Specimen:

Plasma

Collection Medium:

Alternate
Collection Media:

Call laboratory for additional acceptable specimen collection 
containers.

Minimum:

2 mls whole blood in light green top or two 0.6 microtubes

Testing Schedule:

24 hrs/day, 7 days a week, including holidays.

Analytic Time:

2 hours (upon receipt in laboratory)

Reference Range:

Males:         280-800 ng/dL

Females:         6-82 ng/dL

Boys:
  <1 year        12-21 ng/dL
  1-6 years       3-32 ng/dL
  7-12 years      3-68 ng/dL
  13-17 years  28-1110 ng/dL

Comments:

New immunoassay method instituted 3/21/00 at 0900.  Assay should not be 
used in infants under 2 months of age because of positive interference 
in this age group.  Call lab for specific procedure.

Test
Limitations:

The assay is unaffected by icterus (bilirubin is less than 30 mg/dl), 
hemolysis (Hb is less than 1.8 g/dl), lipemia (triglycerides is less 
than 2000 mg/dl) and biotin is less than 30 ng/ml. (criterion: recovery 
within plus or minus 10% of initial value).

In patients receiving therapy with high biotin doses (i.e. is greater 
than 5 mg/day) no sample should be taken until at least 8 hours after 
the last biotin administration.

In vitro tests were performed on 17 commonly used pharmaceuticals. No 
interference with the assay was found.

The risk of interference from potential immunological interactions 
between test components and rare sera has been minimized by the 
inclusion of suitable additives.

In rare cases, interference due to extremely high titers of antibodies 
to ruthenium can occur.

Testosterone contains additives which minimize these effects.

Extremely high titers of antibodies to streptavidin can occur in 
isolated cases and cause interference.

For diagnostic purposes, the testosterone findings should always be 
assessed in conjunction with the patient's medical history, clinical 
examination and other findings.

Methodology:

Electrochemiluminescence Immunoassay

CPT Code:

84403