Testosterone and estradiol assays: current and future trends.

Area of Science:

• Clinical Chemistry
• Endocrinology
• Analytical Chemistry

Background:

• Direct assays for sex steroids on automated analyzers have accuracy and imprecision issues.
• Low-level testosterone and estradiol measurements are particularly problematic in women, children, and hypogonadal males.
• Existing automated systems struggle with routine, accurate measurement of these steroids in diverse populations.

Purpose of the Study:

• To address the limitations of current sex steroid measurement methods.
• To introduce mass spectrometry-based approaches for improved accuracy and precision.
• To establish reliable steroid measurements for all patient demographics.

Main Methods:

• Utilizing gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS).
• Developing higher-order reference method procedures for sex steroid analysis.
• Focusing on improving sensitivity for low-end steroid detection.

Main Results:

• Mass spectrometry-based methods demonstrate promise for accurate and precise testosterone and estradiol measurement.
• These methods are effective across all patient populations, including women and children.
• Established as higher-order reference methods, they address low-end sensitivity issues.

Conclusions:

• Mass spectrometry offers a superior approach to sex steroid measurement compared to traditional direct assays.
• These methods will enable appropriate standardization and the availability of reliable reference materials.
• Inter-laboratory and inter-method result interchangeability will be achieved, improving clinical diagnostics.