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Challenges in Measuring AMH in the Clinical Setting
Hang Wun Raymond Li1, David Mark Robertson2, Chris Burns3
1Department of Obstetrics and Gynaecology, The University of Hong Kong, Queen Mary Hospital, Pokfulam, Hong Kong.
Frontiers in Endocrinology
|June 10, 2021
Summary
Serum anti-Mullerian hormone (AMH) is vital for assessing infertility and ovarian reserve. Current AMH tests lack standardization, prompting the development of a new international reference preparation for improved accuracy in clinical diagnostics.
Area of Science:
- Reproductive endocrinology
- Clinical biochemistry
- Assay standardization
Background:
- Serum anti-Mullerian hormone (AMH) is a key biomarker for functional ovarian reserve, crucial in infertility assessment and treatment.
- AMH guides gonadotropin dosing for in vitro fertilization and assesses ovarian damage from cytotoxic therapies.
- Its utility extends to predicting menopause onset and diagnosing polycystic ovary syndrome.
Purpose of the Study:
- To address the lack of a standardized international reference preparation for anti-Mullerian hormone (AMH) immunoassays.
- To evaluate the commutability of a proposed human AMH reference preparation (code 16/190) across different assay platforms.
- To propose the development of a second-generation reference preparation for improved AMH assay standardization.
Main Methods:
- Comparison of 21 commercially available anti-Mullerian hormone (AMH) immunoassay platforms/methods.
- Investigation of a purified human AMH preparation (code 16/190) as a potential international reference standard.
- Assessment of commutability between the reference preparation and patient serum samples across various immunoassay methods.
Main Results:
- Random-access immunoassay platforms demonstrated the highest reliability among the tested AMH assays.
- The World Health Organization's investigated human AMH preparation (16/190) showed partial success, with commutability observed in some, but not all, immunoassay methods.
- Significant variability exists in AMH assay calibration due to the absence of a common international reference preparation.
Conclusions:
- Standardization of anti-Mullerian hormone (AMH) immunoassays is critical for accurate clinical interpretation of ovarian reserve and related conditions.
- The current human AMH preparation (16/190) has limitations in achieving universal commutability across all assay platforms.
- Development of a novel, second-generation reference preparation is necessary to ensure consistent and reliable AMH measurements globally.
