Assays of Serum Testosterone

Area of Science:

• Endocrinology
• Clinical Chemistry

Background:

• Male hypogonadism diagnosis relies on clinical signs and serum testosterone levels.
• Current testosterone assays include immunoassays and mass spectrometry, with ongoing advancements in accuracy and precision.

Purpose of the Study:

• To highlight the limitations in current testosterone assay comparability.
• To address the absence of a gold standard assay for total testosterone measurement.

Main Methods:

• Review of current clinical laboratory testosterone assay platforms.
• Analysis of assay performance at the lower and upper extremes of the testosterone range.

Main Results:

• Significant advances have improved testosterone assay accuracy and precision.
• Limited comparability exists between different testosterone assay platforms, particularly at extreme concentration ranges.

Conclusions:

• The lack of assay comparability prevents the establishment of a universal gold standard for total testosterone assessment.
• Further development is needed to ensure consistent and comparable testosterone measurements across all platforms.