Test Details
Methodology
Testosterone: high-pressure liquid chromatography (HPLC)/tandem mass spectrometry; free testosterone: equilibrium dialysis
Result Turnaround Time
6 - 10 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
Free testosterone is the fraction of total testosterone that is not bound to circulating proteins. The free fraction is available to diffuse into target cells to interact with receptors or enzymes. The concentration of free testosterone is low relative to total testosterone, typically <3% of the total testosterone concentration. Total circulating testosterone is bound to sex hormone-binding globulin (SHBG) or albumin. Measurement of total and free testosterone is key in diagnosis of androgen excess or deficiency. Free testosterone is best measured by equilibrium dialysis, while total testosterone is measured by HPLC with tandem mass spectrometry.1-3 Free testosterone is estimated in this profile using these recommended techniques.
Tritiated testosterone is added to the sample and allowed to dialyze across a membrane. Once equilibrium has been achieved, the solutions on both sides of the membrane are sampled to determine the percent free testosterone. Total testosterone is measured by HPLC with tandem mass spectrometry. Serum free testosterone is then calculated by multiplying the percent free testosterone by the total testosterone concentration with unit correction.
Special Instructions
This method is recommended for testing women, children, and hypogonadal men.
Limitations
This method is recommended for testing women, children, and hypogonadal men.
Footnotes
Specimen Requirements
Specimen
Serum, frozen
Volume
2 mL
Minimum Volume
1 mL (Note: This volume does not allow for repeat testing.)
Container
Gel-barrier tube or red-top tube
Collection Instructions
Serum must be separated from cells within 45 minutes of venipuncture. Send serum in a plastic transport tube. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 6 days |
Refrigerated | 7 days |
Frozen | 2.6 years |
Freeze/thaw cycles | Stable x9 |
Reference Range
See tables.
Age | Male (ng/dL) | Female (ng/dL) |
|---|---|---|
Premature Infants | ||
26 to 28 wk, day 4 | 59−125 | 5−16 |
31 to 35 wk, day 4 | 37−198 | 5−22 |
Full-term Infants | ||
Newborns, 1 to 7 m | 75−400 | 20−64 |
Prepubertal Children | ||
1 to 10 y | <2.5−10 | |
1 to 9 y | <2.5-10 | |
Adults | ||
>18 y | 264−916 | |
Premenopausal | 10−55 | |
Postmenopausal | 7−40 | |
Tanner Stage | Male | Female | ||
|---|---|---|---|---|
Age (y) | Testosterone (ng/dL) | Age (y) | Testosterone (ng/dL) | |
I | <9.8 | <2.5−10 | <9.2 | <2.5−10 |
II | 9.8−14.5 | 18−150 | 9.2−13.7 | 7−28 |
III | 10.7−15.4 | 100−320 | 10.0−14.4 | 15−35 |
IV | 11.8−16.2 | 200−620 | 10.7−15.6 | 13−32 |
V | 12.8−17.3 | 350−970 | 11.8−18.6 | 20−38 |
Age | Male | Female | ||
|---|---|---|---|---|
% Free | pg/mL | % Free | pg/mL | |
Full-term Infants | ||||
1 to 15 d | 0.9−1.7 | 1.5−31 | 0.8−1.5 | 0.5−2.5 |
1 to 2 m | 0.4−0.8 | 3.3−18 | 0.4−1.1 | 0.1−1.3 |
3 to 4 m | 0.4−1.1 | 0.7−14 | 0.5−1.0 | 0.3−1.1 |
5 to 6 m | 0.4−1.0 | 0.4−4.8 | 0.5−0.8 | 0.2−0.6 |
Prepubertal Children | ||||
1 to 10 y | 0.4−0.9 | 0.15−0.6 | Same as males | |
Puberty: Comprehensive values for free testosterone by dialysis for both males and females throughout puberty are currently unavailable. | ||||
Male | Female | |||
% Free | pg/mL | % Free | pg/mL | |
Adults | 1.5−3.2 | 52−280 | 0.8−1.4 | 1.1−6.3 |
Storage Instructions
Freeze
Causes for Rejection
EDTA plasma; citrated plasma; hemolysis >5%
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 500726 | Testosterone Free MS/Dialysis | 2991-8 | 500160 | Testosterone, Total | ng/dL | 2986-8 |
| 500726 | Testosterone Free MS/Dialysis | 2991-8 | 500727 | % Free Testosterone (Dialysis) | % | 15432-8 |
| 500726 | Testosterone Free MS/Dialysis | 2991-8 | 500728 | Free Testosterone, Serum | pg/mL | 2991-8 |
| Order Code | 500726 | |||||
| Order Code Name | Testosterone Free MS/Dialysis | |||||
| Order Loinc | 2991-8 | |||||
| Result Code | 500160 | |||||
| Result Code Name | Testosterone, Total | |||||
| UofM | ng/dL | |||||
| Result LOINC | 2986-8 | |||||
| Order Code | 500726 | |||||
| Order Code Name | Testosterone Free MS/Dialysis | |||||
| Order Loinc | 2991-8 | |||||
| Result Code | 500727 | |||||
| Result Code Name | % Free Testosterone (Dialysis) | |||||
| UofM | % | |||||
| Result LOINC | 15432-8 | |||||
| Order Code | 500726 | |||||
| Order Code Name | Testosterone Free MS/Dialysis | |||||
| Order Loinc | 2991-8 | |||||
| Result Code | 500728 | |||||
| Result Code Name | Free Testosterone, Serum | |||||
| UofM | pg/mL | |||||
| Result LOINC | 2991-8 |