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Establishing age-specific reference intervals for serum beta-human chorionic gonadotropin using Hoffmann and

Xu Zhu1

  • 1Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing 100730, PR China.

Clinica Chimica Acta; International Journal of Clinical Chemistry
|November 18, 2025
PubMed
Summary

Establishing age-specific reference intervals for serum beta-hCG in women over 45 is crucial. This study provides new reference values to reduce misdiagnosis in perimenopausal and postmenopausal populations.

Keywords:
Hoffmann methodHuman chorionic gonadotropinIndirect methodNonparametric methodReference interval

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Area of Science:

  • Clinical Chemistry
  • Endocrinology
  • Reproductive Medicine

Background:

  • Serum beta-human chorionic gonadotropin (beta-hCG) is a key biomarker for pregnancy and tumor detection.
  • The conventional reference interval (RI) of <5 IU/L is often inadequate for perimenopausal and postmenopausal women due to age-related pituitary secretion.
  • Accurate diagnostics in women aged ≥45 years necessitate age-specific beta-hCG reference values.

Purpose of the Study:

  • To establish age-specific reference intervals (RIs) for serum beta-hCG in women aged 45 years and older.
  • To improve the diagnostic accuracy of beta-hCG testing in perimenopausal and postmenopausal women.
  • To address the limitations of the universal <5 IU/L cutoff in older women.

Main Methods:

  • Retrospective analysis of 17,759 serum beta-hCG records from 2016-2023.
  • Stratification of 5,445 records into age groups: 45-49, 50-54, 55-59, and ≥60 years.
  • Establishment of upper limit RIs using Hoffmann and nonparametric methods, validated by Reference Change Value (RCV) analysis.

Main Results:

  • Median serum beta-hCG levels significantly increased with age, ranging from 0.31 IU/L (45-49 years) to 2.22 IU/L (≥60 years).
  • Age-dependent increases were observed in upper limit RIs.
  • Both Hoffmann and nonparametric methods yielded valid RIs, with narrower confidence intervals for the Hoffmann method.

Conclusions:

  • Age-specific reference intervals for serum beta-hCG are essential for women aged ≥45 years.
  • Utilizing age-specific values enhances diagnostic accuracy and reduces the risk of misdiagnosis in perimenopausal and postmenopausal women.
  • The study underscores the inadequacy of a single reference interval for diverse age groups.