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Testosterone, Free, Equilibrium Ultrafiltration With Total Testosterone, LC/MS-MS

CPT 84402; 84403

Test Details

Methodology

Free: equilibrium ultrafiltration; total: liquid chromatography/tandem mass spectrometry (LC/MS-MS)

Result Turnaround Time

4 - 6 days

Related Documents

For more information, please view the literature below.

Frequently Asked Questions: Testosterone by Mass Spectrometry − New Profiles

Use

Evaluate hirsutism and masculinization in women; evaluate testicular function in clinical states in which the testosterone-binding proteins may be altered (obesity, cirrhosis, thyroid disorders)

Special Instructions

State patient's age and sex on the test request form.

Specimen Requirements

Limitations

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

Custom Additional Information

The concentration of free testosterone is very low, typically <2% of the total testosterone concentration. In most men and women, >50% of total circulating testosterone is bound to sex hormone-binding globulin (SHBG) and most of the rest is bound to albumin.1 Routinely available assay methods used to measure total testosterone are not sensitive enough to quantitate accurately the free testosterone fraction directly. Free testosterone is estimated in this profile by an indirect method, equilibrium ultrafiltration. Tritiated testosterone is added to the sample and allowed to come to equilibrium with testosterone in the serum at physiological temperature.2,3 The amount of the added radiolabeled testosterone must be low enough to ensure that the addition will not significantly increase the total testosterone concentration. Once equilibrium is achieved, the free testosterone is separated from the bound testosterone by filtration through a membrane by centrifugal ultrafiltration.4 The radioactivity of the protein-free ultrafiltrate is measured and used to calculate the percent free testosterone. The concentration of free testosterone is then calculated by multiplying the percent free testosterone by the total testosterone concentration.

Specimen

Serum

Volume

2.2 mL

Minimum Volume

1.8 mL (Note: This volume does not allow for repeat testing.)

Container

Red-top tube or gel-barrier tube

Storage Instructions

Room temperature

Causes for Rejection

Hemolyzed sample; icteric sample; gross lipemia; recently administered isotopes; plasma specimen

Collection Instructions

Serum should be transferred from cells within one hour of collection and transferred to a plastic transport tube.

Stability Requirements

Temperature

Period

Room temperature

7 days

Refrigerated

7 days

Frozen

5.58 years

Freeze/thaw cycles

Stable x9

Reference Range

See table.1

Free Testosterone

Age

Male (ng/dL)

Female (ng/dL)

Cord blood

0.50−2.20

0.40−1.60

1 to 15 d

0.15−3.10

0.05−0.25

1 to 2 m

0.33−0.80

0.01−0.13

3 to 5 m

0.07−1.40

0.03−0.11

6 to 7 m

0.04−0.48

0.02−0.06

6 to 9 y

0.01−0.32

0.01−0.09

10 to 11 y

0.06−0.57

0.10−0.52

12 to 14 y

0.14−15.60

0.10−0.52

15 to 17 y

8.00−15.90

0.10−0.52

Adults

5.00−21.00

0.10−0.85

Percentage of Total Testosterone

Age

Male (%)

Female (%)

Cord blood

2.00−4.40

2.00−3.90

1 to 15 d

0.90−1.70

0.80−1.50

1 to 2 m

0.40−0.80

0.40−1.10

3 to 5 m

0.40−1.10

0.50−1.00

6 to 7 m

0.40−1.00

0.50−0.80

6 to 9 y

0.90−1.70

0.90−1.40

10 to 11 y

1.00−1.90

1.00−1.90

12 to 14 y

1.30−3.00

1.00−1.90

15 to 17 y

1.80−2.70

1.00−1.90

Adults

1.50−4.20

0.50−2.80

Footnotes

1. Wheeler MJ. The determination of bioavailable testosterone. Ann Clin Biochem. 1995; 32(Pt 4):345-357 (review). 7486793
2. Klee GG, Heser DW. Techniques to measure testosterone in the elderly. Mayo Clin Proc. 2000; 75(Suppl):S19-S25. 10959211
3. Gronowski AM, Landau-Levine M. Reproductive endocrine function. In: Burtis CA, Ashwood ER, eds. Tietz Textbook of Clinical Chemistry. 3rd ed. Philadelphia, Pa: WB Saunders Co; 1999:1601-1641.
4. Vlahos I, MacMahon W, Sgoutas D. An improved ultrafiltration method for determining free testosterone in serum. Clin Chem. 1982; 28(11):2286-2291. 7127776

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
070038 Testosterone, F Eqlib+T LC/MS 58952-3 070036 Testosterone, Total, LC/MS ng/dL 2986-8
070038 Testosterone, F Eqlib+T LC/MS 58952-3 070039 Testosterone, Free ng/dL 2991-8
070038 Testosterone, F Eqlib+T LC/MS 58952-3 080770 % Free Testosterone % 15432-8
Order Code070038
Order Code NameTestosterone, F Eqlib+T LC/MS
Order Loinc58952-3
Result Code070036
Result Code NameTestosterone, Total, LC/MS
UofMng/dL
Result LOINC2986-8
Order Code070038
Order Code NameTestosterone, F Eqlib+T LC/MS
Order Loinc58952-3
Result Code070039
Result Code NameTestosterone, Free
UofMng/dL
Result LOINC2991-8
Order Code070038
Order Code NameTestosterone, F Eqlib+T LC/MS
Order Loinc58952-3
Result Code080770
Result Code Name% Free Testosterone
UofM%
Result LOINC15432-8