Analytical and physiological factors affecting the interpretation of serum testosterone concentration in men

Ann Clin Biochem 2006;43:3-12
© 2006 Association for Clinical Biochemistry


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MJ Diver

Department of Clinical Biochemistry & Metabolic Medicine, Royal Liverpool University Hospital, Prescot Street, Liverpool L7 8XP, UK

Most hospital laboratories estimate the concentration of totalcirculating testosterone using a non-extraction method on anautomated multi-channel immunoassay analyser supplied by a smallnumber of multi-national diagnostic companies. Although theseplatforms offer advantages of quick turnaround times, smallvolume sampling and random access analysis, proficiency testingschemes suggest the quality of results produced remains similarto that of the early manual radioimmunoassay. An estimate ofthe bioavailable, non-sex hormone binding globulin (SHBG) boundfraction of circulating testosterone, be that the free or thefree plus albumin-bound, may be a better index of gonadal statusthan total testosterone alone, especially when a borderlinehypogonadal level of total testosterone is found, and may avoidmisclassification of hypogonadal or eugonadal men. Free or bioavailabletestosterone may be calculated or measured. The free androgenindex may not give a true reflection of androgen status in men.In the interpretation of serum testosterone concentrations withresults >40 nmol/L, the possibility of exogenous administrationor abuse needs to be considered. The marked diurnal rhythm intotal testosterone should also be taken into account. Theremay be a diminution of testosterone secretion with advancingage, but the great majority of older men have a circulatingtotal testosterone concentration well within the accepted referenceintervals established for younger men. As testosterone concentrationmay fluctuate markedly both seasonally and from day to day,it may be judicious to measure levels on more than one occasion.

Provided that estimates of serum testosterone are unequivocallyeugonadal (12.5-40 nmol/L) or hypogonadal (<7.0 nmol/L),results produced by routine automated immunoassays will in allprobability give a satisfactory assessment of androgen statusin men.

Routine biochemical assessment of gonadal function in men shouldinclude measurement of early morning luteininzing hormone, folliclestimulating hormone, prolactin and SHBG together with totaltestosterone, and if necessary some estimate of bioactive testosterone.

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