The validity of androgen assays

Problems in the measurement of androgens and in interpreting results have been reviewed and classified as follows: PREANALYTICAL FACTORS: The exact sampling conditions in relation to circadian and seasonal variations, diet, alcohol, physical activity and posture. PHYSIOLOGICAL AND MEDICAL FACTORS: Androgen levels vary according to the patient's general health, stress, sexual activity and smoking habits. ANALYTICAL VARIABLES: Sample preservation and storage variables are often unknown. The different androgen assays used have widely differing accuracy and precision and are subject to large inter-laboratory variation, which especially in women and children can render the results of routinely available direct immunoassays meaningless. INTERPRETATION OF RESULTS: Laboratory reference ranges vary widely, largely independent of methodology, and fail to take into account the log-normal distribution of androgen values, causing errors in clinical diagnosis and treatment. Other unknowns are antagonists such as SHBG, estrogens, catecholamines, cortisol, and anti-androgens. As well as age, androgen receptor polymorphisms play a major role in regulating androgen levels and resistance to their action. CONCLUSIONS: Though laboratory assays can support a diagnosis of androgen deficiency in men, they should not be used to exclude it. It is suggested that there needs to be greater reliance on the history and clinical features, together with careful evaluation of the symptomatology, and where necessary a therapeutic trial of androgen treatment given.