Ordering Recommendation

Acceptable test in the evaluation of suspected hyperandrogenemia in women and children. Acceptable test for evaluating androgen deficiency in men.

Mnemonic
BIO T MASS
Methodology

Quantitative High Performance Liquid Chromatography-Tandem Mass Spectrometry/Electrochemiluminescent Immunoassay
The concentrations of free and bioavailable testosterone are derived from mathematical expressions based on constants for the binding of testosterone to albumin and/or sex hormone binding globulin.

Performed

Sun-Sat

Reported

1-4 days

New York DOH Approval Status
This test is New York DOH 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. Transfer 1 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.8 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

EDTA plasma.

Remarks

This test is suggested for women and children due to an improved sensitivity of testosterone by LC-MS/MS.

Stability

After separation from cells: Ambient: 24 hours; Refrigerated: 1 week; Frozen: 6 months

Reference Interval
Test Number
Components
Reference Interval
0099375 Sex Hormone Binding Globulin
Age Male Female
1-30 days
31-364 days
1-3 years
4-6 years
7-9 years
10-12 years
13-15 years
16-17 years
18 years and older
13-85 nmol/L
70-250 nmol/L
50-180 nmol/L
45-175 nmol/L
28-190 nmol/L
23-160 nmol/L
13-140 nmol/L
10-60 nmol/L
11-80 nmol/L
14-60 nmol/L
60-215 nmol/L
60-190 nmol/L
55-170 nmol/L
35-170 nmol/L
17-155 nmol/L
11-120 nmol/L
19-145 nmol/L
30-135 nmol/L
Tanner Stage I
Tanner Stage II
Tanner Stage III
Tanner Stage IV
Tanner Stage V
26-186 nmol/L
22-169 nmol/L
13-104 nmol/L
11-60 nmol/L
11-71 nmol/L
30-173 nmol/L
16-127 nmol/L
12-98 nmol/L
14-151 nmol/L
23-165 nmol/L

  Testosterone LC-MS, Bioavailable
Female - Bioavailable Testosterone, ng/dL
Male - Bioavailable Testosterone, ng/dL
1-6 years: Less than 1.3 ng/dL
7-9 years: 0.3-5.0 ng/dL
10-11 years: 0.4-9.6 ng/dL
12-13 years: 1.7-18.8 ng/dL
14-15 years: 3.0-22.6 ng/dL
16-17 years: 3.3-28.6 ng/dL
18-30 years: 2.2-20.6 ng/dL
31-40 years: 4.1-25.5 ng/dL
41-51 years: 2.8-16.5 ng/dL
Postmenopausal: 1.5-9.4 ng/dL
Tanner Stage I: 0.3-5.5 ng/dL
Tanner Stage II: 1.2-15.0 ng/dL
Tanner Stage III: 3.8-28.0 ng/dL
Tanner Stage IV: 2.8-39.0 ng/dL
Tanner Stage V: 2.5-23.0 ng/dL
1-6 years: Less than 1.3 ng/dL
7-9 years: 0.3-2.8 ng/dL
10-11 years: 0.1-17.9 ng/dL
12-13 years: 1.4-288.0 ng/dL
14-15 years: 9.5-337.0 ng/dL
16-17 years: 35.0-509.0 ng/dL
18 years and older: 130-680 ng/dL
Tanner Stage I: 0.3-13.0 ng/dL
Tanner Stage II: 0.3-59.0 ng/dL
Tanner Stage III: 1.9-296.0 ng/dL
Tanner Stage IV: 40.0-485.0 ng/dL
Tanner Stage V: 124.0-596.0 ng/dL

0081059 Testosterone Free, Females or Children
Female Free Testosterone, pg/mL
Male Free Testosterone, pg/mL
1-6 years: Less than 0.6 pg/mL
7-9 years: 0.6-1.8 pg/mL
10-11 years: 0.1-3.5 pg/mL
12-13 years: 0.9-6.8 pg/mL
14-15 years: 1.2-7.5 pg/mL
16-17 years: 1.2-9.9 pg/mL
18-30 years: 0.8-7.4 pg/mL
31-40 years: 1.3-9.2 pg/mL
41-51 years: 1.1-5.8 pg/mL
Postmenopausal: 0.6-3.8 pg/mL
Tanner Stage I: Less than 2.2 pg/mL
Tanner Stage II: 0.4-4.5 pg/mL
Tanner Stage III: 1.3-7.5 pg mL
Tanner Stage IV: 1.1-15.5 pg/mL
Tanner Stage V: 0.8-9.2 pg/mL
1-6 years: Less than 0.6 pg/mL
7-9 years: 0.1-0.9 pg/mL
10-11 years: 0.1-6.3 pg/mL
12-13 years: 0.5-98.0 pg/mL
14-15 years: 3-138.0 pg/mL
16-17 years: 38.0-173.0 pg/mL
18 years and older: 47-244 pg/mL
Tanner Stage I: Less than or equal to 3.7 pg/mL
Tanner Stage II: 0.3-21 pg/mL
Tanner Stage III: 1.0-98.0 pg mL
Tanner Stage IV: 35.0-169.0 pg/mL
Tanner Stage V: 41.0-239.0 pg/mL

0081058 Testosterone, Females or Children Effective August 19, 2013
Age
Female
Male
Premature (26-28 weeks) 5-16 ng/dL 59-125 ng/dL
Premature (31-35 weeks) 5-22 ng/dL 37-198 ng/dL
Newborn 20-64 ng/dL 75-400 ng/dL
1-5 months Less than 20 ng/dL 14-363 ng/dL
6-24 months Less than 9 ng/dL Less than 37 ng/dL
2-3 years Less than 20 ng/dL Less than 15 ng/dL
4-5 years Less than 30 ng/dL Less than 19 ng/dL
6-7 years Less than 7 ng/dL Less than 13 ng/dL
8-9 years 1-11ng/dL 2-8 ng/dL
10-11 years 3-32 ng/dL 2-165 ng/dL
12-13 years 6-50 ng/dL 3-619 ng/dL
14-15 years 6-52 ng/dL 31-733 ng/dL
16-17 years 9-58 ng/dL 158-826 ng/dL
18-39 years 9-55 ng/dL 300-1080 ng/dL
40-59 years 9-55 ng/dL 300-890 ng/dL
60 years and older 5-32 ng/dL 300-720 ng/dL
Premenopausal (18 years and older) 9-55 ng/dL Does Not Apply
Postmenopausal 5-32 ng/dL Does Not Apply
Tanner Stage I 2-17 ng/dL 2-15 ng/dL
Tanner Stage II 5-40 ng/dL 3-303 ng/dL
Tanner Stage III 10-63 ng/dL 10-851 ng/dL
Tanner Stage IV-V 11-62 ng/dL 162-847 ng/dL

Interpretive Data

The concentrations of free and bioavailable testosterone are derived from mathematical expressions based on constants for the binding of testosterone to albumin and/or sex hormone binding globulin.

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Note
Hotline History
N/A
CPT Codes

84402; 84403; 84270

Components
Component Test Code* Component Chart Name LOINC
0081058 Testosterone, LC-MS/MS 2986-8
0081096 Testosterone, Free LC-MS/MS 2991-8
0081098 Testosterone LC-MS, Bioavailable 2990-0
0099375 Sex Hormone Binding Globulin 13967-5
* 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
Testosterone, Bioavailable and Sex Hormone Binding Globulin (Includes Total Testosterone), Females or Children