EPIC Code

LAB5500

Performing Lab

UCH Clinical Laboratory – Specials, Toxicology

Collect

One 7mL gold or red top with gel separator (SST)
Minimum volume, 1 mL serum
 

Patient Preparation

Recommend collection before 10:00 am

Pediatric Collection

Minimum volume, 1 mL serum

Unacceptable Conditions

  • Sample not properly identified
  • Incorrect container
  • Sodium citrate
  • Sodium Fluoride/Potassium Oxalate
  • Insufficient sample volume
  • Pooled samples
  • Grossly hemolyzed samples
  • Obvious microbial contamination
  • Heat-inactivated samples
  • Cadaver specimens
  • Other body fluids

 

Storage/Transport Temperature

Internal: Deliver to lab immediately at ambient temperature
Offsite:  Allow to clot for 30 minutes of collection, then centrifuge within 2 hours of collection, transport to lab at 2-8 degrees C. If aliquoting, create two 1mL serum aliquots, transport to lab at 2-8 degrees C.

 

Performed

Monday through Friday

Stability (from collection to initiation)

Whole blood: Ambient, 2 hours
Serum:          Refrigerated (2-8 degrees C), 14 days
                      Frozen (-20 degrees C), 3 months
 

Remarks

Free Testosterone is calculated using the components of this panel that include Total Testosterone LCMS and SHBG direct measurements.

Performed

Monday through Friday

Methodology

Free Testosterone is calculated according to the Vermeulen formula and uses the direct measurements from the Total Testosterone, Quantitative High Performance Liquid Chromatography-Tandem Mass Spectrometry and Sex Hormone Binding Globulin, Chemiluminescent Microparticle Immunosassay (CMIA) tests. 

Reported

2 - 3 days

Synonyms

  • TESTOS MAS
  • LAB8476
  • Testosterone Free

Ordering Recommendations

Most sensitive test for detection of hyperandrogenemia in women and children.  Acceptable test for androgen deficiency in men.

EPIC Code

LAB5500

Reference Interval

Males   Females
Age Free Testo (pg/mL)   Age Free Testo (pg/mL)
1-6 years Less than 0.6   1-6 years Less than 0.6
7-9 years 0.1--0.9   7-9 years 0.6--1.8
10-11 years 0.1--6.3   10-11 years 0.1--3.5
12-13 years 0.5--98.0   12-13 years 0.9--6.8
14-15 years 3.0--138.0   14-15 years 1.2--7.5
16-17 years 38.0--173.0   16-17 years 1.2--9.9
≥18 years 47.0--244.0   18-30 years 0.8--7.4
      31-40 years 1.3--9.2
      41-51 years 1.1--5.8
      >51 years 0.6--3.8

Interpretive Data

Free Testosterone:
 
Free testosterone is calculated with the Vermeulen formula using total testosterone and SHBG concentrations, measured by LCMS and Chemiluminescent Microparticle Immunosassay (CMIA) , respectively.
 
This test was developed and its performance characteristics determined by the UCH Clinical Laboratory.  It has not been cleared or approved by the FDA.  The laboratory is regulated under CLIA as qualified to perform high-complexity testing.  This test is used for clinical purposes.  It should not be regarded as investigational or for research.
 
Tanner Stages (Male):
I:     Less than or equal to 3.7 pg/mL
II:    0.3-21 pg/mL
III:   1.0-98.0 pg/mL
IV:  35.0-169.0 pg/mL
V:   41.0-239.0 pg/mL
 
Tanner Stages (Female):
I:     Less than 2.2 pg/mL
II:    0.4-4.5 pg/mL
III:   1.3-7.5 pg/mL
IV:   1.1-15.5 pg/mL
V:    0.8-9.2 pg/mL
Postmenopausal: 0.6-3.8 pg/mL
 
Reference range not defined for less than 1 year old.
 
