Testosterone, Total

Test Code
TESTO


Alias/See Also
Epic: LAB124


Preferred Specimen

Specimen Type: Serum
Collection ContainerSerum gel

Specimen Volume: 3 mL




Minimum Volume

0.10 mL




Other Acceptable Specimens

Specimen Type: Plasma
Collection ContainerGreen top (Lithium heparin)




Instructions
Centrifuge and separate cells after clot formation and within 4 hours of collection.  Remove the serum from the clot or separator gel as soon as possible after complete clot formation.


Transport Container
Plastic vial


Specimen Stability

Room temperature: 8 hours
Refrigerated (on gel): 8 hours
Refrigerated (off gel): 7 days
Frozen: 7 days




Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Samples stored on gel >8 hours, unlabeled, mislabeled, wrong tube type, hemolyzed, QNS, exceeds specimen stability requirements.




Methodology

Chemiluminescent Microparticle Immunoassay (CMIA)



Setup Schedule

Daily




Report Available

Same day




Limitations

If the Testosterone results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.
Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (HAMA). Such specimens may show either falsely elevated or depressed values when tested with assay kits that employ mouse monoclonal antibodies. Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays. Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed. Additional information may be required for diagnosis. 

 




Reference Range
Males (adult): 241 - 827 ng/dL
Females (adult): 14 - 76 ng/dL



Clinical Significance
The Architect 2nd Generation Testosterone assay is a chemiluminescent microparticle immunoassay for the quantitative determination of testosterone in human serum and plasma.  Testosterone measurements are used in the diagnosis and treatment of disorders involving the male sex hormones, including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism and virilization due to tumors, polycystic ovaries, and andrenogenital syndromes.
The 2nd Generation Testosterone assay releases testosterone from binding proteins and measures total testosterone.  Free testosterone can be calculated from the total testosterone, sex hormone-binding globulin (SHBG) and albumin concentrations.
The concentration of testosterone fluctuates over 24 hours.  The pulsatile release of LH in the night typically leads to a peak of testosterone concentration in the morning.  Time of day, age, sex, puberty, pre- and post-menopause, and disease, all have an influence on testosterone concentration and should be considered in interpreting individual results.



Performing Laboratory

Inova Laboratories

2832 Juniper Street

Fairfax, VA 22031




Last Updated: April 12, 2023
Last Review: N. Wolford, March 9, 2023


The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.