Department of Laboratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, P.R. China.
Department of Pediatrics, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, P.R. China.
Clin Chem Lab Med. 2022 Jul 4;60(9):1416-1425. doi: 10.1515/cclm-2022-0296. Print 2022 Aug 26.
Urinary luteinizing hormone (uLH) and urinary follicle-stimulating hormone (uFSH) have been shown to be useful screening and management tools for children with central precocious puberty. However, studies on uLH and uFSH reference intervals are scarce. Therefore, we aimed to establish reference intervals for uLH and uFSH, according to age, sex, and pubertal status in apparently healthy children aged 6-11 years.
We performed detection capability, precision, accuracy by recovery, linearity, agreement analysis, and stability testing to analyze the method performance of uLH and uFSH. The Clinical Laboratory Standards Institute's C28-A3 criteria was used to establish the reference intervals.
Both uLH and uFSH were stable at 4 °C for 52.6 h and 64.8 days, respectively. The total imprecision of uFSH is within the manufacturer's claim, while the total imprecision of uLH remained within tolerable bias. Both uLH and uFSH could be measured with acceptable detection capability. The recovery rates of the hormones were 87.6-98.8% and 102.8-103.4%, respectively, and therefore within acceptable limits. There were significant correlations between the serum and urine concentrations (LH: r=0.91, p<0.001; FSH: r=0.90, p<0.001). The reference intervals of uLH and uFSH were established according to age, sex, and pubertal status.
We established reference intervals for uLH and uFSH based on age, sex and pubertal status to provide a non-invasive clinical screening tool for precocious puberty in children aged 6-11 years.
尿促黄体生成素（uLH）和尿促卵泡激素（uFSH）已被证明可用于中枢性性早熟儿童的筛查和管理工具。然而，关于 uLH 和 uFSH 参考区间的研究很少。因此，我们旨在根据年龄、性别和青春期状态，为 6-11 岁的健康儿童建立 uLH 和 uFSH 的参考区间。
我们进行了检测能力、精密度、回收率精度、线性、一致性分析和稳定性测试，以分析 uLH 和 uFSH 的方法性能。采用临床实验室标准协会 C28-A3 标准建立参考区间。
uLH 和 uFSH 在 4°C 下分别稳定 52.6 小时和 64.8 天。uFSH 的总不精密度在制造商的要求范围内，而 uLH 的总不精密度仍在可接受的偏差范围内。uLH 和 uFSH 均可测量，具有可接受的检测能力。激素的回收率分别为 87.6-98.8%和 102.8-103.4%，在可接受的范围内。血清和尿液浓度之间存在显著相关性（LH：r=0.91，p<0.001；FSH：r=0.90，p<0.001）。根据年龄、性别和青春期状态建立了 uLH 和 uFSH 的参考区间。
我们根据年龄、性别和青春期状态建立了 uLH 和 uFSH 的参考区间，为 6-11 岁儿童提供了一种非侵入性的性早熟临床筛查工具。
