Highlights
- •Despite the advances in steroid hormone assessment, T measurements vary substantially within and across laboratories.
- •Universally accepted age- and sex-matched reference intervals for testosterone are still lacking.
- •Standardization of testosterone testing among current commercial assays should aim to improve performance at lower concentrations of testosterone.
Abstract
Measurement of serum testosterone (T) level is of utmost importance for the evaluation
of hypogonadism in men and androgen excess in women. Despite the advances in steroid
hormone assessment, substantial variability exists regarding measurement of T concentrations.
Several factors affect T measurement in men, including circadian rhythms, intra-individual
daily variability and transient stressors, while T concentrations in women vary mainly
according to the phase of the menstrual cycle. Most of the available immunoassays
lack the required accuracy when dealing with T concentrations at the lower end of
the normal range for men and across the entire range for females. Consequently, there
is no universally accepted lower T threshold for healthy adult men and most immunoassays
fail to detect states of mild androgen excess in women. Mass spectrometry is considered
the gold-standard method for T measurement; however, due to its complexity and cost,
it has not been widely adopted. To increase accuracy, T in men should be measured
with a fasting morning sample and repeated if the level is found to be low; in women,
measurement must be performed at the follicular phase of the cycle. In both cases,
borderline results may be clarified by the assessment of free testosterone (fT). Since
most fT assays are unreliable, calculated surrogates should be used instead. Collaborative
efforts have been undertaken, with rigorous internal and external quality controls
and the establishment of reference methods, to harmonise the commercial assays.
Keywords
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Article info
Publication history
Published online: April 03, 2019
Accepted:
April 2,
2019
Received in revised form:
March 31,
2019
Received:
January 11,
2019
Identification
Copyright
© 2019 Elsevier B.V. All rights reserved.
