Specimen:

Plasma

Collection Medium:

Alternate
Collection Media:

Call laboratory for additional acceptable specimen collection 
containers.

Minimum:

2 ml in light green top tube or two 0.6 microtubes

Testing Schedule:

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

Analytic Time:

3 hours (upon receipt in laboratory)

Reference Range:

FEMALES - menstrating:
  Follicular phase        3.5 - 12.5 mIU/ml
  Ovulation phase         4.7 - 21.5 mIU/ml
  Luteal phase            1.7 - 7.7 mIU/ml
  Postmenopause          25.8 - 134.8 mIU/ml
MALES:                    1.5 - 12.4 mIU/ml

    AGE            MALE            FEMALE
1 - 3 years   0.2-1.5 mIU/mL   1.2-5.7 mIU/mL
4 - 8 years   0.5-1.6 mIU/mL   0.8-3.0 mIU/mL
Tanner I      0.7-3.1 mIU/mL   0.5-5.1 mIU/mL
Tanner II     1.1-6.9 mIU/mL   2.4-8.7 mIU/mL
Tanner III    1.8-6.2 mIU/mL   3.8-8.1 mIU/mL
Tanner IV     1.8-4.8 mIU/mL   1.1-9.6 mIU/mL
Tanner V      1.4-6.8 mIU/mL   2.0-7.6 mIU/mL

Comments:

New immunoassay method instituted 3/21/00 at 0900.

Test
Limitations:

The assay is unaffected by icterus (bilirubin is less than 64 mg/dl), 
hemolysis (Hb is less than 1,000 gg/dl), lipemia (Intralipid is less 
than 1900 mg/dl) and biotin is less than 60 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.

No interference was observed from rheumatoid factors up to a 
concentration of 2250U/ml.

No high dose hook effect at FSH concentrations of up to 2000 mIU/ml.

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

As with all tests containing monoclonal antibodies, erroneous findings 
may be obtained from samples taken from patients who have been treated 
with monoclonal mouse antibodies or who have received them for 
diagnostic purposes.

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

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

Methodology:

Electrochemiluminescence Immunoassay

CPT Code:

83001