Ordering Recommendation

Use this immunoassay to evaluate hypogonadism in cisgender males and to monitor testosterone hormone therapies. Not recommended when low testosterone concentrations, such as those found in children and cisgender females, are expected. For these individuals, testing by mass spectrometry is recommended; refer to Testosterone (Adult Females, Children, or Individuals on Testosterone-Suppressing Hormone Therapy) (0081058). Free or bioavailable testosterone measurements may provide supportive information.

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 specimen between 6-10 a.m.

Collect

Serum Separator Tube (SST) or Green (Lithium Heparin). Also acceptable: Lavender (K2 EDTA) or Lavender (K3 EDTA).
Pooled Specimens: Collect three samples, 20 minutes apart.

Specimen Preparation

Allow serum specimen to clot completely at room temperature. Separate serum or plasma from cells ASAP or within 2 hours of collection. Transfer 1 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.5 mL)

Pooled Specimens: Spin and pool equal amounts of serum or plasma. Transfer 1 mL of pooled specimen into an ARUP Standard Transport Tube. (Min: 0.5 mL)

Storage/Transport Temperature

Refrigerated. Also acceptable: Frozen.

Unacceptable Conditions
Remarks
Stability

After separation from cells: Ambient: 5 days; Refrigerated: 2 weeks; Frozen: 6 months

Methodology

Quantitative Electrochemiluminescent Immunoassay (ECLIA)

Performed

Sun-Sat

Reported

Within 24 hours

Reference Interval

Test Number
Components
Reference Interval
  Testosterone by Immunoassay
Age Male (ng/dL)
14-15 years 33-585
16-17 years 185-886
18-39 years 300-1080
40-59 years 300-890
60 years and older 300-720
Tanner Stage IV 165-854
Tanner Stage V 194-783

Interpretive Data

Testosterone immunoassays are both imprecise and inaccurate at low testosterone concentrations, such as those found in children and cisgender females. For these individuals, testing by mass spectrometry is recommended; refer to Testosterone (Adult Females, Children, or Individuals on Testosterone-Suppressing Hormone Therapy) (ARUP test code 0081058). Free or bioavailable testosterone measurements may provide supportive information.

For individuals on testosterone hormone therapy, refer to cisgender male reference intervals. No reference intervals have been established for males younger than 14 years or for cisgender females. For a complete set of all established reference intervals, refer to ltd.aruplab.com/Tests/Pub/0070130.

Compliance Category

FDA

Note

Hotline History

N/A

CPT Codes

84403

Components

Component Test Code* Component Chart Name LOINC
0070130 Testosterone by Immunoassay 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

  • male testosterone
  • serum total testosterone
  • total testosterone serum
Testosterone (Adult Males or Individuals on Testosterone Hormone Therapy)