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 Category

Laboratory Developed Test (LDT)

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