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Test Code Epic LAB839 Testosterone, Total and Bioavailable, Serum

Additional Codes

SQ code TETTB

Mayo code TTBS

Test Down Notes

This test is temporarily unavailable. For additional details, see test announcement here.

Reporting Name

Testosterone, Total and Bioavail, S

Specimen Type

Serum Red

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Recommended second-level test for suspected increases or decreases in physiologically active testosterone:

-Assessment of androgen status in cases with suspected or known sex hormone-binding globulin binding abnormalities

-Assessment of functional circulating testosterone in early pubertal boys and older men

-Assessment of functional circulating testosterone in women with symptoms or signs of hyperandrogenism but normal total testosterone levels

-Monitoring of testosterone therapy or antiandrogen therapy in older men and in females


Ordering Guidance


This is the preferred second-level test for suspected increases or decreases in physiologically active testosterone.



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

0.6 mL

Specimen Stability Information

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

Reference Values

TESTOSTERONE, TOTAL:

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.

 

TESTOSTERONE, BIOAVAILABLE:

Males

≤19 years: Not established

20-29 years: 83-257 ng/dL

30-39 years: 72-235 ng/dL

40-49 years: 61-213 ng/dL

50-59 years: 50-190 ng/dL

60-69 years: 40-168 ng/dL

≥70 years: Not established

 

Females (non-oophorectomized)

≤19 years: not established

20-50 years (on oral estrogen): 0.80-4.0 ng/dL

20-50 years (not on oral estrogen): 0.80-10 ng/dL

>50 years: Not established

Day(s) Performed

Monday through Friday

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.

CPT Code Information

84403

84410

LOINC Code Information

Test ID Test Order Name Order LOINC Value
TTBS Testosterone, Total and Bioavail, S 58716-2

 

Result ID Test Result Name Result LOINC Value
82978 Testosterone, Bioavailable, S 2990-0
8533 Testosterone, Total, S 2986-8

Reject Due To

Gross hemolysis OK
Gross lipemia Reject
Gross icterus OK

Method Name

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

BATS: Differential Precipitation/Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

Profile Information

Test ID Reporting Name Available Separately Always Performed
BATS Testosterone, Bioavailable, S No Yes
TTST Testosterone, Total, S Yes Yes

Method Description

Testosterone, Bioavailable:

The method is based on the differential precipitation of sex hormone-binding globulin (SHBG). SHBG bound testosterone is precipitated in patient sample, leaving the bioavailable testosterone in the supernatant. After addition of (13)C-labeled testosterone internal standard (IS), the bioavailable testosterone and IS are extracted from the supernatant. The bioavailable testosterone and IS are then derivatized and analyzed by liquid chromatography tandem mass spectrometry (LC-MS/MS). Bioavailable testosterone shows a strong correlation to free testosterone by equilibrium dialysis and may be considered a suitable alternative.(Unpublished Mayo method)

 

Testosterone, Total:

Deuterated stable isotope (d3-testosterone) is added to a serum sample as internal standard. Protein is precipitated from the mixture. The testosterone and internal standard are extracted from the resulting supernatant by an online extraction utilizing high-throughput liquid chromatography. This is followed by conventional liquid chromatography and analysis on a tandem mass spectrometer equipped with a heated nebulizer ion source. Epitestosterone does not interfere with this LC-MS/MS method for total testosterone.(Unpublished Mayo method)

Report Available

2 to 5 days

Secondary ID

80065