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.
Funding source: Key Research and Development Program of Zhejiang Province
Award Identifier / Grant number: 2020C03121
We thank Mark Cleasby, PhD from Liwen Bianji (Edanz) (www.liwenbianji.cn) for editing the language of a draft of this manuscript.
Research funding: This work was supported by the Key Research and Development Program of Zhejiang Province (2020C03121).
Author contributions: CW and YY conceived and designed the study. MF and YZ participated in the physical examination and sample collecting. KY, YZ, and SM contributed to recording the baseline characteristics and sample transportation. DY, YH, and MD participated in the sample analysis and data collection. YY analyzed the data and drafted the manuscript. CW was responsible for supervision and funding acquisition. All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Informed consent: Informed consent was obtained from all individuals included in this study.
Ethical approval: Research involving human subjects complied with all relevant national regulations, institutional policies and is in accordance with the tenets of the Helsinki Declaration (as revised in 2013), and this study was approved by the Clinical Research Ethics Committee of the First Hospital of Zhejiang University School of Medicine (reference number: (2020) IIT (300)).
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