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First morning voided urinary gonadotropins in children: verification of method performance and establishment of reference intervals

  • Yifan Yao ORCID logo , Shunfeng Mao , Ke Yuan , Minfei He ORCID logo , Minya Dong , Yandi Huang , Donglei Yang , Xiaoyan Zhang , Chen Peng , Yilin Zhu and Chunlin Wang EMAIL logo
Published/Copyright: July 4, 2022
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 60 Issue 9

Abstract

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.

Keywords: follicle-stimulating hormone; luteinizing hormone; precocious puberty; reference interval
Corresponding author: Chunlin Wang, MD, Department of Pediatrics, The First Affiliated Hospital, Zhejiang University School of Medicine, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, P.R. China, Phone: +86-571-87233319, Fax: +86-571-87233319, E-mail:

Funding source: Key Research and Development Program of Zhejiang Province

Award Identifier / Grant number: 2020C03121

Acknowledgments

We thank Mark Cleasby, PhD from Liwen Bianji (Edanz) (www.liwenbianji.cn) for editing the language of a draft of this manuscript.

  1. Research funding: This work was supported by the Key Research and Development Program of Zhejiang Province (2020C03121).

  2. 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.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. 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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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-0296).

Received: 2022-03-27
Accepted: 2022-06-19
Published Online: 2022-07-04
Published in Print: 2022-08-26

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2022-0296
Keywords for this article
follicle-stimulating hormone; luteinizing hormone; precocious puberty; reference interval

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. Clinical Chemistry and Laboratory Medicine: enjoying the present and assessing the future
  4. Rethinking internal quality control: the time is now
  5. Review
  6. Multi-omics analysis from archival neonatal dried blood spots: limitations and opportunities
  7. Opinion Papers
  8. ‘Penelope test’: a practical instrument for checking appropriateness of laboratory tests
  9. Interference by macroprolactin in assays for prolactin: will the In Vitro Diagnostics Regulation lead to a solution at last?
  10. EFLM Paper
  11. Efficiency, efficacy and subjective user satisfaction of alternative laboratory report formats. An investigation on behalf of the Working Group for Postanalytical Phase (WG-POST), of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)
  12. General Clinical Chemistry and Laboratory Medicine
  13. Cross-reactivity in assays for prolactin and optimum screening policy for macroprolactinaemia
  14. Repository of intra- and inter-run variations of quantitative autoantibody assays: a European multicenter study
  15. Stability of direct renin concentration and plasma renin activity in EDTA whole blood and plasma at ambient and refrigerated temperatures from 0 to 72 hours
  16. Comparison of four different immunoassays and a rapid isotope-dilution liquid chromatography-tandem mass spectrometry assay for serum folate
  17. Analytical quality specifications in semen analysis according to the state of the current methodologies
  18. Reference Values and Biological Variations
  19. Short-term biological variation study of plasma hemophilia and thrombophilia parameters in a population of apparently healthy Caucasian adults
  20. First morning voided urinary gonadotropins in children: verification of method performance and establishment of reference intervals
  21. Derivation of sex and age-specific reference intervals for clinical chemistry analytes in healthy Ghanaian adults
  22. Cancer Diagnostics
  23. Serum free light chain analysis: persisting limitations with new kids on the block
  24. Cardiovascular Diseases
  25. Age partitioned and continuous upper reference limits for Ortho VITROS High Sensitivity Troponin I in a healthy paediatric cohort
  26. The predictive value of hemoglobin to creatinine ratio for contrast-induced nephropathy in percutaneous coronary interventions
  27. Infectious Diseases
  28. Health technology assessment to employ COVID-19 serological tests as companion diagnostics in the vaccination campaign against SARS-CoV-2
  29. Evaluation of a laboratory-based high-throughput SARS-CoV-2 antigen assay
  30. Presepsin levels in neonatal cord blood are not influenced by maternal SARS-CoV-2 infection
  31. Letters to the Editors
  32. How to evaluate fixed clinical QC limits vs. risk-based SQC strategies
  33. Reply to Westgard et al.: ‘Keep your eyes wide … as the present now will later be past’*
  34. Platelet phagocytosis by monocytes
  35. Early detection of Candida parapsilosis in peripheral blood as a result of a peripheral blood smear performed after cytographic changes on the Beckman Coulter UniCel DxH 800 hematology
  36. Pseudo-erythroblastosis on Sysmex XN hematology analyzers: a clue to Candida sepsis. Case report and literature review
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  38. Comparison of Sebia Capillarys 3-OCTA with the Tosoh Bioscience HLC®-723G8 method for A1C testing with focus on analytical interferences and variant detection
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