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Test Code TESTOST MS Testosterone, Total, Serum

Reporting Name

Testosterone, Total, S

Useful For

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

 

Evaluation of 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.)

 

Evaluation of women with hirsutism, virilization, and oligoamenorrhea

 

Evaluation of women with symptoms or signs of possible testosterone deficiency

 

Evaluation of infants with ambiguous genitalia or virilization

 

Diagnosis of androgen-secreting tumors


Specimen Required


Container/Tube: 

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 1 mL

Additional Information: Patient's age and sex are required.


Seattle Children's Hospital Note:

Collect 2.0 mL whole blood in a Red top.

Specimen Type

Serum

Specimen Minimum Volume

0.215 mL

Specimen Stability Information

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

Day(s) and Time(s) Performed

Monday through Saturday; Continuous until 2 p.m.

Performing Laboratory

Mayo Medical Laboratories in Rochester

Method Name

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

Portions of this test are covered by patent(s) held by Quest Diagnostics

Method Description

Deuterated stable isotope (d3-testosterone) is added to a 0.2 mL serum sample as internal standard. Protein is precipitated from the mixture by the addition of acetonitrile. The testosterone and internal standard are extracted from the resulting supernatant by an online extraction utilizing high-throughput liquid chromatography (HTLC). This is followed by conventional liquid chromatography and analysis on a tandem mass spectrometer equipped with a heated nebulizer ion source.(Wang C, Catlin DH, Demers LM, et al: Measurement of total testosterone in adult men: comparison of current laboratory methods versus liquid chromatography-tandem mass spectrometry. J Clin Endocrinol Metab 2004;89:534-543; Taieb J, Mathian B, Millot F, et al: Testosterone measured by 10 immunoassays and by isotope-dilution gas chromatography-mass spectrometry in Sera from 116 men, women, and children. Clin Chem 2003;49:1381-1395)

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.

Test Classification

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

CPT Code Information

84403

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

Reject Due To

Hemolysis

Mild OK; Gross OK

Lipemia

Mild OK; Gross OK

Icterus

Mild OK; Gross OK

Other

NA

Testing Algorithm

See Steroid Pathways in Special Instructions

Special Instructions

Forms

If not ordering electronically, complete, print, and send a General Request Form (T239) with the specimen (http://www.mayomedicallaboratories.com/it-mmfiles/general-request-form.pdf).