Total Testosterone:
Refer to ranges for Testosterone by LCMS (Total) LAB5803
 
SHBG:
Refer to ranges for Sex Hormone Binding Globulin LAB3182
 

CPT Codes

Free Testosterone calculation includes: 
   Total Testosterone by LCMS (LAB5803), CPT 84403
   Sex Hormone Binding Globulin by Immunoassay (LAB3182), CPT 84270
 
Collection

EPIC Code

LAB5500

Performing Lab

UCH Clinical Laboratory – Specials, Toxicology

Collect

One 7mL gold or red top with gel separator (SST)
Minimum volume, 1 mL serum
 

Patient Preparation

Recommend collection before 10:00 am

Pediatric Collection

Minimum volume, 1 mL serum

Unacceptable Conditions

  • Sample not properly identified
  • Incorrect container
  • Sodium citrate
  • Sodium Fluoride/Potassium Oxalate
  • Insufficient sample volume
  • Pooled samples
  • Grossly hemolyzed samples
  • Obvious microbial contamination
  • Heat-inactivated samples
  • Cadaver specimens
  • Other body fluids

 

Storage/Transport Temperature

Internal: Deliver to lab immediately at ambient temperature
Offsite:  Allow to clot for 30 minutes of collection, then centrifuge within 2 hours of collection, transport to lab at 2-8 degrees C. If aliquoting, create two 1mL serum aliquots, transport to lab at 2-8 degrees C.

 

Performed

Monday through Friday

Stability (from collection to initiation)

Whole blood: Ambient, 2 hours
Serum:          Refrigerated (2-8 degrees C), 14 days
                      Frozen (-20 degrees C), 3 months
 

Remarks

Free Testosterone is calculated using the components of this panel that include Total Testosterone LCMS and SHBG direct measurements.
Ordering

Performed

Monday through Friday

Methodology

Free Testosterone is calculated according to the Vermeulen formula and uses the direct measurements from the Total Testosterone, Quantitative High Performance Liquid Chromatography-Tandem Mass Spectrometry and Sex Hormone Binding Globulin, Chemiluminescent Microparticle Immunosassay (CMIA) tests. 

Reported

2 - 3 days

Synonyms

  • TESTOS MAS
  • LAB8476
  • Testosterone Free

Ordering Recommendations

Most sensitive test for detection of hyperandrogenemia in women and children.  Acceptable test for androgen deficiency in men.

EPIC Code

LAB5500
Result Interpretation

Reference Interval

Males   Females
Age Free Testo (pg/mL)   Age Free Testo (pg/mL)
1-6 years Less than 0.6   1-6 years Less than 0.6
7-9 years 0.1--0.9   7-9 years 0.6--1.8
10-11 years 0.1--6.3   10-11 years 0.1--3.5
12-13 years 0.5--98.0   12-13 years 0.9--6.8
14-15 years 3.0--138.0   14-15 years 1.2--7.5
16-17 years 38.0--173.0   16-17 years 1.2--9.9
≥18 years 47.0--244.0   18-30 years 0.8--7.4
      31-40 years 1.3--9.2
      41-51 years 1.1--5.8
      >51 years 0.6--3.8

Interpretive Data

Free Testosterone:
 
Free testosterone is calculated with the Vermeulen formula using total testosterone and SHBG concentrations, measured by LCMS and Chemiluminescent Microparticle Immunosassay (CMIA) , respectively.
 
This test was developed and its performance characteristics determined by the UCH Clinical Laboratory.  It has not been cleared or approved by the FDA.  The laboratory is regulated under CLIA as qualified to perform high-complexity testing.  This test is used for clinical purposes.  It should not be regarded as investigational or for research.
 
Tanner Stages (Male):
I:     Less than or equal to 3.7 pg/mL
II:    0.3-21 pg/mL
III:   1.0-98.0 pg/mL
IV:  35.0-169.0 pg/mL
V:   41.0-239.0 pg/mL
 
Tanner Stages (Female):
I:     Less than 2.2 pg/mL
II:    0.4-4.5 pg/mL
III:   1.3-7.5 pg/mL
IV:   1.1-15.5 pg/mL
V:    0.8-9.2 pg/mL
Postmenopausal: 0.6-3.8 pg/mL
 
Reference range not defined for less than 1 year old.
 
Total Testosterone:
Refer to ranges for Testosterone by LCMS (Total) LAB5803
 
SHBG:
Refer to ranges for Sex Hormone Binding Globulin LAB3182
 
Administrative

CPT Codes

Free Testosterone calculation includes: 
   Total Testosterone by LCMS (LAB5803), CPT 84403
   Sex Hormone Binding Globulin by Immunoassay (LAB3182), CPT 84270
 

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