The validity of androgen assays

Area of Science:

• Endocrinology
• Clinical Chemistry
• Laboratory Medicine

Background:

• Androgen levels are influenced by numerous physiological and lifestyle factors.
• Significant variability exists in androgen assay accuracy, precision, and inter-laboratory results.
• Reference ranges often do not account for the natural distribution of androgen values.

Purpose of the Study:

• To review and classify problems in androgen measurement and result interpretation.
• To highlight the limitations of current laboratory assays for androgens.
• To emphasize the importance of clinical assessment in diagnosing androgen-related conditions.

Main Methods:

• Review of pre-analytical factors affecting androgen levels (circadian, seasonal, diet, activity, posture).
• Analysis of analytical variables including sample handling and assay methodologies.
• Evaluation of factors influencing interpretation, such as antagonists and genetic polymorphisms.

Main Results:

• Pre-analytical conditions and patient factors significantly impact androgen levels.
• Assay inaccuracies and inter-laboratory variations can render results unreliable, especially in women and children.
• Laboratory reference ranges are often inadequate for accurate diagnosis.

Conclusions:

• Laboratory androgen assays should not be the sole basis for excluding androgen deficiency in men.
• Clinical history, symptoms, and therapeutic trials are essential for diagnosis.
• Improved diagnostic strategies are needed, integrating clinical judgment with laboratory data.