) were recruited from a cross-sectional study implemented in Wuhan Children's Hospital from September 2022 to August 2023. Serum hs-cTnI levels were detected via the Mindray automated chemiluminescence immunoassay analyzer (CL-6000i). Specific serum hs-cTnI RIs were established according to the Clinical and Laboratory Standards Institute (CLSI) guidelines. The RIs were defined by the nonparametric median (P50), and 2.5, 97.5 [P50 (P2.5-P97.5)] intervals.
Of the 1,355 pediatric participants, serum hs-cTnI concentrations of 1,332 children were measured. The serum overall P50 and 95% interval range (P2.5-P97.5) of serum hs-cTnI was 0.41 (0.00, 44.31) ng/L. This was higher in males of 0.47 (0.00, 44.90) ng/L than in females of 0.36 (0.00, 44.17) ng/L (P<0.01). Age- and sex-specific differences in hs-cTnI levels were observed. The levels were highly variable in children under 1 year of age (especially in newborns), deriving a P50 (P2.5-P97.5) of 22.06 (1.04, 154.22) ng/L, and gradually narrowed and decreased with increasing age, with a markedly lower established P50 (P2.5-P97.5) of 0.36 (0.00, 2.16) ng/L. However, the levels began to increase slightly at the age of 9-12 years and reached a small peak at the age range of 15 to 18 years in males with 0.71 (0.03, 3.29) ng/L, while females were less affected by puberty. Sex- and age-specific RIs for hs-cTnI were established: 5 age-specific RIs in males, 1 day-1 month: 30.16 (8.67, 171.81) ng/L; >1-12 months: 13.20 (0.63, 61.91) ng/L; >1-15 years: 0.36 (0.00, 1.86) ng/L; >15-18 years: 0.71 (0.03, 3.29) ng/L; >18-19 years: 0.52 (0.00, 1.92) ng/L; and 4 age-specific RIs in females, 1 day-1 month: 43.93 (18.82, 146.38) ng/L; >1-12 months: 5.22 (0.92, 42.54) ng/L; >1-6 years: 0.54 (0.00, 2.74) ng/L; >6-19 years: 0.23 (0.00, 1.56) ng/L.
This study preliminarily established age- and sex-specific serum hs-cTnI RIs using the Mindray CL-6000i system in healthy children in Wuhan, China.
肌钙蛋白（Tn）是诊断和预测心肌损伤以及评估儿童因其他全身性疾病导致心脏受累严重程度的重要生物标志物。遗憾的是，高敏心肌肌钙蛋白I（hs-cTnI）的特定参考区间（RIs）极为有限。本研究旨在为中国武汉的新生儿、儿童和青少年建立初步的儿科hs-cTnI参考区间。
从2022年9月至2023年8月在武汉儿童医院开展的一项横断面研究中招募了1355名健康参与者（年龄从1天至19岁）。通过迈瑞全自动化学发光免疫分析仪（CL-6000i）检测血清hs-cTnI水平。根据临床和实验室标准协会（CLSI）指南建立特定的血清hs-cTnI参考区间。参考区间由非参数中位数（P50）以及2.5、97.5 [P50（P2.5 - P97.5）]区间定义。
在1355名儿科参与者中，测量了1332名儿童的血清hs-cTnI浓度。血清hs-cTnI的总体P50和95%区间范围（P2.5 - P97.5）为0.41（0.00，44.31）ng/L。男性为0.47（0.00，44.90）ng/L，高于女性的0.36（0.00，44.17）ng/L（P<0.01）。观察到hs-cTnI水平存在年龄和性别特异性差异。1岁以下儿童（尤其是新生儿）的水平高度可变；其P50（P2.5 - P97.5）为22.06（1.04，154.22）ng/L，且随着年龄增长逐渐变窄并降低，既定的P50（P2.5 - P97.5）显著降低至0.36（0.00，2.来6）ng/L但在9至12岁时水平开始略有上升，在15至18岁的男性中达到一个小峰值，为0.71（0.03，3.29）ng/L，而女性受青春期影响较小。建立了hs-cTnI的性别和年龄特异性参考区间：男性有5个年龄特异性参考区间，1天至月：30.16（8.67，171.81）ng/L；>1至12个月：13.20（0.63，61.91）ng/L；>1至15岁：0.36（0.00，1.86）ng/L；>15至18岁：0.71（0.03，3.29）ng/L；>18至19岁：0.52（0.00，1.92）ng/L；女性有4个年龄特异性参考区间，1天至1个月：43.93（18.82，146.38）ng/L；>1至12个月：5.22（0.92，42.来54）ng/L；>>1至6岁：0.54（0.00，2.74）ng/L；>6至19岁：0.23（0.00，1.56）ng/L。
本研究使用迈瑞CL-6000i系统在中国武汉的健康儿童中初步建立了年龄和性别特异性血清hs-cTnI参考区间。
