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Test Code TTST Testosterone, Total, Mass Spectrometry, Serum

Reporting Name

Testosterone, Total, S

Useful For

Evaluating men with symptoms or signs of possible hypogonadism, such as loss of libido, erectile dysfunction, gynecomastia, osteoporosis, or infertility

 

Evaluating boys with delayed or precocious puberty

 

Monitoring testosterone replacement therapy

 

Monitoring antiandrogen therapy (eg, used in prostate cancer, precocious puberty, treatment of idiopathic hirsutism, male-to-female transgender disorders, etc.)

 

Evaluating women with hirsutism, virilization, and oligoamenorrhea

 

Evaluating women with symptoms or signs of possible testosterone deficiency

 

Evaluating infants with ambiguous genitalia or virilization

 

Diagnosing androgen-secreting tumors

Testing Algorithm

For information see Steroid Pathways

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum Red


Necessary Information


Patient's age and sex are required.



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Red top (serum gel/SST are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Specimen Minimum Volume

0.215 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Red Refrigerated (preferred) 14 days
  Frozen  60 days

Special Instructions

Reference Values

Males

0-5 months: 75-400 ng/dL

6 months-9 years: <7-20 ng/dL

10-11 years: <7-130 ng/dL

12-13 years: <7-800 ng/dL

14 years: <7-1,200 ng/dL

15-16 years: 100-1,200 ng/dL

17-18 years: 300-1,200 ng/dL

≥19 years: 240-950 ng/dL

Tanner Stages*

I (prepubertal): <7-20

II: 8-66

III: 26-800

IV: 85-1,200

V (young adult): 300-950

 

Females

0-5 months: 20-80 ng/dL

6 months-9 years: <7-20 ng/dL

10-11 years: <7-44 ng/dL

12-16 years: <7-75 ng/dL

17-18 years: 20-75 ng/dL

≥19 years: 8-60 ng/dL

Tanner Stages*

I (prepubertal): <7-20

II: <7-47

III: 17-75

IV: 20-75

V (young adult): 12-60

 

*Puberty onset (transition from Tanner stage I to Tanner stage II) occurs for boys at a median age of 11.5 (±2) years and for girls at a median age of 10.5 (±2) years. There is evidence that it may occur up to 1 year earlier in obese girls and in African American girls. For boys, there is no definite proven relationship between puberty onset and body weight or ethnic origin. Progression through Tanner stages is variable. Tanner stage V (young adult) should be reached by age 18.

Day(s) Performed

Monday through Saturday

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

LOINC Code Information

Test ID Test Order Name Order LOINC Value
TTST Testosterone, Total, S 2986-8

 

Result ID Test Result Name Result LOINC Value
8533 Testosterone, Total, S 2986-8

Interpretation

In male patients:

Decreased testosterone levels indicate partial or complete hypogonadism. In hypogonadism, serum testosterone levels are usually below the reference range. The cause is either primary or secondary/tertiary (pituitary/hypothalamic) testicular failure.

 

Primary testicular failure is associated with increased luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels, and decreased total, bioavailable, and free testosterone levels. Causes include:

-Genetic causes (eg, Klinefelter syndrome, XXY males)

-Developmental causes (eg, testicular maldescent)

-Testicular trauma or ischemia (eg, testicular torsion, surgical mishap during hernia operations)

-Infections (eg, mumps)

-Autoimmune diseases (eg, autoimmune polyglandular endocrine failure)

-Metabolic disorders (eg, hemochromatosis, liver failure)

-Orchidectomy

 

Secondary/tertiary hypogonadism, also known as hypogonadotrophic hypogonadism, shows low testosterone and low, or inappropriately "normal" LH/FSH levels. Causes include:

-Inherited or developmental disorders of hypothalamus and pituitary (eg, Kallmann syndrome, congenital hypopituitarism)

-Pituitary or hypothalamic tumors

-Hyperprolactinemia of any cause

-Malnutrition

-Excessive exercise

-Cranial irradiation

-Head trauma

-Medical or recreational drugs (eg, estrogens, gonadotropin releasing hormone [GnRH] analogs, cannabis)

 

Increased testosterone levels:

-In prepubertal boys, increased levels of testosterone are seen in precocious puberty. Further workup is necessary to determine the cause of precocious puberty.

-In men, testicular or adrenal tumors or androgen abuse might be suspected if testosterone levels exceed the upper limit of the normal range by more than 50%.

 

Monitoring testosterone replacement therapy:

Aim of treatment is normalization of serum testosterone and LH. When undergoing testosterone replacement therapy, trough levels of serum testosterone should still be within the normal range, while peak levels should not be significantly above the normal young adult range.

 

Monitoring antiandrogen therapy:

Aim is usually to suppress testosterone levels to castrate levels or below. Evidence shows that lowering testosterone levels to less than 20?ng/dL improves patient survival and delays disease progression.

 

In female patients:

Decreased testosterone levels may be observed in primary or secondary ovarian failure, analogous to the situation in men, alongside the more prominent changes in female hormone levels. Most women with oophorectomy have a significant decrease in testosterone levels.

