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.
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.


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.
Carruthers
Malcolm
M
Centre for Men's Health, London, UK. carruthers@centreformenshealth.co.uk
Trinick
Tom R
TR
Wheeler
Michael J
MJ
D000328:Adult; D000368:Aged; D000728:Androgens / Q000032:analysis* / Q000172:deficiency*; D003955:Diagnostic Tests, Routine / Q000379:methods* / Q000592:standards; D005006:Ethnicity; D015438:Health Behavior; D006801:Humans; D007118:Immunoassay; D008297:Male; D008875:Middle Aged; D006113:United Kingdom
D000728:Androgens
Clin Chem. 2004 Nov;50(11):2101-10
15375014
Clin Chem Lab Med. 2004 Apr;42(4):435-9
15147155
Aging Male. 2005 Sep-Dec;8(3-4):157-61
16390739
Aging Male. 2006 Sep;9(3):165-9
17050116
Fertil Steril. 1998 Feb;69(2):286-92
9496343
J Clin Endocrinol Metab. 2007 Feb;92(2):405-13
17090633
Aging Male. 2002 Sep;5(3):170-6
12471777
J Clin Endocrinol Metab. 1996 May;81(5):1821-6
8626841
J Clin Endocrinol Metab. 2001 May;86(5):1981-5
11344195
Int J Androl. 2003 Jun;26(3):187-94
12755998
J Sex Med. 2006 Nov;3(6):1085-9
17100942
Alcohol Clin Exp Res. 1996 Jun;20(4):711-6
8800389
Alcohol Clin Exp Res. 2003 Apr;27(4):682-5
12711931
Clin Biochem. 2005 Mar;38(3):253-61
15708548
J Steroid Biochem Mol Biol. 1993 Apr;45(4):325-6
8499341
Diabetes Care. 2004 May;27(5):1036-41
15111517
Lancet. 1973 May 5;1(7810):967-8
4121588
Lancet. 1970 Jul 11;1(7663):62-7
4193358
J Clin Endocrinol Metab. 2004 Feb;89(2):534-43
14764758
Clin Endocrinol (Oxf). 2003 Jun;58(6):710-7
12780747
Biol Psychiatry. 2001 Sep 1;50(5):371-6
11543741
Psychoneuroendocrinology. 2004 Nov;29(10):1229-40
15288702
Int J Androl. 2003 Apr;26(2):76-83
12641825
Aging Male. 2006 Jun;9(2):111-22
16916746
Clin Chem. 2003 Aug;49(8):1250-1
12881438
Clin Chem. 2003 Aug;49(8):1381-95
12881456
Br Med Bull. 1951;7(4):307-11
14879029
Clin Chem. 2005 Aug;51(8):1472-9
15961553
Eur J Clin Invest. 2005 Sep;35(9):565-72
16128863
Ann Clin Biochem. 2006 Nov;43(Pt 6):481-7
17132279
Med J Aust. 2000 Mar 6;172(5):220-4
10776394
J Clin Endocrinol Metab. 1994 Nov;79(5):1310-6
7962322
J Clin Endocrinol Metab. 1999 Oct;84(10):3666-72
10523012
Eur J Appl Physiol. 2005 Jan;93(4):375-80
15618989
Aging Male. 2006 Dec;9(4):207-13
17178556
Clin Endocrinol (Oxf). 2003 Mar;58(3):262-6
12608929
J Clin Endocrinol Metab. 2003 Jul;88(7):3099-104
12843149
Trends Endocrinol Metab. 2003 Aug;14(6):289-96
12890594
J Clin Endocrinol Metab. 2002 Feb;87(2):589-98
11836290
JAMA. 2004 Sep 22;292(12):1431-2
15383512
Fertil Steril. 2002 Apr;77(4):660-5
11937111
J Clin Endocrinol Metab. 2005 Nov;90(11):5928-36
16118337
Am J Cardiovasc Drugs. 2005;5(3):141-54
15901202
Arch Intern Med. 2006 Aug 14-28;166(15):1660-5
16908801