BlueCross BlueShield of Tennessee Medical Policy Manual

Testosterone Testing (total, free)

DESCRIPTION

Testosterone is an androgenic hormone. It is responsible for the development of the male external genitalia and secondary sexual characteristics. Male hypogonadism is a condition in which the body doesn't produce enough testosterone. Primary hypogonadism originates from testicular failure. Secondary hypogonadism originates in the hypothalamus or the pituitary gland; either type may be congenital or acquired, or both.

Testosterone circulates in the plasma as free (2-3%), bound to specific plasma proteins (sex hormone-binding globulin, SHBG) (98%) and bioactive or weakly bound to nonspecific proteins such as albumin. Measurement of the serum total testosterone concentration is usually an accurate reflection of testosterone secretion and is the initial test of choice. Measurement of the serum free testosterone concentration is necessary to determine if a low total testosterone is due to low sex hormone-binding globulin (SHBG) or to reduced testosterone production. Typically the testing is done as a fasting early morning lab, repeated the next day or within a week to confirm and then if testosterone therapy should be initiated checked once every 3-12 months.

In females, testosterones main role is as an estrogen precursor. In both genders, it also exerts anabolic effects and influences behavior. Women with polycystic ovary syndrome or androgen secreting tumors may have symptoms of hyperandrogenism based upon either clinical or biochemical signs. Measuring free testosterone instead of or in addition to total testosterone, is the most sensitive test to establish the presence of hyperandrogenemia.

Note: This medical policy does NOT address Gender Reassignment Services.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

2018 Guidelines from the Endocrine Society indicate testosterone (T) testing should be measured with a fasting morning total testosterone concentration initially. Because of day-to-day variations, repeat to confirmation a low total T level (30% of men with an initial low-T concentration have a normal T on repeat measurement). A free testosterone test should be obtained in individuals if the total T is near the lower limit of normal or who have a condition that alters sex hormone–binding globulin.

The lower limit of the normal total T harmonized to the CDC standard in healthy nonobese young men is 264 ng/dL (9.2 nmol/L); this limit could be used for total T assays that are CDC certified. However, the reference range may vary depending on the assay and reference population used. A harmonized reference range for free T has not been established.

The Mayo Clinic (www.mayomedicallaboratories.com) offers the following reference values:

 

Total testosterone ng/dL

Free testosterone ng/dL

men (>19 years)

240-950

5.25-20.7

women (> 20 years)

8-60

0.06-1.08

 

SOURCES

American Association of Clinical Endocrinologists (2002) Medical guidelines for clinical practice for the evaluation and treatment of hypogonadism in adult male patients. Endocrine Practice, 8, (9), 440-456.

American Urological Association. (2010) A consensus statement: toward excellence in testosterone testing. Journal of Clinical Endocrinology & Metabolism, 95 (10), 4542-4548. 

Anawalt, B., Hotaling, J., Walsh, T., and Matsumoto, A. (2012, April) Performance of total testosterone measurement to predict free testosterone for the biochemical evaluation of male hypogonadism. Journal of Urology, 187 (4), 1369-73. Abstract retrieved July 16, 2018 from PubMed database.

Antonio, L., Wu, F., O’Neill, T., Pye, S., Ahern, T., Laurent, M., et al. (2016, July) Low free testosterone is associated with hypogonadal signs and symptoms in men with normal total testosterone. Journal of Endocrinology & Metabolism, 101 (7), 2647-2657. (Level 2 evidence)

Blue Cross Blue Shield Association. Medical Policy Reference Manual. (7:2017) Testosterone Replacement Therapies (5.02.23) Retrieved July 16, 2018 from BlueWeb. (49 articles and/or guidelines reviewed)

Canadian Medical Association. (2015, December) Diagnosis and management of testosterone deficiency syndrome in men: clinical practice guideline. Canadian Medical Association Journal, 187 (18), 1369-1377.

Center for Disease Control. Laboratory Procedure Manual. (2012) Total testosterone in serum. Retrieved July 16, 2018 from www.cdc.com.

Endocrine Society / European Society of Endocrinology. (2018, May) Testosterone therapy in men with hypogonadism: an endocrine society* clinical practice guideline. Journal of Clinical Endocrinology & Metabolism, 103(5), 1715-1744.

Endocrine Society. (2013, December) Diagnosis and treatment of polycystic ovary syndrome: an endocrine society* clinical practice guideline. Journal of Clinical Endocrinology & Metabolism, 98 (12), 4565-4592.

Mayo Clinic. May Medical Laboratories. (2018, July) Test ID: TTFB testosterone, total, bioavailable, and free, serum. Retrieved July 16, 2018 from www.mayomedicallaboratories.com. 

Office on Women’s Health. (2016, January) A fact sheet on: polycystic ovary syndrome (PCOS). Retrieved July 16, 2018 from www.womenshealth.gov.

Shea, J., Wong, P., and Chen, Y. (2014) Free testosterone: clinical utility and important analytical aspects of measurement. Advanced Clinical Chemistry, (63), 59-84. Abstract retrieved July 16, 2018 from PubMed database.

Surampudi, P., Wang, C., and Swerdloff, R. (2012) Hypogonadism in the aging male diagnosis, potential benefits, and risks of testosterone replacement therapy. International Journal of Endocrinology, Article ID 625434, 20 pages.  (Level 2 evidence)

Travison, T., Vesper, H., Orwoll, E., Wu, F.,  Kaufman, J., Wang, Y., et al. (2017, April) Harmonized reference ranges for circulating testosterone levels in men of four cohort studies in the united states and Europe. Journal of Endocrinology & Metabolism, 102 (4), 1161-1173. (Level 2 evidence)

ORIGINAL EFFECTIVE DATE:  12/30/2018

MOST RECENT REVIEW DATE:  12/30/2018  

ID_BT

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