 

Increased testosterone levels may be seen in:

-Congenital adrenal hyperplasia: Non-classical (mild) variants may not present in childhood, but during or after puberty. In addition to testosterone, multiple other androgens or androgen precursors, such as 17-hydroxyprogesterone (OHPG / 17-Hydroxyprogesterone, Serum), are elevated, often to a greater degree than testosterone.

-Prepubertal girls: Analogous to boys, but at lower levels, increased levels of testosterone are seen in precocious puberty.

-Ovarian or adrenal neoplasms: High estrogen values also may be observed and LH and FSH are low or "normal." Testosterone-producing ovarian or adrenal neoplasms often produce total testosterone values above 200 ng/dL.

-Polycystic ovarian syndrome. Hirsutism, acne, menstrual disturbances, insulin resistance and, frequently, obesity form part of this syndrome: Total testosterone levels may be normal or mildly elevated and uncommonly exceed 200 ng/dL.

 

Monitoring testosterone replacement therapy:

The only evidence-based indication for testosterone for women is for hypoactive sexual desire disorder/dysfunction. There are insufficient data for using testosterone for any other symptom/condition or for disease prevention. If it is used, then levels should be kept within the normal range for females at all times. Bioavailable or free testosterone levels should also be monitored to avoid overtreatment.

 

Monitoring antiandrogen therapy:

Antiandrogen therapy is most commonly employed in the management of mild-to-moderate idiopathic female hyperandrogenism, as seen in polycystic ovarian syndrome. Total testosterone levels are a relatively crude guideline for therapy and can be misleading. Therefore, bioavailable or free testosterone should also be monitored to ensure treatment adequacy; see TTFB / Testosterone, Total, Bioavailable, and Free, Serum. However, there are no universally agreed biochemical end points, and the primary treatment end point is the clinical response.

Clinical Reference

1. Manni A, Pardridge WM, Cefalu W, et al: Bioavailability of albumin-bound testosterone. J Clin Endocrinol Metab. 1985;61(4):705-710

2. New MI, Josso N: Disorders of gonadal differentiation and congenital adrenal hyperplasia. Endocrinol Metab Clin North Am 1988;17(2):339-366

3. Dumesic DA: Hyperandrogenic anovulation: A new View of polycystic ovary syndrome. Postgrad Obstet Gynecol. 1995;15(13)

4. Morley JE, Perry HM 3rd. Androgen deficiency in aging men: Role of testosterone replacement therapy. J Lab Clin Med 2000;135(5):370-378

5. Sizonenko PC, Paunier L. Hormonal changes in puberty III: correlation of plasma dehydroepiandrosterone, testosterone, FSH, and LH with stages of puberty and bone age in normal boys and girls and in patients with Addison's disease or hypogonadism or with premature or late adrenarche. J Clin Endocrinol Metab 1975;41(5):894-904

6. Goudas VT, Dumesic DA: Polycystic ovary syndrome. Endocrinol Metab Clin North Am 1997;26(4):893-912

7. Braunstein GD: Androgen insufficiency in women: summary of critical issues. Fertil Steril. 2002 Apr;77 Suppl 4:S94-99

8. Juul A, Skakkebaek NE: Androgens and the aging male. Hum Reprod Update 2002;8(5):423-433

9. Hackbarth JS, Hoyne JB, Grebe SK, Singh RJ. Accuracy of Calculated Free Testosterone Differs between Equations and Depends on Gender and SHBG Concentration. Steroids. 2011;76(1-2):48-55

10. Goldman AL, Bhasin S, Wu FCW, Krishna M, Matsumoto AM, Jasuja R. A Reappraisal of Testosterone's Binding in Circulation: Physiological and Clinical Implications. Endocr Rev. 2017;38(4):302-324. doi:10.1210/er.2017-00025

11. Mulhall JP, Trost LW, Brannigan RE, et al. Evaluation and Management of Testosterone Deficiency: AUA Guideline. J Urol. 2018;200(2):423-432. doi:10.1016/j.juro.2018.03.115

12. Trost L. Update to the Testosterone Guideline. J Urol. 2024;211(4):608-610. doi:10.1097/JU.0000000000003855

13. Al-Sharefi A, Quinton R. Current National and International Guidelines for the Management of Male Hypogonadism: Helping Clinicians to Navigate Variation in Diagnostic Criteria and Treatment Recommendations. Endocrinol Metab (Seoul). 2020;35(3):526-540. doi:10.3803/EnM.2020.760

14. Martin KA, Anderson RR, Chang RJ, et al. Evaluation and Treatment of Hirsutism in Premenopausal Women: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(4):1233-1257.doi:10.1210/jc.2018-00241

15. Crawford ED, Heidenreich A, Lawrentschuk N, et al. Androgen-targeted therapy in men with prostate cancer: evolving practice and future considerations. Prostate Cancer Prostatic Dis. 2019;22(1):24-38. doi:10.1038/s41391-018-0079-0

Report Available

2 to 4 days

Method Name

Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

CPT Code Information

84403

Forms

If not ordering electronically, complete, print, and send a General Request (T239) with the specimen.