Ordering Recommendation

Laboratory reference method for the direct measurement of free testosterone. Not recommended when low concentrations of free testosterone, such as those found in children and cisgender females, are expected. For these individuals, the preferred test is Testosterone, Free and Total, Includes Sex Hormone-Binding Globulin (Adult Females, Children, or Individuals on Testosterone-Suppressing Hormone Therapy) (0081056). Calculated free testosterone is generally adequate for most evaluations of hypogonadism; refer to Testosterone, Free and Total, Includes Sex Hormone-Binding Globulin (Adult Males or Individuals on Testosterone Hormone Therapy) (0070109).

To compare this test to other testosterone tests, refer to the ARUP Testosterone Tests Comparison table.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation

Collect between 6-10 a.m.

Collect

Serum separator tube or green (sodium or lithium heparin).

Specimen Preparation

Separate serum or plasma from cells ASAP or within 2 hours of collection. Transport 1 mL serum or plasma. (Min: 0.4 mL)

Storage/Transport Temperature

Frozen.

Unacceptable Conditions

EDTA plasma.

Remarks
Stability

After separation from cells: Ambient: 24 hours; Refrigerated: 1 week; Frozen: 2 months

Methodology

Quantitative Equilibrium Dialysis/High Performance Liquid Chromatography-Tandem Mass Spectrometry

Performed

Sun, Wed-Sat

Reported

1-6 days

Reference Interval

Test Number
Components
Reference Interval
  Testosterone, Free by Dialysis 18 years and older (Male): 47-244 pg/mL
  Testosterone, Total by Mass Spec
Age Male (ng/dL) Female (ng/dL)
18-39 years 300-1080 Not Applicable
40-59 years 300-890 Not Applicable
60 years and older 300-720 Not Applicable

Interpretive Data

This laboratory reference method for the direct measurement of free testosterone is not recommended when low testosterone concentrations, such as those found in children and cisgender females, are expected. For these individuals, the preferred test is Testosterone, Free and Total, Includes Sex Hormone-Binding Globulin (Adult Females, Children, or Individuals on Testosterone-Suppressing Hormone Therapy) (ARUP test code 0081056).

For individuals on testosterone hormone therapy, refer to cisgender male reference intervals. No reference intervals have been established for males younger than 18 years or for cisgender females. For a complete set of all established reference intervals, refer to ltd.aruplab.com/Tests/Pub/2004246.

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Category

Laboratory Developed Test (LDT)

Note

Hotline History

N/A

CPT Codes

84402; 84403

Components

Component Test Code* Component Chart Name LOINC
2003247 Testosterone, Free by Dialysis 2991-8
2004245 Testosterone, Total by Mass Spec 2986-8
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • Direct dialysis (Testosterone Free & Total by ED/LC-MS/MS (Free) and LC-MS/MS (Total), Adult Males)
  • Total and Free (Testosterone Free & Total by ED/LC-MS/MS (Free) and LC-MS/MS (Total), Adult Males)
Testosterone, Free and Total, by Dialysis and Mass Spectrometry (Adult Males or Individuals on Testosterone Hormone Therapy)