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Published on: October 13, 2018
First morning voided urinary gonadotropins in children: verification of method performance and establishment of
Yifan Yao1, Shunfeng Mao2, Ke Yuan3
1Department of Laboratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, P.R. China.
Insights
This study establishes reference intervals for urinary luteinizing hormone (uLH) and urinary follicle-stimulating hormone (uFSH) in children aged 6-11 years. These findings provide a valuable non-invasive tool for screening and managing central precocious puberty.
Area of Science:
- Pediatric Endocrinology
- Clinical Chemistry
- Reproductive Biology
Background:
- Urinary luteinizing hormone (uLH) and urinary follicle-stimulating hormone (uFSH) are crucial for diagnosing central precocious puberty.
- Establishing reliable reference intervals for these urinary hormones is essential for accurate clinical application.
- Existing studies on uLH and uFSH reference intervals in children are limited.
Purpose of the Study:
- To establish age-, sex-, and pubertal status-specific reference intervals for uLH and uFSH.
- To validate the analytical performance of uLH and uFSH assays for clinical use.
- To provide a non-invasive screening tool for central precocious puberty in children.
Main Methods:
- Assessed method performance including detection capability, precision, accuracy, linearity, and stability for uLH and uFSH.
- Utilized Clinical Laboratory Standards Institute's C28-A3 criteria to establish reference intervals.
- Correlated urinary hormone concentrations with serum levels to ensure validity.
Main Results:
- Both uLH and uFSH demonstrated acceptable stability and measurement performance.
- Recovery rates for uLH and uFSH were within acceptable limits (87.6-98.8% and 102.8-103.4%).
- Significant correlations were observed between serum and urinary hormone concentrations (LH: r=0.91, FSH: r=0.90).
Conclusions:
- Reference intervals for uLH and uFSH were successfully established based on age, sex, and pubertal status.
- These established intervals offer a non-invasive method for the clinical screening of precocious puberty in children aged 6-11 years.
- The findings support the utility of uLH and uFSH as valuable diagnostic tools in pediatric endocrinology.
Objectives:
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.
Methods:
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.
Results:
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.
Conclusions:
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.
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