Harmonization and standardization for selection of high-trueness estradiol assay kits in serum and evaluation of estradiol levels relative to follicle diameters on trigger days - Report - MDSpire

Harmonization and standardization for selection of high-trueness estradiol assay kits in serum and evaluation of estradiol levels relative to follicle diameters on trigger days

  • By

  • Mengxi Guo

  • Zhengquan Wang

  • Xin Chang

  • Xinxin Ren

  • Manman Zhang

  • Yu Tao

  • Hong Pan

  • Ningling Wang

  • Ying Guo

  • Haixia Ding

  • Yu Xiao

  • Yiling Ke

  • Dandan Wu

  • Xiaojun Chen

  • Li Wang

  • Qing Zhang

  • Qinhua Zhang

  • Wen Li

  • July 13, 2026

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Standardization and Harmonization of Estradiol Assay Kits for Accurate Serum Measurement

Overview

This study evaluates the standardization of estradiol (E2) assays and their correlation with follicle diameters on hCG trigger days. Results indicate that LiCA-E2 demonstrates superior performance and a strong correlation with follicle size.

Background

Accurate measurement of serum estradiol is crucial for monitoring follicle development in assisted reproductive technology (ART). Variability in E2 assay results can impact clinical decisions regarding ovulation triggering and the management of ovarian hyperstimulation syndrome (OHSS). Understanding the relationship between E2 levels and follicle diameters is essential for optimizing treatment strategies in ART.

Data Highlights

AssayMean Percent Difference95% Limits of Agreement
LiCA-E20.1%41.4%
Other Assays−2.3% to 17.4%N/A

Key Findings

  • Before harmonization, mean percent differences from LC-MS ranged from −2.3% to 17.4%.
  • LiCA-E2 demonstrated the best performance in terms of trueness.
  • After harmonization, LiCA maintained a mean percent difference of 0.1%.
  • There was a positive correlation between estimated E2 levels and follicle diameters.
  • LiCA exhibited a Pearson's correlation coefficient of r = 0.8077 with follicle diameters.

Clinical Implications

The findings indicate that using harmonized E2 assays can enhance the accuracy of monitoring follicle development in ART.

Conclusion

Harmonization of E2 assays significantly improves their comparability, with LiCA-E2 showing superior performance and a strong correlation with follicle size.

Related Resources & Content

  1. Frontiers in Endocrinology, 2026 -- Association of Estradiol and Progesterone Levels on Human Chorionic Gonadotropin day with Pregnancy Outcomes in IVF/ICSI Fresh Embryo Transfer
  2. Frontiers in Endocrinology, 2026 -- High serum FSH levels on day 7 of stimulation are negatively associated with oocyte retrieval in GnRH antagonist protocols: real-world evidence from 9,969 IVF cycles in China
  3. The Journal of Clinical Endocrinology & Metabolism, 2025 -- Differential Luteinization Characteristics of Cultured Human Granulosa Cells Derived from Small Antral and Preovulatory Follicles
  4. Frontiers in Endocrinology, 2026 -- The ovulation trigger method affects gonadotropin concentrations and gonadotropin receptor expression during final oocyte maturation in women
  5. Improving performance – HoSt | CSP | CDC
  6. ESHRE guideline: ovarian stimulation for IVF/ICSI: an update in 2025 -- Human Reproduction
  7. Prevention of moderate and severe ovarian hyperstimulation syndrome: a guideline
  8. Improving performance – HoSt | CSP | CDC
  9. ESHRE guideline: ovarian stimulation for IVF/ICSI: an update in 2025‡ | Human Reproduction | Oxford Academic
  10. Prevention of moderate and severe ovarian hyperstimulation syndrome: a guideline

Original Source(s)

Harmonization and standardization for selection of high-trueness estradiol assay kits in serum and evaluation of estradiol levels relative to follicle diameters on trigger days

  • by Mengxi Guo, Zhengquan Wang, Xin Chang, Xinxin Ren, Manman Zhang, Yu Tao, Hong Pan, Ningling Wang, Ying Guo, Haixia Ding, Yu Xiao, Yiling Ke, Dandan Wu, Xiaojun Chen, Li Wang, Qing Zhang, Qinhua Zhang, Wen Li

  • July 13, 2026

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