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TESTOSTERONE, FREE and TOTAL, SERUM

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TEST NAME: TESTOSTERONE, FREE and TOTAL, with SHBG, SERUM
Includes: Total Testosterone, Free Testosterone, & SHBG
LAB DEPT: Core Lab Sendouts
 
SPECIMEN REQUIREMENTS
Specimen Type:
 Blood
Container/Tube
 
Preferred:
Gold/Red SST Vacutainer®.
 
Acceptable:
Plain, red-top Vacutainer®.
 
Collection Volume:
4.0 mL (minimum 2.0 mL)
NOTE: Minimum volume does not allow for repeat testing if required
 
Patient Preparation:
None
 
Sample Rejection:
Mislabeled or unlabeled specimens.
 
Special Instructions:
Send to lab promptly
 
LOGISTICS 
Test Availability:
Daily
Turnaround Time:
8-16 days
Test set-up:
Monday-Saturday
Lab Testing Section:
Send-outs
Referred to:
Mayo Medical Laboratories to Esoterix / Test ID: FFTFS
 
INTERPRETIVE
Reference Range:
TESTOSTERONE TOTAL
PREMATURE INFANTS     MALE RANGE(ng/dL)      FEMALE RANGE(ng/dL)
26 – 28 Weeks, Day 4:            59 – 125                              5 – 16
31 – 35 Weeks, Day 4:            37 – 198                              5 – 22
FULL–TERM INFANTS
Newborns:                              75 – 400                              20 – 64
 
Male 1 – 7 Months: Levels decrease rapidly the first week to 20 – 50 ng/dL, then increase to 60 – 400 ng/dL (Mean = 190) between 20 – 60 days. Levels then decline to prepubertal range of < 2.5 – 10 by seven months.
Female 1 – 7 Months: Levels decrease during the first month to <10 ng/dL and remain there until puberty.
 
PREPUBERTAL CHILDREN
Males (1 – 10 Years): < 2.5 – 10
Females (1 – 9 Years): < 2.5 – 10
 
PUBERTY
TANNER
STAGE
AGE
(years)
RANGE
(ng/dL)
MEAN
(ng/dL)
TANNER
STAGE
AGE
(years)
RANGE
(ng/dL)
MEAN
(ng/dL)
MALE
 
 
 
FEMALE
 
 
 
1
<9.8
2.5-10
4.9
1
<9.2
<2.5-10
4.9
2
9.8-14.5
18-150
42
2
9.2-13.7
7-28
18
3
10.7-15.4
100-320
190
3
10.0-14.4
15-35
25
4
11.8-16.2
200-620
372
4
10.7-15.6
13-32
22
5
12.8-17.3
350-970
546
5
11.8-18.6
20-38
28
 
ADULTS >=18 Years       RANGE (ng/dL)
Male:                                  264 – 916
Female:
  Premenopausal:                10 – 55
  Postmenopausal:               7 – 40
 
FREE TESTOSTERONE
MALES:
AGE
(years)
RANGE
(pg/mL)
FEMALES:
AGE
(years)
RANGE
(pg/mL)
 
1 - 15 day
1.5-31
1 - 15 day
0.5-2.5
 
31d - 2 mo
3.3-18
 
31d - 2 mo
0.1-1.3
 
3 - 4 mo
0.7-14
 
3 - 4 mo
0.3-1.1
 
5 - 6 mo
0.4-4.8
 
5 - 6 mo
0.2-0.6
Prepubertal Males and Females: 0.15-0.6 pg/mL
Adult Males:                           52-280 pg/mL
Adult Females:                        1.1-6.3 pg/mL
 
 
PERCENT FREE TESTOSTERONE (by DIALYSIS)
MALES:
AGE
(years)
RANGE
(pg/mL)
FEMALES:
AGE
(years)
RANGE
(pg/mL)
 
1 - 15 day
0.9-1.7
1 - 15 day
0.8-1.5
 
31d - 2 mo
0.4-0.8
 
31d - 2 mo
0.4-1.1
 
3 - 4 mo
0.4-1.1
 
3 - 4 mo
0.5-1.0
 
5 - 6 mo
0.4-1.0
 
5 - 6 mo
0.5-0.8
Prepubertal Males and Females: 0.4-0.9 pg/mL
Adult Males:                           1.5-3.2 pg/mL
Adult Females:                        0.8-1.4 pg/mL
 
Comprehensive values for free testosterone by dialysis throughout puberty are currently unavailable.
 
 
SEX HORMONE BINDING GLOBULIN (SHGB), SERUM*
AGE:                            RANGE (UOM: nmol/L)
1 mo -23 months:                  60.0-252.0
Prepubertal (1-8 yr):              72.0-220.0 
Pubertal
    Males:                                16.0-100.0
    Females:                            36.0-125.0
Adult Males:     
20-49 years:                           16.5-55.9
>49 years:                              19.3-76.4
Adult Females: 
20-49 years:                            24.6-122.0
>49 years:                               17.3-125.0
                                           
*ASR - Analyte Specific Reagent
This test was developed and its performance characteristics determined by Esoterix. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary.
 
Critical Values:
None established
Limitations:
NA
Methodology:
High Pressure Liquid Chromatography (HPLC) Tandem Mass Spectrometry; Equilibrium Dialysis; electrochemiluminescence immunoassay (ECLIA)
Test Classification: This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug administration.
 
ADDITIONAL INFORMATION
For SLCH Laboratory use only
Lab Processing instructions:
Centrifuge specimen to separate within one hour of collection. Transfer specimen to a 5-mL screw-capped plastic transport vial.
 
Processed Volume:
 2.0 mL (minimum 1.0 mL) serum.
 
Transport Temperature:
Frozen
 
Analyte Stability (SERUM):
Ambient (unprocessed): NA
PROCESSED:
Ambient: 48 hours
Refrigerated: 48 hours
Frozen: NA
 
Notes:
1.
Specimen must be separated within 1 hour of collection and removed from gel tube into a plastic vial for transport.
2.
Minimum volume does not allow for repeat analysis if necessary.
 
GENERAL INFORMATION
EPIC order name:
Testosterone, Free  (EPIC Test# LAB173)
Cerner order name:
Testost Free SLC
CPT Codes:
84403: Testost Totl
84402: Testost Free
84270: SHBG
LOINC Value:
Testosterone, Totl; 2986-8
Free Testosterone: 2991-8
Percent Free Testosterone: 15432-8
SHBG: 13967-5
Synonyms:
 
Last Updated: 12/22
Last Reviewed: 12/24

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