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Test Code TESTO Testosterone, Total

Additional Codes

Epic: LAB124

Specimen Required

Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 3.0 mL
Collection Instructions: Centrifuge and separate cells after clot formation and within 4 hours of collection.  Remove serum if testing will be delayed more than 8 hours.

Specimen Minimum Volume

0.10 mL

Specimen Stability

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

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.
 

Reference Range

Males (adult): 241 - 827 ng/dL

Females (adult): 14 - 76 ng/dL

Rejection Due To

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

Day(s) and Time(s) Performed

Daily

Report Available

Same day

Method Name

Chemiluminescent Microparticle Immunoassay (CMIA)

LOINC

2986-8

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.